WorldWideScience

Sample records for reviewing safety analysis

  1. Periodic safety review of the HTR-10 safety analysis

    International Nuclear Information System (INIS)

    Chen Fubing; Zheng Yanhua; Shi Lei; Li Fu

    2015-01-01

    Designed by the Institute of Nuclear and New Energy Technology (INET) of Tsinghua University, the 10 MW High Temperature Gas-cooled Reactor-Test Module (HTR-10) is the first modular High Temperature Gas-cooled Reactor (HTGR) in China. According to the nuclear safety regulations of China, the periodic safety review (PSR) of the HTR-10 was initiated by INET after approved by the National Nuclear Safety Administration (NNSA) of China. Safety analysis of the HTR-10 is one of the key safety factors of the PSR. In this paper, the main contents in the review of safety analysis are summarized; meanwhile, the internal evaluation on the review results is presented by INET. (authors)

  2. IAEA Review for Gap Analysis of Safety Analysis Capability

    International Nuclear Information System (INIS)

    Basic, Ivica; Kim, Manwoong; Huges, Peter; Lim, B-K; D'Auria, Francesco; Louis, Vidard Michael

    2014-01-01

    improvement of nuclear safety in the participating host organization and host member countries. To achieve this goal, the EM is to establish a process of discussion and comparison of gap findings, which will lead to sharing of information, experience, strengths and weaknesses among the participants, and foster regional cooperation to improve the weaknesses and improve safety generally. The pilot mission was conducted from 28 October to 1 November for one week at the National Nuclear Agency (BATAN) in Indonesia by the mission team formulated with 6 international experts who have considerable knowledge and experience in the field of safety analysis such as the deterministic safety analysis (DSA) and probabilistic safety analysis (PSA). Some comments and recommendations were given to BATAN management to support the establishment and maintenance of safety analysis capability and human resource, organizational and training aspects. Those aspects are important as a measure of the progress being made and an indicator of areas in SATG within the framework of the Extra-budgetary Programme on the Safety of Nuclear Installations in Southeast Asia, the Pacific, and Far East Countries (the EBP-Asia) or other cooperation programme, such as the IAEA Technical Cooperation programme. Provided in 2013 the Review of Gap Analysis for BATAN (Indonesian Nuclear Safety Regulatory Body) could be good reference for all other newcomer countries which started or plans nuclear power plant installation. (authors)

  3. Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

    Energy Technology Data Exchange (ETDEWEB)

    DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

    2007-04-12

    This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

  4. Management implementation plan for a safety analysis and review system

    International Nuclear Information System (INIS)

    Hulburt, D.A.; Berkey, B.D.

    1981-04-01

    The US Department of Energy has issued an Order, DOE 5481.1, which establishes uniform requirements for the preparation and review of Safety Analysis for DOE Operations. The Management Implementation Plan specified herein establishes the administrative procedures and technical requirements for implementing DOE 5481.1 to Operations under the cognizance of the Pittsburgh Energy Technology Center. This Implementation Plan is applicable to all present and future Operations under the cognizance of PETC. The Plan identifies those Operations for which DOE 5481.1 is applicable and those Operations for which no further analysis is required because the initial determination and review has concluded that DOE 5481.1 does not apply

  5. Safety evaluation review of the prototype license application safety analysis report

    International Nuclear Information System (INIS)

    1991-08-01

    The US Nuclear Regulatory Commission (NRC) staff and consultants reviewed a Prototype License Application Safety Analysis Report (PLASAR) submitted by the US Department of Energy (DOE) for the belowground vault (BGV) alternative method of low-level radioactive waste disposal. In Volume 1 of NUREG-1375, the NRC staff provided the safety review results for an earth-mounded concrete bunker PLASAR. In the current report, the staff focused its review on the design, construction, and operational aspects of the BGV PLASAR. The staff developed review comments and questions using the Standard Review Plan (SRP), Rev. 1 (NUREG-1200) as the basis for evaluating the acceptability of the information provided in the BGV PLASAR. The detailed review comments provided in this report are intended to be useful guidance to facility developers and State regulators in addressing issues likely to be encountered in the review of a license application for a low-level-waste disposal facility. 44 refs

  6. Review of design criteria and safety analysis of safety class electric building for fuel test loop

    Energy Technology Data Exchange (ETDEWEB)

    Kim, J. Y.

    1998-02-01

    Steady state fuel test loop will be equipped in HANARO to obtain the development and betterment of advanced fuel and materials through the irradiation tests. HANARO fuel test loop was designed for CANDU and PWR fuel testing. Safety related system of Fuel Test Loop such as emergency cooling water system, component cooling water system, safety ventilation system, high energy line break mitigation system and remote control room was required 1E class electric supply to meet the safety operation in accordance with related code. Therefore, FTL electric building was designed to construction and install the related equipment based on seismic category I. The objective of this study is to review the design criteria and analysis the safety function of safety class electric building for fuel test loop, and this results will become guidance for the irradiation testing in future. (author). 10 refs., 6 tabs., 30 figs.

  7. Standard Review Plan for the review of safety analysis reports for nuclear power plants: LWR edition

    International Nuclear Information System (INIS)

    1987-06-01

    The Standard Review Plan (SRP) is prepared for the guidance of staff reviewers in the Office of Nuclear Reactor Regulation in performing safety reviews of applications to construct or operate nuclear power plants. The principal purpose of the SRP is to assure the quality and uniformity of staff reviews and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. It is also a purpose of the SRP to make information about regulatory matters widely available and to improve communication and understanding of the staff review process by interested members of the public and the nuclear power industry. The safety review is primarily based on the information provided by an applicant in a Safety Analysis Report (SAR). The SAR must be sufficiently detailed to permit the staff to determine whether the plant can be built and operated without undue risk to the health and safety of the public. The SAR is the principal document in which the applicant provides the information needed to understand the basis upon which this conclusion has been reached. The individual SRP sections address, in detail, who performs the review, the matters that are reviewed, the basis for review, how the review is accomplished, and the conclusions that are sought. The safety review is performed by 25 primary branches. One of the objectives of the SRP is to assign the review responsibilities to the various branches and to define the sometimes complex interfaces between them. Each SRP section identifies the branch that has the primary review responsibility for that section. In some review areas the primary branch may require support, and the branches that are assigned these secondary review responsibilities are also identified for each SRP section

  8. 49 CFR 209.501 - Review of rail transportation safety and security route analysis.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Review of rail transportation safety and security....820 § 209.501 Review of rail transportation safety and security route analysis. (a) Review of route... establish that the route chosen by the carrier poses the least overall safety and security risk, the...

  9. SKI - ASAR - O3. As operated Safety Analysis Report. Recurring safety review 1996 Oskarshamn 3

    International Nuclear Information System (INIS)

    1997-12-01

    According to Swedish law, the reactor owner is responsible for performing a safety review and writing a ''ASAR''-report. The Nuclear Power Inspectorate (SKI) examines this report, and reports the findings to the government (the ''SKI-ASAR'' report). Each Swedish reactor should pass through three full ASAR reviews during its life-time, similar to the licensing inspection before start-up of the reactor. The first series ASAR was delivered by OKG to SKI in December 1996, and forms the basis for the SKI analysis in the present report

  10. SKI - ASAR - F3. As operated Safety Analysis Report. Recurring safety review 1996 Forsmark 3

    International Nuclear Information System (INIS)

    1997-12-01

    According to Swedish law, the reactor owner is responsible for performing a safety review and writing a ''ASAR''-report. The Nuclear Power Inspectorate (SKI) examines this report, and reports the findings to the government (the ''SKI-ASAR'' report). Each Swedish reactor should pass through three full ASAR reviews during its life-time, similar to the licensing inspection before start-up of the reactor. The first series ASAR was delivered by FKA to SKI in December 1996, and forms the basis for the SKI analysis in the present report

  11. SKI - ASAR - R1. As operated Safety Analysis Report. Recurring safety review 1995 Ringhals 1

    International Nuclear Information System (INIS)

    2000-01-01

    According to Swedish law, the reactor owner is responsible for performing a safety review and writing a so called ASAR-report. The Nuclear Power Inspectorate (SKI) examines this report, and reports the findings to the government (the so called SKI-ASAR-report). Each Swedish reactor should pass through three full ASAR reviews during its lifetime, similar to the licensing inspection before start-up of the reactor. The second series ASAR was delivered by the Ringhals utility to SKI in September 1995, and forms the basis for the SKI analysis in the present report

  12. Safety analysis and review system: a Department of Energy safety assurance tool

    International Nuclear Information System (INIS)

    Rosenthal, H.B.

    1981-01-01

    The concept of the Safety Analysis and Review System is not new. It has been used within the Department and its predecessor agencies, Atomic Energy Commission (AEC) and Energy Research and Development Administration (ERDA), for over 20 years. To minimize the risks from nuclear reactor and power plants, the AEC developed a process to support management authorization of each operation through identification and analysis of potential hazards and the measures taken to control them. As the agency evolved from AEC through ERDA to the Department of Energy, its responsibilities were broadened to cover a diversity of technologies, including those associated with the development of fossil, solar, and geothermal energy. Because the safety analysis process had proved effective in a technology of high potential hazard, the Department investigated the applicability of the process to the other technologies. This paper describes the system and discusses how it is implemented within the Department

  13. Standard review plan for reviewing safety analysis reports for dry metallic spent fuel storage casks

    International Nuclear Information System (INIS)

    1988-01-01

    The Cask Standard Review Plan (CSRP) has been prepared as guidance to be used in the review of Cask Safety Analysis Reports (CSARs) for storage packages. The principal purpose of the CSRP is to assure the quality and uniformity of storage cask reviews and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. The CSRP also sets forth solutions and approaches determined to be acceptable in the past by the NRC staff in dealing with a specific safety issue or safety-related design area. These solutions and approaches are presented in this form so that reviewers can take consistent and well-understood positions as the same safety issues arise in future cases. An applicant submitting a CSAR does not have to follow the solutions or approaches presented in the CSRP. However, applicants should recognize that the NRC staff has spent substantial time and effort in reviewing and developing their positions for the issues. A corresponding amount of time and effort will probably be required to review and accept new or different solutions and approaches

  14. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    International Nuclear Information System (INIS)

    Herborn, D.I.

    1991-10-01

    The requirements for Westinghouse Hanford independent review of the Preliminary Safety Analysis Report (PSAR) are contained in Section 1.0, Subsection 4.3 of WCH-CM-4-46. Specifically, this manual requires the following: (1) Formal functional reviews of the HWVP PSAR by the future operating organization (HWVP Operations), and the independent review organizations (HWVP and Environmental Safety Assurance, Environmental Assurance, and Quality Assurance); and (2) Review and approval of the HWVP PSAR by the Tank Waste Disposal (TWD) Subcouncil of the Safety and Environmental Advisory Council (SEAC), which provides independent advice to the Westinghouse Hanford President and executives on matters of safety and environmental protection. 7 refs

  15. Lift truck safety review

    International Nuclear Information System (INIS)

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter's Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given

  16. Lift truck safety review

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

  17. 78 FR 4477 - Review of Safety Analysis Reports for Nuclear Power Plants, Introduction

    Science.gov (United States)

    2013-01-22

    ... Analysis Reports for Nuclear Power Plants: LWR Edition.'' The new subsection is the Standard Review Plan... Nuclear Power Plants: Integral Pressurized Water Reactor (iPWR) Edition.'' DATES: Comments must be filed... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Review of Safety Analysis Reports for Nuclear Power...

  18. Safety review advisor

    International Nuclear Information System (INIS)

    Boshers, J.A.; Uhrig, R.E.; Alguindigue, I.A.; Burnett, C.G.

    1991-01-01

    The University of Tennessee's Nuclear Engineering department, in cooperation with the Tennessee Valley Authority (TVA), is evaluating the feasibility of utilizing an expert system to aid in 10CFR50.59 evaluations. This paper discusses the history of 10CFR50.59 reviews, and details the development approach used in the construction of a prototype Safety Review Advisor (SRA). The goals for this expert system prototype are to aid the engineer in the evaluation process by directing his attention to the appropriate critical issues, increase the efficiency, consistency, and thoroughness of the evaluation process, and provide a foundation of appropriate Safety Analysis Report (SAR) references for the reviewer

  19. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    International Nuclear Information System (INIS)

    Herborn, D.I.

    1993-11-01

    Westinghouse Hanford Company (WHC) is the Integrating Contractor for the Hanford Waste Vitrification Plant (HWVP) Project, and as such is responsible for preparation of the HWVP Preliminary Safety Analysis Report (PSAR). The HWVP PSAR was prepared pursuant to the requirements for safety analyses contained in US Department of Energy (DOE) Orders 4700.1, Project Management System (DOE 1987); 5480.5, Safety of Nuclear Facilities (DOE 1986a); 5481.lB, Safety Analysis and Review System (DOE 1986b) which was superseded by DOE order 5480-23, Nuclear Safety Analysis Reports, for nuclear facilities effective April 30, 1992 (DOE 1992); and 6430.lA, General Design Criteria (DOE 1989). The WHC procedures that, in large part, implement these DOE requirements are contained in WHC-CM-4-46, Nonreactor Facility Safety Analysis Manual. This manual describes the overall WHC safety analysis process in terms of requirements for safety analyses, responsibilities of the various contributing organizations, and required reviews and approvals

  20. Standard Review Plan for the review of safety analysis reports for nuclear power plants, Revision No. 7 to Section 9

    International Nuclear Information System (INIS)

    1978-03-01

    Revision No. 1 to Section 9 of the Standard Review Plan incorporates changes that have been developed since the original issuance in September 1975, many of which are editorial in nature, to reflect current staff practice in the review of safety analysis reports for nuclear power plants

  1. Guide for reviewing safety analysis reports for packaging: Review of quality assurance requirements

    International Nuclear Information System (INIS)

    Moon, D.W.

    1988-10-01

    This review section describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging which are important to safety. The design effort, operation's plans, and quality assurance requirements should be integrated to achieve a system in which the independent QA program is not overly stringent and the application of QA requirements is commensurate with safety significance. The reviewer must verify that the applicant's QA section in the SARP contains package-specific QA information required by DOE Orders and federal regulations that demonstrate compliance. 8 refs

  2. Packaging review guide for reviewing safety analysis reports for packagings: Revision 0

    International Nuclear Information System (INIS)

    Fischer, L.E.; Chou, C.K.; Lloyd, W.R.; Mount, M.E.; Nelson, T.A.; Schwartz, M.W.; Witte, M.C.

    1987-09-01

    The Department of Energy (DOE) has established procedures for obtaining certification of packagings used by DOE and its contractors for the transport of radioactive materials. These certification review policies and procedures are established to ensure that DOE packaging designs and operations meet safety criteria at least equivalent to the standards prescribed by the Nuclear Regulatory Commission (NRC) certification process for packaging. The Packaging Review Guide (PRG) is not a DOE order, but has been prepared as guidance for the Packaging Certification Staff (PCS) under the Certifying Official, Office of Security Evaluations, or designated representatives. The principal purpose of the PRG is to assure the quality and uniformity of PCS reviews, and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. The PRG also sets forth solutions and approaches determined to be acceptable in the past by the PCS in dealing with a specific safety issue or safety-related design area. These solutions and approaches are presented in this form so that reviewers can take consistent and well-understood positions as the same safety issues arise in future cases. An applicant submitting a SARP does not have to follow the solutions or approaches presented in the PRG. However, applicants should recognize that the PCS has spent substantial time and effort in reviewing and developing their positions for the issues. A corresponding amount of time and effort will probably be required to review and accept new or different solutions and approaches. Finally, it is also a purpose of the PRG to make information about DOE certification policy and procedures widely available to DOE field offices, DOE contractors, federal agencies, and interested members of the public. 7 refs., 15 figs., 14 tabs

  3. Safety review advisor

    International Nuclear Information System (INIS)

    Boshers, J.A.; Alguindigue, I.E.; Uhrig, R.E.

    1989-01-01

    The University of Tennessee's Nuclear Engineering Department, in cooperation with the Tennessee Valley Authority (TVA), is evaluating the feasibility of utilizing an expert system to aid in 10CFR50.59 evaluations. This paper discusses the history of 10CFR50.59 reviews, and details the development approach used in the construction of a prototype Safety Review Advisor (SRA). The goals for this expert system prototype are to (1) aid the engineer in the evaluation process by directing his attention to the appropriate critical issues, (2) increase the efficiency, consistency, and thoroughness of the evaluation process, and (3) provide a foundation of appropriate Safety Analysis Report (SAR) references for the reviewer. 6 refs., 2 figs

  4. ITER final design report, cost review and safety analysis (FDR) and relevant documents

    International Nuclear Information System (INIS)

    1999-01-01

    This volume contains the fourth major milestone report and documents associated with its acceptance, review and approval. This ITER Final Design Report, Cost Review and Safety Analysis was presented to the ITER Council at its 13th meeting in February 1998 and was approved at its extraordinary meeting on 25 June 1998. The contents include an outline of the ITER objectives, the ITER parameters and design overview as well as operating scenarios and plasma performance. Furthermore, design features, safety and environmental characteristics and schedule and cost estimates are given

  5. SKI - ASAR - B1/B2 As operated Safety Analysis Report. Recurring safety review 1995 Barsebaeck 1 and 2

    International Nuclear Information System (INIS)

    1996-12-01

    According to Swedish law, the reactor owner is responsible for performing a safety review and writing a so called ASAR-report. The Nuclear Power Inspectorate (SKI) examines this report, and reports the findings to the government (the so called SKI-ASAR-report). Each Swedish reactor should pass through three full ASAR reviews during its lifetime, similar to the licensing inspection before start-up of the reactor. The second series ASAR was delivered by the Barsebaeck utility to SKI in September 1995, and forms the basis for the SKI analysis in the present report

  6. Packaging review guide for reviewing safety analysis reports for packagings: Revision 1

    International Nuclear Information System (INIS)

    Fisher, L.E.; Chou, C.K.; Lloyd, W.R.; Mount, M.E.; Nelson, T.A.; Schwartz, M.W.; Witte, M.C.

    1988-10-01

    The Department of Energy (DOE) has established procedures for obtaining certification of packagings used by DOE and its contractors for the transport of radioactive materials. The principal purpose of this document is to assure the quality and uniformity of PCS reviews and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. The Packaging Review Guide (PRG) also sets forth solutions and approaches determined to be acceptable in the past in dealing with a specific safety issue or safety-related design area. These solutions and approaches are presented in this form so that reviewers can take consistent and well-understood positions as the same safety issues arise in future cases. An applicant submitting a SARP does not have to follow the solutions or approaches presented. It is also a purpose of the PRG to make information about DOE certification policy and procedures widely available to DOE field offices, DOE contractors, federal agencies, and interested members of the public. 77 refs., 16 figs., 15 tabs

  7. Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

    2015-01-01

    Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity

  8. International review of Kursk unit 1 in-depth safety analysis report

    International Nuclear Information System (INIS)

    Chouha, M.; Bolshov, L.; Butcher, P.; Janke, R.; Parsons, T.; Weber, J.P.

    2004-01-01

    The paper presents the objectives, organisation, main findings and conclusions of the international review of the Kursk unit 1 safety analysis report (K1IRSR). The K1IRSR was administered by RISKAUDIT IRSN/GRS international and carried out by international experts from 7 western countries plus the Russian Federation, under the supervision of the safety review group (SRG) of the European bank for reconstruction and development (EBRD). The project was financed by the nuclear safety account (NSA) administered by the EBRD. The Russian experts worked under a contract with IBRAE financed by Rosenergoatom. The main conclusions were that the SAR followed a correct approach, broadly in line with Russian and international guidance documents, but needed improvement in structure and content. It established that the safety level of the unit has been increased significantly by the modernisation programme. The important deviations of the unit from current Russian regulations and the IAEA safety issues for RBMK are either fully resolved or are being addressed to the extent possible by compensatory measures to further reduce the risk. The K1IRSR experts have made a number of recommendations for improvement of the K1SAR. The authors agreed to take the recommendations into account in future revision of the K1SAR. (orig.)

  9. Nuclear Safety Review 2013

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-07-15

    The Nuclear Safety Review 2013 focuses on the dominant nuclear safety trends, issues and challenges in 2012. The Executive Overview provides crosscutting and worldwide nuclear safety information along with a summary of the major sections covered in this report. Sections A-E of this report cover improving radiation, transport and waste safety; strengthening safety in nuclear installations; improving regulatory infrastructure and effectiveness; enhancing emergency preparedness and response (EPR); and civil liability for nuclear damage. The Appendix provides details on the activities of the Commission on Safety Standards (CSS), and activities relevant to the IAEA Safety Standards. The world nuclear community has made noteworthy progress in strengthening nuclear safety in 2012, as promoted by the IAEA Action Plan on Nuclear Safety (hereinafter referred to as ''the Action Plan''). For example, an overwhelming majority of Member States with operating nuclear power plants (NPPs) have undertaken and essentially completed comprehensive safety reassessments ('stress tests') with the aim of evaluating the design and safety aspects of plant robustness to protect against extreme events, including: defence in depth, safety margins, cliff edge effects, multiple failures, and the prolonged loss of support systems. As a result, many have introduced additional safety measures including mitigation of station blackout. Moreover, the IAEA's peer review services and safety standards have been reviewed and strengthened where needed. Capacity building programmes have been built or improved, and EPR programmes have also been reviewed and improved. Furthermore, in 2012, the IAEA continued to share lessons learned from the Fukushima Daiichi accident with the nuclear community including through three international experts' meetings (IEMs) on reactor and spent fuel safety, communication in the event of a nuclear or radiological emergency, and protection against extreme earthquakes and tsunamis.

  10. Nuclear Safety Review 2013

    International Nuclear Information System (INIS)

    2013-07-01

    The Nuclear Safety Review 2013 focuses on the dominant nuclear safety trends, issues and challenges in 2012. The Executive Overview provides crosscutting and worldwide nuclear safety information along with a summary of the major sections covered in this report. Sections A-E of this report cover improving radiation, transport and waste safety; strengthening safety in nuclear installations; improving regulatory infrastructure and effectiveness; enhancing emergency preparedness and response (EPR); and civil liability for nuclear damage. The Appendix provides details on the activities of the Commission on Safety Standards (CSS), and activities relevant to the IAEA Safety Standards. The world nuclear community has made noteworthy progress in strengthening nuclear safety in 2012, as promoted by the IAEA Action Plan on Nuclear Safety (hereinafter referred to as ''the Action Plan''). For example, an overwhelming majority of Member States with operating nuclear power plants (NPPs) have undertaken and essentially completed comprehensive safety reassessments ('stress tests') with the aim of evaluating the design and safety aspects of plant robustness to protect against extreme events, including: defence in depth, safety margins, cliff edge effects, multiple failures, and the prolonged loss of support systems. As a result, many have introduced additional safety measures including mitigation of station blackout. Moreover, the IAEA's peer review services and safety standards have been reviewed and strengthened where needed. Capacity building programmes have been built or improved, and EPR programmes have also been reviewed and improved. Furthermore, in 2012, the IAEA continued to share lessons learned from the Fukushima Daiichi accident with the nuclear community including through three international experts' meetings (IEMs) on reactor and spent fuel safety, communication in the event of a nuclear or radiological emergency, and protection against extreme earthquakes and tsunamis

  11. Timing of Formal Phase Safety Reviews for Large-Scale Integrated Hazard Analysis

    Science.gov (United States)

    Massie, Michael J.; Morris, A. Terry

    2010-01-01

    Integrated hazard analysis (IHA) is a process used to identify and control unacceptable risk. As such, it does not occur in a vacuum. IHA approaches must be tailored to fit the system being analyzed. Physical, resource, organizational and temporal constraints on large-scale integrated systems impose additional direct or derived requirements on the IHA. The timing and interaction between engineering and safety organizations can provide either benefits or hindrances to the overall end product. The traditional approach for formal phase safety review timing and content, which generally works well for small- to moderate-scale systems, does not work well for very large-scale integrated systems. This paper proposes a modified approach to timing and content of formal phase safety reviews for IHA. Details of the tailoring process for IHA will describe how to avoid temporary disconnects in major milestone reviews and how to maintain a cohesive end-to-end integration story particularly for systems where the integrator inherently has little to no insight into lower level systems. The proposal has the advantage of allowing the hazard analysis development process to occur as technical data normally matures.

  12. Review of the safety analysis of the Ignalina Nuclear Power Plant

    International Nuclear Information System (INIS)

    Weber, J.P.

    1999-01-01

    Description of the review of safety analysis report (SAR) of Ignalina NPP is presented. this review, called RSR, was conducted by independent group of international experts. SAR and RSR represented a unique international effort in a very short time. It was first attempt to provide Western-type SAR for any Soviet designed NPP. SAR was completed in December 1996, RSR was completed in March 1997. SAR has produced 85 reports, available on CR-ROM and RSR produced 86 reports also available on CD-ROM. SAR presented a large list of recommendations. RSR agreed with most of SAR recommendations and added further recommendations. SAR and RSR contributed significantly to better understanding of RBMK plant behaviour. Ignalina NPP has responded to the SAR/RSR recommendations by an ambitious Safety Improvement Programme SIP-2 which currently is under implementation

  13. LESSONS LEARNED IN DEVELOPMENT OF THE HANFORD SWOC MASTER DOCUMENTED SAFETY ANALYSIS (MDSA) and IMPLEMENTATION VALIDATION REVIEW (IVR)

    International Nuclear Information System (INIS)

    MORENO, M.R.

    2004-01-01

    DOE set clear expectations on a cost-effective approach for achieving compliance with the Nuclear Safety Management requirements (20 CFR 830, Nuclear Safety Rule), which ensured long-term benefit to Hanford, via issuance of a nuclear safety strategy in February 2003. To facilitate implementation of these expectations, tools were developed to streamline and standardize safety analysis and safety document development with the goal of a shorter and more predictable DOE approval cycle. A Hanford Safety Analysis and Risk Assessment Handbook (SARAH) was approved to standardize methodologies for development of safety analyses. A Microsoft Excel spreadsheet (RADIDOSE) was approved for the evaluation of radiological consequences for accident scenarios often postulated at Hanford. Standard safety management program chapters were approved for use as a means of compliance with the programmatic chapters of DOE-STD-3009, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports''. An in-process review was developed between DOE and the Contractor to facilitate DOE approval and provide early course correction. The new Documented Safety Analysis (DSA) developed to address the operations of four facilities within the Solid Waste Operations Complex (SWOC) necessitated development of an Implementation Validation Review (IVR) process. The IVR process encompasses the following objectives: safety basis controls and requirements are adequately incorporated into appropriate facility documents and work instructions, facility personnel are knowledgeable of controls and requirements, and the DSA/TSR controls have been implemented. Based on DOE direction and safety analysis tools, four waste management nuclear facilities were integrated into one safety basis document. With successful completion of implementation of this safety document, lessons-learned from the in-process review, safety analysis tools and IVR process were documented for future action

  14. K Basin safety analysis

    International Nuclear Information System (INIS)

    Porten, D.R.; Crowe, R.D.

    1994-01-01

    The purpose of this accident safety analysis is to document in detail, analyses whose results were reported in summary form in the K Basins Safety Analysis Report WHC-SD-SNF-SAR-001. The safety analysis addressed the potential for release of radioactive and non-radioactive hazardous material located in the K Basins and their supporting facilities. The safety analysis covers the hazards associated with normal K Basin fuel storage and handling operations, fuel encapsulation, sludge encapsulation, and canister clean-up and disposal. After a review of the Criticality Safety Evaluation of the K Basin activities, the following postulated events were evaluated: Crane failure and casks dropped into loadout pit; Design basis earthquake; Hypothetical loss of basin water accident analysis; Combustion of uranium fuel following dryout; Crane failure and cask dropped onto floor of transfer area; Spent ion exchange shipment for burial; Hydrogen deflagration in ion exchange modules and filters; Release of Chlorine; Power availability and reliability; and Ashfall

  15. KHNP special safety review

    International Nuclear Information System (INIS)

    Lee, Tae-Ho; Lee, Bang-Jin; Lee, Soung-Hee; Park, Goon-Cherl

    2009-01-01

    Commemorating the 30 year anniversary of commercial nuclear power plant operation in KOREA, Korea Hydro and Nuclear Power Co., Ltd. (KHNP) has conducted a Special Safety Review (SSR) of its 20 operating units to understand their safety performance and to identify any areas that need improvement. The SSR reviewed all 20 operating units for 2 weeks per site. Areas that were reviewed are Safety Margins, Plant Performance, Employee Safety, Employee Performance and Performance Improvement Process. Each review team consisted of international and domestic members. The international reviewers were from IAEA, WANO and INPO. The domestic reviewers consisted of professors, Engineering Company, Research Institute and KHNP experts. The review confirmed safe and reliable operations of the 20 nuclear units. The common understanding resulted from the SSR is as follows. Firstly, KHNP corporate and its plants confirmed and shared mutual understanding on recurring areas for improvements, especially in the areas of Organizational Effectiveness, Industrial Safety, Human Performance, Configuration Management, Operations, Equipment Performance and Material Condition. Secondly, KHNP understood that plant and department level performances are directly related to the leadership and competency of the management team including supervisors. Thirdly, the strengths of individual stations that consistently have produced good results need to be shared with the other KHNP stations. Finally, KHNP learned that strong corporate leadership and support are needed to resolve most of the areas for improvement since they are common to all KHNP stations. (author)

  16. Technical basis for the ITER final design report, cost review and safety analysis (FDR)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    The ITER final design report, cost review and safety analysis (FDR) is the 4th major milestone, representing the progress made in the ITER Engineering Design Activities. With the approval of the Detailed Design Report (DDR), the design work was concentrated on the requirements of operation, with only relatively minor changes to design concepts of major components. The FDR is the culmination of almost 6 years collaborative design and supporting technical work by the ITER Joint Central Team and Home Teams under the terms of the ITER EDA Agreement. Refs, figs, tabs

  17. Technical basis for the ITER final design report, cost review and safety analysis (FDR)

    International Nuclear Information System (INIS)

    1998-01-01

    The ITER final design report, cost review and safety analysis (FDR) is the 4th major milestone, representing the progress made in the ITER Engineering Design Activities. With the approval of the Detailed Design Report (DDR), the design work was concentrated on the requirements of operation, with only relatively minor changes to design concepts of major components. The FDR is the culmination of almost 6 years collaborative design and supporting technical work by the ITER Joint Central Team and Home Teams under the terms of the ITER EDA Agreement

  18. Technical basis for the ITER detailed design report, cost review and safety analysis (DDR)

    International Nuclear Information System (INIS)

    1997-01-01

    The ITER Detailed Design Report (DDR), Cost Review and Safety Analysis is the 3rd major milestone representing the progress made in the ITER Engineering Design Activities. With the approval of the Interim Design Report (IDR), it has been possible to freeze the main concepts and system approaches for ITER and to develop the design in more detail for the individual components and sub-systems. This report, although designed to be fully understandable as a separate document, focusses particularly on the main changes since the IDR

  19. Technical basis for the ITER detailed design report, cost review and safety analysis (DDR)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-01

    The ITER Detailed Design Report (DDR), Cost Review and Safety Analysis is the 3rd major milestone representing the progress made in the ITER Engineering Design Activities. With the approval of the Interim Design Report (IDR), it has been possible to freeze the main concepts and system approaches for ITER and to develop the design in more detail for the individual components and sub-systems. This report, although designed to be fully understandable as a separate document, focusses particularly on the main changes since the IDR. Refs, figs, tabs

  20. Review of criticality safety and shielding analysis issues for transportation packages

    International Nuclear Information System (INIS)

    Parks, C.V.; Broadhead, B.L.

    1995-01-01

    The staff of the Nuclear Engineering Applications Section (NEAS) at Oak Ridge National Laboratory (ORNL) have been involved for over 25 years with the development and application of computational tools for use in analyzing the criticality safety and shielding features of transportation packages carrying radioactive material (RAM). The majority of the computational tools developed by ORNL/NEAS have been included within the SCALE modular code system (SCALE 1995). This code system has been used throughout the world for the evaluation of nuclear facility and package designs. With this development and application experience as a basis, this paper highlights a number of criticality safety and shielding analysis issues that confront the designer and reviewer of a new RAM package. Changes in the types and quantities of material that need to be shipped will keep these issues before the technical community and provide challenges to future package design and certification

  1. Systematic review and meta-analysis of behavioral interventions to improve child pedestrian safety.

    Science.gov (United States)

    Schwebel, David C; Barton, Benjamin K; Shen, Jiabin; Wells, Hayley L; Bogar, Ashley; Heath, Gretchen; McCullough, David

    2014-09-01

    Pedestrian injuries represent a pediatric public health challenge. This systematic review/meta-analysis evaluated behavioral interventions to teach children pedestrian safety. Multiple strategies derived eligible manuscripts (published before April 1, 2013, randomized design, evaluated behavioral child pedestrian safety interventions). Screening 1,951 abstracts yielded 125 full-text retrievals. 25 were retained for data extraction, and 6 were later omitted due to insufficient data. In all, 19 articles reporting 25 studies were included. Risk of bias and quality of evidence were assessed. Behavioral interventions generally improve children's pedestrian safety, both immediately after training and at follow-up several months later. Quality of the evidence was low to moderate. Available evidence suggested interventions targeting dash-out prevention, crossing at parked cars, and selecting safe routes across intersections were effective. Individualized/small-group training for children was the most effective training strategy based on available evidence. Behaviorally based interventions improve children's pedestrian safety. Efforts should continue to develop creative, cost-efficient, and effective interventions. © The Author 2014. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  2. Human reliability analysis for probabilistic safety assessments - review of methods and issues

    International Nuclear Information System (INIS)

    Srinivas, G.; Guptan, Rajee; Malhotra, P.K.; Ghadge, S.G.; Chandra, Umesh

    2011-01-01

    It is well known that the two major events in World Nuclear Power Plant Operating history, namely the Three Mile Island and Chernobyl, were Human failure events. Subsequent to these two events, several significant changes have been incorporated in Plant Design, Control Room Design and Operator Training to reduce the possibility of Human errors during plant transients. Still, human error contribution to Risk in Nuclear Power Plant operations has been a topic of continued attention for research, development and analysis. Probabilistic Safety Assessments attempt to capture all potential human errors with a scientifically computed failure probability, through Human Reliability Analysis. Several methods are followed by different countries to quantify the Human error probability. This paper reviews the various popular methods being followed, critically examines them with reference to their criticisms and brings out issues for future research. (author)

  3. Efficacy and safety of miconazole for oral candidiasis: a systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, L-W; Fu, J-Y; Hua, H; Yan, Z-M

    2016-04-01

    The objective of this study is to assess the efficacy and safety of miconazole for treating oral candidiasis. Twelve electronic databases were searched for randomized controlled trials evaluating treatments for oral candidiasis and complemented by hand searching. The clinical and mycological outcomes, as well as adverse effects, were set as the primary outcome criteria. Seventeen trials were included in this review. Most studies were considered to have a high or moderate level of bias. Miconazole was more effective than nystatin for thrush. For HIV-infected patients, there was no significant difference in the efficacy between miconazole and other antifungals. For denture wearers, microwave therapy was significantly better than miconazole. No significant difference was found in the safety evaluation between miconazole and other treatments. The relapse rate of miconazole oral gel may be lower than that of other formulations. This systematic review and meta-analysis indicated that miconazole may be an optional choice for thrush. Microwave therapy could be an effective adjunct treatment for denture stomatitis. Miconazole oral gel may be more effective than other formulations with regard to long-term results. However, future studies that are adequately powered, large-scale, and well-designed are needed to provide higher-quality evidence for the management of oral candidiasis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Safety of Running Two Rooms: A Systematic Review and Meta-Analysis of Overlapping Neurosurgical Procedures.

    Science.gov (United States)

    Self, D Mitchell; Ilyas, Adeel; Stetler, William R

    2018-04-27

    Overlapping surgery, a long-standing practice within academic neurosurgery centers nationwide, has recently come under scrutiny from the government and media as potentially harmful to patients. Therefore, the objective of this systematic review and meta-analysis is to determine the safety of overlapping neurosurgical procedures. The authors performed a systematic review and meta-analysis in accordance with PRISMA guidelines. A review of PubMed and Medline databases was undertaken with the search phrase "overlapping surgery AND neurosurgery AND outcomes." Data regarding patient demographics, type of neurosurgical procedure, and outcomes and complications were extracted from each study. The principle summary measure was odds ratio (OR) of the association of overlapping versus non-overlapping surgery with outcomes. The literature search yielded a total of 36 studies, of which 5 studies met inclusion criteria and were included in this study. These studies included a total of 25,764 patients undergoing neurosurgical procedures. Overlapping surgery was associated with an increased likelihood of being discharged home (OR = 1.32; 95% CI 1.20 to 1.44; P < 0.001) and a reduced 30-day unexpected return to the operating room (OR = 0.79; 95% CI 0.72 to 0.87; P < 0.001). Overlapping surgery did not significantly affect OR of length of surgery, 30-day mortality, or 30-day readmission. Overlapping neurosurgical procedures were not associated with worse patient outcomes. Additional, prospective studies are needed to further assess the safety overlapping procedures. Copyright © 2018. Published by Elsevier Inc.

  5. Safety analysis fundamentals

    International Nuclear Information System (INIS)

    Wright, A.C.D.

    2002-01-01

    This paper discusses the safety analysis fundamentals in reactor design. This study includes safety analysis done to show consequences of postulated accidents are acceptable. Safety analysis is also used to set design of special safety systems and includes design assist analysis to support conceptual design. safety analysis is necessary for licensing a reactor, to maintain an operating license, support changes in plant operations

  6. A Review and Comparative Analysis of Security Risks and Safety Measures of Mobile Health Apps

    Directory of Open Access Journals (Sweden)

    Karen Scott

    2015-11-01

    Full Text Available In line with a patient-centred model of healthcare, Mobile Health applications (mhealth apps provide convenient and equitable access to health and well-being resources and programs that can enable consumers to monitor their health related problems, understand specific medical conditions and attain personal fitness goals. This increase in access and control comes with an increase in risk and responsibility to identify and manage the associated risks, such as the privacy and security of consumers’ personal and health information. Based on a review of the literature, this paper identifies a set of risk and safety features for evaluating mHealth apps and uses those features to conduct a comparative analysis of the 20 most popular mHealth apps. The comparative analysis reveals that current mHealth apps do pose a risk to consumers. To address the safety and privacy concerns, recommendations to consumers and app developers are offered together with consideration of mHealth app future trends.

  7. Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

    Science.gov (United States)

    Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

    2017-08-01

    Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Suitability review of FMEA and reliability analysis for digital plant protection system and digital engineered safety features actuation system

    Energy Technology Data Exchange (ETDEWEB)

    Kim, I. S.; Kim, T. K.; Kim, M. C.; Kim, B. S.; Hwang, S. W.; Ryu, K. C. [Hanyang Univ., Seoul (Korea, Republic of)

    2000-11-15

    Of the many items that should be checked out during a review stage of the licensing application for the I and C system of Ulchin 5 and 6 units, this report relates to a suitability review of the reliability analysis of Digital Plant Protection System (DPPS) and Digital Engineered Safety Features Actuation System (DESFAS). In the reliability analysis performed by the system designer, ABB-CE, fault tree analysis was used as the main methods along with Failure Modes and Effect Analysis (FMEA). However, the present regulatory technique dose not allow the system reliability analysis and its results to be appropriately evaluated. Hence, this study was carried out focusing on the following four items ; development of general review items by which to check the validity of a reliability analysis, and the subsequent review of suitability of the reliability analysis for Ulchin 5 and 6 DPPS and DESFAS L development of detailed review items by which to check the validity of an FMEA, and the subsequent review of suitability of the FMEA for Ulchin 5 and 6 DPPS and DESFAS ; development of detailed review items by which to check the validity of a fault tree analysis, and the subsequent review of suitability of the fault tree for Ulchin 5 and 6 DPPS and DESFAS ; an integrated review of the safety and reliability of the Ulchin 5 and 6 DPPS and DESFAS based on the results of the various reviews above and also of a reliability comparison between the digital systems and the comparable analog systems, i.e., and analog Plant Protection System (PPS) and and analog Engineered Safety Features Actuation System (ESFAS). According to the review mentioned above, the reliability analysis of Ulchin 5 and 6 DPPS and DESFAS generally satisfies the review requirements. However, some shortcomings of the analysis were identified in our review such that the assumed test periods for several equipment were not properly incorporated in the analysis, and failures of some equipment were not included in the

  9. CYD-TDV dengue vaccine: systematic review and meta-analysis of efficacy, immunogenicity and safety.

    Science.gov (United States)

    Godói, Isabella Piassi; Lemos, Livia Lovato Pires; de Araújo, Vânia Eloisa; Bonoto, Braúlio Cesar; Godman, Brian; Guerra Júnior, Augusto Afonso

    2017-03-01

    Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia ® ) was the first vaccine to gain regulatory approval to try and address this problem. Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine. Meta-analysis and systematic review. The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2-16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events. CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population.

  10. Safety analysis for research reactors

    International Nuclear Information System (INIS)

    2008-01-01

    computational tools and presentation of the results of the analysis. It also discusses various factors that need to be considered to ensure that the safety analysis is of an acceptable quality. In specific terms, the calculations and methods in this report can be used for the safety analysis of newly designed research reactors, modifications and experiments with impact on safety, and upgrades of existing reactors, and can also be used for updating or reassessing previous safety analyses of operating research reactors. This publication will be particularly useful to organizations, safety analysts and reviewers in fulfilling regulatory requirements and recommendations related to the preparation of the safety analysis and its presentation in the safety analysis report. In addition, it will help regulators conduct safety reviews and assessments of the topics covered

  11. Nuclear Safety Review for 2014

    International Nuclear Information System (INIS)

    2014-07-01

    The Nuclear Safety Review 2014 focuses on the dominant nuclear safety trends, issues and challenges in 2013. The Executive Overview provides general nuclear safety information along with a summary of the major issues covered in this report: strengthening safety in nuclear installations; improving radiation, transport and waste safety; enhancing emergency preparedness and response (EPR); improving regulatory infrastructure and effectiveness; and strengthening civil liability for nuclear damage. The Appendix provides details on the activities of the Commission on Safety Standards, and activities relevant to the Agency’s safety standards. The global nuclear community has made steady and continuous progress in strengthening nuclear safety in 2013, as promoted by the IAEA Action Plan on Nuclear Safety (hereinafter referred to as “the Action Plan”) and reported in Progress in the Implementation of the IAEA Action Plan on Nuclear Safety (document GOV/INF/2013/8-GC(57)/INF/5), and the Supplementary Information to that report and Progress in the Implementation of the IAEA Action Plan on Nuclear Safety (document GOV/INF/2014/2). • Significant progress continues to be made in several key areas, such as assessments of safety vulnerabilities of nuclear power plants (NPPs), strengthening of the Agency’s peer review services, improvements in EPR capabilities, strengthening and maintaining capacity building, and protecting people and the environment from ionizing radiation. The progress that has been made in these and other areas has contributed to the enhancement of the global nuclear safety framework. • Significant progress has also been made in reviewing the Agency’s safety standards, which continue to be widely applied by regulators, operators and the nuclear industry in general, with increased attention and focus on vitally important areas such as design and operation of NPPs, protection of NPPs against severe accidents, and EPR. • The Agency continued to

  12. An approach to review design bases and safety analysis of earlier generation atomic power plants; a case study of TAPS

    International Nuclear Information System (INIS)

    Malhotra, P.K.; Bajaj, S.S.

    2002-01-01

    The twin unit boiling water reactor (BWR) station at TAPS has completed 30 years of power operation and for further extending plant operating life, a fresh extensive exercise involving review of plant operating performance, aging management and review of design bases and safety analysis has been carried out. The review exercise resulted in assessment of acceptability of identified non-conformances and recommendation for compensatory measures in the form of design modification or plant operating procedures. The second part of the exercise is related to safety analysis, which is carried out in view of the plant modifications done and advances taken place in methodologies of analytical techniques. Chiefly, it involves LOCA analysis done for various break sizes at different locations and plant transient studies. It also includes the fatigue analysis of the reactor pressure vessel. The related review approach adopted is presented here

  13. Ignalina Safety Analysis Group

    International Nuclear Information System (INIS)

    Ushpuras, E.

    1995-01-01

    The article describes the fields of activities of Ignalina NPP Safety Analysis Group (ISAG) in the Lithuanian Energy Institute and overview the main achievements gained since the group establishment in 1992. The group is working under the following guidelines: in-depth analysis of the fundamental physical processes of RBMK-1500 reactors; collection, systematization and verification of the design and operational data; simulation and analysis of potential accident consequences; analysis of thermohydraulic and neutronic characteristics of the plant; provision of technical and scientific consultations to VATESI, Governmental authorities, and also international institutions, participating in various projects aiming at Ignalina NPP safety enhancement. The ISAG is performing broad scientific co-operation programs with both Eastern and Western scientific groups, supplying engineering assistance for Ignalina NPP. ISAG is also participating in the joint Lithuanian - Swedish - Russian project - Barselina, the first Probabilistic Safety Assessment (PSA) study of Ignalina NPP. The work is underway together with Maryland University (USA) for assessment of the accident confinement system for a range of breaks in the primary circuit. At present the ISAG personnel is also involved in the project under the grant from the Nuclear Safety Account, administered by the European Bank for reconstruction and development for the preparation and review of an in-depth safety assessment of the Ignalina plant

  14. The procedures used to review safety analysis reports for packagings submitted to the US Department of Energy for certification

    International Nuclear Information System (INIS)

    Popper, G.F.; Raske, D.T.; Turula, P.

    1988-01-01

    This paper presents an overview of the procedures used at the Argonne National Laboratory (ANL) to review Safety Analysis Reports for Packagings (SARPs) submitted to the US Department of Energy (DOE) for issuance of a Certificate of Compliance. Prior to certification and shipment of a packaging for the transport of radioactive materials, a SARP must be prepared describing the design, contents, analyses, testing, and safety features of the packaging. The SARP must be reviewed to ensure that the specific packaging meets all DOE orders and federal regulations for safe transport. The ANL SARP review group provides an independent review and evaluation function for the DOE to ensure that the packaging meets all the prescribed requirements. This review involves many disciplines and includes evaluating the general information, drawings, construction details, operating procedures, maintenance and test programs, and the quality assurance plan for compliance with requirements. 14 refs., 6 figs

  15. Internal safety review team at Comanche Peak SES

    Energy Technology Data Exchange (ETDEWEB)

    Davis, D [Comanche Peak Steam Electric Staion, Texas Utilities, TX (United States)

    1997-09-01

    The presentations describes the following issues: levels of defense in depth; internal safety review organizations; methods used to perform safety assessment; safety committee review; quality verification; root cause analysis; human performance program; industry operating experience.

  16. Lessons Learned in Preparation and Review of Safety Analysis Report of PUSPATI TRIGA Reactor in Malaysia

    International Nuclear Information System (INIS)

    Maskin, Mazleha; Choi, Kwang Sik

    2010-01-01

    PUSPATI TRIGA Reactor (RTP) is the one and only research reactor in Malaysia. Since the day it was supplied by General Atomic (GA) in 1983, periodic safety reviews were carried out but not published in the form of a complete SAR. In fact, the original SAR (SAR 1983) document was provided by GA as soon as GA was selected as the supplier of RTP. The focus of this report is on the lessons learned from the preparation of SAR. The lessons learned were to address the preparation and regulatory review of the second SAR (SAR 2006). Realizing that safety is important as RTP is aging, the experiences and lessons learned from SAR development and updating processes are of great value for all parties involved. The purpose of this report is to consolidate and organize the lessons learned and suggest the best practice for the next SAR development both in preparation and regulatory review

  17. Lessons Learned in Preparation and Review of Safety Analysis Report of PUSPATI TRIGA Reactor in Malaysia

    Energy Technology Data Exchange (ETDEWEB)

    Maskin, Mazleha [Korea Advanced Institute for Science and Technology, Daejeon (Korea, Republic of); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2010-05-15

    PUSPATI TRIGA Reactor (RTP) is the one and only research reactor in Malaysia. Since the day it was supplied by General Atomic (GA) in 1983, periodic safety reviews were carried out but not published in the form of a complete SAR. In fact, the original SAR (SAR 1983) document was provided by GA as soon as GA was selected as the supplier of RTP. The focus of this report is on the lessons learned from the preparation of SAR. The lessons learned were to address the preparation and regulatory review of the second SAR (SAR 2006). Realizing that safety is important as RTP is aging, the experiences and lessons learned from SAR development and updating processes are of great value for all parties involved. The purpose of this report is to consolidate and organize the lessons learned and suggest the best practice for the next SAR development both in preparation and regulatory review

  18. Scenario Analysis for the Safety Assessment of Nuclear Waste Repositories: A Critical Review.

    Science.gov (United States)

    Tosoni, Edoardo; Salo, Ahti; Zio, Enrico

    2018-04-01

    A major challenge in scenario analysis for the safety assessment of nuclear waste repositories pertains to the comprehensiveness of the set of scenarios selected for assessing the safety of the repository. Motivated by this challenge, we discuss the aspects of scenario analysis relevant to comprehensiveness. Specifically, we note that (1) it is necessary to make it clear why scenarios usually focus on a restricted set of features, events, and processes; (2) there is not yet consensus on the interpretation of comprehensiveness for guiding the generation of scenarios; and (3) there is a need for sound approaches to the treatment of epistemic uncertainties. © 2017 Society for Risk Analysis.

  19. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

    Energy Technology Data Exchange (ETDEWEB)

    Chopra, Omesh K. [Argonne National Lab., IL (United States). Environmental Science Division; Diercks, Dwight R. [Argonne National Lab., IL (United States). Nuclear Engineering Division; Ma, David Chia-Chiun [Argonne National Lab., IL (United States). Environmental Science Division; Garud, Yogendra S. [Argonne National Lab., IL (United States). Environmental Science Division

    2013-12-17

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In the U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978

  20. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

    International Nuclear Information System (INIS)

    Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun; Garud, Yogendra S.

    2013-01-01

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC's assessment processes. In the U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978 and

  1. Safety profiles of Tripterygium wilfordii Hook F: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Chi Zhang

    2016-11-01

    Full Text Available Objective: Tripterygium wilfordii Hook F (TwHF is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs. We aimed to undertake a clinically informative, systematic safety profile of TwHF.Methods: We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs. Results: We screened 4,137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8% in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95%CI 11.9%, 14.9%, 11.7% (95% CI 10.3%, 13.3%, 7.8% (95%CI 6.3%-9.5%, 6.5% (95%CI 5.7%-7.4% and 4.9% (95%CI 1.6%, 14.3%, respectively. The prevalence of irregular menstruation (IM was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03. TwHF use has lower risk of weight gain (OR 0.12 [95%CI 0.04 to 0.39] and hair loss (OR 0.37 [95% CI 0.18 to 0.78]. Furthermore, long-term aspirin use (> 6 months has a higher AEs incidence (31.0% [95% CI 24.5%-38.5%].Conclusion: Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF.

  2. Effectiveness of Occupational Health and Safety Training: A Systematic Review with Meta-Analysis

    Science.gov (United States)

    Ricci, Federico; Chiesi, Andrea; Bisio, Carlo; Panari, Chiara; Pelosi, Annalisa

    2016-01-01

    Purpose: This meta-analysis aims to verify the efficacy of occupational health and safety (OHS) training in terms of knowledge, attitude and beliefs, behavior and health. Design/methodology/approach: The authors included studies published in English (2007-2014) selected from ten databases. Eligibility criteria were studies concerned with the…

  3. Standard Review Plan for the review of safety analysis reports for nuclear power plants, updates. Irregular repts

    International Nuclear Information System (INIS)

    1980-01-01

    The Standard Review Plan (SRP) is prepared for the guidance of staff reviewers in the Office of Nuclear Reactor Regulation in performing safety reviews of applications to construct or operate nuclear power plants. The principal purpose of the SRP is to assure the quality and uniformity of staff reviews, and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. It is also a purpose of the SRP to make information about regulatory matters widely available and to improve communication and understanding of the staff review process by interested members of the public and the nuclear power industry. The Standard Review Plan is written so as to cover a variety of site conditions and plant designs. Each section is written to provide the complete procedure and all acceptance criteria for all of the areas of review pertinent to that section. However, for any given application, the staff reviewers may select and emphasize particular aspects of each SRP section as is appropriate for the application

  4. Occupational Health and Safety in Ethiopia: A review of Situational Analysis and Needs Assessment.

    Science.gov (United States)

    Kumie, Abera; Amera, Tadesse; Berhane, Kiros; Samet, Jonathan; Hundal, Nuvjote; G/Michael, Fitsum; Gilliland, Frank

    2016-01-01

    The current rapid economic development has brought changes in workplaces in developing countries, including Ethiopia. The organization of occupational health and safety services is not yet resilient enough to handle the growing demands for workers' health in the context of industrialization. There is limited information on the gaps and needs of occupational health services in workplaces in Ethiopia. The present review article describes the existing profile of occupational safety and health services in Ethiopia and identifies the current gaps and needs in the services. Secondary data sources were reviewed using a structured checklist to explore the status of occupational safety, health services and related morbidity. Local literature was consulted in order to describe the type and prevalence of work related hazards, patterns of industries and of workforce. Published articles were searched in Google, Google scholar, PUBMED, and HINARI databases. Relevant heads of stakeholder organizations and experts were interviewed to verify the gaps that were synthesized using desk review. Ethiopia is an agrarian country that is industrializing rapidly with a focus on construction, manufacturing, mining, and road infrastructure. An estimated work force of about two million is currently engaged in the public and private sectors. Males constitute the majority of this workforce. Most of the workforce has basic primary education. Commonly observed hazards in the workplace include occupational noise and dust of various types in manufacturing sectors and chemical exposures in the flower industry. Injury in both the agriculture and the manufacturing sectors is another workplace hazard commonly observed in the country. A lack of information made assessing workplace exposures in detail difficult. The prevalence of noise exposure was found to be high with the potential to seriously impact hearing capacity. Exposure to dust in textile and cement factories greatly exceeded international

  5. Regulatory review of NPP Krsko Periodic Safety Review

    International Nuclear Information System (INIS)

    Lovincic, D.; Muehleisen, A.; Persic, A.

    2004-01-01

    At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

  6. A review of the South Texas Project probabilistic safety analysis for accident frequency estimates and containment binning

    International Nuclear Information System (INIS)

    Wheeler, T.A.; Lambright, J.A.; Sype, T.T.; Darby, J.L.; Walsh, B.

    1991-08-01

    The objective of this review is to evaluate the South Texas Project (STP) Probabilistic Safety Analysis (PSA) for the USNRC. The PSA was reviewed for thoroughness of analysis, accuracy in plant modeling, legitimacy of assumptions, and overall quality of the work. The review is limited to the internal event analysis and the fire sequence analysis. This review is not a quantitative evaluation of the adequacy of the PSA. The adequacy of the PSA depends on the intended uses and must be addressed on a case-by-case basis by the licensee and the NRC. This review identifies strengths, weakness, and areas where additional clarification would assist the NRC in evaluating the PSA for specific regulatory purposes. The licensee, Houston Lighting and Power (HL ampersand P), reviewed a draft version of this report prior to its final release to the USNRC. The responses provided by HL ampersand P are provided in detail in appendices to this report, and they are summarized in the main body of the report. All issues raised during the review were adequately addressed by HL ampersand P in the responses. 27 refs., 4 tabs

  7. Nuclear Safety Review for 2015

    International Nuclear Information System (INIS)

    2015-06-01

    The Nuclear Safety Review 2015 focuses on the dominant nuclear safety trends, issues and challenges in 2014. The Executive Overview provides general nuclear safety information along with a summary of the major issues covered in this report: improving radiation, transport and waste safety; strengthening safety in nuclear installations; enhancing emergency preparedness and response (EPR); and strengthening civil liability for nuclear damage. The Appendix provides details on the activities of the Commission on Safety Standards (CSS), and activities relevant to the Agency’s safety standards. The global nuclear community continued to make steady progress in improving nuclear safety throughout the world in 2014; and, the Agency and its Member States continued to implement the IAEA Action Plan on Nuclear Safety (hereinafter referred to as “the Action Plan”), which was endorsed by the General Conference in 2011 after the Fukushima Daiichi accident in March 2011. • Significant progress has been made in reviewing and revising various Agency’s safety standards in areas such as management of radioactive waste, design basis hazard levels, protection of nuclear power plants (NPPs) against severe accidents, design margins to avoid cliff edge effects, multiple facilities at one site, and strengthening the prevention of unacceptable radiological consequences to the public and the environment, communications and EPR. In addition, the Guidelines for Drafting IAEA Safety Standards and Nuclear Security Series Publications was issued in July 2014.• The Agency continued to analyse the relevant technical aspects of the Fukushima Daiichi accident and to share and disseminate lessons learned to the wider nuclear community. In 2014, the Agency organized two international experts’ meetings (IEMs), one on radiation protection and one on severe accident management. Reports from previous IEMs were also published in 2014: IAEA Report on Human and Organizational Factors in Nuclear

  8. A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children.

    Science.gov (United States)

    Stassijns, Jorgen; Bollaerts, Kaatje; Baay, Marc; Verstraeten, Thomas

    2016-02-03

    New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children. We carried out a systematic search for safety data from published clinical trials on newly adjuvanted vaccines in children ≤10 years of age. Serious adverse events (SAEs), solicited AEs, unsolicited AEs and AEs of special interest were evaluated for four new adjuvants: the immuno-stimulants containing adjuvant systems AS01 and AS02, and the squalene containing oil-in-water emulsions AS03 and MF59. Relative risks (RR) were calculated, comparing children receiving newly adjuvanted vaccines to children receiving other vaccines with a variety of antigens, both adjuvanted and unadjuvanted. Twenty-nine trials were included in the meta-analysis, encompassing 25,056 children who received at least one dose of the newly adjuvanted vaccines. SAEs did not occur more frequently in adjuvanted groups (RR 0.85, 95%CI 0.75-0.96). Our meta-analyses showed higher reactogenicity following administration of newly adjuvanted vaccines, however, no consistent pattern of solicited AEs was observed across adjuvant systems. Pain was the most prevalent AE, but often mild and of short duration. No increased risks were found for unsolicited AEs, febrile convulsions, potential immune mediated diseases and new onset of chronic diseases. Our meta-analysis did not show any safety concerns in clinical trials of the newly adjuvanted vaccines in children ≤10 years of age. An unexplained increase of meningitis in one Phase III AS01-adjuvanted malaria trial and the link between narcolepsy and the AS03-adjuvanted pandemic vaccine illustrate that continued safety monitoring is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Safety balance: Analysis of safety systems

    International Nuclear Information System (INIS)

    Delage, M.; Giroux, C.

    1990-12-01

    Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

  10. Systematic review and meta-analysis of educational interventions designed to improve medication administration skills and safety of registered nurses.

    Science.gov (United States)

    Härkänen, Marja; Voutilainen, Ari; Turunen, Elina; Vehviläinen-Julkunen, Katri

    2016-06-01

    The aim of this study is to evaluate the nature, quality and effectiveness of educational interventions designed to increase the medication administration skills and safety of registered nurses working in hospitals. A systematic review with meta-analysis. Intervention studies designed to increase the medication administration skills and safety of nurses, indexed in one or more databases (CINAHL, PubMed, Scopus, Cochrane, PsycInfo, or Medic), and published in peer-reviewed journals between January 2000 and April 2015. The nature of the interventions was evaluated by narrative analysis, the quality of studies was assessed using the Effective Public Health Practise Project Quality Assessment Tool and the effectiveness of the interventions was ascertained by calculating effect sizes and conducting a meta-analysis. A total of 755 studies were identified and 14 intervention studies were reviewed. Interventions differed by their nature, including traditional classroom training, simulation, e-learning, slide show presentations, interactive CD-ROM programme, and the use of posters and pamphlets. All interventions appeared to improve medication administration safety and skills based on original p-values. Only five studies reached strong (n=1) or moderate (n=4) quality ratings and one of them had to be omitted from the meta-analysis due unclear measures of dispersion. The meta-analysis favoured the interventions, the pooled effect size (Hedges' g) was large, 1.06. The most effective interventions were a blended learning programme including e-learning and a 60-min PowerPoint presentation. The least effective educational intervention, an interactive internet-based e-learning course, was reported in the study that achieved the only strong quality rating. It is challenging to recommend any specific intervention, because all educational interventions seem to have a positive effect, although the size of the effect greatly varies. In the future, studies sharing similar contents and

  11. Efficacy and Safety of Tranexamic Acid in Melasma: A Meta-analysis and Systematic Review.

    Science.gov (United States)

    Kim, Hyun Jung; Moon, Seok Hoon; Cho, Sang Hyun; Lee, Jeong Deuk; Kim, Hei Sung

    2017-07-06

    Tranexamic acid is a novel treatment option for melasma; however, there is no consensus on its use. This systematic review searched major databases for relevant publications to March 2016. Eleven studies with 667 participants were included. Pooled data from tranexamic acid-only observational studies with pre- and post-treatment Melasma Area and Severity Index (MASI) showed a decrease of 1.60 in MASI (95% confidence interval (CI), 1.20-2.00; ptranexamic acid. The addition of tranexamic acid to routine treatment modalities resulted in a further decrease in MASI of 0.94 (95% CI 0.10-1.79; p = 0.03). Side-effects were minor, with a few cases reporting hypo-menorrhoea, mild abdominal discomfort, and transient skin irritation. These results support the efficacy and safety of tranexamic acid, either alone or as an adjuvant to routine treatment modalities for melasma.

  12. Insight from a Critical Review on the Safety Analysis of Nuclear Fuel Cycle Facility for Domestic Regulatory System

    International Nuclear Information System (INIS)

    Hong, Soon Joon; Chung, Young Wook; Jeong, Seung Young

    2010-01-01

    Korea has 20 nuclear power plants in operation, and 10,761 ton of spent fuel deposited in plant sites. The capacity of reservoir for spent fuel in plant sites is to begin to be full in 2016. The light water reactors of 16 units generate around 320 ton/year and the heavy water reactors of 4 units around 380 ton/year in Korea. And the electricity generated by nuclear power plants is planned to increase up to 59% share by 2030. Spent fuel classified as high level radioactive waste in law is characterized by high level radiation, high heat generation, and high radiological toxicity. In the contrary, it is also a very useful domestic energy source. Thus, the safe management of spent fuel is very important confronting job in nuclear industry. Advanced fuel cycle (AFC) using pyro-process is an innovative technology, by which environmental load is drastically relieved because the extracted long-lived fission products are burn in fast breeder reactors. Domestic nuclear industry also has a perspective road map for the construction of AFC facilities. However, there is not a sufficiently detailed licensing regulatory system yet. Moreover, there is no systematic frame for the safety evaluation. This paper reviews the safety analysis system of foreign fuel cycle facilities. Critical review leads to the insight for setting-up safety analysis system of domestic AFC facilities

  13. AGI Safety Literature Review

    OpenAIRE

    Everitt, Tom; Lea, Gary; Hutter, Marcus

    2018-01-01

    The development of Artificial General Intelligence (AGI) promises to be a major event. Along with its many potential benefits, it also raises serious safety concerns (Bostrom, 2014). The intention of this paper is to provide an easily accessible and up-to-date collection of references for the emerging field of AGI safety. A significant number of safety problems for AGI have been identified. We list these, and survey recent research on solving them. We also cover works on how best to think of ...

  14. Joint IAEA/NEA workshop proceedings on regulatory review of plant safety analysis - Abstracts, Summary and Conclusions

    International Nuclear Information System (INIS)

    Lacey, Derek; Drozd, Andrzej; Husarcek, Jan; Modro, Mike

    1999-01-01

    Based on the final discussion, the seminar was a valuable exchange of information and helpful in understanding the safety analysis and regulatory review issues. It gave a chance for some countries to see 'where they are' regulatory-wise with respect to other countries. There was a strong support for a follow-up workshop within the next two years. A general opinion expressed by most of the participants was that the suggested next seminar should be based more on an 'overall safety analysis' review rather than on very detailed presentations on specific issues. Also, there should be more discussions on Emergency Operating Procedures (EOPs) and emergency planning. In addition, to establish a 'common language', the development of a glossary of terms would be most helpful. In general, all of the participating countries are adapting regulatory and licensing practices previously developed by other countries. Such an approach allows to utilise and rely on a broad experience of countries with a well established nuclear power industry, strong regulatory organisation and licensing practices. Since there are obvious differences in engineering traditions and in countries' legal/regulatory frameworks, questions arise about how to reconcile these differences in adapting and developing practices suitable for a given country. It was advised as a good practice to identify from the very beginning what needs to be done and the goals to be accomplished not only in the perspective of safety and technical requirements but also in the context of the economical, political, legal and regulatory situation in a given country. There has to be a consistency in any approach, but one can never follow 'blindly' the others. It became quite obvious that the needs of countries with a big nuclear program are very different from those of 'small' countries. Adaptation of other countries' rules is a big effort in itself (e.g., Romania applying Canadian regulations). In addition, the French-German co

  15. Nuclear safety review for 1984

    International Nuclear Information System (INIS)

    1985-08-01

    This publication is based on the fourth Nuclear Safety Review prepared by the IAEA Secretariat for presentation to the Board of Governors. It discusses relevant international activities in 1984 and the current status of nuclear safety and radiation protection, and looks ahead to anticipated developments

  16. Removing unreasonable conservatisms in DOE safety analysis

    International Nuclear Information System (INIS)

    BISHOP, G.E.

    1999-01-01

    While nuclear safety analyses must always be conservative, invoking excessive conservatisms does not provide additional margins of safety. Rather, beyond a fairly narrow point, conservatisms skew a facility's true safety envelope by exaggerating risks and creating unreasonable bounds on what is required for safety. The conservatism has itself become unreasonable. A thorough review of the assumptions and methodologies contained in a facility's safety analysis can provide substantial reward, reducing both construction and operational costs without compromising actual safety

  17. Reactor Safety Analysis

    International Nuclear Information System (INIS)

    Arien, B.

    2000-01-01

    The objective of SCK-CEN's programme on reactor safety is to develop expertise in probabilistic and deterministic reactor safety analysis. The research programme consists of two main activities, in particular the development of software for reliability analysis of large systems and participation in the international PHEBUS-FP programme for severe accidents. Main achievements in 1999 are reported

  18. Preclosure Safety Analysis Guide

    International Nuclear Information System (INIS)

    D.D. Orvis

    2003-01-01

    A preclosure safety analysis (PSA) is a required element of the License Application (LA) for the high- level radioactive waste repository at Yucca Mountain. This guide provides analysts and other Yucca Mountain Repository Project (the Project) personnel with standardized methods for developing and documenting the PSA. The definition of the PSA is provided in 10 CFR 63.2, while more specific requirements for the PSA are provided in 10 CFR 63.112, as described in Sections 1.2 and 2. The PSA requirements described in 10 CFR Part 63 were developed as risk-informed performance-based regulations. These requirements must be met for the LA. The PSA addresses the safety of the Geologic Repository Operations Area (GROA) for the preclosure period (the time up to permanent closure) in accordance with the radiological performance objectives of 10 CFR 63.111. Performance objectives for the repository after permanent closure (described in 10 CFR 63.113) are not mentioned in the requirements for the PSA and they are not considered in this guide. The LA will be comprised of two phases: the LA for construction authorization (CA) and the LA amendment to receive and possess (R and P) high-level radioactive waste (HLW). PSA methods must support the safety analyses that will be based on the differing degrees of design detail in the two phases. The methods described herein combine elements of probabilistic risk assessment (PRA) and deterministic analyses that comprise a risk-informed performance-based safety analysis. This revision to the PSA guide was prepared for the following objectives: (1) To correct factual and typographical errors. (2) To provide additional material suggested from reviews by the Project, the U.S. Department of Energy (DOE), and U.S. Nuclear Regulatory Commission (NRC) Staffs. (3) To update material in accordance with approaches and/or strategies adopted by the Project. In addition, a principal objective for the planned revision was to ensure that the methods and

  19. Effects and safety of acupuncture for DFUs: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Ting Shuai

    2016-01-01

    Full Text Available Objective: To systematically evaluate the effect and safety of acupuncture for the treatment of diabetic foot ulcers (DFUs. Methods: Six databases, including Pubmed, Web of Science, EMbase, the Cochrane Library, the Chinese Biomedical Literature Database (CBM, and the China National Knowledge Infrastructure (CNKI, were electronic searched for randomized controlled trials (RCTs. Retrieval periods from each database were stopped until 30 October, 2014. Cochrane risk of bias assessment tool was used to assess the methodological quality of included studies. Results: A total of 8 trials involving 481 participants met the inclusion criteria. The results of meta and descriptive analysis suggested that acupuncture effectively improved total effective rate of DFUs, shortened ulcer healing time , and improved the blood flow volume, but acupuncture did not ameliorate vessel diameter and peak velocity. No serious adverse events were identified in acupuncture group. Conclusions: Acupuncture is more effective in shortening overall treatment time. Acupuncture has advantages over the control group in curative effect.

  20. Linking Safety Analysis to Safety Requirements

    DEFF Research Database (Denmark)

    Hansen, Kirsten Mark

    Software for safety critical systems must deal with the hazards identified by safety analysistechniques: Fault trees, event trees,and cause consequence diagrams can be interpreted as safety requirements and used in the design activity. We propose that the safety analysis and the system design use...

  1. The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

    Science.gov (United States)

    Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

    2018-01-01

    The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  2. Does clinical supervision of health professionals improve patient safety? A systematic review and meta-analysis.

    Science.gov (United States)

    Snowdon, David A; Hau, Raphael; Leggat, Sandra G; Taylor, Nicholas F

    2016-09-01

    To determine whether clinical supervision (CS) of health professionals improves patient safety. Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. Thirty-two studies across three health professions [medicine (n = 29), nursing (n = 2) and paramedicine (n = 1)] were selected. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Risk ratios (RR) were calculated for patient safety outcomes of mortality, complications, adverse events, reoperation following initial surgery, conversion to more invasive surgery and readmission to hospital. Results of meta-analyses provided low-quality evidence that supervision of medical professionals reduced the risk of mortality (RR 0.76, 95% CI 0.60-0.95, I(2) = 76%) and supervision of medical professionals and paramedics reduced the risk of complications (RR 0.69, 95% CI 0.53-0.89, I(2) = 76%). Due to a high level of statistical heterogeneity, sub-group analyses were performed. Sub-group analyses provided moderate-quality evidence that direct supervision of surgery significantly reduced the risk of mortality (RR 0.68, 95% CI 0.50-0.93, I(2) = 33%) and direct supervision of medical professionals conducting non-surgical invasive procedures significantly reduced the risk of complications (RR 0.33, 95% CI 0.24-0.46, I(2) = 0%). CS was associated with safer surgery and other invasive procedures for medical practitioners. There was a lack of evidence about the relationship between CS and safer patient care for non-medical health professionals. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Safety analysis for 'Fugen'

    International Nuclear Information System (INIS)

    1997-10-01

    The improvement of safety in nuclear power stations is an important proposition. Therefore also as to the safety evaluation, it is important to comprehensively and systematically execute it by referring to the operational experience and the new knowledge which is important for the safety throughout the period of use as well as before the construction and the start of operation of nuclear power stations. In this report, the results when the safety analysis for ''Fugen'' was carried out by referring to the newest technical knowledge are described. As the result, it was able to be confirmed that the safety of ''Fugen'' has been secured by the inherent safety and the facilities which were designed for securing the safety. The basic way of thinking on the safety analysis including the guidelines to be conformed to is mentioned. As to the abnormal transient change in operation and accidents, their definition, the events to be evaluated and the standards for judgement are reported. The matters which were taken in consideration at the time of the analysis are shown. The computation programs used for the analysis were REACT, HEATUP, LAYMON, FATRAC, SENHOR, LOTRAC, FLOOD and CONPOL. The analyses of the abnormal transient change in operation and accidents are reported on the causes, countermeasures, protective functions and results. (K.I.)

  4. Reviews on Food Safety

    International Nuclear Information System (INIS)

    Wilkins, E.

    2004-01-01

    Food safety is an increasing concern. The desire for rapid, specific methods for the detection of viable potential pathogens has grown into a necessity. Microbial contamination of meat, fresh fruits, and vegetables has become a mounting concern during the last decade due to emphasis on their importance in a healthy diet and the recognition of new food borne pathogens such as Campylobacter jejuni, Escherichia coli 0157:H7, and Listeria monocytogenes. This paper presents an overview of different commercial techniques for identification of bacteria such as: III-nitride on Silicon Chips for detection of live bacteria, Optical Biosensors, Piezoelectric-based acoustic wave devices, Electrochemical Biosensors, Immunogenic Techniques, Polymerase chain reaction

  5. Reviews on Food Safety

    Energy Technology Data Exchange (ETDEWEB)

    Wilkins, E [Department of Chemical and Nuclear Engineering. University orNew Mexico. 209 Farris Engineering Center. Albuquerque. NM 117131 (Ukraine)

    2004-07-01

    Food safety is an increasing concern. The desire for rapid, specific methods for the detection of viable potential pathogens has grown into a necessity. Microbial contamination of meat, fresh fruits, and vegetables has become a mounting concern during the last decade due to emphasis on their importance in a healthy diet and the recognition of new food borne pathogens such as Campylobacter jejuni, Escherichia coli 0157:H7, and Listeria monocytogenes. This paper presents an overview of different commercial techniques for identification of bacteria such as: III-nitride on Silicon Chips for detection of live bacteria, Optical Biosensors, Piezoelectric-based acoustic wave devices, Electrochemical Biosensors, Immunogenic Techniques, Polymerase chain reaction.

  6. Review of best estimate plus uncertainty methods of thermal-hydraulic safety analysis

    International Nuclear Information System (INIS)

    Prosek, A.; Mavko, B.

    2003-01-01

    In 1988 United States Nuclear Regulatory Commission approved the revised rule on the acceptance of emergency core cooling system (ECCS) performance. Since that there has been significant interest in the development of codes and methodologies for best-estimate loss-of-coolant accident (LOCAs) analyses. Several new best estimate plus uncertainty methods (BEPUs) were developed in the world. The purpose of the paper is to review the developments in the direction of best estimate approaches with uncertainty quantification and to discuss the problems in practical applications of BEPU methods. In general, the licensee methods are following original methods. The study indicated that uncertainty analysis with random sampling of input parameters and the use of order statistics for desired tolerance limits of output parameters is today commonly accepted and mature approach. (author)

  7. Reactor Safety Analysis

    International Nuclear Information System (INIS)

    Arien, B.

    1998-01-01

    The objective of SCK-CEN's programme on reactor safety is to develop expertise in probabilistic and deterministic reactor safety analysis. The research programme consists of four main activities, in particular the development of software for reliability analysis of large systems and participation in the international PHEBUS-FP programme for severe accidents, the development of an expert system for the aid to diagnosis; the development and application of a probabilistic reactor dynamics method. Main achievements in 1999 are reported

  8. Safety margins in deterministic safety analysis

    International Nuclear Information System (INIS)

    Viktorov, A.

    2011-01-01

    The concept of safety margins has acquired certain prominence in the attempts to demonstrate quantitatively the level of the nuclear power plant safety by means of deterministic analysis, especially when considering impacts from plant ageing and discovery issues. A number of international or industry publications exist that discuss various applications and interpretations of safety margins. The objective of this presentation is to bring together and examine in some detail, from the regulatory point of view, the safety margins that relate to deterministic safety analysis. In this paper, definitions of various safety margins are presented and discussed along with the regulatory expectations for them. Interrelationships of analysis input and output parameters with corresponding limits are explored. It is shown that the overall safety margin is composed of several components each having different origins and potential uses; in particular, margins associated with analysis output parameters are contrasted with margins linked to the analysis input. While these are separate, it is possible to influence output margins through the analysis input, and analysis method. Preserving safety margins is tantamount to maintaining safety. At the same time, efficiency of operation requires optimization of safety margins taking into account various technical and regulatory considerations. For this, basic definitions and rules for safety margins must be first established. (author)

  9. NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

    Science.gov (United States)

    Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

    2003-01-01

    The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

  10. The efficacy and safety of onabotulinumtoxinA in treating idiopathic OAB: A systematic review and meta-analysis.

    Science.gov (United States)

    Cui, Yuanshan; Zhou, Xin; Zong, Huantao; Yan, Huilei; Zhang, Yong

    2015-06-01

    We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating idiopathic OAB. A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of onabotulinumtoxinA for the treatment of idiopathic OAB. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Eight publications involving a total of 1,320 patients were used in the analysis, including six RCTs that compared onabotulinumtoxinA with placebo. OnabotulinumtoxinA significantly decreased the mean number of urinary incontinence (UI) per day -2.77 versus -1.01 (the standardized mean difference (SMD) = -1.68, 95% CI = -2.06 to -1.31, P SMD = -1.82, 95% CI = -2.61 to -1.02, P SMD = 63.82, 95% CI = 38.14 to 89.50, P SMD = 33.05, 95% CI = 22.45 to 43.66, P infections (UTI; P < 0.00001) and clean intermittent catheterization (CIC; P < 0.00001). This meta-analysis indicates that onabotulinumtoxinA to be an effective treatment for idiopathic overactive bladder symptoms with side effects primarily localized to urinary tract. © 2014 Wiley Periodicals, Inc.

  11. Post Chernobyl safety review at Ontario Hydro

    International Nuclear Information System (INIS)

    Frescura, G.M.; Luxat, J.C.; Jobe, C.

    1991-01-01

    It is generally recognized that the Chernobyl Unit 4 accident did not reveal any new phenomena which had not been previously identified in safety analyses. However, the accident provided a tragic reminder of the potential consequences of reactivity initiated accidents (RIAs) and stimulated nuclear plant operators to review their safety analyses, operating procedures and various operational and management aspects of nuclear safety. Concerning Ontario Hydro, the review of the accident performed by the corporate body responsible for nuclear safety policy and by the Atomic Energy Control Board (the Regulatory Body) led to a number of specific recommendations for further action by various design, analysis and operation groups. These recommendations are very comprehensive in terms of reactor safety issues considered. The general conclusion of the various studies carried out in response to the recommendations, is that the CANDU safety design and the procedures in place to identify and mitigate the consequences of accidents are adequate. Improvements to the reliability of the Pickering NGSA shutdown system and to some aspects of safety management and staff training, although not essential, are possible and would be pursued. In support of this conclusion, the paper describes some of the studies that were carried out and discusses the findings. The first part of the paper deals with safety design aspects. While the second is concerned with operational aspects

  12. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB and XDR-TB : systematic review and meta-analysis

    NARCIS (Netherlands)

    Sotgiu, Giovanni; Centis, Rosella; D'Ambrosio, Lia; Alffenaar, Jan-William C.; Anger, Holly A.; Caminero, Jose A.; Castiglia, Paolo; De Lorenzo, Saverio; Ferrara, Giovanni; Koh, Won-Jung; Schecter, Giesela F.; Shim, Tae S.; Singla, Rupak; Skrahina, Alena; Spanevello, Antonio; Udwadia, Zarir F.; Villar, Miquel; Zampogna, Elisabetta; Zellweger, Jean-Pierre; Zumla, Alimuddin; Migliori, Giovanni Battista

    2012-01-01

    Linezolid is used off-label to treat multidrug-resistant tuberculosis (MDR-TB) in absence of systematic evidence. We performed a systematic review and meta-analysis on efficacy, safety and tolerability of linezolid-containing regimes based on individual data analysis. 12 studies (11 countries from

  13. Standard Review Plan for the review of a license application for a low-level radioactive waste disposal facility: Safety analysis report

    International Nuclear Information System (INIS)

    1988-01-01

    The Standard Review Plan (SRP) (NUREG-1200) provides guidance to staff reviewers in the Office of Nuclear Material Safety and Safeguards who perform safety reviews of applications to construct and operate low-level radioactive waste disposal facilities. The SRP ensures the quality and uniformity of the staff reviews and presents a well-defined base from which to evaluate proposed changes in the scope and requirements of the staff reviews. The SRP makes information about the regulatory licensing process widely available and serves to improve the understanding of the staff's review process by interested members of the public and the industry. Each individual SRP addresses the responsibilities of persons performing the review, the matters that are reviewed, the Commission's regulations and acceptance criteria necessary for the review, how the review is accomplished, the conclusions that are appropriate, and the implementation requirements

  14. Standard review plan for the review of a license application for a low-level radioactive waste disposal facility: Safety analysis report

    International Nuclear Information System (INIS)

    1987-01-01

    The Standard Review Plan (SRP) (NUREG-1200) provides guidance to staff reviewers in the Office of Nuclear Material Safety and Safeguards who perform safety reviews of applications to construct and operate low-level radioactive waste disposal facilities. The SRP ensures the quality and uniformity of the staff reviews and presents a well-defined base from which to evaluate proposed changes in the scope and requirements of the staff reviews. The SRP makes information about the regulatory licensing process widely available and serves to improve the understanding of the staff's review process by interested members of the public and the nuclear power industry. Each individual SRP addresses the responsibilities of persons performing the review, the matters that are reviewed, the Commission's regulations and acceptance criteria necessary for the review, how the review is accomplished, the conclusions that are appropriate, and the implementation requirements

  15. Efficacy and Safety of Autologous Fat Transfer in Facial Reconstructive Surgery: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Krastev, Todor K; Beugels, Jip; Hommes, Juliette; Piatkowski, Andrzej; Mathijssen, Irene; van der Hulst, Rene

    2018-03-29

    The use of autologous fat transfer (AFT) or lipofilling for correcting contour deformities is seen as one of the major breakthroughs in reconstructive plastic surgery. Its applications in facial reconstructive surgery have been of particular interest owing to the prospect of achieving autologous reconstruction by a minimally invasive approach. However, its unpredictability and variable degree of resorption have limited its utility and much skepticism still exists regarding its efficacy. Furthermore, more than 2 decades of clinical research have produced a highly fragmented body of evidence that has not been able to provide definite answers. To investigate the safety and efficacy of AFT in facial reconstruction through a systematic review and meta-analysis. A literature search was performed in PubMed, Embase, and the Cochrane Library from inception to October 11, 2017. All published studies investigating the efficacy and safety of AFT in facial reconstructive surgery. Two independent reviewers performed data extraction systematically, adhering to the PRISMA guidelines. Summary measures were pooled in a random-effects model meta-analysis. The patient and surgeon satisfaction, graft survival, number of AFT sessions, and the incidence of AFT-related complications were the main outcomes of interest in this meta-analysis. This systematic review resulted in the inclusion 52 relevant studies consisting of 1568 unique patients. These included 4 randomized clinical trials, 11 cohort studies, and 37 case series. The overall follow-up averaged 1.3 years after AFT. Meta-analysis revealed a very high overall patient satisfaction rate of 91.1% (95% CI, 85.1%-94.8%) and overall surgeon satisfaction rate of 88.6% (95% CI, 83.4%-92.4%). The number of AFT sessions required to achieve the desired result was 1.5 (95% CI, 1.3-1.7) and 50% to 60% of the injected volume was retained at 1 year. Only 4.8% (95% CI, 3.3%-6.9%) of procedures resulted in clinical complications. To our knowledge

  16. Reactor safety analysis

    International Nuclear Information System (INIS)

    Arien, B.

    1998-01-01

    Risk assessments of nuclear installations require accurate safety and reliability analyses to estimate the consequences of accidental events and their probability of occurrence. The objective of the work performed in this field at the Belgian Nuclear Research Centre SCK-CEN is to develop expertise in probabilistic and deterministic reactor safety analysis. The four main activities of the research project on reactor safety analysis are: (1) the development of software for the reliable analysis of large systems; (2) the development of an expert system for the aid to diagnosis; (3) the development and the application of a probabilistic reactor-dynamics method, and (4) to participate in the international PHEBUS-FP programme for severe accidents. Progress in research during 1997 is described

  17. Patient safety during procedural sedation using capnography monitoring : A systematic review and meta-analysis

    NARCIS (Netherlands)

    Saunders, Rhodri; Struys, Michel M. R. F.; Pollock, Richard F.; Mestek, Michael; Lightdale, Jenifer R.

    2017-01-01

    Objective: To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone. Design and setting: Systematic literature review and random

  18. Subseabed disposal safety analysis

    International Nuclear Information System (INIS)

    Koplick, C.M.; Kabele, T.J.

    1982-01-01

    This report summarizes the status of work performed by Analytic Sciences Corporation (TASC) in FY'81 on subseabed disposal safety analysis. Safety analysis for subseabed disposal is divided into two phases: pre-emplacement which includes all transportation, handling, and emplacement activities; and long-term (post-emplacement), which is concerned with the potential hazard after waste is safely emplaced. Details of TASC work in these two areas are provided in two technical reports. The work to date, while preliminary, supports the technical and environmental feasibility of subseabed disposal of HLW

  19. The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report

    International Nuclear Information System (INIS)

    Nelson, R.C.; Gray, L.B.; Huff, D.A.

    1989-01-01

    The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment of the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System

  20. A systematic review and meta-analysis of the effectiveness of food safety education interventions for consumers in developed countries.

    Science.gov (United States)

    Young, Ian; Waddell, Lisa; Harding, Shannon; Greig, Judy; Mascarenhas, Mariola; Sivaramalingam, Bhairavi; Pham, Mai T; Papadopoulos, Andrew

    2015-08-26

    Foodborne illness has a large public health and economic burden worldwide, and many cases are associated with food handled and prepared at home. Educational interventions are necessary to improve consumer food safety practices and reduce the associated burden of foodborne illness. We conducted a systematic review and targeted meta-analyses to investigate the effectiveness of food safety education interventions for consumers. Relevant articles were identified through a preliminary scoping review that included: a comprehensive search in 10 bibliographic databases with verification; relevance screening of abstracts; and extraction of article characteristics. Experimental studies conducted in developed countries were prioritized for risk-of-bias assessment and data extraction. Meta-analysis was conducted on data subgroups stratified by key study design-intervention-population-outcome categories and subgroups were assessed for their quality of evidence. Meta-regression was conducted where appropriate to identify possible sources of between-trial heterogeneity. We identified 79 relevant studies: 17 randomized controlled trials (RCTs); 12 non-randomized controlled trials (NRTs); and 50 uncontrolled before-and-after studies. Several studies did not provide sufficient details on key design features (e.g. blinding), with some high risk-of-bias ratings due to incomplete outcome data and selective reporting. We identified a moderate to high confidence in results from two large RCTs investigating community- and school-based educational training interventions on behaviour outcomes in children and youth (median standardized mean difference [SMD] = 0.20, range: 0.05, 0.35); in two small RCTs evaluating video and written instructional messaging on behavioural intentions in adults (SMD = 0.36, 95% confidence interval [CI]: 0.02, 0.69); and in two NRT studies for university-based education on attitudes of students and staff (SMD = 0.26, 95% CI: 0.10, 0.43). Uncontrolled before

  1. Manpower analysis in transportation safety. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Bauer, C.S.; Bowden, H.M.; Colford, C.A.; DeFilipps, P.J.; Dennis, J.D.; Ehlert, A.K.; Popkin, H.A.; Schrader, G.F.; Smith, Q.N.

    1977-05-01

    The project described provides a manpower review of national, state and local needs for safety skills, and projects future manning levels for transportation safety personnel in both the public and private sectors. Survey information revealed that there are currently approximately 121,000 persons employed directly in transportation safety occupations within the air carrier, highway and traffic safety, motor carrier, pipeline, rail carrier, and marine carrier transportation industry groups. The projected need for 1980 is over 145,000 of which over 80 percent will be in highway safety. An analysis of transportation tasks is included, and shows ten general categories about which the majority of safety activities are focused. A skills analysis shows a generally high level of educational background and several years of experience are required for most transportation safety jobs. An overall review of safety programs in the transportation industry is included, together with chapters on the individual transportation modes.

  2. Safety analysis - current and future regulatory challenges

    Energy Technology Data Exchange (ETDEWEB)

    Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

    2015-07-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  3. Safety analysis - current and future regulatory challenges

    International Nuclear Information System (INIS)

    Jamieson, T.

    2015-01-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  4. Computer aided safety analysis

    International Nuclear Information System (INIS)

    1988-05-01

    The document reproduces 20 selected papers from the 38 papers presented at the Technical Committee/Workshop on Computer Aided Safety Analysis organized by the IAEA in co-operation with the Institute of Atomic Energy in Otwock-Swierk, Poland on 25-29 May 1987. A separate abstract was prepared for each of these 20 technical papers. Refs, figs and tabs

  5. Preliminary safety analysis methodology for the SMART

    Energy Technology Data Exchange (ETDEWEB)

    Bae, Kyoo Hwan; Chung, Y. J.; Kim, H. C.; Sim, S. K.; Lee, W. J.; Chung, B. D.; Song, J. H. [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2000-03-01

    This technical report was prepared for a preliminary safety analysis methodology of the 330MWt SMART (System-integrated Modular Advanced ReacTor) which has been developed by Korea Atomic Energy Research Institute (KAERI) and funded by the Ministry of Science and Technology (MOST) since July 1996. This preliminary safety analysis methodology has been used to identify an envelope for the safety of the SMART conceptual design. As the SMART design evolves, further validated final safety analysis methodology will be developed. Current licensing safety analysis methodology of the Westinghouse and KSNPP PWRs operating and under development in Korea as well as the Russian licensing safety analysis methodology for the integral reactors have been reviewed and compared to develop the preliminary SMART safety analysis methodology. SMART design characteristics and safety systems have been reviewed against licensing practices of the PWRs operating or KNGR (Korean Next Generation Reactor) under construction in Korea. Detailed safety analysis methodology has been developed for the potential SMART limiting events of main steam line break, main feedwater pipe break, loss of reactor coolant flow, CEA withdrawal, primary to secondary pipe break and the small break loss of coolant accident. SMART preliminary safety analysis methodology will be further developed and validated in parallel with the safety analysis codes as the SMART design further evolves. Validated safety analysis methodology will be submitted to MOST as a Topical Report for a review of the SMART licensing safety analysis methodology. Thus, it is recommended for the nuclear regulatory authority to establish regulatory guides and criteria for the integral reactor. 22 refs., 18 figs., 16 tabs. (Author)

  6. Software safety hazard analysis

    International Nuclear Information System (INIS)

    Lawrence, J.D.

    1996-02-01

    Techniques for analyzing the safety and reliability of analog-based electronic protection systems that serve to mitigate hazards in process control systems have been developed over many years, and are reasonably well understood. An example is the protection system in a nuclear power plant. The extension of these techniques to systems which include digital computers is not well developed, and there is little consensus among software engineering experts and safety experts on how to analyze such systems. One possible technique is to extend hazard analysis to include digital computer-based systems. Software is frequently overlooked during system hazard analyses, but this is unacceptable when the software is in control of a potentially hazardous operation. In such cases, hazard analysis should be extended to fully cover the software. A method for performing software hazard analysis is proposed in this paper

  7. Safety Review Services, Site Review Services and IRRS

    International Nuclear Information System (INIS)

    Yllera, Javier

    2010-01-01

    The selection and the evaluation of the site for a nuclear power plant are crucial parts of establishing a nuclear power programme and can be significantly affected by costs, public acceptance and safety considerations. Siting is the process of selecting a suitable site for a facility. This is area containing the plant, defined by a boundary and under effective control of the Plant Management. For safety related issues comparison within topics is generally quite straightforward. For example, sites with relatively higher seismic hazard would be penalized in comparison with those in more stable areas. The site for the NPP is generally chosen at a relatively ‘aseismic’ part of the country. This generally means that well known seismogenic sources are more than at least 50 kms from the site. The proposed sites for nuclear installations shall be examined with respect to the frequency and the severity of natural and human induced events and phenomena that could affect the safety of the installation. The Events unconnected with the operation of a facility or activity which could have an effect on the safety of the facility or activity. The relationship between the site and the design for the nuclear installation shall be examined to ensure that the radiological risk to the public and the environment arising from releases defined by the source terms is acceptably low. The Nuclear Regulatory Authority should issue a document that sets out the technical safety and security criteria against which the Site Permit Application for a new NPP will be reviewed. The objective of the Site Safety Review Services (SSRS) is provided upon request from a Member State. An independent review and assessment of the site and nuclear installation safety in relation to external natural and man induced hazards. This is to make recommendations on additional analysis or plant modifications to be carried out in order to comply with the IAEA Safety Standards and to enhance safety

  8. Safety of continuing aspirin therapy during spinal surgery: A systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Chenggui; Wang, Guodong; Liu, Xiaoyang; Li, Yang; Sun, Jianmin

    2017-11-01

    Questions whether to continue or discontinue aspirin administration in the perioperative period of spinal surgery has not been systematically evaluated. The present systematic review is carried out to assess the impact of continuing aspirin administration on the bleeding and cardiovascular events in perispinal surgery period. Studies were retrieved through MEDLINE, EMBASE, and Springer Link Databases (search terms, aspirin, continue or discontinue, and spinal fusion), bibliographies of the articles retrieved, and the authors' reference files. We included studies that enrolled patients who underwent spinal surgery who were anticoagulated with aspirin alone and that reported bleeding or cardiovascular events as an outcome. Study quality was assessed using a validated form. 95% confidence interval (95% CI) was pooled to give summary estimates of bleeding and cardiovascular risk. We identified 4 studies assessing bleeding risk associated with aspirin continuation or cardiovascular risk with aspirin discontinuation during spinal surgery. The continuation of aspirin will not increase the risk of blood loss during the spinal surgery (95% CI, -111.72 to -0.59; P = .05). Also, there was no observed increase in the operative time (95% CI, -33.29 to -3.89; P = .01) and postoperative blood transfusion (95% CI, 0.00-0.27; P = .05). But as for the cardiovascular risk without aspirin continuation and mean hospital length of stay with aspirin continuation, we did not get enough samples to make an accurate decision about their relations with aspirin. Patients undergoing spinal surgery with continued aspirin administration do not have an increased risk for bleeding. In addition, there is no observed increase in the operation time and postoperative blood transfusion.

  9. Status of safety analysis reports

    International Nuclear Information System (INIS)

    Cserhati, A.

    1999-01-01

    The safety regulation connected to both of the Atomic Acts from 1980 and 1996 requires preparation of the Preliminary Safety Analysis Report (PSAR) as well as Final SAR (FSAR). In this respect the licensing procedure for the construction and commissioning of Paks NPP did not formally deviate from the standards applied in developed countries; this is particularly true if comparison is made with the standards applied for commissioning NPPs in the second half of the seventies. By the time the overall development of internationally accepted safety standards and some existing deficiencies of earlier SAR made necessary a general reassessment of the plant safety (AGNES project). The carried out PSR for Paks-1 and 2 also added a valuable contribution to the SAR content, however a formal update of SAR is not made yet. A Hungarian nuclear authority decree from 1997 obligates the licensee to prepare and submit a major upgrade of FSAR until the mid of 2000, after finishing the PSR for Paks-3 and 4. From this date a periodic update of FSAR is required every year. The operational license renewal affects only the PSR but not the FSAR updating. The new Nuclear Safety Code outlines the contents of PSAR and FSAR, based on US NRC Reg. Guide 1. 70. Rev. 3. Hungary by now can fulfill the upgrading of SAR without major external technical or financial help. The AGNES project covered the safety analysis chapters of SAR. It was financed mainly by the country. In the project there have been involved in limited cases as performers the VTT (Finland), Belgatom (Belgium), GRS (Germany), etc., the IVO (Finland) fulfilled tasks of an independent reviewer for safety analysis. The AGNES had certain interconnection with the similar IAEA RER safety reassessment project for WWER-440/213. The PSR for Paks-1 and 2 have been carried out by the Paks staff from the resources of the plant. During the evaluation of several parts of Paks-3 and 4 PSR documentation the authority intends to use certain

  10. Status of safety analysis reports

    Energy Technology Data Exchange (ETDEWEB)

    Cserhati, A

    1999-06-01

    The safety regulation connected to both of the Atomic Acts from 1980 and 1996 requires preparation of the Preliminary Safety Analysis Report (PSAR) as well as Final SAR (FSAR). In this respect the licensing procedure for the construction and commissioning of Paks NPP did not formally deviate from the standards applied in developed countries; this is particularly true if comparison is made with the standards applied for commissioning NPPs in the second half of the seventies. By the time the overall development of internationally accepted safety standards and some existing deficiencies of earlier SAR made necessary a general reassessment of the plant safety (AGNES project). The carried out PSR for Paks-1 and 2 also added a valuable contribution to the SAR content, however a formal update of SAR is not made yet. A Hungarian nuclear authority decree from 1997 obligates the licensee to prepare and submit a major upgrade of FSAR until the mid of 2000, after finishing the PSR for Paks-3 and 4. From this date a periodic update of FSAR is required every year. The operational license renewal affects only the PSR but not the FSAR updating. The new Nuclear Safety Code outlines the contents of PSAR and FSAR, based on US NRC Reg. Guide 1. 70. Rev. 3. Hungary by now can fulfill the upgrading of SAR without major external technical or financial help. The AGNES project covered the safety analysis chapters of SAR. It was financed mainly by the country. In the project there have been involved in limited cases as performers the VTT (Finland), Belgatom (Belgium), GRS (Germany), etc., the IVO (Finland) fulfilled tasks of an independent reviewer for safety analysis. The AGNES had certain interconnection with the similar IAEA RER safety reassessment project for WWER-440/213. The PSR for Paks-1 and 2 have been carried out by the Paks staff from the resources of the plant. During the evaluation of several parts of Paks-3 and 4 PSR documentation the authority intends to use certain

  11. Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis

    Science.gov (United States)

    2013-01-01

    Background Tofacitinib is a disease-modifying antirheumatic drug (DMARD) which was recently approved by US Food and Drug Administration (FDA). There are several randomised clinical trials (RCTs) that have investigated the efficacy and safety of tofacitinib in adult patients with rheumatoid arthritis (RA). A systematic review with a meta-analysis of RCTs was undertaken to determine the efficacy and safety of tofacitinib in treating patients with RA. Methods Electronic and clinical trials register databases were searched for published RCTs of tofacitinib between 2009 and 2013. Outcomes of interest include 20% and 50% improvement in the American College of Rheumatology Scale (ACR20 and ACR50) response rates, rates of infection, the number of immunological/haematological adverse events (AEs), deranged laboratory results (hepatic, renal, haematological tests and lipoprotein level) and the incidence of drug withdrawal. Results Eight RCTs (n = 3,791) were reviewed. Significantly greater ACR20 response rates were observed in patients receiving tofacitinib 5 and 10 mg bid (twice daily) versus placebo at week 12, with risk ratios (RR) of 2.20 (95% CI 1.58, 3.07) and 2.38 (95% CI 1.81, 3.14) respectively. The effect was maintained at week 24 for 5 mg bid (RR 1.94; 95% CI 1.55, 2.44) and 10 mg bid (RR 2.20; 95% CI 1.76, 2.75). The ACR50 response rate was also significantly higher for patients receiving tofacitinib 5 mg bid (RR 2.91; 95% CI 2.03, 4.16) and 10 mg bid (RR 3.32; 95% CI 2.33, 4.72) compared to placebo at week 12. Patients in the tofacitinib group had significantly lower mean neutrophil counts, higher serum creatinine, higher percentage change of LDL/HDL and a higher risk of ALT/AST > 1 ULN (upper limit of normal) versus placebo. There were no significant differences in AEs and withdrawal due to AEs compared to placebo. Conclusion Tofacitinib is efficacious and well tolerated in patients with MTX-resistant RA up to a period of 24 weeks. However

  12. Safety and efficiency of flow diverters for treating small intracranial aneurysms: A systematic review and meta-analysis.

    Science.gov (United States)

    Yao, Xiyang; Ma, Junwei; Li, Haiying; Shen, Haitao; Lu, Xiaojun; Chen, Gang

    2017-02-01

    Background We evaluated the safety and efficiency of flow diverters (FDs) in treating small intracranial aneurysms (IAs). Materials and Methods We reviewed the literature published in PubMed and EMBASE. R for Project software was used to calculate the complete aneurysm occlusion rates, procedure-related neurologic mortality, procedure-related neurologic morbidity and procedure-related permanent morbidity. Results Ten observational studies were included in this analysis. The complete aneurysm occlusion rate was 84.23% (80.34%-87.76%), the procedure-related neurologic mortality was 0.87% (0.29%-1.74%), the procedure-related neurologic morbidity rate was 5.22% (3.62%-7.1%), the intracerebral haemorrhage rate was 1.42% (0.64%-2.49%), the ischemic rate was 2.35% (1.31%-3.68%), the subarachnoid haemorrhage rate was 0.03% (0%-0.32%) and the procedure-related permanent morbidity was 2.41% (0.81%-4.83%). Conclusions Treatment of small IAs with FDs may be correlated with high complete occlusion rates and low complication rates. Future long-term follow-up randomized trials will determine the optimal treatment for small IAs.

  13. Nuclear safety review requirements for launch approval

    International Nuclear Information System (INIS)

    Sholtis, J.A. Jr.; Winchester, R.O.

    1992-01-01

    Use of nuclear power systems in space requires approval which is preceded by extensive safety analysis and review. This careful study allows an informed risk-benefit decision at the highest level of our government. This paper describes the process as it has historically been applied to U.S. isotopic power systems. The Ulysses mission, launched in October 1990, is used to illustrate the process. Expected variations to deal with reactor-power systems are explained

  14. Systematic review and meta-analysis of the efficacy and safety of amfepramone and mazindol as a monotherapy for the treatment of obese or overweight patients

    OpenAIRE

    Lucchetta, Rosa Camila; Riveros, Bruno Salgado; Pontarolo, Roberto; Radominski, Rosana Bento; Otuki, Michel Fleith; Fernandez-Llimos, Fernando; Correr, Cassyano Januário

    2017-01-01

    The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global eva...

  15. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  16. Nuclear Safety Research Review Committee

    International Nuclear Information System (INIS)

    Todreas, N.E.

    1990-01-01

    The Nuclear Safety Research Review Committee has had a fundamental difficulty because of the atmosphere that has existed since it was created. It came into existence at a time of decreasing budgets. For any Committee the easiest thing is to tell the Director what additional to do. That does not really help him a lot in this atmosphere of reduced budgets which he reviewed for you on Monday. Concurrently the research arm of Nuclear Regulatory Commission has recognized that the scope of its activity needed to be increased rather than decreased. In the last two-and-a-half-year period, human factors work was reinstated, radiation and health effects investigations were reinvigorated, research in the waste area was given significant acceleration. Further, accident management came into being, and the NRC finally got back into the TMI-2 area. So with all of those activities being added to the program at the same time that the research budget was going down, the situation has become very strained. What that leads to regarding Committee membership is a need for technically competent generalists who will be able to sit as the Division Directors come in, as the contractors come in, and sort the wheat from the chaff. The Committee needs people who are interested in and have a broad perspective on what regulatory needs are and specifically how safety research activities can contribute to them. The author summarizes the history of the Committee, the current status, and plans for the future

  17. An efficacy and safety comparison between different stentriever designs in acute ischaemic stroke: a systematic review and meta-analysis

    International Nuclear Information System (INIS)

    Grech, R.; Pullicino, R.; Thornton, J.; Downer, J.

    2016-01-01

    Aim: To assess the recanalisation rates and long-term functional outcomes of the Solitaire and Trevo devices; to compare these results to those from the Solitaire With the Intention For Thrombectomy (SWIFT) trial and TREVO 2 studies; and to assess for statistical differences in the outcomes between the two devices. Materials and methods: A systematic review and meta-analysis of studies that utilised stentrievers in the treatment of acute ischaemic stroke was conducted. The results were compared to those of the SWIFT and TREVO 2 trials and outcome differences between Trevo (Stryker, Kalamazoo, Michigan, USA) and Solitaire (ev3/Covidien, Irvine, California, USA) were analysed statistically. Results: Solitaire had a lower mortality rate compared to Trevo (16.2% [95% confidence interval {CI}: 13.1%, 19.8%] versus 22.2% [95% CI: 10.8%, 40.2%]) and achieved a higher rate of functional independence (52.1% [95% CI: 46.3%, 57.8%] versus 47.6% [95% CI: 36.7%, 58.8%]). Statistical tests, however, failed to demonstrate significant differences in either functional outcomes or 3-month mortality rates. No significant differences were noted in weighted mean recanalisation rates between the Solitaire and Trevo groups. Conclusion: Stentrievers achieve a high rate of recanalisation and functional independence in acute ischaemic stroke and have a relatively good safety profile. No significant differences in functional outcomes, mortality, and symptomatic intra-cranial haemorrhage could be demonstrated between two popular stentrievers designs, namely Trevo and Solitaire. - Highlights: • We conducted a meta-analysis of stentrievers in acute ischaemic stroke. • We assessed recanalization rates and functional outcomes of stentrievers. • We also explored any differences between different stentriever designs. • We failed to demonstrate significant differences between Trevo and Solitaire.

  18. Safety of Patient Mobilization and Rehabilitation in the Intensive Care Unit. Systematic Review with Meta-Analysis.

    Science.gov (United States)

    Nydahl, Peter; Sricharoenchai, Thiti; Chandra, Saurabh; Kundt, Firuzan Sari; Huang, Minxuan; Fischill, Magdalena; Needham, Dale M

    2017-05-01

    Early mobilization and rehabilitation of patients in intensive care units (ICUs) may improve physical function, and reduce the duration of delirium, mechanical ventilation, and ICU length of stay. However, safety concerns are an important barrier to widespread implementation. To synthesize safety data regarding patient mobilization and rehabilitation in the ICU, including falls, removal of endotracheal tubes, removal or dysfunction of intravascular catheters, removal of other catheters/tubes, cardiac arrest, hemodynamic changes, and desaturation. Systematic literature review, including searches of five databases. Eligible studies evaluated patients who received mobilization-related interventions in the ICU. Exclusion criteria included: (1) case series with fewer than 10 patients; (2) majority of patients under 18 years of age; and (3) data not reported to permit calculation of incidence of safety events. Number of patients, mobilization/rehabilitation sessions, potential safety events, and events with negative consequences (e.g., requiring intervention or additional therapy). Heterogeneity was assessed by I 2 statistics, and bias assessed by the Newcastle-Ottawa Scale and Cochrane risk of bias assessment. The literature search identified 20,660 titles. There were 48 eligible publications evaluating 7,546 patients, with 583 potential safety events occurring in 22,351 mobilization/rehabilitation sessions. There was a total of 583 (2.6%) potential safety events with heterogeneity in the definitions for these events. For the safety event types that could be meta-analyzed, pooled incidences per 1,000 mobilization/rehabilitation sessions (95% confidence interval), were: hemodynamic changes, 3.8 (1.3-11.4), and desaturation, 1.9 (0.9-4.3). A total of 24 studies of 3,404 patients reported on any consequences of potential safety events (e.g., needing to increase dose of vasopressor due to mobility-related hypotension), with a frequency of 0.6% in 14,398 mobilization

  19. The efficacy and safety of oxandrolone treatment for patients with severe burns: A systematic review and meta-analysis.

    Science.gov (United States)

    Li, Hui; Guo, Yinan; Yang, Zhenyu; Roy, Mridul; Guo, Qulian

    2016-06-01

    The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of using oxandrolone in patients with severe burns. PubMed, Medline, Ovid, Cochrane Library, Elsevier Science, ProQuest, and Springer Link databases were searched. Randomized trials were included, and clinically important measures were selected. The outcomes were pooled with Revman 5.2. Other outcomes that could not be pooled were described in detail. Finally, 15 randomized controlled trials (RCTs) were identified for analysis in this review, including 806 participants. 1. Mortality, infection, and hepatic function: Oxandrolone therapy did not affect mortality (relative risk (RR)=0.85, 95% confidence interval (CI)=(0.38, 1.89), P=0.69) or infection (RR=0.87, (0.69, 1.11), P=0.26). The two groups (oxandrolone group vs. control group) showed no significant difference in liver dysfunction (RR=1.15, (0.83, 1.59), P=0.41). All the 15 RCTs reported no incidence of hepatic insufficiency in controls or treatment groups. 2. In the catabolic phase: Treatment with oxandrolone shortened length of stay by 3.02 (2.37, 3.66) days, donor-site healing time by 4.41 (3.41, 5.41) days, the time between surgical procedures by 0.63 (0.11, 1.16) days, as well as reduced weight loss by 5 (3.70, 6.30) kg and nitrogen loss by 8.19 (6.87, 9.52) g/day, with all PTreatment with oxandrolone shortened the length of stay to 6.45 (4.20, 8.69) days, as well as decreased weight loss by 0.86 (0.76, 0.96) kg/week and reduction of lean body mass by 5% (3.34, 6.66), with all Ptreatment led to an additional gain in lean body mass of 3.99% (3.08, 4.89) after 6 months and 10.78% (9.92, 11.64) after 12 months in patients with severe burns, with all Ptreatment of severe burns with oxandrolone is significantly effective without obvious side effects. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  20. Efficacy and Safety of Alfuzosin as Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Chenli Liu

    Full Text Available Alfuzosin has been widely used to treat benign prostatic hyperplasia and prostatitis, and is claimed to be a selective agent for the lower urinary tract with low incidence of adverse side-effects and hypotensive changes. Recently, several randomized controlled trials have reported using Alfuzosin as an expulsive therapy of ureteral stones. Tamsulosin, another alpha blocker, has also been used as an agent for the expulsive therapy for ureteral stones. It is unclear whether alfuzosin has similar efficacy as Tamsulosin in the management of ureteral stones.To perform a systematic review and analysis of literatures comparing Alfuzosin with Tamsulosin or standard conservative therapy for the treatment of ureteral stones less than 10 mm in diameter.A systematic literature review was performed in December 2014 using Pubmed, Embase, and the Cochrane library databases to identify relevant studies. All randomized and controlled trials were included. A subgroup analysis was performed comparing Alfuzosin with control therapy on the management of distal ureteral stones.Alfuzosin provided a significantly higher stone-free rate than the control treatments (RR: 1.85; 95% confidence interval [CI], 1.35-2.55; p<0.001, and a shorter stone expulsion time (Weighted mean difference [WMD]: -4.20 d, 95%CI, -6.19 to -2.21; p<0.001, but it has a higher complication rate (RR: 2.02; 95% CI, 1.30-3.15; p<0.01. When Alfuzosin was compared to Tamsulosin, there was no significant difference in terms of stone-free rate (RR: 0.90; 95% CI, 0.79-1.02; p = 0.09 as well as the stone expulsion time (WMD: 0.52 d, 95%CI, -1.61 to 2.64; p = 0.63. The adverse effects of Alfuzosin were similar to those of Tamsulosin (RR: 0.88; 95% CI, 0.61-1.26; p = 0.47.Alfuzosin is a safe and effective agent for the expulsive therapy of ureteral stones smaller than 10 mm in size. It is more effective than therapeutic regiment without alpha blocker. It is equivalent to Tamsulosin in its effectiveness and

  1. Radwaste Disposal Safety Analysis

    International Nuclear Information System (INIS)

    Hwang, Yong Soo; Kang, C. H.; Lee, Y. M.; Lee, S. H.; Jeong, J. T.; Choi, J. W.; Park, S. W.; Lee, H. S.; Kim, J. H.; Jeong, M. S.

    2010-02-01

    For the purpose of evaluating annual individual doses from a potential repository disposing of radioactive wastes from the operation of the prospective advanced nuclear fuel cycle facilities in Korea, the new safety assessment approaches are developed such as PID methods. The existing KAERI FEP list was reviewed. Based on these new reference and alternative scenarios are developed along with a new code based on the Goldsim. The code based on the compartment theory can be applied to assess both normal and what if scenarios. In addition detailed studies on THRC coupling is studied. The oriental biosphere study ends with great success over the completion of code V and V with JAEA. The further development of quality assurance, in the form of the CYPRUS+ enables handy use of it for information management

  2. The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

    NARCIS (Netherlands)

    Abbott, T. E. F.; Ahmad, T.; Phull, M. K.; Fowler, A. J.; Hewson, R.; Biccard, B. M.; Chew, M. S.; Gillies, M.; Pearse, R. M.; Pearse, Rupert M.; Beattie, Scott; Clavien, Pierre-Alain; Demartines, Nicolas; Fleisher, Lee A.; Grocott, Mike; Haddow, James; Hoeft, Andreas; Holt, Peter; Moreno, Rui; Pritchard, Naomi; Rhodes, Andrew; Wijeysundera, Duminda; Wilson, Matt; Ahmed, Tahania; Everingham, Kirsty; Hewson, Russell; Januszewska, Marta; Phull, Mandeep-Kaur; Halliwell, Richard; Shulman, Mark; Myles, Paul; Schmid, Werner; Hiesmayr, Michael; Wouters, Patrick; de Hert, Stefan; Lobo, Suzana; Fang, Xiangming; Rasmussen, Lars; Futier, Emmanuel; Biais, Matthieu; Venara, Aurélien; Slim, Karem; Sander, Michael; Koulenti, Despoina; Arvaniti, Kostoula; Chan, Mathew; Kulkarni, Atul; Chandra, Susilo; Tantri, Aida; Geddoa, Emad; Abbas, Muntadhar; Della Rocca, Giorgio; Sivasakthi, Datin; Mansor, Marzida; Luna, Pastor; Bouwman, Arthur; Buhre, Wolfgang; Beavis, Vanessa; Campbell, Douglas; Short, Tim; Osinaike, Tunde; Matos, Ricardo; Grigoras, Ioana; Kirov, Mikhail; Protsenko, Denis; Biccard, Bruce; Aldecoa, Cesar; Chew, Michelle; Hofer, Christoph; Hubner, Martin; Ditai, James; Szakmany, Tamas; Fleisher, Lee; Ferguson, Marissa; MacMahon, Michael; Cherian, Ritchie; Currow, Helen; Kanathiban, Kathirgamanathan; Gillespie, David; Pathmanathan, Edward; Phillips, Katherine; Reynolds, Jenifer; Rowley, Joanne; Douglas, Jeanene; Kerridge, Ross; Garg, Sameer; Bennett, Michael; Jain, Megha; Alcock, David; Terblanche, Nico; Cotter, Rochelle; Leslie, Kate; Stewart, Marcelle; Zingerle, Nicolette; Clyde, Antony; Hambidge, Oliver; Rehak, Adam; Cotterell, Sharon; Huynh, Wilson Binh Quan; McCulloch, Timothy; Ben-Menachem, Erez; Egan, Thomas; Cope, Jennifer; Fellinger, Paul; Haisjackl, Markus; Haselberger, Simone; Holaubek, Caroline; Lichtenegger, Paul; Scherz, Florian; Hoffer, Franz; Cakova, Veronika; Eichwalder, Andreas; Fischbach, Norbert; Klug, Reinhold; Schneider, Elisabeth; Vesely, Martin; Wickenhauser, Reinhart; Grubmueller, Karl Gernot; Leitgeb, Marion; Lang, Friedrich; Toro, Nancy; Bauer, Marlene; Laengle, Friedrich; Haberl, Claudia; Mayrhofer, Thomas; Trybus, Christoph; Buerkle, Christian; Forstner, Karin; Germann, Reinhard; Rinoesl, Harald; Schindler, Elke; Trampitsch, Ernst; Bogner, Gerhard; Dankl, Daniel; Duenser, Martin; Fritsch, Gerhard; Gradwohl-Matis, Ilse; Hartmann, Andreas; Hoelzenbein, Thomas; Jaeger, Tarkan; Landauer, Franz; Lindl, Gregor; Lux, Michael; Steindl, Johannes; Stundner, Ottokar; Szabo, Christian; Bidgoli, Jawad; Verdoodt, Hans; Forget, Patrice; Kahn, David; Lois, Fernande; Momeni, Mona; Prégardien, Caroline; Pospiech, Audrey; Steyaert, Arnaud; Veevaete, Laurent; de Kegel, Dirk; de Jongh, Karen; Foubert, Luc; Smitz, Carine; Vercauteren, Marcel; Poelaert, Jan; van Mossevelde, Veerle; Abeloos, Jacques; Bouchez, Stefaan; Coppens, Marc; de Baerdemaeker, Luc; Deblaere, Isabel; de Bruyne, Ann; Fonck, Kristine; Heyse, Bjorn; Jacobs, Tom; Lapage, Koen; Moerman, Anneliese; Neckebroek, Martine; Parashchanka, Aliaksandra; Roels, Nathalie; van den Eynde, Nancy; Vandenheuvel, Michael; Limmen, JurgenVan; Vanluchene, Ann; Vanpeteghem, Caroline; Wyffels, Piet; Huygens, Christel; Vandenbempt, Punitha; van de Velde, Marc; Dylst, Dimitri; Janssen, Bruno; Schreurs, Evelien; Aleixo, Fábia Berganton; Candido, Keulle; Batista, Hugo Dias; Guimarães, Mario; Guizeline, Jaqueline; Hoffmann, João; Lobo, Francisco Ricardo Marques; Nascimento, Vinícius; Nishiyama, Katia; Pazetto, Lucas; Souza, Daniela; Rodrigues, Rodrigo Souza; Vilela Dos Santos, Ana Maria; Jardim, Jaquelline; Sá Malbouisson, Luiz Marcelo; Silva, Joao; Nascimento Junior, Paulo do; Baio, Thalissa Hermínia; Pereira de Castro, Gabriel Isaac; Watanabe Oliveira, Henri Roger; Amendola, Cristina Prata; Cardoso, Gutemberg; Ortega, Daniela; Brotto, Ana Flavia; de Oliveira, Mirella Cristine; Réa-Neto, Álvaro; Dias, Fernando; Travi, Maria Eduarda; Zerman, Luiza; Azambuja, Pedro; Knibel, Marcos Freitas; Martins, Antonio; Almeida, William; Neto, Calim Neder; Tardelli, Maria Angela; Caser, Eliana; Machado, Marcio; Aguzzoli, Crisitiano; Baldisserotto, Sérgio; Tabajara, Fernanda Beck; Bettega, Fernanda; Rodrigues Júnior, La Hore Correa; de Gasperi, Julia; Faina, Lais; Nolasco, Marcos Farias; Ferreira da Costa Fischer, Bruna; Fosch de Campos Ferreira, Mariana; Hartmann, Cristina; Kliemann, Marta; Hubert Ribeiro, Gustavo Luis; Fraga, Julia Merladete; Netto, Thiago Motta; Pozza, Laura Valduga; Wendling, Paulo Rafael; Azevedo, Caroline; Garcia, Juliana; Lopes, Marcel; Maia, Bernardo; Maselli, Paula; Melo, Ralph; Mendes, Weslley; Neves, Matheus; Ney, Jacqueline; Piras, Claudio; Applewhaite, Christopher; Carr, Adrienne; Chow, Lorraine; Duttchen, Kaylene; Foglia, Julena; Greene, Michael; Hinther, Ashley; Houston, Kendra; McCormick, Thomas Jared; Mikhayel, Jennifer; Montasser, Sam; Ragan, Alex; Suen, Andrew; Woolsey, Adrianna; Yu, Hai Chuan; Funk, Duane; Kowalski, Stephen; Legaspi, Regina; McDonald, Heather; Siddiqui, Faisal; Pridham, Jeremy; Rowe, Bernadette; Sampson, Sonia; Thiessen, Barton; Zbitnew, Geoff; Bernard, Andre; George, Ronald; Jones, Philip; Moor, Rita; Siddiqui, Naveed; Wolfer, Alexandra; Tran, Diem; Winch, Denyse; Dobson, Gary; McCormick, Thomas; Montasser, Osama; Hall, Richard; Baghirzada, Leyla; Curley, Gerard; Dai, Si Yuan; Hare, Gregory; Lee, Esther; Shastri, Uma; Tsui, Albert; Yagnik, Anmol; Alvares, Danielle; Choi, Stephen; Dwyer, Heather; Flores, Kathrina; McCartney, Colin; Somascanthan, Priya; Carroll, Jo; Pazmino-Canizares, Janneth; Ami, Noam; Chan, Vincent; Perlas, Anahi; Argue, Ruth; Huang, Yang; Lavis, Katie; Mayson, Kelly; Cao, Ying; Gao, Hong; Hu, Tingju; Lv, Jie; Yang, Jian; Yang, Yang; Zhong, Yi; Zhou, Jing; Zou, Xiaohua; He, Miao; Li, Xiaoying; Luo, Dihuan; Wang, Haiying; Yu, Tian; Chen, Liyong; Wang, Lijun; Cai, Yunfei; Cao, Zhongming; Li, Yanling; Lian, Jiaxin; Sun, Haiyun; Wang, Sheng; Wang, Zhipeng; Wang, Kenru; Zhu, Yi; Du, Xindan; Fan, Hao; Fu, Yunbin; Huang, Lixia; Huang, Yanming; Hwan, Haifang; Luo, Hong; Qu, Pi-Sheng; Tao, Fan; Wang, Zhen; Wang, Guoxiang; Wang, Shun; Zhang, Yan; Zhang, Xiaolin; Chen, Chao; Wang, Weixing; Liu, Zhengyuan; Fan, Lihua; Tang, Jing; Chen, Yijun; Chen, Yongjie; Han, Yangyang; Huang, Changshun; Liang, Guojin; Shen, Jing; Wang, Jun; Yang, Qiuhong; Zhen, Jungang; Zhou, Haidong; Chen, Junping; Chen, Zhang; Li, Xiaoyu; Meng, Bo; Ye, Haiwang; Zhang, Xiaoyan; Bi, Yanbing; Cao, Jianqiao; Guo, Fengying; Lin, Hong; Liu, Yang; Lv, Meng; Shi, Pengcai; Song, Xiumei; Sun, Chuanyu; Sun, Yongtao; Wang, Yuelan; Wang, Shenhui; Zhang, Min; Chen, Rong; Hou, Jiabao; Leng, Yan; Meng, Qing-Tao; Qian, Li; Shen, Zi-Ying; Xia, Zhong-Yuan; Xue, Rui; Zhang, Yuan; Zhao, Bo; Zhou, Xian-Jin; Chen, Qiang; Guo, Huinan; Guo, Yongqing; Qi, Yuehong; Wang, Zhi; Wei, Jianfeng; Zhang, Weiwei; Zheng, Lina; Bao, Qi; Chen, Yaqiu; Chen, Yijiao; Fei, Yue; Hu, Nianqiang; Hu, Xuming; Lei, Min; Li, Xiaoqin; Lv, Xiaocui; Miao, Fangfang; Ouyang, Lingling; Qian, Lu; Shen, Conyu; Sun, Yu; Wang, Yuting; Wang, Dong; Wu, Chao; Xu, Liyuan; Yuan, Jiaqi; Zhang, Lina; Zhang, Huan; Zhang, Yapping; Zhao, Jinning; Zhao, Chong; Zhao, Lei; Zheng, Tianzhao; Zhou, Dachun; Zhou, Haiyan; Zhou, Ce; Lu, Kaizhi; Zhao, Ting; He, Changlin; Chen, Hong; Chen, Shasha; Cheng, Baoli; He, Jie; Jin, Lin; Li, Caixia; Li, Hui; Pan, Yuanming; Shi, Yugang; Wen, Xiao Hong; Wu, Shuijing; Xie, Guohao; Zhang, Kai; Zhao, Bing; Lu, Xianfu; Chen, Feifei; Liang, Qisheng; Lin, Xuewu; Ling, Yunzhi; Liu, Gang; Tao, Jing; Yang, Lu; Zhou, Jialong; Chen, Fumei; Cheng, Zhonggui; Dai, Hanying; Feng, Yunlin; Hou, Benchao; Gong, Haixia; Hu, Chun Hua; Huang, Haijin; Huang, Jian; Jiang, Zhangjie; Li, Mengyuan; Lin, Jiamei; Liu, Mei; Liu, Weicheng; Liu, Zhen; Liu, Zhiyi; Luo, Foquan; Ma, Longxian; Min, Jia; Shi, Xiaoyun; Song, Zhiping; Wan, Xianwen; Xiong, Yingfen; Xu, Lin; Yang, Shuangjia; Zhang, Qin; Zhang, Hongyan; Zhang, Huaigen; Zhang, Xuekang; Zhao, Lili; Zhao, Weihong; Zhao, Weilu; Zhu, Xiaoping; Bai, Yun; Chen, Linbi; Chen, Sijia; Dai, Qinxue; Geng, Wujun; Han, Kunyuan; He, Xin; Huang, Luping; Ji, Binbin; Jia, Danyun; Jin, Shenhui; Li, Qianjun; Liang, Dongdong; Luo, Shan; Lwang, Lulu; Mo, Yunchang; Pan, Yuanyuan; Qi, Xinyu; Qian, Meizi; Qin, Jinling; Ren, Yelong; Shi, Yiyi; Wang, Junlu; Wang, Junkai; Wang, Leilei; Xie, Junjie; Yan, Yixiu; Yao, Yurui; Zhang, Mingxiao; Zhao, Jiashi; Zhuang, Xiuxiu; Ai, Yanqiu; Du, Fang; He, Long; Huang, Ledan; Li, Zhisong; Li, Huijuan; Li, Yetong; Li, Liwei; Meng, Su; Yuan, Yazhuo; Zhang, Enman; Zhang, Jie; Zhao, Shuna; Ji, Zhenrong; Pei, Ling; Wang, Li; Chen, Chen; Dong, Beibei; Li, Jing; Miao, Ziqiang; Mu, Hongying; Qin, Chao; Su, Lin; Wen, Zhiting; Xie, Keliang; Yu, Yonghao; Yuan, Fang; Hu, Xianwen; Zhang, Ye; Xiao, Wangpin; Zhu, Zhipeng; Dai, Qingqing; Fu, Kaiwen; Hu, Rong; Hu, Xiaolan; Huang, Song; Li, Yaqi; Liang, Yingping; Yu, Shuchun; Guo, Zheng; Jing, Yan; Tang, Na; Wu, Jie; Yuan, Dajiang; Zhang, Ruilin; Zhao, Xiaoying; Li, Yuhong; Bai, Hui-Ping; Liu, Chun-Xiao; Liu, Fei-Fei; Ren, Wei; Wang, Xiu-Li; Xu, Guan-Jie; Hu, Na; Li, Bo; Ou, Yangwen; Tang, Yongzhong; Yao, Shanglong; Zhang, Shihai; Kong, Cui-Cui; Liu, Bei; Wang, Tianlong; Xiao, Wei; Lu, Bo; Xia, Yanfei; Zhou, Jiali; Cai, Fang; Chen, Pushan; Hu, Shuangfei; Wang, Hongfa; Xu, Qiong; Hu, Liu; Jing, Liang; Li, Bin; Liu, Qiang; Liu, Yuejiang; Lu, Xinjian; Peng, Zhen Dan; Qiu, Xiaodong; Ren, Quan; Tong, Youliang; Wang, Jin; Wen, Yazhou; Wu, Qiong; Xia, Jiangyan; Xie, Jue; Xiong, Xiapei; Xu, Shixia; Yang, Tianqin; Ye, Hui; Yin, Ning; Yuan, Jing; Zeng, Qiuting; Zhang, Baoling; Zheng, Kang; Cang, Jing; Chen, Shiyu; Fan, Yu; Fu, Shuying; Ge, Xiaodong; Guo, Baolei; Huang, Wenhui; Jiang, Linghui; Jiang, Xinmei; Liu, Yi; Pan, Yan; Ren, Yun; Shan, Qi; Wang, Jiaxing; Wang, Fei; Wu, Chi; Zhang, Xiaoguang; Christiansen, Ida Cecilie; Granum, Simon Nørgaard; Rasmussen, Bodil Steen; Daugaard, Morten; Gambhir, Rajiv; Brandsborg, Birgitte; Steingrímsdóttir, Guðný Erla; Jensen-Gadegaard, Peter; Olsen, Karsten Skovgaard; Siegel, Hanna; Eskildsen, Katrine Zwicky; Gätke, Mona Ring; Wibrandt, Ida; Heintzelmann, Simon Bisgaard; Wiborg Lange, Kai Henrik; Lundsgaard, Rune Sarauw; Amstrup-Hansen, Louise; Hovendal, Claus; Larsen, Michael; Lenstrup, Mette; Kobborg, Tina; Larsen, Jens Rolighed; Pedersen, Anette Barbre; Smith, Søren Hübertz; Oestervig, Rebecca Monett; Afshari, Arash; Andersen, Cheme; Ekelund, Kim; Secher, Erik Lilja; Beloeil, Helene; Lasocki, Sigismond; Ouattara, Alexandre; Sineus, Marlene; Molliex, Serge; Legouge, Marie Lim; Wallet, Florent; Tesniere, Antoine; Gaudin, Christophe; Lehur, Paul; Forsans, Emma; de Rudnicki, Stéphane; Maudet, Valerie Serra; Mutter, Didier; Sojod, Ghassan; Ouaissi, Mehdi; Regimbeau, Jean-Marc; Desbordes, Jacques; Comptaer, Nicolas; Manser, Diae El; Ethgen, Sabine; Lebuffe, Gilles; Auer, Patrick; Härtl, Christine; Deja, Maria; Legashov, Kirill; Sonnemann, Susanne; Wiegand-Loehnert, Carola; Falk, Elke; Habicher, Marit; Angermair, Stefan; Laetsch, Beatrix; Schmidt, Katrin; von Heymann, Christian; Ramminger, Axel; Jelschen, Florian; Pabel, Svenja; Weyland, Andreas; Czeslick, Elke; Gille, Jochen; Malcharek, Michael; Sablotzki, Armin; Lueke, Katharina; Wetzel, Peter; Weimann, Joerg; Lenhart, Franz-Peter; Reichle, Florian; Schirmer, Frederike; Hüppe, Michael; Klotz, Karl; Nau, Carla; Schön, Julika; Mencke, Thomas; Wasmund, Christina; Bankewitz, Carla; Baumgarten, Georg; Fleischer, Andreas; Guttenthaler, Vera; Hack, Yvonne; Kirchgaessner, Katharina; Männer, Olja; Schurig-Urbaniak, Marlen; Struck, Rafael; van Zyl, Rebekka; Wittmann, Maria; Goebel, Ulrich; Harris, Sarah; Veit, Siegfried; Andreadaki, Evangelia; Souri, Flora; Katsiadramis, Ioannis; Skoufi, Anthi; Vasileiou, Maria; Aimoniotou-Georgiou, Eleni; Katsourakis, Anastasios; Veroniki, Fotini; Vlachogianni, Glyceria; Petra, Konstantina; Chlorou, Dimitra; Oloktsidou, Eirini; Ourailoglou, Vasileios; Papapostolou, Konstantinos; Tsaousi, Georgia; Daikou, Panagoula; Dedemadi, Georgia; Kalaitzopoulos, Ioannis; Loumpias, Christos; Bristogiannis, Sotirios; Dafnios, Nikolaos; Gkiokas, Georgios; Kontis, Elissaios; Kozompoli, Dimitra; Papailia, Aspasia; Theodosopoulos, Theodosios; Bizios, Christol; Koutsikou, Anastasia; Moustaka, Aleaxandra; Plaitakis, Ioannis; Armaganidis, Apostolos; Christodoulopoulou, Theodora; Lignos, Mihail; Theodorakopoulou, Maria; Asimakos, Andreas; Ischaki, Eleni; Tsagkaraki, Angeliki; Zakynthinos, Spyros; Antoniadou, Eleni; Koutelidakis, Ioannis; Lathyris, Dimitrios; Pozidou, Irene; Voloudakis, Nikolaos; Dalamagka, Maria; Elena, Gkonezou; Chronis, Christos; Manolakaki, Dimitra; Mosxogiannidis, Dimitris; Slepova, Tatiana; Tsakiridou, Isaia-Sissy; Lampiri, Claire; Vachlioti, Anastasia; Panagiotakis, Christos; Sfyras, Dimitrios; Tsimpoukas, Fotios; Tsirogianni, Athanasia; Axioti, Elena; Filippopoulos, Andreas; Kalliafa, Elli; Kassavetis, George; Katralis, Petros; Komnos, Ioannis; Pilichos, Georgios; Ravani, Ifigenia; Totis, Antonis; Apagaki, Eymorfia; Efthymiadi, Andromachi; Kampagiannis, Nikolaos; Paraforou, Theoniki; Tsioka, Agoritsa; Georgiou, Georgios; Vakalos, Aristeidis; Bairaktari, Aggeliki; Charitos, Efthimios; Markou, George; Niforopoulou, Panagiota; Papakonstantinou, Nikolaos; Tsigou, Evdoxia; Xifara, Archontoula; Zoulamoglou, Menelaos; Gkioni, Panagiota; Karatzas, Stylianos; Kyparissi, Aikaterini; Mainas, Efstratios; Papapanagiotou, Ioannis; Papavasilopoulou, Theonymfi; Fragandreas, George; Georgopoulou, Eleni; Katsika, Eleni; Psarras, Kyriakos; Synekidou, Eirini; Verroiotou, Maria; Vetsiou, Evangelia; Zaimi, Donika; Anagnou, Athina; Apostolou, Konstantinos; Melissopoulou, Theodora; Rozenberg, Theophilos; Tsigris, Christos; Boutsikos, Georgios; Kalles, Vasileios; Kotsalas, Nikolaos; Lavdaiou, Christina; Paikou, Fotini; Panagou, Georgia-Laura; Spring, Anna; Botis, Ioannis; Drimala, Maria; Georgakakis, Georgios; Kiourtzieva, Ellada; Ntouma, Panagiota; Prionas, Apostolos; Xouplidis, Kyriakos; Dalampini, Eleftheria; Giannaki, Chrysavgi; Iasonidou, Christina; Ioannidis, Orestis; Lavrentieva, Athina; Lavrentieva, Athena; Papageorgiou, George; Kokkinoy, Maria; Stafylaraki, Maria; Gaitanakis, Stylianos; Karydakis, Periclis; Paltoglou, Josef; Ponireas, Panagiotis; Chaloulis, Panagiotis; Provatidis, Athanasios; Sousana, Anisoglou; Gardikou, Varvara Vanessa; Konstantivelli, Maria; Lataniotou, Olga; Lisari, Elisavet; Margaroni, Maria; Stamatiou, Konstantinos; Nikolaidis, Edouardos; Pnevmatikos, Ioannis; Sertaridou, Eleni; Andreou, Alexandros; Arkalaki, Eleni; Athanasakis, Elias; Chaniotaki, Fotini; Chatzimichali, Chatzimichali Aikaterini; Christofaki, Maria; Dermitzaki, Despina; Fiorentza, Klara; Frantzeskos, Georgios; Geromarkaki, Elisavet; Kafkalaki, Kalliopi; Kalogridaki, Marina; Karydi, Konstyllia; Kokkini, Sofia; Kougentakis, Georgios; Lefaki, Tatiana; Lilitsis, Emmanouhl; Makatounaki, Aikaterini; Malliotakis, Polychronis; Michelakis, Dimosthenis; Neonaki, Maria; Nyktari, Vasileia; Palikyra, Iliana; Papadakis, Eleftherios; Papaioannou, Alexandra; Sfakianakis, Konstantinos; Sgouraki, Maria; Souvatzis, Xenia; Spartinou, Anastasia; Stefanidou, Nefeli; Syrogianni, Paulina; Tsagkaraki, Georgia; Arnaoutoglou, Elena; Arnaoutoglou, Christina; Bali, Christina; Bouris, Vasilios; Doumos, Rodamanthos; Gkini, Konstantia-Paraskevi; Kapaktsi, Clio; Koulouras, Vasilios; Lena, Arian; Lepida, Dimitra; Michos, Evangelos; Papadopoulos, Dimitrios; Paschopoulos, Minas; Rompou, Vaia Aliki; Siouti, Ioanna; Tsampalas, Stavros; Ververidou, Ourania; Zilis, Georgios; Charlalampidoy, Alexandra; Christodoulidis, Gregory; Flossos, Andreas; Stamoulis, Konstantinos; Chan, Matthew; Tsang, Man Shing Caleb; Tsang, Man Shing; Lai, Man Ling; Yip, Chi Pang; Heymans Chan, Hey Man; Law, Bassanio; Li, Wing Sze; Chu, Hiu Man; Koo, Emily Gar Yee; Lam, Chi Cheong Joe; Cheng, Ka Ho; Lam, Tracy; Chu, Susanna; Lam, Wing Yan; Wong, Kin Wai Kevin; Kwok, Dilys; Hung, Ching Yue Janice; Chan, Wai Kit Jacky; Wong, Wing Lam; Chung, Chun Kwong Eric; Ma, Shu Kai; Kaushik, Shuchi; Shah, Bhagyesh; Shah, Dhiren; Shah, Sanjay; Ar, Praburaj; Muthuchellappan, Radhakrishnan; Agarwal, Vandana; Divatia, Jigeeshu; Mishra, Sanghamitra; Nimje, Ganesh; Pande, Swati; Savarkar, Sukhada; Shrivastava, Aditi; Thomas, Martin; Yegnaram, Shashikant; Hidayatullah, Rahmat; Puar, Nasman; Niman, Sumara; Indra, Imai; Hamzah, Zulkarnain; Yuliana, Annika; Abidin, Ucu Nurhadiat; Dursin, Ade Nurkacan; Kurnia, Andri; Susanti, Ade; Handayani, Dini; Alit, Mahaalit Aribawa; Arya, Aryabiantara; Senapathi, Tjokorda Gde Agung; Utara, Utara Hartawan; Wid, Widnyana Made; Wima, Semarawima; Wir, Wiryana Made; Jehosua, Brillyan; Kaunang, Jonathan; Lantang, Eka Yudha; Najoan, Rini; Waworuntu, Neil; Awad, Hadi; Fuad, Akram; Geddoa, Burair; Khalaf, Abdel Razzaq; Al Hussaini, Sabah; Albaj, Safauldeensalem; Kenber, Maithem; Bettinelli, Alessandra; Spadaro, Savino; AlbertoVolta, Carlo; Giancarlo, Luigi; Sottosanti, Vicari; Copetti, Elisa; Spagnesi, Lorenzo; Toretti, Ilaria; Alloj, Chiara; Cardellino, Silvano; Carmino, Livio; Costanzo, Eleonora; Fanfani, Lucia Caterina; Novelli, Maria Teresa; Roasio, Agostino; Bellandi, Mattia; Beretta, Luigi; Bignami, Elena; Bocchino, Speranza; Cabrini, Luca; Corti, Daniele; Landoni, Giovanni; Meroni, Roberta; Moizo, Elena; Monti, Giacomo; Pintaudi, Margherita; Plumari, Valentina Paola; Taddeo, Daiana; Testa, Valentina; Winterton, Dario; Zangrillo, Alberto; Cloro, Luigi Maria; Colangelo, Chiara; Colangelo, Antonio; Rotunno, Giuseppe; Paludi, Miguel Angel; Maria, Cloro Paolo; Pata, Antonio; Parrini, Vieri; Gatta, Alessandro; Nastasi, Mauro; Tinti, Carla; Baroselli, Antonio; Arrigo, Mario; Benevento, Angelo; Bottini, Corrado; Cannavo', Maurizio; Gastaldi, Christian; Marchesi, Alessandro; Pascazio, Angelantonio; Pata, Francesco; Pozzi, Emilio; Premoli, Alberto; Tessera, Gaetano; Boschi, Luca; D'Andrea, Rocco; Ghignone, Federico; Poggioli, Gilberto; Sibilio, Andrea; Taffurelli, Mario; Ugolini, Giampaolo; Ab Majid, Mohd Azuan; Ab Rahman, Rusnah; Joseph, James; Pathan, Furquan; Sybil Shah, Mohammad Hafizshah; Yap, Huey Ling; Cheah, Seleen; Chin, Im Im; Looi, Ji Keon; Tan, Siew Ching; Visvalingam, Sheshendrasurian; Kwok, Fan Yin; Lee, Chew Kiok; Tan, Tse Siang; Wong, Sze Meng; Abdullah, Noor Hairiza; Liew, Chiat Fong; Luxuman, Lovenia; Mohd Zin, Nor Hafizah; Norddin, Muhamad Faiz; Raja Alias, Raja Liza; Wong, Juan Yong; Yong, Johnny; Bin Mustapha, Mohd Tarmimi; Chan, Weng Ken; Dzulkipli, Norizawati; Kuan, Pei Xuan; Lee, Yew Ching; Alias, Anita; Guok, Eng Ching; Jee, Chiun Chen; Ramon, Brian Rhadamantyne; Wong, Cheng Weng; Abd Ghafar, Fara Nur Idayu; Aziz, Faizal Zuhri; Hussain, Nabilah; Lee, Hooi Sean; Sukawi, Ismawaty; Woon, Yuan Liang; Abd Hadi, Husni Zaeem; Ahmad Azam, Ummi Azmira; Alias, Abdul Hafiz; Kesut, Saiful Aizar; Lee, Jun May; Ooi, Dar Vin; Sulaiman, Hetty Ayuni; Lih, Tengku Alini Tengku; Veerakumaran, Jeyaganesh; Rojas, Eder; Resendiz, Gerardo Esteban Alvarez; Zapata, Darcy Danitza Mari; López, Julio Cesar Jesús Aguilar; Flores, Armando Adolfo Alvarez; Amador, Juan Carlos Bravo; Avila, Erendira Jocelin Dominguez; Aquino, Laura Patricia González; Rodriguez, Ricardo Lopez; Landa, Mariana Torres; Urias, Emma; Hollmann, Markus; Hulst, Abraham; Preckel, Benedikt; Koopman-van Gemert, Ankie; Buise, Marc; Tolenaar, Noortje; Weber, Eric; de Fretes, Jennifer; Houweling, Peter; Ormskerk, Patricia; van Bommel, Jasper; Lance, Marcus; Smit-Fun, Valerie; van Zundert, Tom; Baas, Peter; Donald de Boer, Hans; Sprakel, Joost; Elferink-Vonk, Renske; Noordzij, Peter; van Zeggeren, Laura; Brand, Bastiaan; Spanjersberg, Rob; ten Bokkel-Andela, Janneke; Numan, Sandra; van Klei, Wilton; van Zaane, Bas; Boer, Christa; van Duivenvoorde, Yoni; Hering, Jens Peter; van Rossum, Sylvia; Zonneveldt, Harry; Campbell, Doug; Hoare, Siobhan; Santa, Sahayam; Ali, Marlynn; Allen, Sara Jane; Bell, Rachel; Choi, Hyun-Min David; Drake, Matthew; Farrell, Helen; Hayes, Katia; Higgie, Kushlin; Holmes, Kerry; Jenkins, Nicole; Kim, Chang Joon; Kim, Steven; Law, Kiew Chai; McAllister, Davina; Park, Karen; Pedersen, Karen; Pfeifer, Leesa; Pozaroszczyk, Anna; Salmond, Timothy; Steynor, Martin; Tan, Michael; Waymouth, Ellen; Ab Rahman, Ahmad Sufian; Armstrong, John; Dudson, Rosie; Jenkins, Nia; Nilakant, Jayashree; Richard, Seigne; Virdi, Pardeep; Dixon, Liane; Donohue, Roana; Farrow, Mehreen; Kennedy, Ross; Marissa, Henderson; McKellow, Margie; Nicola, Delany; Pascoe, Rebecca; Roberts, Stephen John; Rowell, George; Sumner, Matthew; Templer, Paul; Chandrasekharan, Shardha; Fulton, Graham; Jammer, Ib; More, Richard; Wilson, Leona; Chang, Yuan Hsuan; Foley, Julia; Fowler, Carolyn; Panckhurst, Jonathan; Sara, Rachel; Stapelberg, Francois; Cherrett, Veronica; Ganter, Donna Louise; McCann, Lloyd; Gilmour, Fiona; Lumsden, Rachelle; Moores, Mark; Olliff, Sue; Sardareva, Elitza; Tai, Joyce; Wikner, Matthew; Wong, Christopher; Chaddock, Mark; Czepanski, Carolyn; McKendry, Patrick; Polakovic, Daniel; Polakovich, Daniel; Robert, Axe; Belda, Margarita Tormo; Norton, Tracy; Alherz, Fadhel; Barneto, Lisa; Ramirez, Alberto; Sayeed, Ahmed; Smith, Nicola; Bennett, Cambell; McQuoid, Shane; Jansen, Tracy-Lee; Nico, Zin; Scott, John; Freschini, David; Freschini, Angela; Hopkins, Brian; Manson, Lara; Stoltz, Deon; Bates, Alexander; Davis, Simon; Freeman, Victoria; McGaughran, Lynette; Williams, Maya; Sharma, Swarna Baskar; Burrows, Tom; Byrne, Kelly; English, Duane; Johnson, Robert; Manikkam, Brendon; Naidoo, Shaun; Rumball, Margot; Whittle, Nicola; Franks, Romilla; Gibson-Lapsley, Hannah; Salter, Ryan; Walsh, Dean; Cooper, Richard; Perry, Katherine; Obobolo, Amos; Sule, Umar Musa; Ahmad, Abdurrahman; Atiku, Mamuda; Mohammed, Alhassan Datti; Sarki, Adamu Muhammad; Adekola, Oyebola; Akanmu, Olanrewaju; Durodola, Adekunle; Olukoju, Olusegun; Raji, Victor; Olajumoke, Tokunbo; Oyebamiji, Emmanuel; Adenekan, Anthony; Adetoye, Adedapo; Faponle, Folayemi; Olateju, Simeon; Owojuyigbe, Afolabi; Talabi, Ademola; Adenike, Odewabi; Adewale, Badru; Collins, Nwokoro; Ezekiel, Emmanuel; Fatungase, Oluwabunmi Motunrayo; Grace, Anuforo; Sola, Sotannde; Stella, Ogunmuyiwa; Ademola, Adeyinka; Adeolu, Augustine A.; Adigun, Tinuola; Akinwale, Mukaila; Fasina, Oluyemi; Gbolahan, Olalere; Idowu, Olusola; Olonisakin, Rotimi Peter; Osinaike, Babatunde Babasola; Asudo, Felicia; Mshelia, Danladi; Abdur-Rahman, Lukman; Agodirin, Olayide; Bello, Jibril; Bolaji, Benjamin; Oyedepo, Olanrewaju Olubukola; Ezike, Humphrey; Iloabachie, Ikechukwu; Okonkwo, Ikemefuna; Onuora, Elias; Onyeka, Tonia; Ugwu, Innocent; Umeh, Friday; Alagbe-Briggs, Olubusola; Dodiyi-Manuel, Amabra; Echem, Richard; Obasuyi, Bright; Onajin-Obembe, Bisola; Bandeira, Maria Expedito; Martins, Alda; Tomé, Miguel; Costa, Ana Cristina Miranda Martins; Krystopchuk, Andriy; Branco, Teresa; Esteves, Simao; Melo, Marco António; Monte, Júlia; Rua, Fernando; Martins, Isabel; Pinho-Oliveira, Vítor Miguel; Rodrigues, Carla Maria; Cabral, Raquel; Marques, Sofia; Rêgo, Sara; Jesus, Joana Sofia Teixeira; Marques, Maria Conceição; Romao, Cristina; Dias, Sandra; Santos, Ana Margarida; Alves, Maria Joao; Salta, Cristina; Cruz, Salome; Duarte, Célia; Paiva, António Armando Furtado; Cabral, Tiago do Nascimento; Faria E Maia, Dionisio; Correia da Silva, Rui Freitas Mendonça; Langner, Anuschka; Resendes, Hernâni Oliveira; Soares, Maria da Conceição; Abrunhosa, Alexandra; Faria, Filomena; Miranda, Lina; Pereira, Helena; Serra, Sofia; Ionescu, Daniela; Margarit, Simona; Mitre, Calin; Vasian, Horatiu; Manga, Gratiela; Stefan, Andreea; Tomescu, Dana; Filipescu, Daniela; Paunescu, Marilena-Alina; Stefan, Mihai; Stoica, Radu; Gavril, Laura; Pătrășcanu, Emilia; Ristescu, Irina; Rusu, Daniel; Diaconescu, Ciresica; Iosep, Gabriel Florin; Pulbere, Dorin; Ursu, Irina; Balanescu, Andreea; Grintescu, Ioana; Mirea, Liliana; Rentea, Irina; Vartic, Mihaela; Lupu, Mary-Nicoleta; Stanescu, Dorin; Streanga, Lavinea; Antal, Oana; Hagau, Natalia; Patras, Dumitru; Petrisor, Cristina; Tosa, Flaviu; Tranca, Sebastian; Copotoiu, Sanda Maria; Ungureanu, Liviu Lucian; Harsan, Cristian Remus; Papurica, Marius; Cernea, Daniela Denisa; Dragoescu, Nicoleta Alice; CarmenVaida, Laura Aflori; Ciobotaru, Oana Roxana; Aignatoaie, Mariana; Carp, Cristina Paula; Cobzaru, Isabelle; Mardare, Oana; Purcarin, Bianca; Tutunaru, Valentin; Ionita, Victor; Arustei, Mirela; Codita, Anisoara; Busuioc, Mihai; Chilinciuc, Ion; Ciobanu, Cristina; Belciu, Ioana; Tincu, Eugen; Blaj, Mihaela; Grosu, Ramona-Mihaela; Sandu, Gigel; Bruma, Dana; Corneci, Dan; Dutu, Madalina; Krepil, Adriana; Copaciu, Elena; Dumitrascu, Clementina Oana; Jemna, Ramona; Mihaescu, Florentina; Petre, Raluca; Tudor, Cristina; Ursache, Elena; Kulikov, Alexander; Lubnin, Andrey; Grigoryev, Evgeny; Pugachev, Stanislav; Tolmasov, Alexander; Hussain, Ayyaz; Ilyina, Yana; Roshchina, Anna; Iurin, Aleksandr; Chazova, Elena; Dunay, Artem; Karelov, Alexey; Khvedelidze, Irina; Voldaeva, Olga; Belskiy, Vladislav; Dzhamullaev, Parvin; Grishkowez, Elena; Kretov, Vladimir; Levin, Valeriy; Molkov, Aleksandr; Puzanov, Sergey; Samoilenko, Aleksandr; Tchekulaev, Aleksandr; Tulupova, Valentina; Utkin, Ivan; Allorto, Nikki Leigh; Bishop, David Gray; Builu, Pierre Monji; Cairns, Carel; Dasrath, Ashish; de Wet, Jacques; Hoedt, Marielle den; Grey, Ben; Hayes, Morgan Philip; Küsel, Belinda Senta; Shangase, Nomcebo; Wise, Robert; Cacala, Sharon; Farina, Zane; Govindasamy, Vishendran; Kruse, Carl-Heinz; Lee, Carolyn; Marais, Leonard; Naidoo, Thinagrin Dhasarthun; Rajah, Chantal; Rodseth, Reitze Nils; Ryan, Lisa; von Rhaden, Richard; Adam, Suwayba; Alphonsus, Christella; Ameer, Yusuf; Anderson, Frank; Basanth, Sujith; Bechan, Sudha; Bhula, Chettan; Biccard, Bruce M.; Biyase, Thuli; Buccimazza, Ines; Cardosa, Jorge; Chen, James; Daya, Bhavika; Drummond, Leanne; Elabib, Ali; Abdel Goad, Ehab Helmy; Goga, Ismail E.; Goga, Riaz; Harrichandparsad, R.; Hodgson, Richard E.; Jordaan, J.; Kalafatis, Nicky; Kampik, Christian; Landers, A. T.; Loots, Emil; Madansein, Rajhmum; Madaree, Anil; Madiba, Thandinkosi E.; Manzini, Vukani T.; Mbuyisa, Mbali; Moodley, Rajan; Msomi, Mduduzi; Mukama, Innocent; Naidoo, Desigan; Naidoo, Rubeshan; Naidu, Tesuven K.; Ntloko, Sindiswa; Padayachee, Eneshia; Padayachee, Lucelle; Phaff, Martijn; Pillay, Bala; Pillay, Desigan; Pillay, Lutchmee; Ramnarain, Anupa; Ramphal, Suren R.; Ryan, Paul; Saloojee, Ahmed; Sebitloane, Motshedisi; Sigcu, Noluyolo; Taylor, Jenna L.; Torborg, Alexandra; Visser, Linda; Anderson, Philip; Conradie, Alae; de Swardt, Mathew; de Villiers, Martin; Eikman, Johan; Liebenberg, Riaan; Mouton, Johan; Paton, Abbey; van der Merwe, Louwrence; Wilscott-Davids, Candice; Barrett, Wendy Joan; Bester, Marlet; de Beer, Johan; Geldenhuys, Jacques; Gouws, Hanni; Potgieter, Jan-Hendrik; Strydom, Magdel; WilberforceTurton, Edwin; Chetty, Rubendraj R.; Chirkut, Subash; Cronje, Larissa; de Vasconcellos, Kim; Dube, Nokukhanya Z.; Gama, N. Sibusiso; Green, Garyth M.; Green-Thompson, Randolph; Kinoo, Suman Mewa; Kistnasami, Prenolin; Maharaj, Kapil; Moodley, Manogaran S.; Mothae, Sibongile J.; Naidoo, Ruvashni; Aslam F Noorbhai, M.; Rughubar, Vivesh; Reddy, Jenendhiran; Singh, Avesh; Skinner, David L.; Smith, Murray J.; Singh, Bhagwan; Misra, Ravi; Naidoo, Maheshwar; Ramdharee, Pireshin; Selibea, Yvonne; Sewpersad, Selina; Sham, Shailendra; Wessels, Joseph D.; Africander, Cucu; Bejia, Tarek; Blakemore, Stephen P.; Botes, Marisa; Bunwarie, Bimalshakth; Hernandez, Carlos B.; Jeeraz, Mohammud A.; Legutko, Dagmara A.; Lopez, Acela G.; de Meyer, Jenine N.; Muzenda, Tanaka; Naidoo, Noel; Patel, Maryam; Pentela, Rao; Junge, Marina; Mansoor, Naj; Rademan, Lana; Scislowski, Pawel; Seedat, Ismail; van den Berg, Bianca; van der Merwe, Doreen; van Wyk, Steyn; Govender, Komalan; Naicker, Darshan; Ramjee, Rajesh; Saley, Mueen; Kuhn, Warren Paul; Matos-Puig, Roel; Alberto Lisi, Zaheer Moolla; Perez, Gisela; Beltran, Anna Valle; Lozano, Angels; Navarro, Carlos Delgado; Duca, Alejandro; Ernesto, Ernesto Pastor Martinez; Ferrando, Carlos; Fuentes, Isabel; García-Pérez, Maria Luisa; Gracia, Estefania; Palomares, Ana Izquierdo; Katime, Antonio; Miñana, Amanda; Incertis, Raul Raul; Romero, Esther; Romero Garcia, Carolina Soledad; Rubio, Concepcion; Artiles, Tania Socorro; Soro, Marina; Valls, Paola; Laguarda, Gisela Alaman; Benavent, Pau; Cuenca, Vicente Chisbert; Cueva, Andreu; Lafuente, Matilde; Parra, Asuncion Marques; Rodrigo, Alejandra Romero; Sanchez-Morcillo, Silvia; Tormo, Sergi; Redondo, Francisco Javier; de Andrés Ibanez, José Antonio; Diago, Lorena Gómez; José Hernández Cádiz, Maria; Manuel, Granell Gil; Peris, Raquel; Saiz, Cristina; Vivo, Jose Tatay; Soto, Maria Teresa Tebar; Brunete, Tamara; Cancho, David; Delgado García, David R.; Zamudio, Diana; del Valle, Santiago Garcia; Serrano, M. Luz; Alonso, Eduardo; Anillo, Victor; Maseda, Emilio; Salgado, Patricia; Suarez, Luis; Suarez-de-la-Rica, Alejandro; Villagrán, María José; Alonso, José Ignacio; Cabezuelo, Estefania; Garcia-Saiz, Irene; Lopez del Moral, Olga; Martín, Silvia; Gonzalez, Alba Perez; Doncel, Ma Sherezade Tovar; Vera, Martin Agüero; José Ávila Sánchez, Francisco; Castaño, Beatriz; Moreira, Beatriz Castaño; Risco, Sahely Flores; Martín, Daniel Paz; Martín, Fernando Pérez; Poza, Paloma; Ruiz, Adela; Serna Martínez, Wilson Fabio; Vicente, Bárbara Vázquez; Dominguez, Saul Velaz; Fernández, Salvador; Munoz-López, Alfonso; Bernat, Maria Jose; Mas, Arantxa; Planas, Kenneth; Jawad, Monir; Saeed, Yousif; Hedin, Annika; Levander, Helena; Holmström, Sandra; Lönn, David; Zoerner, Frank; Åkring, Irene; Widmark, Carl; Zettergren, Jan; Liljequist, Victor Aspelund; Nystrom, Lena; Odeberg-Wernerman, Suzanne; Oldner, Anders; Fagerlund, Malin Jonsson; Reje, Patrik; Lyckner, Sara; Sperber, Jesper; Adolfsson, Anne; Klarin, Bengt; Ögren, Katrin; Barras, Jean-Pierre; Bührer, Thomas; Despotidis, Vasileios; Helmy, Naeder; Holliger, Stephan; Raptis, Dimitri Aristotle; Schmid, Roger; Meyer, Antoine; Jaquet, Yves; Kessler, Ulf; Muradbegovic, Mirza; Nahum, Solange R.; Rotunno, Teresa; Schiltz, Boris; Voruz, François; Worreth, Marc; Christoforidis, Dimitri; Popeskou, Sotirios Georgios; Furrer, Markus; Prevost, Gian Andrea; Stocker, Andrea; Lang, Klaus; Breitenstein, Stefan; Ganter, Michael T.; Geisen, Martin; Soll, Christopher; Korkmaz, Michelle; Lubach, Iris; Schmitz, Michael; Meyer Zu Schwabedissen, Moritz; Moritz, Meyer Zu Schwabedissen; Zingg, Urs; Hillermann, Thomas; Wildi, Stefan; Pinto, Bernardo Bollen; Walder, Bernhard; Mariotti, Giustina; Slankamenac, Ksenija; Namuyuga, Mirioce; Kyomugisha, Edward; Kituuka, Olivia; Shikanda, Anne Wesonga; Kakembo, Nasser; Tom, Charles Otim; Antonina, Webombesa; Bua, Emmanuel; Ssettabi, Eden Michael; Epodoi, Joseph; Kabagenyi, Fiona; Kirya, Fred; Dempsey, Ged; Seasman, Colette; Nawaz Khan, Raja Basit; Kurasz, Claire; Macgregor, Mark; Shawki, Burhan; Francis, Daren; Hariharan, Vimal; Chau, Simon; Ellis, Kate; Butt, Georgina; Chicken, Dennis-Wayne; Christmas, Natasha; Allen, Samantha; Daniel, Gayatri Daniel; Dempster, Angie; Kemp, Juliette; Matthews, Lewis; Mcglone, Philip; Tambellini, Joanne; Trodd, Dawn; Freitas, Katie; Garg, Atul; Gupta, Janesh Kumar; Karpate, Shilpaja; Kulkarni, Aditi; O'Hara, Chloe; Troko, Jtroko; Angus, Kirsty; Bradley, Jacqueline; Brennan, Emma; Brooks, Carolyn; Brown, Janette; Brown, Gemma; Finch, Amanda; Gratrix, Karen; Hesketh, Sue; Hill, Gillian; Jeffs, Carol; Morgan, Maureen; Pemberton, Chris; Slawson, Nicola; Spickett, Helen; Swarbrick, Gemma; Thomas, Megan; van Duyvenvoorde, Greta; Brennan, Andrew; Briscoe, Richard; Cooper, Sarah; Lawton, Tom; Northey, Martin; Senaratne, Rashmi; Stanworth, Helen; Burrows, Lorna; Cain, Helen; Craven, Rachael; Davies, Keith; Jonas, Attila; Pachucki, Marcin; Walkden, Graham; Davies, Helen; Gudaca, Mariethel; Hobrok, Maria; Arawwawala, Dilshan; Fergey, Lauren; Gardiner, Matthew; Gunn, Jacqueline; Johnson, Lyndsay; Lofting, Amanda; Lyle, Amanda; Neela, Fiona Mc; Smolen, Susan; Topliffe, Joanne; Williams, Sarah; Bland, Martin; Balaji, Packianathaswamy; Kaura, Vikas; Lanka, Prasad; Smith, Neil; Ahmed, Ahmed; Myatt, John; Shenoy, Ravikiran; Soon, Wai Cheong; Tan, Jessica; Karadia, Sunny; Self, James; Durant, Emma; Tripathi, Shiva; Bullock, Clare; Campbell, Debbie; Ghosh, Alison; Hughes, Thomas; Zsisku, Lajos; Bengeri, Sheshagiri; Cowton, Amanda; Khalid, Mohammed Shazad; Limb, James; McAdam, Colin; Porritt, Mandy; Rafi, M. Amir; Shekar, Priya; Adams, David; Harden, Catherine; Hollands, Heidi; King, Angela; March, Linda; Minto, Gary; Patrick, Abigail; Squire, Rosalyn; Waugh, Darren; Kumara, Paramesh; Simeson, Karen; Yarwood, Jamie; Browning, Julie; Hatton, Jonathan; Julian, Howes; Mitra, Atideb; Newton, Maria; Pernu, Pawan Kootelu; Wilson, Alison; Commey, Thelma; Foot, Helen; Glover, Lyn; Gupta, Ajay; Lancaster, Nicola; Levin, Jill; Mackenzie, Felicity; Mestanza, Claire; Nofal, Emma; Pout, Lauren; Varden, Rosanna; Wild, Jonathan; Jones, Stephanie; Moreton, Sarah; Pulletz, Mark; Davies, Charlotte; Martin, Matthew; Thomas, Sian; Burns, Karen; McArthur, Carol; Patel, Panna; Lau, Gary; Rich, Natalie; Davis, Fiona; Lyons, Rachel; Port, Beth; Prout, Rachel; Smith, Christopher; Adelaja, Yemi; Bennett, Victoria; Bidd, Heena; Dumitrescu, Alexandra; Murphy, Jacqui Fox; Keen, Abigail; Mguni, Nhlanhla; Ong, Cheng; Adams, George; Boshier, Piers; Brown, Richard; Butryn, Izabella; Chatterjee, Jayanta; Freethy, Alexander; Lockwood, Geoffrey; Tsakok, Maria; Tsiligiannis, Sophia; Peat, William; Stephenson, Lorraine; Bradburn, Mike; Pick, Sara; Cunha, Pedro; Olagbaiye, Olufemi; Tayeh, Salim; Packianathaswamy, Balaji; Abernethy, Caroline; Balasubramaniam, Madhu; Bennett, Rachael; Bolton, David; Martinson, Victoria; Naylor, Charde; Bell, Stephanie; Heather, Blaylock; Kushakovsky, Vlad; Alcock, Liam; Alexander, Hazel; Anderson, Colette; Baker, Paul; Brookes, Morag; Cawthorn, Louise; Cirstea, Emanuel; Clarkson, Rachel; Colling, Kerry; Coulter, Ian; Das, Suparna; Haigh, Kathryn; Hamdan, Alhafidz; Hugill, Keith; Kottam, Lucksy; Lisseter, Emily; Mawdsley, Matthew; McGivern, Julie; Padala, Krishnaveni; Phelps, Victoria; Ramesh Kumar, Vineshykaa; Stewart, Kirsten; Towse, Kayley; Tregonning, Julie; Vahedi, Ali; Walker, Alycon; Baines, Duncan; Bilolikar, Anjali; Chande, Shiv; Copley, Edward; Dunk, Nigel; Kulkarni, Raghavendra; Kumar, Pawan; Metodiev, Yavor; Ncomanzi, Dumisani; Raithatha, Bhavesh; Raymode, Parizade; Szafranski, Jan; Twohey, Linda; Watt, Philip; Weatherall, Lucie; Weatherill, J.; Whitman, Zoe; Wighton, Elinor; Abayasinghe, Chamika; Chan, Alexander; Darwish, Sharif; Gill, James; Glasgow, Emma; Hadfield, Daniel; Harris, Clair; Hopkins, Phil; Kochhar, Arun; Kunst, Gudrun; Mellis, Clare; Pool, Andrew; Riozzi, Paul; Selman, Andrew; Smith, Emma-Jane; Vele, Liana; Gercek, Yuksel; Guy, Kramer; Holden, Douglas; Watson, Nicholas; Whysall, Karen; Andreou, Prematie; Hales, Dawn; Thompson, Jonathan; Bowrey, Sarah; McDonald, Shara; Gilmore, Jemma; Hills, Vicky; Kelly, Chan; Kelly, Sinead; Lloyd, Geraint; Abbott, Tom; Gall, Lewis; Torrance, Hew; Vivian, Mark; Berntsen, Emer; Nolan, Tracey; Turner, Angus; Vohra, Akbar; Brown, Andrew; Clark, Richard; Coughlan, Elaine; Daniel, Conway; Patvardhan, Chinmay; Pearson, Rachel; Predeep, Sheba; Saad, Hesham; Shanmugam, Mohanakrishnan; Varley, Simon; Wylie, Katharine; Cooper, Lucy; Makowski, Arystarch; Misztal, Beata; Moldovan, Eliza; Pegg, Claire; Donovan, Andrew; Foot, Jayne; Large, Simon; Claxton, Andrew; Netke, Bhagyashree; Armstrong, Richard; Calderwood, Claire; Kwok, Andy; Mohr, Otto; Oyeniyi, Peter; Patnaik, Lisa; Post, Benjamin; Ali, Sarah; Arshad, Homa; Baker, Gerard; Brenner, Laura; Brincat, Maximilian; Brunswicker, Annemarie; Cox, Hannah; Cozar, Octavian Ionut; Cheong, Edward; Durst, Alexander; Fengas, Lior; Flatt, Jim; Glister, Georgina; Narwani, Vishal; Photi, Evangelos; Rankin, Adeline; Rosbergen, Melissa; Tan, Mark; Beaton, Ceri; Horn, Rachel; Hunt, Jane; Rousseau, Guy; Stancombe, Lucia; Absar, Mohammed; Allsop, Joanne; Drinkwater, Zoe; Hodgkiss, Tracey; Smith, Kirsty; Brown, Jamie; Alexander-Sefre, Farhad; Campey, Lorraine; Dudgeon, Lucy; Hall, Kathryn; Hitchcock, Rachael; James, Lynne; Smith, Kate; Winstone, Ulrika; Ahmad, Norfaizan; Bauchmuller, Kris; Harrison, Jonathan; Jeffery, Holly; Miller, Duncan; Pinder, Angela; Pothuneedi, Sailaja; Rosser, Jonathan; Sanghera, Sumayer; Swift, Diane; Walker, Rachel; Bester, Delia; Cavanagh, Sarah; Cripps, Heather; Daniel, Harvey; Lynch, Julie; Paton, Alison; Pyke, Shirley; Scholefield, John; Whitworth, Helen; Bottrill, Fiona; Ramalingam, Ganesh; Webb, Stephen; Akerman, Nik; Antill, Philip; Bourner, Lynsey; Buckley, Sarah; Castle, Gail; Charles, Rob; Eggleston, Christopher; Foster, Rebecca; Gill, Satwant; Lindley, Kate; Lklouk, Mohamed; Lowery, Tracey; Martin, Oliver; Milne, David; O'Connor, Patrick; Ratcliffe, Andrew; Rose, Alastair; Smith, Annie; Varma, Sandeep; Ward, Jackie; Barcraft-Barnes, Helena; Camsooksai, Julie; Colvin, Carolyn; Reschreiter, Henrik; Tbaily, Lee; Venner, Nicola; Hamilton, Caroline; Kelly, Lewis; Toth-Tarsoly, Piroska; Dodsworth, Kerry; Foord, Denise; Gordon, Paul; Hawes, Elizabeth; Lamb, Nikki; Mouland, Johanna; Nightingale, Jeremy; Rose, Steve; Schrieber, Joe; Al'Amri, Khalid; Aladin, Hafiz; Arshad, Mohammed Asif; Barraclough, James; Bentley, Conor; Bergin, Colin; Carrera, Ronald; Clarkson, Aisling; Collins, Michelle; Cooper, Lauren; Denham, Samuel; Griffiths, Ewen; Ip, Peter; Jeyanthan, Somasundaram; Joory, Kavita; Kaur, Satwant; Marriott, Paul; Mitchell, Natalie; Nagaiah, Sukumar; Nilsson, Annette; Parekh, Nilesh; Pope, Martin; Seager, Joseph; Serag, Hosam; Tameem, Alifia; Thomas, Anna; Thunder, Joanne; Torrance, Andrew; Vohra, Ravinder; Whitehouse, Arlo; Wong, Tony; Blunt, Mark; Wong, Kate; Giles, Julian; Reed, Isabelle; Weller, Debbie; Bell, Gillian; Birch, Julie; Damant, Rose; Maiden, Jane; Mewies, Clare; Prince, Claire; Radford, Jane; Reynolds, Tim; Balain, Birender; Banerjee, Robin; Barnett, Andrew; Burston, Ben; Davies, Kirsty; Edwards, Jayne; Evans, Chris; Ford, David; Gallacher, Pete; Hill, Simon; Jaffray, David; Karlakki, Sudheer; Kelly, Cormac; Kennedy, Julia; Kiely, Nigel; Lewthwaite, Simon; Marquis, Chris; Ockendon, Matthew; Phillips, Stephen; Pickard, Simon; Richardson, James; Roach, Richard; Smith, Tony; Spencer-Jones, Richard; Steele, Niall; Steen, Julie; van Liefland, Marck; White, Steve; Faulds, Matthew; Harris, Meredyth; Kelly, Carrie; Nicol, Scott; 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Bertram, Wendy; Looseley, Alex; Mouton, Ronelle; Hanna, George; Arnold, Glenn; Arya, Shobhit; Balfoussia, Danai; Baxter, Linden; Harris, James; Jones, Craig; Knaggs, Alison; Markar, Sheraz; Perera, Anisha; Scott, Alasdair; Shida, Asako; Sirha, Ravneet; Wright, Sally; Frost, Victoria; Gray, Catherine; Andrews, Emma; Arrandale, Lindsay; Barrett, Stephen; Cifra, Elna; Cooper, Mariese; Dragnea, Dragos; Elna, Cifra; Maclean, Jennifer; Meier, Sonja; Milliken, Donald; Munns, Christopher; Ratanshi, Nadir; Ramessur, Suneil; Salvana, Abegail; Watson, Anthony; Ali, Hani; Campbell, Gill; Critchley, Rebecca; Endersby, Simon; Hicks, Catherine; Liddle, Alison; Pass, Marc; Ritchie, Charlotte; Thomas, Charlotte; Too, Lingxi; Welsh, Sarah; Gill, Talvinder; Johnson, Joanne; Reed, Joanne; Davis, Edward; Papadopoullos, Sam; Attwood, Clare; Biffen, Andrew; Boulton, Kerenza; Gray, Sophie; Hay, David; Mills, Sarah; Montgomery, Jane; Riddell, Rory; Simpson, James; Bhardwaj, Neeraj; Paul, Elaine; Uwubamwen, Nosakhare; Alexander, Maini; Arrich, James; Arumugam, Swarna; Blackwood, Douglas; Boggiano, Victoria; Brown, Robyn; Chan, Yik Lam; Chatterjee, Devnandan; Chhabra, Ashok; Christian, Rachel; Costelloe, Hannah; Matthewman, Madeline Coxwell; Dalton, Emma; Darko, Julia; Davari, Maria; Dave, Tejal; Deacon, Matthew; Deepak, Shantal; Edmond, Holly; Ellis, Jessica; El-Sayed, Ahmed; Eneje, Philip; English, Rose; Ewe, Renee; Foers, William; Franklin, John; Gallego, Laura; Garrett, Emily; Goldberg, Olivia; Goss, Harry; Greaves, Rosanna; Harris, Rudy; Hennings, Charles; Jones, Eleanor; Kamali, Nelson; Kokkinos, Naomi; Lewis, Carys; Lignos, Leda; Malgapo, Evaleen Victoria; Malik, Rizwana; Milne, Andrew; Mulligan, John-Patrick; Nicklin, Philippa; Palipane, Natasha; Parsons, Thomas; Piper, Rebecca; Prakash, Rohan; Ramesh, Byron; Rasip, Sarah; Reading, Jacob; Rela, Mariam; Reyes, Anna; Stephens, Robert; Rooms, Martin; Shah, Karishma; Simons, Henry; Solanki, Shalil; Spowart, Emma; Stevens, Amy; Thomas, Christopher; 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Kumar, Suhas; Cotterill, Donna; Hodzovic, Emil; Hosdurga, Gurunath; Miles, Edward; Saunders, Glenn; Campbell, Marta; Chan, Peter; Jemmett, Kim; Raj, Ashok; Naik, Aditi; Oshowo, Ayo; Ramamoorthy, Rajarajan; Shah, Nimesh; Sylvan, Axel; Blyth, Katharine; Burtenshaw, Andrew; Freeman, David; Johnson, Emily; Lo, Philip; Martin, Terry; Plunkett, Emma; Wollaston, Julie; Allison, Joanna; Carroll, Christine; Craw, Nicholas; Craw, Sarah; Pitt-Kerby, Tressy; Rowland-Axe, Rebecca; Spurdle, Katie; McDonald, Andrew; Simon, Davies; Sinha, Vivek; Smith, Thomas; Banner-Goodspeed, Valerie; Boone, Myles; Campbell, Kathleen; Lu, Fengxin; Scannell, Joseph; Sobol, Julia; Balajonda, Naraida; Clemmons, Karen; Conde, Carlos; Elgasim, Magdi; Funk, Bonita; Hall, Roger; Hopkins, Thomas; Olaleye, Omowunmi; Omer, Omer; Pender, Michelle; Porto, Angelo; Stevens, Alice; Waweru, Peter; Yeh, Erlinda; Bodansky, Daniella; Evans, Adam; Kleopoulos, Steven; Maril, Robert; Mathney, Edward; Sanchez, Angela; Tinuoye, Elizabeth; Bateman, Brian; Eng, Kristen; Jiang, Ning; Ladha, Karim; Needleman, Joseph; Chen, Lee-Lynn; Lane, Rondall; Robinowitz, David; Ghushe, Neil; Irshad, Mariam; O'Connor, John; Patel, Samir; Takemoto, Steven; Wallace, Art; Mazzeffi, Michael; Rock, Peter; Wallace, Karin; Zhu, Xiaomao; Chua, Pandora; Mattera, Matthew; Sharar, Rebecca; Thilen, Stephan; Treggiari, Miriam; Morgan, Angela; Sofjan, Iwan; Subramaniam, Kathirvel; Avidan, Michael; Maybrier, Hannah; Muench, Maxwell; Wildes, Troy

    2018-01-01

    The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of

  3. NPP Krsko Periodic Safety Review action plan

    International Nuclear Information System (INIS)

    Bilic Zabric, T.

    2006-01-01

    In the current, internationally accepted, safety philosophy Periodic Safety Reviews (PSRs) are comprehensive reviews aimed at the verification that an operating NPP remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain an acceptable level of safety. These reviews are complementary to the routine and special safety reviews. They are long time-scale reviews intended to deal with the cumulative effects of plant ageing, modifications, operating experience and technical developments, which are not so easily comprehended over the shorter time-scale routine of safety reviews. The review was completed in 2005 and the next period will see the implementation of the action plan including some plant upgrades. The action plan lists issues that should be implemented at NPP Krsko together with associated milestones. The milestones were assumed based on best estimate resource availability and their ends can be potentially floated. In some cases, multiple corrective measures may be postulated to provide resolution for a given safety issue. The Slovenian Nuclear Safety Administration by decree approved the first periodic safety review and the implementation plan of activities arising from it. The entire implementation plan must be carried out by 15 October 2010. Report on the second periodic safety review must be submitted by the NEK not later than 15 December 2013. (author)

  4. Technical Review Report for the Model 9975-96 Package Safety Analysis Report for Packaging (S-SARP-G-00003, Revision 0, January 2008)

    International Nuclear Information System (INIS)

    West, M.

    2009-01-01

    This Technical Review Report (TRR) documents the review, performed by the Lawrence Livermore National Laboratory (LLNL) Staff, at the request of the U.S. Department of Energy (DOE), on the Safety Analysis Report for Packaging, Model 9975, Revision 0, dated January 2008 (S-SARP-G-00003, the SARP). The review includes an evaluation of the SARP, with respect to the requirements specified in 10 CFR 71, and in International Atomic Energy Agency (IAEA) Safety Standards Series No. TS-R-1. The Model 9975-96 Package is a 35-gallon drum package design that has evolved from a family of packages designed by DOE contractors at the Savannah River Site. Earlier package designs, i.e., the Model 9965, the Model 9966, the Model 9967, and the Model 9968 Packagings, were originally designed and certified in the early 1980s. In the 1990s, updated package designs that incorporated design features consistent with the then newer safety requirements were proposed. The updated package designs at the time were the Model 9972, the Model 9973, the Model 9974, and the Model 9975 Packagings, respectively. The Model 9975 Package was certified by the Packaging Certification Program, under the Office of Safety Management and Operations. The safety analysis of the Model 9975-85 Packaging is documented in the Safety Analysis Report for Packaging, Model 9975, B(M)F-85, Revision 0, dated December 2003. The Model 9975-85 Package is certified by DOE Certificate of Compliance (CoC) package identification number, USA/9975/B(M)F-85, for the transportation of Type B quantities of uranium metal/oxide, 238 Pu heat sources, plutonium/uranium metals, plutonium/uranium oxides, plutonium composites, plutonium/tantalum composites, 238 Pu oxide/beryllium metal.

  5. Development of safety analysis technology for LMR

    International Nuclear Information System (INIS)

    Hahn, Do Hee; Kwon, Y. M.; Kim, K. D.

    2000-05-01

    The analysis methodologies as well as the analysis computer code system for the transient, HCDA, and containment performance analyses, which are required for KALIMER safety analyses, have been developed. The SSC-K code has been developed based on SSC-L which is an analysis code for loop type LMR, by improving models necessary for the KALIMER system analysis, and additional models have been added to the code. In addition, HCDA analysis model has been developed and the containment performance analysis code has been also improved. The preliminary basis for the safety analysis has been established, and the preliminary safety analyses for the key design features have been performed. In addition, a state-of-art analysis for LMR PSA and overseas safety and licensing requirements have been reviewed. The design database for the systematic management of the design documents as well as design processes has been established as well

  6. Development of safety analysis technology for LMR

    Energy Technology Data Exchange (ETDEWEB)

    Hahn, Do Hee; Kwon, Y. M.; Kim, K. D. [and others

    2000-05-01

    The analysis methodologies as well as the analysis computer code system for the transient, HCDA, and containment performance analyses, which are required for KALIMER safety analyses, have been developed. The SSC-K code has been developed based on SSC-L which is an analysis code for loop type LMR, by improving models necessary for the KALIMER system analysis, and additional models have been added to the code. In addition, HCDA analysis model has been developed and the containment performance analysis code has been also improved. The preliminary basis for the safety analysis has been established, and the preliminary safety analyses for the key design features have been performed. In addition, a state-of-art analysis for LMR PSA and overseas safety and licensing requirements have been reviewed. The design database for the systematic management of the design documents as well as design processes has been established as well.

  7. Nuclear safety review for the year 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-08-01

    The Nuclear Safety Review reports on worldwide efforts to strengthen nuclear, radiation and transport safety and the safety of radioactive waste management. The final version of the Nuclear Safety Review for the Year 2002 was prepared in the light of the discussion by the Board of Governors in March 2002. This report presents an overview of the current issues and trends in nuclear, radiation, transport and radioactive waste safety at the end of 2002. This overview is supported by a more detailed factual account of safety-related events and issues worldwide during 2002. National authorities and the international community continued to reflect and act upon the implications of the events of II September 2001 for nuclear, radiation, transport and waste safety. In the light of this, the Agency has decided to transfer the organizational unit on nuclear security from the Department of Safeguards to the Department of Nuclear Safety (which thereby becomes the Department of Nuclear Safety and Security). By better exploiting the synergies between safety and security and promoting further cross-fertilization of approaches, the Agency is trying to help build up mutually reinforcing global regimes of safety and security. However, the Nuclear Safety Review for the Year 2002 addresses only those areas already in the safety programme. This short analytical overview is supported by a second part (corresponding to Part I of the Nuclear Safety Reviews of previous years), which describes significant safety-related events and issues worldwide during 2002. A Draft Nuclear Safety Review for the Year 2002 was submitted to the March 2003 session of the Board of Governors in document GOV/2003/6.

  8. Nuclear safety review for the year 2002

    International Nuclear Information System (INIS)

    2003-08-01

    The Nuclear Safety Review reports on worldwide efforts to strengthen nuclear, radiation and transport safety and the safety of radioactive waste management. The final version of the Nuclear Safety Review for the Year 2002 was prepared in the light of the discussion by the Board of Governors in March 2002. This report presents an overview of the current issues and trends in nuclear, radiation, transport and radioactive waste safety at the end of 2002. This overview is supported by a more detailed factual account of safety-related events and issues worldwide during 2002. National authorities and the international community continued to reflect and act upon the implications of the events of II September 2001 for nuclear, radiation, transport and waste safety. In the light of this, the Agency has decided to transfer the organizational unit on nuclear security from the Department of Safeguards to the Department of Nuclear Safety (which thereby becomes the Department of Nuclear Safety and Security). By better exploiting the synergies between safety and security and promoting further cross-fertilization of approaches, the Agency is trying to help build up mutually reinforcing global regimes of safety and security. However, the Nuclear Safety Review for the Year 2002 addresses only those areas already in the safety programme. This short analytical overview is supported by a second part (corresponding to Part I of the Nuclear Safety Reviews of previous years), which describes significant safety-related events and issues worldwide during 2002. A Draft Nuclear Safety Review for the Year 2002 was submitted to the March 2003 session of the Board of Governors in document GOV/2003/6

  9. Fire safety analysis: methodology

    International Nuclear Information System (INIS)

    Kazarians, M.

    1998-01-01

    From a review of the fires that have occurred in nuclear power plants and the results of fire risk studies that have been completed over the last 17 years, we can conclude that internal fires in nuclear power plants can be an important contributor to plant risk. Methods and data are available to quantify the fire risk. These methods and data have been subjected to a series of reviews and detailed scrutiny and have been applied to a large number of plants. There is no doubt that we do not know everything about fire and its impact on a nuclear power plants. However, this lack of knowledge or uncertainty can be quantified and can be used in the decision making process. In other words, the methods entail uncertainties and limitations that are not insurmountable and there is little or no basis for the results of a fire risk analysis fail to support a decision process

  10. Deep Borehole Disposal Safety Analysis.

    Energy Technology Data Exchange (ETDEWEB)

    Freeze, Geoffrey A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Stein, Emily [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Price, Laura L. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); MacKinnon, Robert J. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Tillman, Jack Bruce [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2016-10-01

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept. It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.

  11. US nuclear safety review and experience

    International Nuclear Information System (INIS)

    Gilinsky, V.

    1977-01-01

    The nuclear safety review of commercial nuclear power reactors has changed over the years from the relatively simple review of Dresden 1 in 1955 to the highly complex and sophisticated regulatory process which characterizes today's reviews. Four factors have influenced this evolution: (1) maturing of the technology and industry; (2) development of the regulatory process and associated staff; (3) feedback of operating experience; and (4) public awareness and participation. The NRC's safety review responsibilities start before an application is tendered and end when the plant is decommissioned. The safety review for reactor licensing is a comprehensive, two-phase process designed to assure that all the established conservative acceptance criteria are satisfied. Operational safety is assured through a strong inspection and enforcement program which includes shutting down operating facilities when necessary to protect the health and safety of the public. The safety of operating reactors is further insured through close regulation of license changes and selective backfitting of new regulatory requirements. An effective NRC standards development program has been implemented and coordinates closely with the national standards program. A confirmatory safety research program has been developed. Both of these efforts are invaluable to the nuclear safety review because they provide the staff with key tools needed to carry out its regulatory responsibilities. Both have been given increased emphasis since the formation of the NRC in 1975. The safety review process will continue to evolve, but changes will be slower and more deliberate. It will be influenced by standardization, early site reviews and development of advanced reactor concepts. New legislation may make possible changes which will simplify and shorten the regulatory process. Certainly the experience provided by the increasing number and types of operating plants will have a very strong impact on future trends in the

  12. Review and investigations of oscillatory flow behaviour of a horizontal ceiling opening for nuclear containment and fire safety analysis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, P.K.; Singh, R.K.; Ghosh, A.K. [Bhabha Atomic Research Centre, Trombay, Mumbai (India). Reactor Safety Div.

    2011-05-15

    In the thermal hydraulics codes developed for fire safety analysis and for containment thermal hydraulic analysis, junctions in the multi-compartment geometries is often modeled as uni-directional junctions. However, ceiling junctions are known to depict unstable/oscillatory bi-directional flow behavior. Detailed investigations have been carried out to understand the unstable flow behaviour of a junction by analyzing an earlier reported experiment and its subsequent two dimensional numerical RANS based study of fire in an enclosure. The authors attempt more realistic and desired three dimensional and inherently transient large eddy simulations using a computer code Fire Dynamics Simulator (FDS). The paper presents the details of the analysis, the results obtained and further studies required to be conducted so that the findings can be applied to the fire/containment thermal hydraulics analysis codes successfully. (orig.)

  13. A literature review of safety culture.

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

    2013-03-01

    Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavor was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of

  14. Periodic safety reviews of nuclear power plants

    International Nuclear Information System (INIS)

    Toth, Csilla

    2009-01-01

    Operational nuclear power plants (NPPs) are generally subject to routine reviews of plant operation and special safety reviews following operational events. In addition, many Member States of the International Atomic Energy Agency (IAEA) have initiated systematic safety reassessment, termed periodic safety review (PSR), to assess the cumulative effects of plant ageing and plant modifications, operating experience, technical developments, site specific, organizational and human aspects. These reviews include assessments of plant design and operation against current safety standards and practices. PSRs are considered an effective way of obtaining an overall view of actual plant safety, to determine reasonable and practical modifications that should be made in order to maintain a high level of safety throughout the plant's operating lifetime. PSRs can be used as a means to identify time limiting features of the plant. The trend is to use PSR as a condition for deciding whether to continue operation of the plant beyond the originally established design lifetime and for assessing the status of the plant for long term operation. To assist Member States in the implementation of PSR, the IAEA develops safety standards, technical documents and provides different services: training courses, workshops, technical meetings and safety review missions for the independent assessment of the PSR at NPPs, including the requirements for PSR, the review process and the PSR final reports. This paper describes the PSR's objectives, scopes, methods and the relationship of PSR with other plant safety related activities and recent experiences of Member States in implementation of PSRs at NPPs. (author)

  15. Reviewing industrial safety in nuclear power plants

    International Nuclear Information System (INIS)

    1990-02-01

    This document contains guidance and reference materials for Operational Safety Review Team (OSART) experts, in addition to the OSART Guidelines (TECDOC-449), for use in the review of industrial safety activities at nuclear power plants. It sets out objectives for an excellent industrial safety programme, and suggests investigations which should be made in evaluating industrial safety programmes. The attributes of an excellent industrial safety programme are listed as examples for comparison. Practical hints for reviewing industrial safety are discussed, so that the necessary information can be obtained effectively through a review of documents and records, discussions with counterparts, and field observations. There are several annexes. These deal with major features of industrial safety programmes such as safety committees, reporting and investigation systems and first aid and medical facilities. They include some examples which are considered commendable. The document should be taken into account not only when reviewing management, organization and administration but also in the review of related areas, such as maintenance and operations, so that all aspects of industrial safety in an operating nuclear power plant are covered

  16. Literature review of environmental qualification of safety-related electric cables: Literature analysis and appendices. Volume 2

    International Nuclear Information System (INIS)

    Lofaro, R.; Bowerman, B.; Carbonaro, J.

    1996-04-01

    In support of the US NRC Environmental Qualification (EQ) Research Program, a literature review was performed to identify past relevant work that could be used to help fully or partially resolve issues of interest related to the qualification of low-voltage electric cable. A summary of the literature reviewed is documented in Volume 1 of this report. In this, Volume 2 of the report, dossiers are presented which document the issues selected for investigation in this program, along with recommendations for future work to resolve the issues, when necessary. The dossiers are based on an analysis of the literature reviewed, as well as expert opinions. This analysis includes a critical review of the information available from past and ongoing work in thirteen specific areas related to EQ. The analysis for each area focuses on one or more questions which must be answered to consider a particular issue resolved. Results of the analysis are presented, along with recommendations for future work. The analysis is documented in the form of a dossier for each of the areas analyzed

  17. Reliability analysis of PLC safety equipment

    Energy Technology Data Exchange (ETDEWEB)

    Yu, J.; Kim, J. Y. [Chungnam Nat. Univ., Daejeon (Korea, Republic of)

    2006-06-15

    FMEA analysis for Nuclear Safety Grade PLC, failure rate prediction for nuclear safety grade PLC, sensitivity analysis for components failure rate of nuclear safety grade PLC, unavailability analysis support for nuclear safety system.

  18. Reliability analysis of PLC safety equipment

    International Nuclear Information System (INIS)

    Yu, J.; Kim, J. Y.

    2006-06-01

    FMEA analysis for Nuclear Safety Grade PLC, failure rate prediction for nuclear safety grade PLC, sensitivity analysis for components failure rate of nuclear safety grade PLC, unavailability analysis support for nuclear safety system

  19. Efficacy and safety of co-administered ivermectin plus albendazole for treating soil-transmitted helminths: A systematic review, meta-analysis and individual patient data analysis.

    Science.gov (United States)

    Palmeirim, Marta S; Hürlimann, Eveline; Knopp, Stefanie; Speich, Benjamin; Belizario, Vicente; Joseph, Serene A; Vaillant, Michel; Olliaro, Piero; Keiser, Jennifer

    2018-04-01

    The soil-transmitted helminths (STH), Ascaris lumbricoides, Trichuris trichiura and hookworms, infect 1.5 billion people worldwide and cause an estimated burden of 3.3 million disability-adjusted life years (DALYs). Current control strategies focus on morbidity reduction through preventive chemotherapy (PC) but the most commonly used recommended drugs (albendazole and mebendazole) are particularly inefficacious against T. trichiura. This, together with the threat of emerging drug resistance, calls for new control strategies, including co-administration with other anthelminthics. Ivermectin plus albendazole is widely used against lymphatic filariasis, but its efficacy and safety against STH infections has not yet been fully understood. We conducted a systematic literature review and meta-analysis on the efficacy and safety of ivermectin-albendazole co-administration in five different databases (i.e. PubMed, ISI Web of Science, ScienceDirect, CENTRAL and clinicaltrials.gov) from 1960 to January 2018. Four studies reporting efficacy of ivermectin-albendazole against STH infections and five studies on its safety met the selection criteria and were included for quantitative analysis. Ivermectin-albendazole was significantly associated with lower risk (risk ratio (RR) = 0.44, 95% confidence interval (CI) = 0.31-0.62) for T. trichiura infection after treatment compared to albendazole alone. The co-administration revealed no or only a marginal benefit on cure and egg reduction rates over albendazole alone for A. lumbricoides and hookworm infections. Adverse events (AEs) occurring after ivermectin-albendazole co-administration were mostly mild and transient. Overall, the number of individuals reporting any AE was not different (RR = 1.09, 95% CI = 0.87-1.36) in co-treated and albendazole-treated patients. However, although not statistically significant, sub-group analysis showed a tendency for slightly more AEs in patients with filariasis treated with ivermectin

  20. Efficacy and safety of co-administered ivermectin plus albendazole for treating soil-transmitted helminths: A systematic review, meta-analysis and individual patient data analysis

    Science.gov (United States)

    Palmeirim, Marta S.; Hürlimann, Eveline; Knopp, Stefanie; Belizario, Vicente; Joseph, Serene A.; Olliaro, Piero

    2018-01-01

    Background The soil-transmitted helminths (STH), Ascaris lumbricoides, Trichuris trichiura and hookworms, infect 1.5 billion people worldwide and cause an estimated burden of 3.3 million disability-adjusted life years (DALYs). Current control strategies focus on morbidity reduction through preventive chemotherapy (PC) but the most commonly used recommended drugs (albendazole and mebendazole) are particularly inefficacious against T. trichiura. This, together with the threat of emerging drug resistance, calls for new control strategies, including co-administration with other anthelminthics. Ivermectin plus albendazole is widely used against lymphatic filariasis, but its efficacy and safety against STH infections has not yet been fully understood. Methods and findings We conducted a systematic literature review and meta-analysis on the efficacy and safety of ivermectin-albendazole co-administration in five different databases (i.e. PubMed, ISI Web of Science, ScienceDirect, CENTRAL and clinicaltrials.gov) from 1960 to January 2018. Four studies reporting efficacy of ivermectin-albendazole against STH infections and five studies on its safety met the selection criteria and were included for quantitative analysis. Ivermectin-albendazole was significantly associated with lower risk (risk ratio (RR) = 0.44, 95% confidence interval (CI) = 0.31–0.62) for T. trichiura infection after treatment compared to albendazole alone. The co-administration revealed no or only a marginal benefit on cure and egg reduction rates over albendazole alone for A. lumbricoides and hookworm infections. Adverse events (AEs) occurring after ivermectin-albendazole co-administration were mostly mild and transient. Overall, the number of individuals reporting any AE was not different (RR = 1.09, 95% CI = 0.87–1.36) in co-treated and albendazole-treated patients. However, although not statistically significant, sub-group analysis showed a tendency for slightly more AEs in patients with filariasis

  1. NPP Krsko periodic safety review. Safety assessment and analyses

    International Nuclear Information System (INIS)

    Basic, I.; Spiler, J.; Thaulez, F.

    2002-01-01

    Definition of a PSR (Periodic Safety Review) project is a comprehensive safety review of a plant after ten years of operation. The objective is a verification by means of a comprehensive review using current methods that the plant remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. The overall goals of the NEK PSR Program are defined in compliance with the basic role of a PSR and the current practice typical for most of the countries in EU. This practice is described in the related guides and good practice documents issued by international organizations. The overall goals of the NEK PSR are formulated as follows: to demonstrate that the plant is as safe as originally intended; to evaluate the actual plant status with respect to aging and wear-out identifying any structures, systems or components that could limit the life of the plant in the foreseeable future, and to identify appropriate corrective actions, where needed; to compare current level of safety in the light of modern standards and knowledge, and to identify where improvements would be beneficial for minimizing deviations at justifiable costs. The Krsko PSR will address the following safety factors: Operational Experience, Safety Assessment, EQ and Aging Management, Safety Culture, Emergency Planning, Environmental Impact and Radioactive Waste.(author)

  2. Nuclear Safety Review for the Year 2003

    International Nuclear Information System (INIS)

    2004-08-01

    The Nuclear Safety Review reports on worldwide efforts to strengthen nuclear, radiation and transport safety and the safety of radioactive waste management. In line with the suggestions made by the Board of Governors in March 2002, the first part is more analytical and less descriptive. This short analytical overview is supported by a second part, which describes significant safety related events and issues worldwide during 2003. A Draft Nuclear Safety Review for the Year 2003 was submitted to the March 2004 session of the Board of Governors in document GOV/2004/3. The final version of the Nuclear Safety Review for the Year 2003 was prepared in the light of the discussion by the Board.

  3. The importance of human cognitive models in the safety analysis report of nuclear power plants - a comparative review

    International Nuclear Information System (INIS)

    Alvarenga, Marco A.B.; Araujo Goes, Alexandre G. de

    1997-01-01

    The chapter 18 of the Brazilian NPPs Safety Analysis Report (SAR) deals with Human Factor Engineering (HFE). The chapter evaluation is distributed among ten topics. One of them, the HRA (Human Reliability Analysis) becomes the central subject of the whole analysis, generating information to the other topics, as for example, high risk operational critical sequences. The HRA methods used in the past concerned the approach of modeling the human being as a component (hardware), based in a failure or success bivalent logic. In the last ten years, several human cognitive models were developed to be used in the nuclear field as well as in the conventional industry, mainly in the military aviation. In this paper, we describe their main features, comparing some models to each other, with the main purpose of determining the minimal characteristics acceptable for NPPs licensing, being part of these cognitive models, to be used mainly in the evaluation of HRAs from SARs in the NPPs. (author). 10 refs

  4. SRTC criticality safety technical review: Phase 1 criticality analysis for the 9972-9975 family of shipping casks: (SRT-CMA-940003)

    International Nuclear Information System (INIS)

    Rathbun, R.

    1994-01-01

    Review of SRT-CMA-940003, ''Phase I Criticality Analysis For The 9972-9975 Family Of Shipping Casks (U). (SRT-CMA-940003).'' January 22, 1994, has been performed by the SRTC Applied Physics Group. The NCSE is a criticality assessment of the 9972-9975 family of shipping casks. This work is a follow-on of a previous criticality safety evaluation, with the differences between this and the previous evaluation are that now wall tolerances are modeled and more sophisticated analytical methods are applied. The NCSE under review concludes that, with one exception, the previously specified plutonium and uranium mass limits for 9972-9975 family of shipping casks do ensure that WSRC Nuclear Criticality Safety Manual requirements (ref. 1) are satisfied. The one exception is that the plutonium mass limit for the 9974 cask had to be reduced from 4.4 to 4.3 kg. In contrast, the 7.5 kg uranium mass limit for the 9974 cask was raised to 14.5 kg, making the uranium mass identical for all casks in this family. This technical review consisted of an independent check of the methods and models employed, application of ANSI/ANS 8.1 and 8.15, and verification of WSRC Nuclear Criticality Safety Manual procedures

  5. Nuclear Safety: Technical progress review, January--March 1989

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E. G. [ed.

    1989-01-01

    This review journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  6. Safety analysis procedures for PHWR

    International Nuclear Information System (INIS)

    Min, Byung Joo; Kim, Hyoung Tae; Yoo, Kun Joong

    2004-03-01

    The methodology of safety analyses for CANDU reactors in Canada, a vendor country, uses a combination of best-estimate physical models and conservative input parameters so as to minimize the uncertainty of the plant behavior predictions. As using the conservative input parameters, the results of the safety analyses are assured the regulatory requirements such as the public dose, the integrity of fuel and fuel channel, the integrity of containment and reactor structures, etc. However, there is not the comprehensive and systematic procedures for safety analyses for CANDU reactors in Korea. In this regard, the development of the safety analyses procedures for CANDU reactors is being conducted not only to establish the safety analyses system, but also to enhance the quality assurance of the safety assessment. In the first phase of this study, the general procedures of the deterministic safety analyses are developed. The general safety procedures are covered the specification of the initial event, selection of the methodology and accident sequences, computer codes, safety analysis procedures, verification of errors and uncertainties, etc. Finally, These general procedures of the safety analyses are applied to the Large Break Loss Of Coolant Accident (LBLOCA) in Final Safety Analysis Report (FSAR) for Wolsong units 2, 3, 4

  7. Occupational Safety Review of High Technology Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Lee Cadwallader

    2005-01-31

    This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

  8. Internet Safety and Security Surveys - A Review

    DEFF Research Database (Denmark)

    Sharp, Robin

    This report gives a review of investigations into Internet safety and security over the last 10 years. The review covers a number of surveys of Internet usage, of Internet security in general, and of Internet users' awareness of issues related to safety and security. The focus and approach...... of the various surveys is considered, and is related to more general proposals for investigating the issues involved. A variety of proposals for how to improve levels of Internet safety and security are also described, and they are reviewed in the light of studies of motivational factors which affect the degree...

  9. Krsko NPP Periodic Safety Review program

    International Nuclear Information System (INIS)

    Basic, I.; Spiler, J.; Novsak, M.

    2001-01-01

    The need for conducting a Periodic Safety Review for the Krsko NPP has been clearly recognized both by the NEK and the regulator (SNSA). The PSR would be highly desirable both in the light of current trends in safety oversight practices and because of many benefits it is capable to provide. On January 11, 2001 the SNSA issued a decision requesting the Krsko NPP to prepare a program and determine a schedule for the implementation of the program for 'Periodic Safety Review of NPP Krsko'. The program, which is required to be in accordance with the IAEA safety philosophy and with the EU practice, was submitted for the approval to the SNSA by the end of March 2001. The paper summarizes Krsko NPP Periodic Safety Review Program [1] including implemented SNSA and IAEA Expert Mission comments.(author)

  10. Nuclear Safety Review for the Year 2012

    International Nuclear Information System (INIS)

    2012-07-01

    The Nuclear Safety Review for the Year 2012 contains an analytical overview of the dominant trends, issues and challenges worldwide in 2011 and the Agency's efforts to strengthen the global nuclear safety framework. This year's report also highlights issues and activities related to the accident at the Fukushima Daiichi nuclear power plant. The analytical overview is supported by the Appendix at the end of this document, entitled: The IAEA Safety Standards: Activities during 2011. A draft version of the Nuclear Safety Review for the Year 2012 was submitted to the March 2012 session of the Board of Governors in document GOV/2012/6. The final version of the Nuclear Safety Review for the Year 2012 was prepared in light of the discussions held during the Board of Governors and also of the comments received.

  11. Nuclear Safety Review for the Year 2010

    International Nuclear Information System (INIS)

    2011-07-01

    The Agency, as a leading organization for promoting international cooperation among its Member States, is in a unique position to observe global trends, issues and challenges in nuclear safety and security through a wide variety of activities related to the establishment of safety standards and security guidelines and their application. The contents of this Nuclear Safety Review reflect the emerging nuclear safety trends, issues and challenges for 2010, as well as recapitulate the Agency's activities intended to further strengthen the global nuclear safety and security framework in all areas of nuclear, radiation, waste and transport safety. The accident at the Fukushima Daiichi Nuclear Power Plant, caused by the extraordinary disasters of the earthquake and tsunamis that struck Japan on 11 March 2011, continues to be assessed. As this report focuses on developments in 2010, the accident and its implications are not addressed here, but will be addressed in future reports of the Agency. The international nuclear community maintained a high level of safety performance in 2010. Nuclear power plant safety performance remained high, and indicated an improved trend in the number of emergency shutdowns as well in the level of energy available during these shutdowns. In addition, more States explored or expanded their interests in nuclear power programmes, and more faced the challenge of establishing the required regulatory infrastructure, regulatory supervision and safety management over nuclear installations and the use of ionizing radiation. Issues surrounding radiation protection and radioecology continued as trends in 2010. For example, increased public awareness of exposure to and environmental impacts of naturally occurring radioactive material (NORM) as well as nuclear legacy sites has led to increased public concern. In addition, human resources in radiation protection and radioecology have been lost as a result of retirement and of the migration of experts to

  12. Efficacy, tolerability, and safety of hypnosis in adult irritable bowel syndrome: systematic review and meta-analysis.

    Science.gov (United States)

    Schaefert, Rainer; Klose, Petra; Moser, Gabriele; Häuser, Winfried

    2014-06-01

    To assess the efficacy, tolerability, and safety of hypnosis in adult irritable bowel syndrome by a meta-analysis of randomized controlled trials. Studies were identified by a literature search of the databases Allied and Complementary Medicine Database, Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, PubMed, PsycINFO, and Scopus (from inception to June 30, 2013). Primary outcomes were adequate symptom relief, global gastrointestinal score, and safety. Summary relative risks (RRs) with number needed to treat (NNT) and standardized mean differences (SMDs) with 95% confidence intervals (95% CIs) were calculated using random-effects models. Eight randomized controlled trials with a total of 464 patients and a median of 8.5 (7-12) hypnosis sessions over a median of 12 (5-12) weeks were included into the analysis. At the end of therapy, hypnosis was superior to control conditions in producing adequate symptom relief (RR, 1.69 [95% CI = 1.14-2.51]; NNT, 5 [3-10]) and in reducing global gastrointestinal score (SMD, 0.32 [95% CI = -0.56 to -0.08]). At long-term follow-up, hypnosis was superior to controls in adequate symptom relief (RR, 2.17 [95% CI = 1.22-3.87]; NNT, 3 [2-10]), but not in reducing global gastrointestinal score (SMD, -0.57 [-1.40 to 0.26]). One (0.4%) of 238 patients in the hypnosis group dropped out due to an adverse event (panic attack). This meta-analysis demonstrated that hypnosis was safe and provided long-term adequate symptom relief in 54% of patients with irritable bowel syndrome refractory to conventional therapy.

  13. Safety review and approval process for the TFTR

    International Nuclear Information System (INIS)

    Levine, J.D.; Howe, H.J.; Howe, K.E.

    1983-01-01

    The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices

  14. Summary of the technical review of the safety analysis reports for packaging (SARP) for the transnuclear transport/storage casks: TN-BRP and TN-REG

    International Nuclear Information System (INIS)

    1986-07-01

    The Safety Analysis Reports for Packaging for two spent fuel shipping casks were technically reviewed by the Oak Ridge National Laboratory. The casks were designed by Transnuclear, Inc., for shipment of 85 Big Rock Point boiling water reactor fuel elements and 40 R.E. Ginna pressurized water reactor fuel elements from West Valley, New York, to Idaho Falls, Idaho. The intent of the review was to ensure compliance of the casks with the requirements the applicable Federal Regulations contained in 10 CFR Pt. 71 and allow issuance of Department of Energy Certificates of Compliance for transport by the Department of Energy Idaho Operations Office. The review was performed by a team of Oak Ridge National Laboratory staff assembled for their expertise in criticality analysis, shielding, metallurgy, nondestructive testing, thermal analysis, structural analysis, and containment. This report describes the review processes, the findings in each technical area, and the overall conclusion that a Certificate of Compliance could be issued for the proposed single shipment under the specified conditions and constraints

  15. The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

    2017-01-01

    Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

  16. Efficacy and Safety of Chinese Medicinal Herbs for the Treatment of Hyperuricemia: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Jianping Lin

    2016-01-01

    Full Text Available Background. Chinese medicinal herbs may be useful for the treatment of hyperuricemia, but there has been no systematic assessment of their efficacy and safety. Objectives. To systematically assess the efficacy and safety of Chinese medicinal herbs for the treatment of hyperuricemia. Methods. Six electronic databases were searched from their inception to December 2015. Randomized controlled clinical trials (RCTs were included. Cochrane criteria were applied to assess the risk of bias. Data analysis was performed using RevMan software version 5.2. Results. Eleven RCTs with 838 patients were included. There was no significant difference in serum uric acid between Chinese medicinal herbs and traditional Western medicine (SME: 0.19, 95% CI: −0.04 to 0.43; p=0.10. In terms of overall efficacy, the Chinese medicinal herbs were significantly superior to Western medicine (RR: 1.11; 95% CI: 1.04 to 1.17; p=0.0007. The Chinese medicinal herbs were better than Western medicine in reducing the adverse reactions (RR: 0.30; 95% CI: 0.15 to 0.62; p=0.001. And all these funnel plots showed unlikelihood of publishing bias. Conclusions. The results indicate that Chinese medicinal herbs may have greater overall efficacy with fewer adverse drug reactions, although the evidence is weak owing to the low methodological quality and the small number of the included trials.

  17. Status of Ignalina's safety analysis reports

    International Nuclear Information System (INIS)

    Uspuras, E.

    1999-01-01

    Ignalina NPP is unique among RBMK type reactors in the scope and comprehensiveness of international studies which have been performed to verify its design parameters and analyze risk levels. International assistance took several forms, a very valuable mod of assistance utilized the knowledge of international experts in extensive international studies whose purpose was: collection, systematization and verification of plant design data; analysis of risk levels; recommendations leading to improvements in the safety lave; transfer of state of the art analytical methodology to Lithuanian specialists. The major large scale international studies include: probabilistic risk analysis; extensive international study meant to provide comprehensive overview of plant status with special emphasis on safety aspects; an extensive review of the Safety Analysis Report by an independent group of international experts. In spite of the safety improvements and analyses which have been performed at the Ignalina NPP, much remains to be done in the nearest future

  18. Krsko periodic safety review project prioritization process

    International Nuclear Information System (INIS)

    Basic, I.; Vrbanic, I.; Spiler, J.; Lambright, J.

    2004-01-01

    Definition of a Krsko Periodic Safety Review (PSR) project is a comprehensive safety review of a plant after last ten years of operation. The objective is a verification by means of a comprehensive review using current methods that Krsko NPP remains safety when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. This objective encompasses the three main criteria or goals: confirmation that the plant is as safe as originally intended, determination if there are any structures, systems or components that could limit the life of the plant in the foreseeable future, and comparison the plant against modern safety standards and to identify where improvements would be beneficial at justifiable cost. Krsko PSR project is structured in the three phases: Phase 1: Preparation of Detailed 10-years PSR Program, Phase 2: Performing of 10-years PSR Program and preparing of associated documents (2001-2003), and Phase 3: Implementation of the prioritized compensatory measures and modifications (development of associated EEAR, DMP, etc.) after agreement with the SNSA on the design, procedures and time-scales (2004-2008). This paper presents the NEK PSR results of work performed under Phase 2 focused on the ranking of safety issues and prioritization of corrective measures needed for establishing an efficient action plan. Safety issues were identified in Phase 2 during the following review processes: Periodic Safety Review (PSR) task; Krsko NPP Regulatory Compliance Program (RCP) review; Westinghouse Owner Group (WOG) catalog items screening/review; SNSA recommendations (including IAEA RAMP mission suggestions/recommendations).(author)

  19. The necessity of periodic fire safety review

    International Nuclear Information System (INIS)

    Mowrer, D.S.

    1998-01-01

    Effective fire safety requires the coordinated integration of many diverse elements. Clear fire safety objectives are defined by plant management and/or regulatory authorities. Extensive and time-consuming systematic analyses are performed. Fire safety features (both active and passive) are installed and maintained, and administrative programs are established and implemented to achieve the defined objectives. Personnel are rigorously trained. Given the time, effort and monetary resources expended to achieve a specific level of fire safety, conducting periodic assessments to verify that the specified level of fire safety has been achieved and is maintained is a matter of common sense. Periodic fire safety reviews and assessment play an essential role in assuring continual nuclear safety in the world's power plants

  20. System safety engineering analysis handbook

    Science.gov (United States)

    Ijams, T. E.

    1972-01-01

    The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

  1. Computer codes for safety analysis

    International Nuclear Information System (INIS)

    Holland, D.F.

    1986-11-01

    Computer codes for fusion safety analysis have been under development in the United States for about a decade. This paper will discuss five codes that are currently under development by the Fusion Safety Program. The purpose and capability of each code will be presented, a sample given, followed by a discussion of the present status and future development plans

  2. Safety analysis reports. Current status (third key report)

    International Nuclear Information System (INIS)

    1999-01-01

    A review of Ukrainian regulations and laws concerned with Nuclear power and radiation safety is presented with an overview of the requirements for the Safety Analysis Report Contents. Status of Safety Analysis Reports (SAR) is listed for each particular Ukrainian NPP including SAR development schedules. Organisational scheme of SAR development works includes: general technical co-ordination on Safety Analysis Report development; list of leading organisations and utilization of technical support within international projects

  3. Ignalina Safety Analysis Group's report for the year 1998

    International Nuclear Information System (INIS)

    Uspuras, E.; Augutis, J.; Bubelis, E.; Cesna, B.; Kaliatka, A.

    1999-02-01

    Results of Ignalina NPP Safety Analysis Group's research are presented. The main fields of group's activities in 1998 were following: safety analysis of reactor's cooling system, safety analysis of accident localization system, investigation of the problem graphite - fuel channel, reactor core modelling, assistance to the regulatory body VATESI in drafting regulations and reviewing safety reports presented by Ignalina NPP during the process of licensing of unit 1

  4. Nuclear safety review for the year 2001

    International Nuclear Information System (INIS)

    2002-07-01

    The Nuclear Safety Review for the Year 2001 reports on worldwide efforts to strengthen nuclear and radiation safety, including radioactive waste safety. It is in three parts. Part 1 describes those events in 2001 that have, or may have, significance for nuclear, radiation and waste safety worldwide. It includes developments such as new initiatives in international cooperation, events of safety significance and events that may be indicative of trends in safety. Part 2 describes some of the IAEA's efforts to strengthen international co-operation in nuclear, radiation and waste safety during 2001. It covers legally binding international agreements, non-binding safety standards, and provisions for the application of safety standards. This is done in a very brief manner, because these issues are addressed in more detail in the Agency's Annual Report for 2001. Part 3 presents a brief look ahead to some issues that are likely to be prominent in the coming year(s). The topics covered were selected by the IAEA Secretariat on the basis of trends observed in recent years, account being taken of planned or expected future developments. A draft of the Nuclear Safety Review for the Year 2001 was presented to the March 2002 session of IAEA's Board of Governors. This final version has been prepared taking account of the discussion in the Board. In some places, information has been added to describe developments early in 2002 that were considered pertinent to the discussion of events during 2001

  5. The efficacy and safety of aripiprazole for tic disorders in children and adolescents: A systematic review and meta-analysis.

    Science.gov (United States)

    Wang, Shuai; Wei, Yan-Zhao; Yang, Jian-Hong; Zhou, Yu-Ming; Cheng, Yu-Hang; Yang, Chao; Zheng, Yi

    2017-08-01

    The aims are to evaluate the efficacy and safety of aripiprazole for tic disorders (TDs) in children and adolescents. We searched PubMed, Embase, PsychINFO, Cochrane database as well as Chinese databases of CNKI, VIP, CBM and Wanfang from the database inception to October 2016, and 17 full-text studies (N=1305) were included in our article. The meta-analysis of 10 studies (N=817) showed that there was no significant difference in the reduction of total YGTSS score between aripiprazole and other drugs, and meta-analysis of 7 studies (n=324) which used tic symptom control ≧30% as outcome measure showed that there was no significant difference between aripiprazole and other treatments. The most common AEs of aripiprazole were the drowsiness, nausea/vomiting and increased appetite, and meta analysis which used the TESS scale as the outcome measurement showed that there was a significant difference between aripiprazole and haloperidol. In conclusion, these data provide moderate quality evidence that aripiprazole could be an effective and safe treatment option for TDs, and results from further trials are urgently needed to extend this evidence base. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  6. Nuclear safety review for the year 1997

    International Nuclear Information System (INIS)

    1998-12-01

    The Nuclear Safety Review attempts to summarize the global nuclear safety scene during 1997. It starts with discussion of significant safety related events worldwide: International cooperation; reactor facilities; radioactive waste management; medical uses of radiation sources; events at other facilities and transport of radioactive material. This is followed by a description of principal IAEA activities that contributed to global nuclear safety, namely: legally binding international agreements; non-binding safety standards and their application. The third part highlights developments in Member States as they reported them. The review closes with a description of issues that are likely to be prominent in the coming year(s). A draft version was submitted to the March 1998 session of the IAEA Board of Governors, and this final version has been prepared in light of the discussion in the Board and was submitted for information to the 42nd session of the IAEA General Conference

  7. Effects and safety of oral tolvaptan in patients with congestive heart failure: A systematic review and network meta-analysis.

    Directory of Open Access Journals (Sweden)

    Mei-Yi Wu

    Full Text Available Several studies reported treatment benefits of tolvaptan in patients with congestive heart failure (CHF. However, the optimal dosage remains unclear. We aimed to compare different dosage of tolvaptan to determine the optimal dosage in terms of the efficacy and safety.We searched MEDLINE, PubMed, EMBASE, Cochrane CENTRAL and ClinicalTrials.gov through Aug 31, 2016. Randomized controlled trials (RCTs comparing tolvaptan of different dosages or to placebo in patients with CHF were included. We used network meta-analysis to look for the optimal dosage in terms of effectiveness and safety. Urine output, body weight change and change in serum sodium were the main outcomes of efficacy. Adverse effects were the secondary outcomes. Quality was assessed by Cochrane risk-of-bias tool.Twelve RCTs reporting 14 articles with 5793 patients (mean age, 65.7 ± 11.9 years; 73.7% man were included. Compared with placebo, the tolvaptan 30 mg had similar effects to tolvaptan 45-90 mg in terms of urine output (mean difference [MD] 2.03 liter; 95% confidence interval [CI] 1.3 to 2.71, body weight change (MD -1.12 kg; 95% CI -1.37 to -0.88 and change in serum sodium (MD 3.06 meq/L; 95% CI 2.43 to 3.68. Compared with placebo, tolvaptan of different dosage showed a non-significant higher risk of adverse effects.These findings suggest that tolvaptan 30 mg and 45 mg may be the optimum dosage for CHF patients, because of its ability to provide favourable clinical results without greater adverse effects. However, tolvaptan is not beneficial for reducing all-cause mortality in CHF patients.

  8. Safety analysis reports - new strategies

    International Nuclear Information System (INIS)

    Booth, J.A.

    1994-01-01

    Within the past year there have been many external changes in the requirements of safety analysis reports. Now there is emphasis on open-quotes graded approachesclose quotes depending on the Hazard Classification of the project. The Energy Facility Contractors Group (EFCOG) has a Safety Analysis Working Group. The results of this group for the past year are discussed as well as the implications for EG ampersand G. New strategies include ideas for incorporating the graded approach, auditable safety documents, additional guidance for Hazard Classification per DOE-STD-1027-92. The emphasis in the paper is on those projects whose hazard classification is category three or less

  9. Nulcear Safety: Technical progress review, October--December 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    Nuclear Safety is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  10. Nuclear Safety: Volume 29, No. 3: Technical progress review

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-07-01

    Nuclear Safety is a review journal that covers significant development in the field of nuclear safety. Its scope included the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated. Individual papers have been cataloged separately.

  11. Safety assessment of research reactors and preparation of the safety analysis report

    International Nuclear Information System (INIS)

    1994-01-01

    This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors

  12. Review of cause-based decision tree approach for the development of domestic standard human reliability analysis procedure in low power/shutdown operation probabilistic safety assessment

    International Nuclear Information System (INIS)

    Kang, D. I.; Jung, W. D.

    2003-01-01

    We review the Cause-Based Decision Tree (CBDT) approach to decide whether we incorporate it or not for the development of domestic standard Human Reliability Analysis (HRA) procedure in low power/shutdown operation Probabilistic Safety Assessment (PSA). In this paper, we introduce the cause based decision tree approach, quantify human errors using it, and identify merits and demerits of it in comparision with previously used THERP. The review results show that it is difficult to incorporate the CBDT method for the development of domestic standard HRA procedure in low power/shutdown PSA because the CBDT method need for the subjective judgment of HRA analyst like as THERP. However, it is expected that the incorporation of the CBDT method into the development of domestic standard HRA procedure only for the comparision of quantitative HRA results will relieve the burden of development of detailed HRA procedure and will help maintain consistent quantitative HRA results

  13. Safety-critical event risk associated with cell phone tasks as measured in naturalistic driving studies: A systematic review and meta-analysis.

    Science.gov (United States)

    Simmons, Sarah M; Hicks, Anne; Caird, Jeff K

    2016-02-01

    A systematic review and meta-analysis of naturalistic driving studies involving estimates of safety-critical event risk associated with handheld device use while driving is described. Fifty-seven studies identified from targeted databases, journals and websites were reviewed in depth, and six were ultimately included. These six studies, published between 2006 and 2014, encompass seven sets of naturalistic driver data and describe original research that utilized naturalistic methods to assess the effects of distracting behaviors. Four studies involved non-commercial drivers of light vehicles and two studies involved commercial drivers of trucks and buses. Odds ratios quantifying safety-critical event (SCE) risk associated with talking, dialing, locating or answering, and texting or browsing were extracted. Stratified meta-analysis of pooled odds ratios was used to estimate SCE risk by distraction type; meta-regression was used to test for sources of heterogeneity. The results indicate that tasks that require drivers to take their eyes off the road, such as dialing, locating a phone and texting, increase SCE risk to a greater extent than tasks that do not require eyes off the road such as talking. Although talking on a handheld device did not increase SCE risk, further research is required to determine whether it indirectly influences SCE risk (e.g., by encouraging other cell phone activities). In addition, a number of study biases and quality issues of naturalistic driving studies are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Nuclear Safety Review for the Year 2010

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-15

    The contents of this Nuclear Safety Review reflect the emerging nuclear safety trends, issues and challenges for 2010, as well as recapitulate the Agency's activities intended to further strengthen the global nuclear safety and security framework in all areas of nuclear, radiation, waste and transport safety. Nuclear power plant safety performance remained high, and indicated an improved trend in the number of emergency shutdowns as well in the level of energy available during these shutdowns. In addition, more States explored or expanded their interests in nuclear power programmes, and more faced the challenge of establishing the required regulatory infrastructure, regulatory supervision and safety management over nuclear installations and the use of ionizing radiation. Issues surrounding radiation protection and radioecology continued as trends in 2010. For example, increased public awareness of exposure to and environmental impacts of naturally occurring radioactive material (NORM) as well as nuclear legacy sites has led to increased public concern. In addition, human resources in radiation protection and radioecology have been lost as a result of retirement and of the migration of experts to other fields. It is clear that safety continues to be a work in progress. The global nuclear power industry continued to require substantial efforts by designers, manufacturers, operators, regulators and other stakeholders to satisfy diverse quality and safety requirements and licensing processes, along with the recognized need in industry and among regulators to standardize and harmonize these requirements and processes. In some cases, plans for nuclear power programme development moved faster than the establishment of the necessary regulatory and safety infrastructure and capacity. To assist Member States in this effort, the Regulatory Cooperation Forum (RCF) was formed in June 2010. The RCF is a regulator-to-regulator forum that optimizes regulatory support from Member

  15. The efficacy and safety of alectinib in the treatment of ALK+ NSCLC: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Fan JS

    2018-03-01

    Full Text Available Junsheng Fan,1,2,* Zengfei Xia,1,* Xiaoli Zhang,1,* Yuqing Chen,1 Ruolan Qian,1 Sihan Liu,1 Danming You,1 Jian Zhang,1 Peng Luo1 1Department of Oncology, Zhujiang Hospital of Southern Medical University, Guangzhou, China; 2Department of Respiratory Medicine, Shanghai Tenth People’s Hospital, Tongji University, Shanghai, China *These authors contributed equally to this work Background: Alectinib is a second-generation anaplastic lymphoma kinase (ALK inhibitor approved by the US Food and Drug Administration to treat crizotinib-refractory non-small cell lung cancer. We performed this meta-analysis to synthesize the results of different clinical trials to evaluate the efficacy and safety of alectinib. Methods: A search of 3 databases, including PubMed, Web of Science, and the Cochrane Library, was performed from the inception of each database through September 5, 2017. We have pooled the overall response rate (ORR, disease control rate, progression-free survival, and intracranial ORR to evaluate the efficacy of alectinib. Discontinuation rate, rate of dose reduction or interruption due to adverse events as well as the incidence of several adverse events were aggregated to evaluate its safety. Results: A total of 8 studies with 626 patients have been included in our study. The pooled efficacy parameters are as follows: ORR 70% (95% CI: 57% to 82%, disease control rate 88% (95% CI: 82% to 94%, progression-free survival 9.36 months (95% CI: 7.38% to 11.34%, and intracranial ORR 52% (95% CI: 45% to 59%. ALK inhibitor-naïve patients tend to have better responses than crizotinib-pretreated patients. The aggregate discontinuation rate is 7% (95% CI: 4% to 10%, and the pooled rate of dose reduction or interruption is 33% (95% CI: 24% to 42%. The incidences of most adverse events were relatively low, while the incidences of 2 frequently reported adverse events, myalgia (18% and anemia (25%, were even higher than with the first-generation ALK inhibitor

  16. Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

    Science.gov (United States)

    Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

    2017-06-01

    Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

  17. Updated safety analysis of ITER

    International Nuclear Information System (INIS)

    Taylor, Neill; Baker, Dennis; Ciattaglia, Sergio; Cortes, Pierre; Elbez-Uzan, Joelle; Iseli, Markus; Reyes, Susana; Rodriguez-Rodrigo, Lina; Rosanvallon, Sandrine; Topilski, Leonid

    2011-01-01

    An updated version of the ITER Preliminary Safety Report has been produced and submitted to the licensing authorities. It is revised and expanded in response to requests from the authorities after their review of an earlier version in 2008, to reflect enhancements in ITER safety provisions through design changes, to incorporate new and improved safety analyses and to take into account other ITER design evolution. The updated analyses show that changes to the Tokamak cooling water system design have enhanced confinement and reduced potential radiological releases as well as removing decay heat with very high reliability. New and updated accident scenario analyses, together with fire and explosion risk analyses, have shown that design provisions are sufficient to minimize the likelihood of accidents and reduce potential consequences to a very low level. Taken together, the improvements provided a stronger demonstration of the very good safety performance of the ITER design.

  18. Updated safety analysis of ITER

    Energy Technology Data Exchange (ETDEWEB)

    Taylor, Neill, E-mail: neill.taylor@iter.org [ITER Organization, CS 90 046, 13067 St Paul Lez Durance Cedex (France); Baker, Dennis; Ciattaglia, Sergio; Cortes, Pierre; Elbez-Uzan, Joelle; Iseli, Markus; Reyes, Susana; Rodriguez-Rodrigo, Lina; Rosanvallon, Sandrine; Topilski, Leonid [ITER Organization, CS 90 046, 13067 St Paul Lez Durance Cedex (France)

    2011-10-15

    An updated version of the ITER Preliminary Safety Report has been produced and submitted to the licensing authorities. It is revised and expanded in response to requests from the authorities after their review of an earlier version in 2008, to reflect enhancements in ITER safety provisions through design changes, to incorporate new and improved safety analyses and to take into account other ITER design evolution. The updated analyses show that changes to the Tokamak cooling water system design have enhanced confinement and reduced potential radiological releases as well as removing decay heat with very high reliability. New and updated accident scenario analyses, together with fire and explosion risk analyses, have shown that design provisions are sufficient to minimize the likelihood of accidents and reduce potential consequences to a very low level. Taken together, the improvements provided a stronger demonstration of the very good safety performance of the ITER design.

  19. Uncertainty analysis for Ulysses safety evaluation report

    International Nuclear Information System (INIS)

    Frank, M.V.

    1991-01-01

    As part of the effort to review the Ulysses Final Safety Analysis Report and to understand the risk of plutonium release from the Ulysses spacecraft General Purpose Heat Source---Radioisotope Thermal Generator (GPHS-RTG), the Interagency Nuclear Safety Review Panel (INSRP) and the author performed an integrated, quantitative analysis of the uncertainties of the calculated risk of plutonium release from Ulysses. Using state-of-art probabilistic risk assessment technology, the uncertainty analysis accounted for both variability and uncertainty of the key parameters of the risk analysis. The results show that INSRP had high confidence that risk of fatal cancers from potential plutonium release associated with calculated launch and deployment accident scenarios is low

  20. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis.

    Directory of Open Access Journals (Sweden)

    Kalle J Aaltonen

    Full Text Available Five-tumour necrosis factor (TNF-blockers (infliximab, etanercept, adalimumab, certolizumab pegol and golimumab are available for treatment of rheumatoid arthritis. Only few clinical trials compare one TNF-blocker to another. Hence, a systematic review is required to indirectly compare the substances. The aim of our study is to estimate the efficacy and the safety of TNF-blockers in the treatment of rheumatoid arthritis (RA and indirectly compare all five currently available blockers by combining the results from included randomized clinical trials (RCT.A systematic literature review was conducted using databases including: MEDLINE, SCOPUS (including EMBASE, Cochrane library and electronic search alerts. Only articles reporting double-blind RCTs of TNF-blockers vs. placebo, with or without concomitant methotrexate (MTX, in treatment of RA were selected. Data collected were information of patients, interventions, controls, outcomes, study methods and eventual sources of bias.Forty-one articles reporting on 26 RCTs were included in the systematic review and meta-analysis. Five RCTs studied infliximab, seven etanercept, eight adalimumab, three golimumab and three certolizumab. TNF-blockers were more efficacious than placebo at all time points but were comparable to MTX. TNF-blocker and MTX combination was superior to either MTX or TNF-blocker alone. Increasing doses did not improve the efficacy. TNF-blockers were relatively safe compared to either MTX or placebo.No single substance clearly rose above others in efficacy, but the results of the safety analyses suggest that etanercept might be the safest alternative. Interestingly, MTX performs nearly identically considering both efficacy and safety aspects with a margin of costs.

  1. 49 CFR 659.27 - Internal safety and security reviews.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Internal safety and security reviews. 659.27... State Oversight Agency § 659.27 Internal safety and security reviews. (a) The oversight agency shall... safety and security reviews in its system safety program plan. (b) The internal safety and security...

  2. Efficacy and Safety of Anti-Interleukin-5 Therapy in Patients with Asthma: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Fa-Ping Wang

    Full Text Available Recent trials have assessed the efficacy and safety of novel monoclonal antibodies such as reslizumab and benralizumab. However, the overall efficacy and safety anti-interleukin (IL 5 treatment in asthma have not been thoroughly assessed.Randomized controlled trials (RCTs of anti-IL-5 treatment on patients with asthma published up to October 2016 in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL that reported pulmonary function, quality of life scores, asthmatic exacerbation rate, blood and sputum eosinophil counts, short-acting β-agonist (SABA rescue use, and adverse events were included. The pooled mean difference, and relative risks (RR, and 95% confidence intervals (CIs were calculated using random-effects models.Twenty studies involving 7100 patients were identified. Pooled analysis revealed significant improvements in FEV1 (first second forced expiratory volume (MD = 0.09, 95% CI: 0.06-0.12, I2 = 10%, FEV1% (MD = 3.75, 95% CI: 1.66-5.83, I2 = 19%, Asthma Quality of Life Questionnaire (AQLQ score (MD = 0.22, 95% CI: 0.15-0.30, I2 = 0%, decreased blood, sputum eosinophils and asthmatic exacerbation (RR = 0.66, 95% CI: 0.59-0.73, I2 = 51%; peak expiratory flow (PEF (MD = 5.45, 95% CI: -2.83-13.72, I2 = 0%, histamine PC20 (MD = -0.62, 95% CI: -1.92-0.68, I2 = 0% or SABA rescue use (MD = -0.11, 95% CI: -0.3-0.07, I2 = 30% were unaffected; adverse events were not increased (RR = 0.93, 95% CI: 0.89-0.98, I2 = 46%. No publication bias was observed (Egger's P = 0.78.Anti-interleukin 5 monoclonal therapies for asthma could be safe for slightly improving FEV1 (or FEV1% of predicted value, quality of life, and reducing exacerbations risk and blood and sputum eosinophils, but have no significant effect on PEF, histamine PC20, and SABA rescue use. Further trials required to establish to clarify the optimal antibody for different patients.

  3. Systematic review and meta-analysis of the efficacy and safety of Biqi capsule in rheumatoid arthritis patients.

    Science.gov (United States)

    Chen, Xiu-Min; Wu, Jia-Qi; Huang, Qing-Chun; Zhang, Jian-Yong; Pen, Jian-Hong; Huang, Zhi-Sheng; Chu, Yong-Liang; He, Xiao-Hong; Wang, Mao-Jie; Huang, Run-Yue

    2018-06-01

    Biqi capsule is a Traditional Chinese Medicine preparation for treating rheumatoid arthritis (RA), and clinical studies have indicatedthat its effect may be more beneficial than that of Western medicine. The present study aimed to estimate the efficacy and safety of Biqi capsule alone or combined with methotrexate (MTX) compared with MTX alone for treating RA by performing a meta-analysis of randomized controlled trials and controlled clinical trials. A systematic literature search of studies published until March 2017 was performed. References from relevant studies were screened to obtain additional articles. The results were independently evaluated for relevance, and full-text studies were assessed for eligibility. The risk of bias was assessed using the Cochrane collaboration tool for assessing risk of bias. Out of 558 citations that were initially retrieved, a total of 5 studies comprising 522 patients met the inclusion criteria. The risk of bias of these trials was generally unclear or high. Meta-analysis indicated that Biqi capsule had better effects on C-reactive protein [standardized mean difference (SMD), -7.05; 95% CI -(10.77-3.33)] and tender joint count [SMD, -3.02; 95% CI, -(3.81-2.22)] and fewer adverse effects (AEs) than MTX [relative risk (RR), 0.19; 95% CI, 0.08-0.43]. Biqi capsule plus MTX was superior to MTX in terms of the total effect (RR, 1.17; 95% CI, 1.06-1.28), rheumatoid factor [SMD, -12.54; 95% CI, -(16.87-8.20)], swollen joint count [SMD, -1.50; 95% CI, -(1.99-1.01)], score of joint swelling [SMD -2.07; 95% CI, -(2.76-1.38)], tender joint count [SMD, -2.16; 95% CI, -(2.86-1.47)] and score of joint tenderness [SMD, -4.69; 95% CI, -(5.92-3.47)]. There was no difference in AEs between Biqi capsule plus MTX and MTX (RR, 0.71; 95% CI, 0.34-1.50). In conclusion, the present study indicated that compared with MTX, Biqi capsule plus MTX appeared to have more benefits but that Biqi capsule alone was not better for RA patients than MTX. In the

  4. Efficacy and safety of polymyxins for the treatment of Acinectobacter baumannii infection: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Qianqian Liu

    Full Text Available BACKGROUND: Multi-drug resistance among Acinetobacter baumannii increases the need for polymyxins. We conducted a meta-analysis aimed to assess the efficacy and safety of polymyxins for the treatment of Acinetobacter baumannii infection. METHODS: We searched PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL, CNKI, Chinese Biomedical Literature Database up to November 1, 2013, to identify published studies, and we searched clinical trial registries to identify completed unpublished studies. Randomized controlled trials and cohort studies were considered for inclusion. Data were extracted on clinical response, microbiological response, mortality, length of stay and adverse events. RESULTS: 12 controlled studies, comparing 677 patients, were included. Although clinical (odds ratio 1.421, 95% confidence interval 0.722-2.797 and microbiological (OR 1.416, 95% CI 0.369-5.425 response rates favored the polymyxins group, these differences were not significant. Treatment with polymyxins vs. controls did not affect hospital mortality (OR 0.506, 95% CI 0.101-2.536, lengths of hospital stay (standard mean difference -0.221, 95% CI 0.899-0.458 or nephrotoxicity (OR 1.192, 95% CI 0.436-3.261. The combination of polymyxins with other antibiotics achieved similar clinical response rates to its monotherapy regimen (OR 0.601, 95% CI 0.320-1.130. CONCLUSIONS: Our results suggest that polymyxins may be as safe and as efficacious as standard antibiotics for the treatment of A. baumannii infection. There is no strong evidence that combination regimen of polymyxins is superior to monotherapy regimen.

  5. Efficacy and safety of polymyxins for the treatment of Acinectobacter baumannii infection: a systematic review and meta-analysis.

    Science.gov (United States)

    Liu, Qianqian; Li, Wenzhang; Feng, Yulin; Tao, Chuanmin

    2014-01-01

    Multi-drug resistance among Acinetobacter baumannii increases the need for polymyxins. We conducted a meta-analysis aimed to assess the efficacy and safety of polymyxins for the treatment of Acinetobacter baumannii infection. We searched PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CNKI, Chinese Biomedical Literature Database up to November 1, 2013, to identify published studies, and we searched clinical trial registries to identify completed unpublished studies. Randomized controlled trials and cohort studies were considered for inclusion. Data were extracted on clinical response, microbiological response, mortality, length of stay and adverse events. 12 controlled studies, comparing 677 patients, were included. Although clinical (odds ratio 1.421, 95% confidence interval 0.722-2.797) and microbiological (OR 1.416, 95% CI 0.369-5.425) response rates favored the polymyxins group, these differences were not significant. Treatment with polymyxins vs. controls did not affect hospital mortality (OR 0.506, 95% CI 0.101-2.536), lengths of hospital stay (standard mean difference -0.221, 95% CI 0.899-0.458) or nephrotoxicity (OR 1.192, 95% CI 0.436-3.261). The combination of polymyxins with other antibiotics achieved similar clinical response rates to its monotherapy regimen (OR 0.601, 95% CI 0.320-1.130). Our results suggest that polymyxins may be as safe and as efficacious as standard antibiotics for the treatment of A. baumannii infection. There is no strong evidence that combination regimen of polymyxins is superior to monotherapy regimen.

  6. Preparation of NPP Dukovany periodic safety review

    International Nuclear Information System (INIS)

    Dubsky, L.; Vymazal, P.

    2004-01-01

    Dukovany NPP in Czech Republic performs a periodic safety review for the second time after approximately 20 years of operation. The history of the Safety Report and its transformation into an internationally accepted form complying with IAEA standards is described. The deterministic and probabilistic assessment of the plant's safety-related design and state is applied to determine whether and to what extend the relevant protective goals are fulfilled by the existing plant design. A description of the step-by-step process is presented together with the creation of methods and criteria for PSR evaluation prepared by Nuclear Research Institute Rez

  7. Nuclear safety review for the year 2000

    International Nuclear Information System (INIS)

    2001-06-01

    The nuclear safety review for the year 2000 reports on worldwide efforts to strengthen nuclear and radiation safety, including radioactive waste safety. It is in three parts: Part 1 describes those events in 2000 that have, or may have, significance for nuclear, radiation and waste safety worldwide. It includes developments such as new initiatives in international cooperation, events of safety significance and events that may be indicative of trends in safety; Part 2 describes some of the IAEA efforts to strengthen international co-operation in nuclear, radiation and waste safety during 2000. It covers legally binding international agreements, non-binding safety standards, and provisions for the application of safety standards. This is done in a very brief manner, because these issues are addressed in more detail in the Agency's Annual Report for 2000; Part 3 presents a brief look ahead to some issues that are likely to be prominent in the coming year(s). The topics covered were selected by the IAEA Secretariat on the basis of trends observed in recent years, account being taken of planned or expected future developments. A draft of the Nuclear Safety Review for the Year 2000 was presented to the March 2001 session of the IAEA Board of Governors. This final version has been prepared taking account of the discussion in the Board. In some places, information has been added to describe developments early in 2001 that were considered pertinent to the discussion of events during 2000. In such cases, a note containing the more recent information has been provided in the form of a footnote

  8. Efficacy, acceptability and safety of guided imagery/hypnosis in fibromyalgia - A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zech, N; Hansen, E; Bernardy, K; Häuser, W

    2017-02-01

    This systematic review aimed at evaluating the efficacy, acceptability and safety of guided imagery/hypnosis (GI/H) in fibromyalgia. Cochrane Library, MEDLINE, PsycINFO and SCOPUS were screened through February 2016. Randomized controlled trials (RCTs) comparing GI/H with controls were analysed. Primary outcomes were ≥50% pain relief, ≥20% improvement of health-related quality of life, psychological distress, disability, acceptability and safety at end of therapy and 3-month follow-up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI).Seven RCTs with 387 subjects were included into a comparison of GI/H versus controls. There was a clinically relevant benefit of GI/H compared to controls on ≥50% pain relief [RD 0.18 (95% CI 0.02, 0.35)] and psychological distress [SMD -0.40 (95% CI -0.70, -0.11)] at the end of therapy. Acceptability at the end of treatment for GI/H was not significantly different to the control. Two RCTs with 95 subjects were included in the comparison of hypnosis combined with cognitive behavioural therapy (CBT) versus CBT alone. Combined therapy was superior to CBT alone in reducing psychological distress at the end of therapy [SMD -0.50 (95% CI -0.91, -0.09)]. There were no statistically significant differences between combined therapy and CBT alone in other primary outcomes at the end of treatment and follow-up. No study reported on safety. GI/H hold promise in a multicomponent management of fibromyalgia. We provide a systematic review with meta-analysis on guided imagery and hypnosis for fibromyalgia. Current analyses endorse the efficacy and tolerability of guided imagery/hypnosis and of the combination of hypnosis with cognitive-behavioural therapy in reducing key symptoms of fibromyalgia. © 2016 European Pain Federation - EFIC®.

  9. Operating experience and systems analysis at Trillo NPP: A program intended for systematic review of plant safety systems to assess design basis requirements compliance

    International Nuclear Information System (INIS)

    Vega, R. de la

    1996-01-01

    The program was defined to apply to all plant safety systems and/or systems included in plant Technical Specifications. The goal of the program was to ensure, by systematic design, construction, and commissioning review, the adequacy of safety systems, structures and components to fulfill their safety functions. Also, as a result of the program, it was established that a complete, unambiguous, systematic, design basis definition shall take place. And finally, a complete documental review of the plant design shall result from the program execution

  10. Development of Safety Review Guide for the Periodic Safety Review of Reactor Vessel Internals

    International Nuclear Information System (INIS)

    Park, Jeongsoon; Ko, Hanok; Kim, Seonjae; Jhung, Myungjo

    2013-01-01

    Aging management of the reactor vessel internals (RVIs) is one of the important issues for long-term operation of nuclear power plants (NPPs). Safety review on the assessment and management of the RVI aging is conducted through the process of a periodic safety review (PSR). The regulatory body should check that reactor facilities sustain safety functions in light of degradation due to aging and that the operator of a nuclear power reactor establishes and implements management program to deal with degradation due to aging in order to guarantee the safety functions and the safety margin as a result of PSR. KINS(Korea Institute of Nuclear Safety) has utilized safety review guides (SRG) which provide guidance to KINS staffs in performing safety reviews in order to assure the quality and uniformity of staff safety reviews. The KINS SRGs for the continued operation of pressurized water reactors (PWRs) published in 2006 contain areas of review regarding aging management of RVIs in chapter 2 (III.2.15, Appendix 2.0.1). However unlike the SRGs for the continued operation, KINS has not officially published the SRGs for the PSR of PWRs, but published them as a form of the research report. In addition to that, the report provides almost same review procedures for aging assessment and management of RVIs with the ones provided in the SRGs for the continued operation, it cannot provide review guidance specific to PSRs. Therefore, a PSR safety review guide should be developed for RVIs in PWRs. In this study, a draft PSR safety review guide for reactor vessel internals in PWRs is developed and provided. In this paper, a draft PSR safety review guide for reactor vessel internals (PSR SRG-RVIs) in PWRs is introduced and main contents of the draft are provided. However, since the PSR safety review guides for areas other than RVIs in the pressurized water reactors (PWRs) are expected to be developed in the near future, the draft PSR SRG-RVIs should be revisited to be compatible with

  11. Safety analysis of nuclear power plants

    International Nuclear Information System (INIS)

    Selvatici, E.

    1981-01-01

    A study about the safety analysis of nuclear power plant, giving emphasis to how and why to do is presented. The utilization of the safety analysis aiming to perform the licensing requirements is discussed, and an example of the Angra 2 and 3 safety analysis is shown. Some presented tendency of the safety analysis are presented and examples are shown.(E.G.) [pt

  12. Systematic review and meta-analysis of the efficacy and safety of amfepramone and mazindol as a monotherapy for the treatment of obese or overweight patients.

    Science.gov (United States)

    Lucchetta, Rosa Camila; Riveros, Bruno Salgado; Pontarolo, Roberto; Radominski, Rosana Bento; Otuki, Michel Fleith; Fernandez-Llimos, Fernando; Correr, Cassyano Januário

    2017-05-01

    The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status.

  13. Efficacy and safety assessment of isolated ultrafiltration compared to intravenous diuretics for acutely decompensated heart failure: a systematic review with meta-analysis.

    Science.gov (United States)

    De Vecchis, R; Esposito, C; Ariano, C

    2014-04-01

    Intravenous diuretics at relatively high doses are currently used for treating acute decompensated heart failure (ADHF). However, the existence of harmful side effects diuretic-related, such as electrolyte abnormalities, symptomatic hypotension and marked neuro-hormonal activation have led researchers to implement alternative therapeutic tools such as isolated ultrafiltration (IUF). Our study aimed to compare intravenous diuretics vs. IUF as regards their respective efficacy and safety in ADHF patients through systematic review and meta-analysis of data derived from relevant randomized controlled trials. 6 studies grouping a total of 477 patients were included in the systematic review. By contrast, data from only three studies were pooled for the meta-analysis, because of different adopted outcomes or marked dissimilarities in the data presentation . Weight loss at 48 h was greater in IUF group compared to the diuretics group [weighted mean difference (WMD)=1.77 kg; 95%CI: 1.18-2.36 kg; Pdiuretics group (WMD=1.2 liters; 95%CI: 0.73-1.67 liters; P 0.3 mg/dl at 48 hours, was similar to the one found in the diuretics group (OR=1.33; 95% CI: 0.81-2.16 P=0.26). On the basis of this meta-analysis, IUF induced greater weight loss and larger fluid removal compared to iv diuretics in ADHF patients, whereas the probability of developing WRF was not significantly different in the comparison between iv diuretics and IUF.

  14. A probabilistic safety assessment PEER review: Case study on the use of probabilistic safety assessment for safety decisions

    International Nuclear Information System (INIS)

    1989-10-01

    The purpose of this case study is to illustrate, using an actual example, the organizing and carrying out of an independent peer review of a draft full-scope (level 3) probabilistic safety assessment. The specific findings of the peer review are of less importance than the approach taken, the interaction between sponsor and study team, and the technical and administrative issues that can arise during a peer review. This case study will examine the following issues: how the scope of the peer review was established, based on how it was to be used by the review sponsoring body; how the level of effort was determined, and what this determination meant for the technical quality of the review; how the team of peer reviewers was selected; how the review itself was carried out; what findings were made; what was done with these findings by both the review sponsoring body and the PSA analysis team. 9 refs, 2 figs, 1 tab

  15. Technical Review Report for the Model 9977 Safety Analysis Report for Packaging Addendum 1 Justification for DNDO Contents

    Energy Technology Data Exchange (ETDEWEB)

    West, M H

    2008-12-17

    The Model 9977 Package is currently certified for Content Envelope C.1, {sup 238}Pu Heat Sources, either in Radioisotope Thermoelectric Generator (RTG), or in Food-Pack Can configurations, under Certificate of Compliance (CoC) Certificate Number 9977 and Package Identification Number USA/9977/B(M)F-96 (DOE). Addendum 1, Justification for DNDO Contents,--the Submittal--supplements Revision 2 of the Safety Analysis Report for Packaging for the Model 9977 Package. The Submittal adds five new contents to the Model 9977 Package, Content Envelopes, AC.1 through AC.5. The Content Envelopes are neptunium metal, the beryllium-reflected plutonium ball (BeRP Ball), plutonium/uranium metal, plutonium/uranium metal with enhanced wt% {sup 240}Pu (to 50 wt%), and uranium metal. The last three Content Envelopes are stabilized to DOE-STD-3013. These Content Envelopes will be shipped to the Device Assembly Facility (DAF) at the Nevada Test Site (NTS), where they will reside, and, hence, to off-site locations in support of the Department of Homeland Security (DHS) Domestic Nuclear Detection Office (DNDO). The new certificate will apply to a limited number of Model 9977 Packages. At the same time, the Submittal requests an extension of the periodic maintenance requirements from one (1) year to up to five (5) years using Radio-Frequency Identification (RFID) temperature-monitoring systems to measure the ambient storage temperature in order to ensure that the temperature of the Viton{reg_sign} O-rings for the 6-inch Containment Vessel (6CV) remain less than 200 F. The RFIDs have been developed by Argonne National Laboratory. An on-going surveillance program at the K-Area Materials Storage (KAMS) facility at the Savannah River Site, and an on-going examination of Viton{reg_sign} O-rings from mock Primary Containment Vessels (PCVs) at Savannah River National Laboratory (SRNL) provide the technical justification for the extension of the periodic maintenance interval. Where extended

  16. Efficacy and safety of etanercept in the treatment of sciatica: A systematic review and meta-analysis.

    Science.gov (United States)

    Jing, Shangfei; Yang, Chenyuan; Zhang, Xiaofei; Wen, Shuzheng; Li, Yuankui

    2017-10-01

    Etanercept might be promising to alleviate sciatica caused by lumbar disc herniation and spinal stenosis. However, the results remained controversial. We conducted a systematic review and meta-analysis to evaluate the efficacy of etanercept in patients with sciatica. PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) and Controlled clinical trials (CCT) assessing the efficacy of etanercept on sciatica caused by lumbar disc herniation and spinal stenosis were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome was leg pain scores. Meta-analysis was performed using random-effect model. Four RCTs and one CCT involving 184 patients were included in the meta-analysis. Overall, compared with placebo, etanercept could significantly reduce leg pain (Std. mean difference=-0.83; 95% CI=-1.59 to -0.06; P=0.03) and back pain (Std. mean difference=-1.89; 95% CI=-3.34 to -0.43; P=0.01). However, when comparing etanercept to steroids there was no significant difference in the relief of leg pain (Std. mean difference=-1.18; 95% CI=-3.21 to 0.84; P=0.25) and back pain (Std. mean difference=-0.29; 95% CI=-1.26 to 0.67; P=0.55). Etanercept showed no increase in Oswestry Disability Index (ODI) compared with placebo (Std. mean difference=-0.83; 95% CI=-2.03 to 0.37; P=0.18) and steroids (Std. mean difference=-0.19; 95% CI=-1.15 to 0.77; P=0.70). Etanercept treatment was associated with a significantly reduced pain in leg and back compared to placebo and may possibly improve leg pain relief compared to steroids, but failed to improve ODI. Etanercept should be recommended for sciatica with caution because of heterogeneity. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Study protocol for a framework analysis using video review to identify latent safety threats: trauma resuscitation using in situ simulation team training (TRUST).

    Science.gov (United States)

    Fan, Mark; Petrosoniak, Andrew; Pinkney, Sonia; Hicks, Christopher; White, Kari; Almeida, Ana Paula Siquiera Silva; Campbell, Douglas; McGowan, Melissa; Gray, Alice; Trbovich, Patricia

    2016-11-07

    Errors in trauma resuscitation are common and have been attributed to breakdowns in the coordination of system elements (eg, tools/technology, physical environment and layout, individual skills/knowledge, team interaction). These breakdowns are triggered by unique circumstances and may go unrecognised by trauma team members or hospital administrators; they can be described as latent safety threats (LSTs). Retrospective approaches to identifying LSTs (ie, after they occur) are likely to be incomplete and prone to bias. To date, prospective studies have not used video review as the primary mechanism to identify any and all LSTs in trauma resuscitation. A series of 12 unannounced in situ simulations (ISS) will be conducted to prospectively identify LSTs at a level 1 Canadian trauma centre (over 800 dedicated trauma team activations annually). 4 scenarios have already been designed as part of this protocol based on 5 recurring themes found in the hospital's mortality and morbidity process. The actual trauma team will be activated to participate in the study. Each simulation will be audio/video recorded from 4 different camera angles and transcribed to conduct a framework analysis. Video reviewers will code the videos deductively based on a priori themes of LSTs identified from the literature, and/or inductively based on the events occurring in the simulation. LSTs will be prioritised to target interventions in future work. Institutional research ethics approval has been acquired (SMH REB #15-046). Results will be published in peer-reviewed journals and presented at relevant conferences. Findings will also be presented to key institutional stakeholders to inform mitigation strategies for improved patient safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  18. Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis.

    Science.gov (United States)

    Achilli, Chiara; Pundir, Jyotsna; Ramanathan, Parimalam; Sabatini, Luca; Hamoda, Haitham; Panay, Nick

    2017-02-01

    To systematically review and summarize the existing evidence related to the efficacy and safety of transdermal T in postmenopausal women for the treatment of hypoactive sexual desire disorder (HSDD). Systematic reviews and meta-analysis. Not applicable. Seven randomized controlled trials enrolled 3,035 participants; 1,350 women were randomized to treatment with T patch, and 1,379 women were randomized to placebo. None. Primary outcome: satisfying sexual episodes. sexual activity, orgasm, Profile of Female Sexual Function domains (desire), personal distress score, adverse events, acne, increased hair growth, facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction, total adverse events, serious adverse events, withdrawal from study, and follow-up rate. The T group had significantly more satisfying sexual episodes, sexual activity, orgasms, desire, significant change in Personal Distress Scale score, androgenic adverse events, acne, and hair growth compared with the placebo group. There was no significant difference between the two groups in increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study. The short-term efficacy in terms of improvement of sexual function and safety of transdermal T in naturally and surgically menopausal women affected by HSDD either on or not on estrogen progestin hormone therapy is evident from this systematic review. The use of transdermal T is associated with increase in androgenic adverse events such as acne but is not associated with any serious adverse events. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  19. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  20. Review of fuel safety criteria in France

    Energy Technology Data Exchange (ETDEWEB)

    Boutin, Sandrine; Graff, Stephanie; Foucher-Taisne, Aude; Dubois, Olivier [Institut de Radioprotection et du Surete Nucleaire, Fontenay-aux-Roses (France)

    2018-01-15

    Fuel safety criteria for the first barrier, based on state-of-the-art at the time, were first defined in the 1970s and came from the United States, when the French nuclear program was initiated. Since then, there has been continuous progress in knowledge and in collecting experimental results thanks to the experiments carried out by utilities and research institutes, to the operating experience, as well as to the generic R and D programs, which aim notably at improving computation methodologies, especially in Reactivity-Initiated accident and Loss-of-Coolant Accident conditions. In this context, the French utility EDF proposed new fuel safety criteria, or reviewed and completed existing safety demonstration covering the normal operating, incidental and accidental conditions of Pressurised Water Reactors. IRSN assessed EDF's proposals and presented its conclusions to the Advisory Committee for Reactors Safety of the Nuclear Safety Authority in June 2017. This review focused on the relevance of historical limit values or parameters of fuel safety criteria and their adequacy with the state-of-the-art concerning fuel physical phenomena (e.g. Pellet-Cladding Mechanical Interaction in incidental conditions, clad embrittlement due to high temperature oxidation in accidental conditions, clad ballooning and burst during boiling crisis and fuel melting).

  1. Review of fuel safety criteria in France

    International Nuclear Information System (INIS)

    Boutin, Sandrine; Graff, Stephanie; Foucher-Taisne, Aude; Dubois, Olivier

    2018-01-01

    Fuel safety criteria for the first barrier, based on state-of-the-art at the time, were first defined in the 1970s and came from the United States, when the French nuclear program was initiated. Since then, there has been continuous progress in knowledge and in collecting experimental results thanks to the experiments carried out by utilities and research institutes, to the operating experience, as well as to the generic R and D programs, which aim notably at improving computation methodologies, especially in Reactivity-Initiated accident and Loss-of-Coolant Accident conditions. In this context, the French utility EDF proposed new fuel safety criteria, or reviewed and completed existing safety demonstration covering the normal operating, incidental and accidental conditions of Pressurised Water Reactors. IRSN assessed EDF's proposals and presented its conclusions to the Advisory Committee for Reactors Safety of the Nuclear Safety Authority in June 2017. This review focused on the relevance of historical limit values or parameters of fuel safety criteria and their adequacy with the state-of-the-art concerning fuel physical phenomena (e.g. Pellet-Cladding Mechanical Interaction in incidental conditions, clad embrittlement due to high temperature oxidation in accidental conditions, clad ballooning and burst during boiling crisis and fuel melting).

  2. [Efficacy and safety of rituximab in the treatment of primary antiphospholipid syndrome: analysis of 24 cases from the bibliography review].

    Science.gov (United States)

    Pons, Isaac; Espinosa, Gerard; Cervera, Ricard

    2015-02-02

    Antiphospholipid syndrome (APS) is characterized by the presence of antiphospholipid antibodies (aPL) and thrombotic and/or obstetric manifestations. Patients without another associated autoimmune disease are considered to have primary APS. Some patients develop thrombosis recurrence despite anticoagulant treatment and some clinical features do not respond to standard therapy. Rituximab may be an alternative in these cases. We review the published scientific evidence on the use of rituximab in the treatment of primary APS. Description of a case and review of the literature with descriptive analysis of the demographic, clinical, and immunologic features, treatment and outcome of patients. We identified 24 patients (15 women [62.5%]), with a mean age of 37.0 ± 13.4 years. The reasons for the use of rituximab were thrombocytopenia (41.7%), skin involvement (33.3%), neurologic and heart valve involvement (12.5%), hemolytic anemia (8.3%) and pulmonary and renal involvement (4.2%). Lupus anticoagulant was present in 72.7% of the cases, the IgG and IgM isotypes of anticardiolipin antibodies in 75 and 50%, respectively, and the anti-β2GPI (IgG e IgM) antibodies in 80% of patients. Thirteen (54.1%) patients received 2 doses of 1,000 mg of rituximab fortnightly, 10 (41.7%) 4 doses of 375 mg/m(2) weekly and one (4.2%) 8 doses of 375 mg/m(2) weekly. Eleven (45.8%) patients presented a complete clinical response, 7 (29.2%) a partial response and 6 (25%) did not respond to rituximab. Four patients with clinical improvement presented with aPL titer decrease and in one patient, aPL levels did not change. In one patient without clinical response, aPL remained positive. A clinical-immunologic dissociation existed in 2 additional cases. The results obtained suggest a possible potential benefit of rituximab in the treatment of some clinical manifestations of primary APS such as thrombocytopenia, skin and heart valve involvement. Copyright © 2013 Elsevier España, S.L.U. All rights

  3. Economic consideration of nuclear safety and cost benefit analysis in nuclear safety regulation

    International Nuclear Information System (INIS)

    Choi, Y. S.; Choi, K. S.; Choi, K. W.; Song, I. J.; Park, D. K.

    2001-01-01

    For the optimization of nuclear safety regulation, understanding of economic aspects of it becomes increasingly important together with the technical approach used so far to secure nuclear safety. Relevant economic theories on private and public goods were reviewed to re-illuminate nuclear safety from the economic perspective. The characteristics of nuclear safety as a public good was reviewed and discussed in comparison with the car safety as a private safety good. It was shown that the change of social welfare resulted from the policy change induced can be calculated by the summation of compensating variation(CV) of individuals. It was shown that the value of nuclear safety could be determined in monetary term by this approach. The theoretical background and history of cost benefit analysis of nuclear safety regulation were presented and topics for future study were suggested

  4. Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Raghavendra Charan P Makam

    Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

  5. Development of web-based safety review advisory system

    International Nuclear Information System (INIS)

    Kim, M. W.; Lee, H. C.; Park, S. O.; Lee, K. H.; Hur, K. Y.; Lee, S. J.; Choi, S. S.; Kang, C. M.

    2002-01-01

    For the development of an expert system supporting the safety review of nuclear power plants, the application was implemented after gathering necessary theoretical background and practical requirements. The general and the detail functional specifications were established, and they are investigated by KINS (Korea Institute of Nuclear Safety). The Safety Review Advisory System(SRAS), this application on web-server environment was developed according to the above specifications. Reviews can do their safety reviewing regardless of their speciality or reviewing experiences because SRAS is operated by the safety review plans which are converted to standardized format. When the safety reviewing is carried out by using SRAS, the results of safety reviewing are accumulated in the database and may be utilized later usefully, and we can grasp safety reviewing progress. Users of SRAS are categorized into four groups, administrator, project manager, project reviewer and general reviewer. Each user group is delegated appropriate access capability. The function and some screen shots of SRAS are described

  6. Development of safety review advisory system for nuclear power plants

    International Nuclear Information System (INIS)

    Kim, M. W.; Lee, H. C.; Park, S. O.; Park, W. J.; Lee, J. I.; Hur, K. Y.; Choi, S. S.; Lee, S. J.; Kang, C. M.

    2001-01-01

    For the development of an expert system supporting the safety review of nuclear power plants, the application program was implemented after gathering necessary theoretical background and practical requirements. The general and the detail functional specifications were established, and they were investigated by the safety review experts at KINS. Safety Review Advisory System (SRAS), the windows application on client-server environment was developed according to the above specifications. Reviewers can do their safety reviewing regardless of speciality or reviewing experiences because SRAS is operated by the safety review plans which are converted to standardized format. When the safety reviewing is carried out by using SRAS, the results of safety reviewing are accumulated in the database and may be utilized later usefully, and we can grasp safety reviewing progress. Users of SRAS are categorized into three groups, administrator, project manager, and reviewer. Each user group has appropriate access capability. The function and some screen shots of SRAS are described in this paper

  7. Computer aided safety analysis 1989

    International Nuclear Information System (INIS)

    1990-04-01

    The meeting was conducted in a workshop style, to encourage involvement of all participants during the discussions. Forty-five (45) experts from 19 countries, plus 22 experts from the GDR participated in the meeting. A list of participants can be found at the end of this volume. Forty-two (42) papers were presented and discussed during the meeting. Additionally an open discussion was held on the possible directions of the IAEA programme on Computer Aided Safety Analysis. A summary of the conclusions of these discussions is presented in the publication. The remainder of this proceedings volume comprises the transcript of selected technical papers (22) presented in the meeting. It is the intention of the IAEA that the publication of these proceedings will extend the benefits of the discussions held during the meeting to a larger audience throughout the world. The Technical Committee/Workshop on Computer Aided Safety Analysis was organized by the IAEA in cooperation with the National Board for Safety and Radiological Protection (SAAS) of the German Democratic Republic in Berlin. The purpose of the meeting was to provide an opportunity for discussions on experiences in the use of computer codes used for safety analysis of nuclear power plants. In particular it was intended to provide a forum for exchange of information among experts using computer codes for safety analysis under the Technical Cooperation Programme on Safety of WWER Type Reactors (RER/9/004) and other experts throughout the world. A separate abstract was prepared for each of the 22 selected papers. Refs, figs tabs and pictures

  8. Comprehensive review of the maritime safety regimes.

    NARCIS (Netherlands)

    S. Knapp (Sabine); Ph.H.B.F. Franses (Philip Hans)

    2007-01-01

    textabstractThis report presents a comprehensive review of the maritime safety regimes and provides recommendations on how to improve the system. The results show a complex legal framework which generates a high amount of inspections and overlapping of inspection areas where no cross-recognition is

  9. REVIEW OF SAFETY AND TOLERANCE OF OMALIZUMAB

    Directory of Open Access Journals (Sweden)

    A.V. Emel'yanov

    2008-01-01

    Full Text Available The review of safety of monoclonal anti-ige-antibodies (xolair — a new medication for the treatment of severe allergic bronchial asthma is presented. Local and system adverse events, originating after injection of medicament in clinical studies and following administration in patients are discussed.Key words: children, bronchial asthma, monoclonal anti Ige antibodies.

  10. Light-water reactor safety analysis codes

    International Nuclear Information System (INIS)

    Jackson, J.F.; Ransom, V.H.; Ybarrondo, L.J.; Liles, D.R.

    1980-01-01

    A brief review of the evolution of light-water reactor safety analysis codes is presented. Included is a summary comparison of the technical capabilities of major system codes. Three recent codes are described in more detail to serve as examples of currently used techniques. Example comparisons between calculated results using these codes and experimental data are given. Finally, a brief evaluation of current code capability and future development trends is presented

  11. Clinical Efficacy, Safety, and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine (CYD-TDV in Children: A Systematic Review with Meta-analysis

    Directory of Open Access Journals (Sweden)

    Moffat Malisheni

    2017-08-01

    Full Text Available BackgroundDengue hemorrhagic fever is the leading cause of hospitalization and death in children living in Asia and Latin America. There is an urgent need for an effective and safe dengue vaccine to reduce morbidity and mortality in this high-risk population given the lack of dengue specific treatment at present. This review aims to determine the efficacy, safety, and immunogenicity of CYD-TDV vaccine in children.MethodsThis is a systematic review including meta-analysis of randomized controlled clinical trial data from Embase, Medline, the Cochrane Library, Web of Science, and ClinicalTrials.gov. Studies that assessed CYD-TDV vaccine efficacy [(1 − RR*100], safety (RR, and immunogenicity (weighted mean difference in children were included in this study. Random effects model was employed to analyze patient-level data extracted from primary studies.ResultsThe overall efficacy of CYD-TDV vaccine was 54% (40–64, while serotype-specific efficacy was 77% (66–85 for DENV4, 75% (65–82 for DENV3, 50% (36–61 for DENV1, and 34% (14–49 for DENV2. 15% (−174–74 vaccine efficacy was obtained for the unknown serotype. Meta-analysis of included studies with longer follow-up time (25 months revealed that CYD-TDV vaccine significantly increased the risk of injection site reactions (RR = 1.1: 1.04–1.17; p-value = 0.001. Immunogenicity (expressed as geometric mean titers in descending order was 439.7 (331.7–547.7, 323 (247 – 398.7, 144.1 (117.9–170.2, and 105 (88.7–122.8 for DENV3, DENV2, DENV1, and DENV4, respectively.ConclusionCYD-TDV vaccine is effective and immunogenic in children overall. Reduced efficacy of CYD-TDV vaccine against DENV2 notoriously known for causing severe dengue infection and dengue outbreaks cause for serious concern. Post hoc meta-analysis of long-term follow-up data (≥25 months from children previously vaccinated with CYD-TDV vaccine is needed to make a conclusion regarding CYD-TDV vaccine

  12. Operating plant safety analysis needs

    International Nuclear Information System (INIS)

    Young, M.Y.; Love, D.S.

    1992-01-01

    The primary objective for nuclear power station owners is to operate and manage their plants safely. However, there is also a need to provide economical electric power, which requires that the unit be operated as efficiently as possible, consistent with the safety requirements. The objectives cited above can be achieved through the identification and use of available margins inherent in the plant design. As a result of conservative licensing and analytical approaches taken in the past, many of these margins may be found in the safety analysis limits within which plants currently operate. Improvements in the accuracy of the safety analysis, and a more realistic treatment of plant initial and boundary conditions, can make this margin available for a variety of uses which enhance plant performance, help to reduce O and M costs, and may help to extend licensed operation. Opportunities for improvement exist in several areas in the accident analysis normally performed for Chapter 15 of the FSAR. For example, recent modifications to the ECCS rule, 10CFR50.46 and Appendix K, allow use of margins previously unavailable in the analysis of the Loss of Coolant Accident (LOCA). To take advantage of this regulatory change, new methods are being developed to analyze both the large and small break loss of coolant accident (LOCA). As this margin is used, enhancements in the analysis of other transients will become necessary. The paper discusses accident analysis methods, future development needs, and analysis margin utilization in specific accident scenarios

  13. Systematic review and meta-analysis of the efficacy and safety of amfepramone and mazindol as a monotherapy for the treatment of obese or overweight patients

    Directory of Open Access Journals (Sweden)

    Rosa Camila Lucchetta

    Full Text Available The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (<180 days; mean difference (MD -1.281 kg; p<0.05; I2: 0.0%; p=0.379 and long-term (≥180 days; MD -6.518 kg; p<0.05; I2: 0.0%; p=0.719. Only studies with long-term follow up reported efficacy in terms of abdominal circumference and 5-10% weight reduction. These results corroborated the finding that the efficacy of amfepramone is greater than that of placebo. Treatment with mazindol showed greater short-term weight loss than that with placebo (MD -1.721 kg; p<0.05; I2: 0.9%; p=0.388. However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct meta-analysis. Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status.

  14. Review on JMTR safety design for LEU core conversion

    International Nuclear Information System (INIS)

    Komori, Yoshihiro; Yokokawa, Makoto; Saruta, Toru; Inada, Seiji; Sakurai, Fumio; Yamamoto, Katsumune; Oyamada, Rokuro; Saito, Minoru

    1993-12-01

    Safety of the JMTR was fully reviewed for the core conversion to low enriched uranium fuel. Fundamental policies for the JMTR safety design were reconsidered based on the examination guide for safety design of test and research reactors, and safety of the JMTR was confirmed. This report describes the safety design of the JMTR from the viewpoint of major functions for reactor safety. (author)

  15. Medication safety programs in primary care: a scoping review.

    Science.gov (United States)

    Khalil, Hanan; Shahid, Monica; Roughead, Libby

    2017-10-01

    Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome

  16. SEISMIC ANALYSIS FOR PRECLOSURE SAFETY

    Energy Technology Data Exchange (ETDEWEB)

    E.N. Lindner

    2004-12-03

    The purpose of this seismic preclosure safety analysis is to identify the potential seismically-initiated event sequences associated with preclosure operations of the repository at Yucca Mountain and assign appropriate design bases to provide assurance of achieving the performance objectives specified in the Code of Federal Regulations (CFR) 10 CFR Part 63 for radiological consequences. This seismic preclosure safety analysis is performed in support of the License Application for the Yucca Mountain Project. In more detail, this analysis identifies the systems, structures, and components (SSCs) that are subject to seismic design bases. This analysis assigns one of two design basis ground motion (DBGM) levels, DBGM-1 or DBGM-2, to SSCs important to safety (ITS) that are credited in the prevention or mitigation of seismically-initiated event sequences. An application of seismic margins approach is also demonstrated for SSCs assigned to DBGM-2 by showing a high confidence of a low probability of failure at a higher ground acceleration value, termed a beyond-design basis ground motion (BDBGM) level. The objective of this analysis is to meet the performance requirements of 10 CFR 63.111(a) and 10 CFR 63.111(b) for offsite and worker doses. The results of this calculation are used as inputs to the following: (1) A classification analysis of SSCs ITS by identifying potential seismically-initiated failures (loss of safety function) that could lead to undesired consequences; (2) An assignment of either DBGM-1 or DBGM-2 to each SSC ITS credited in the prevention or mitigation of a seismically-initiated event sequence; and (3) A nuclear safety design basis report that will state the seismic design requirements that are credited in this analysis. The present analysis reflects the design information available as of October 2004 and is considered preliminary. The evolving design of the repository will be re-evaluated periodically to ensure that seismic hazards are properly

  17. SEISMIC ANALYSIS FOR PRECLOSURE SAFETY

    International Nuclear Information System (INIS)

    E.N. Lindner

    2004-01-01

    The purpose of this seismic preclosure safety analysis is to identify the potential seismically-initiated event sequences associated with preclosure operations of the repository at Yucca Mountain and assign appropriate design bases to provide assurance of achieving the performance objectives specified in the Code of Federal Regulations (CFR) 10 CFR Part 63 for radiological consequences. This seismic preclosure safety analysis is performed in support of the License Application for the Yucca Mountain Project. In more detail, this analysis identifies the systems, structures, and components (SSCs) that are subject to seismic design bases. This analysis assigns one of two design basis ground motion (DBGM) levels, DBGM-1 or DBGM-2, to SSCs important to safety (ITS) that are credited in the prevention or mitigation of seismically-initiated event sequences. An application of seismic margins approach is also demonstrated for SSCs assigned to DBGM-2 by showing a high confidence of a low probability of failure at a higher ground acceleration value, termed a beyond-design basis ground motion (BDBGM) level. The objective of this analysis is to meet the performance requirements of 10 CFR 63.111(a) and 10 CFR 63.111(b) for offsite and worker doses. The results of this calculation are used as inputs to the following: (1) A classification analysis of SSCs ITS by identifying potential seismically-initiated failures (loss of safety function) that could lead to undesired consequences; (2) An assignment of either DBGM-1 or DBGM-2 to each SSC ITS credited in the prevention or mitigation of a seismically-initiated event sequence; and (3) A nuclear safety design basis report that will state the seismic design requirements that are credited in this analysis. The present analysis reflects the design information available as of October 2004 and is considered preliminary. The evolving design of the repository will be re-evaluated periodically to ensure that seismic hazards are properly

  18. Holistic safety analysis for advanced nuclear power plants

    International Nuclear Information System (INIS)

    Alvarenga, M.A.B.; Guimaraes, A.C.F.

    1992-01-01

    This paper reviews the basic methodology of safety analysis used in the ANGRA-I and ANGRA-II nuclear power plants, its weaknesses, the problems with public acceptance of the risks, the future of the nuclear energy in Brazil, as well as recommends a new methodology, HOLISTIC SAFETY ANALYSIS, to be used both in the design and licensing phases, for advanced reactors. (author)

  19. Safety analysis SFR 1. Long-term safety

    Energy Technology Data Exchange (ETDEWEB)

    2008-12-15

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

  20. Safety analysis SFR 1. Long-term safety

    International Nuclear Information System (INIS)

    2008-12-01

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

  1. Safety analysis SFR 1. Long-term safety

    Energy Technology Data Exchange (ETDEWEB)

    2008-12-15

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the

  2. Periodic safety review of the experimental fast reactor JOYO. Review of the activity for safety

    International Nuclear Information System (INIS)

    Maeda, Yukimoto; Kashimura, Youichi; Suzuki, Toshiaki; Isozaki, Kazunori; Hoshiba, Hideaki; Kitamura, Ryoichi; Nakano, Tomoyuki; Takamatsu, Misao; Sekine, Takashi

    2005-02-01

    Periodic safety review (Review of the activity for safety) which consisted of 'Comprehensive evaluation of operation experience' and Incorporation of the latest technical knowledge' was carried out up to January 2005. 1. Comprehensive evaluation of operation experience. It was confirmed that the effectual activities for safety through the operation of JOYO were carried out in terms of (1) Operation management, (2) Maintenance management, (3) Fuel management, (4) Radiation management, (5) Radioactive waste management, (6) Emergency planning and (7) Feedback of incidents and failures. 2. Reflection of the latest technical knowledge. It was confirmed that the latest technical knowledge including regulation and guide line established by Nuclear Safety Commission of Japan until March 31st. 2003 were properly reflected in impressing the safety of the reactor. As a result, it was evaluated that the activity for safety was carried out effectually, and no additional measure was identified continual safe operation of the reactor. (author)

  3. Waste Isolation Pilot Plant Safety Analysis Report

    International Nuclear Information System (INIS)

    1995-11-01

    The following provides a summary of the specific issues addressed in this FY-95 Annual Update as they relate to the CH TRU safety bases: Executive Summary; Site Characteristics; Principal Design and Safety Criteria; Facility Design and Operation; Hazards and Accident Analysis; Derivation of Technical Safety Requirements; Radiological and Hazardous Material Protection; Institutional Programs; Quality Assurance; and Decontamination and Decommissioning. The System Design Descriptions'' (SDDS) for the WIPP were reviewed and incorporated into Chapter 3, Principal Design and Safety Criteria and Chapter 4, Facility Design and Operation. This provides the most currently available final engineering design information on waste emplacement operations throughout the disposal phase up to the point of permanent closure. Also, the criteria which define the TRU waste to be accepted for disposal at the WIPP facility were summarized in Chapter 3 based on the WAC for the Waste Isolation Pilot Plant.'' This Safety Analysis Report (SAR) documents the safety analyses that develop and evaluate the adequacy of the Waste Isolation Pilot Plant Contact-Handled Transuranic Wastes (WIPP CH TRU) safety bases necessary to ensure the safety of workers, the public and the environment from the hazards posed by WIPP waste handling and emplacement operations during the disposal phase and hazards associated with the decommissioning and decontamination phase. The analyses of the hazards associated with the long-term (10,000 year) disposal of TRU and TRU mixed waste, and demonstration of compliance with the requirements of 40 CFR 191, Subpart B and 40 CFR 268.6 will be addressed in detail in the WIPP Final Certification Application scheduled for submittal in October 1996 (40 CFR 191) and the No-Migration Variance Petition (40 CFR 268.6) scheduled for submittal in June 1996. Section 5.4, Long-Term Waste Isolation Assessment summarizes the current status of the assessment

  4. Waste Isolation Pilot Plant Safety Analysis Report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-11-01

    The following provides a summary of the specific issues addressed in this FY-95 Annual Update as they relate to the CH TRU safety bases: Executive Summary; Site Characteristics; Principal Design and Safety Criteria; Facility Design and Operation; Hazards and Accident Analysis; Derivation of Technical Safety Requirements; Radiological and Hazardous Material Protection; Institutional Programs; Quality Assurance; and Decontamination and Decommissioning. The System Design Descriptions`` (SDDS) for the WIPP were reviewed and incorporated into Chapter 3, Principal Design and Safety Criteria and Chapter 4, Facility Design and Operation. This provides the most currently available final engineering design information on waste emplacement operations throughout the disposal phase up to the point of permanent closure. Also, the criteria which define the TRU waste to be accepted for disposal at the WIPP facility were summarized in Chapter 3 based on the WAC for the Waste Isolation Pilot Plant.`` This Safety Analysis Report (SAR) documents the safety analyses that develop and evaluate the adequacy of the Waste Isolation Pilot Plant Contact-Handled Transuranic Wastes (WIPP CH TRU) safety bases necessary to ensure the safety of workers, the public and the environment from the hazards posed by WIPP waste handling and emplacement operations during the disposal phase and hazards associated with the decommissioning and decontamination phase. The analyses of the hazards associated with the long-term (10,000 year) disposal of TRU and TRU mixed waste, and demonstration of compliance with the requirements of 40 CFR 191, Subpart B and 40 CFR 268.6 will be addressed in detail in the WIPP Final Certification Application scheduled for submittal in October 1996 (40 CFR 191) and the No-Migration Variance Petition (40 CFR 268.6) scheduled for submittal in June 1996. Section 5.4, Long-Term Waste Isolation Assessment summarizes the current status of the assessment.

  5. Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis.

    Science.gov (United States)

    Serrano, Ana Julissa; Begoña, Leire; Anitua, Eduardo; Cobos, Raquel; Orive, Gorka

    2013-12-01

    The aim of this meta-analysis was to evaluate the efficacy and safety of two bisphosphonates (alendronate and zoledronate) in the treatment of postmenopausal osteoporosis. The incidence of fractures was considered as primary endpoint. Only randomized trials with a follow-up period of 1 year or more were included in this systematic review and meta-analysis. We excluded studies that included patients with secondary osteoporosis especially in relation to therapy with corticosteroids or other drugs or diseases known to affect bone mineral density. Studies published as subgroup analysis, extension studies, economic evaluations, and comparisons with active control were excluded. The methodological quality of controlled clinical trials that met these inclusion criteria was evaluated. No studies were excluded from analysis due to lack of quality. The risk ratio of hip, vertebral and wrist fractures for alendronate were 0.61 [95% confidence interval (CI) 0.40-0.93], 0.54 (95% CI 0.44-0.66) and 0.65 (95% CI 0.33-1.25), respectively. Zoledronate risk ratio was 0.62 (95% CI 0.46-0.82) and 0.38 (95% CI 0.22-0.67) for hip and vertebral fractures, respectively.

  6. Statistical considerations on safety analysis

    International Nuclear Information System (INIS)

    Pal, L.; Makai, M.

    2004-01-01

    The authors have investigated the statistical methods applied to safety analysis of nuclear reactors and arrived at alarming conclusions: a series of calculations with the generally appreciated safety code ATHLET were carried out to ascertain the stability of the results against input uncertainties in a simple experimental situation. Scrutinizing those calculations, we came to the conclusion that the ATHLET results may exhibit chaotic behavior. A further conclusion is that the technological limits are incorrectly set when the output variables are correlated. Another formerly unnoticed conclusion of the previous ATHLET calculations that certain innocent looking parameters (like wall roughness factor, the number of bubbles per unit volume, the number of droplets per unit volume) can influence considerably such output parameters as water levels. The authors are concerned with the statistical foundation of present day safety analysis practices and can only hope that their own misjudgment will be dispelled. Until then, the authors suggest applying correct statistical methods in safety analysis even if it makes the analysis more expensive. It would be desirable to continue exploring the role of internal parameters (wall roughness factor, steam-water surface in thermal hydraulics codes, homogenization methods in neutronics codes) in system safety codes and to study their effects on the analysis. In the validation and verification process of a code one carries out a series of computations. The input data are not precisely determined because measured data have an error, calculated data are often obtained from a more or less accurate model. Some users of large codes are content with comparing the nominal output obtained from the nominal input, whereas all the possible inputs should be taken into account when judging safety. At the same time, any statement concerning safety must be aleatory, and its merit can be judged only when the probability is known with which the

  7. Development of web-based safety review advisory system

    International Nuclear Information System (INIS)

    Kim, M. W.; Hur, K. Y.; Lee, S. J.; Choi, S. J.

    2002-01-01

    For the development of an expert system supporting the safety review of nuclear power plants, the application was implemented after gathering necessary theoretical background and practical requirements. The general and the detail functional specifications were established, and they are investigated by KINS. Safety Review Advisory System (SRAS), this application on web-server environment was developed according to the above specifications. Reviews can do their safety reviewing regardless of their speciality or reviewing experiences because SRAS is operated by the safety review plans which are converted to standardized format. When the safety reviewing is carried out by using SRAS, the results of safety reviewing are accumulated in the database and may be utilized later usefully, and we can grasp safety reviewing progress. Users of SRAS are categorized into four groups, administrator, project manager, project reviewer and general reviewer. Each user group is delegated appropriate access capability. The function and some screen shots of SRAS are described

  8. Safety in Serbian animal source food industry and the impact of hazard analysis and critical control points: A review

    Science.gov (United States)

    Tomašević, I.; Đekić, I.

    2017-09-01

    There is a significant lack of HACCP-educated and/or HACCP-highly trained personnel within the Serbian animal source food workforces and veterinary inspectors, and this can present problems, particularly in hazard identification and assessment activities. However, despite obvious difficulties, HACCP benefits to the Serbian dairy industry are widespread and significant. Improving prerequisite programmes on the farms, mainly through infrastructural investments in milk collectors and transportation vehicles on one hand, and increasing hygiene awareness of farmers through training on the other hand has improved the safety of milk. The decline in bacterial numbers on meat contact surfaces, meat handlers’ hands and cooling facilities presents strong evidence of improved process hygiene and justifies the adoption of HACCP in Serbian meat establishments. Apart from the absence of national food poisoning statistics or national foodborne disease databases, the main obstacle to fully recognising the impact of HACCP on the safety of animal source food in Serbia is the lack of research regarding the occurrence of chemical and/or physical hazards interrelated with its production.

  9. Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis.

    Science.gov (United States)

    Cheng, Cai-Qi; Xu, Hao; Liu, Ling; Wang, Rui-Nan; Liu, Yu-Ting; Li, Jing; Zhou, Xi-Kun

    2016-04-01

    Pilocarpine has been used widely in the treatment of dry mouth and glaucoma. In this review, the authors assessed the efficacy and safety of pilocarpine for patients with head and neck cancer who have radiation-induced xerostomia. The authors conducted a systematic search including meta-analyses and randomized controlled trials in the following databases: MEDLINE, Embase, Cochrane Library, and Science Citation Index Expanded. The primary outcome was the severity of xerostomia (measured using visual analog scale [VAS] scores). Adverse events were other outcomes of interest. The authors performed meta-analyses where appropriate. The authors used the Cochrane Collaboration's tool for assessing risk of bias to assess the quality of the study. The authors identified 6 studies (including 752 patients in total). The results of a meta-analysis of 3 articles showed that pilocarpine was associated with a 12-point increase in VAS score (mean difference, 12.00; 95% confidence interval [CI], 1.93-22.08; P = .02) and higher rates of adverse events compared with placebo in terms of sweating (odds ratio [OR], 3.71; 95% CI, 2.34-5.86; P xerostomia in patients with head and neck cancer. However, the authors of this systematic review found the best available evidence in the meta-analysis in 3 studies, 1 of which showed no effect. The authors of this systematic review suggest that these patients take 5 milligrams of pilocarpine 3 times daily, and that there is need for further study. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  10. [Improving patient safety through voluntary peer review].

    Science.gov (United States)

    Kluge, S; Bause, H

    2015-01-01

    The intensive care unit (ICU) is one area of the hospital in which processes and communication are of primary importance. Errors in intensive care units can lead to serious adverse events with significant consequences for patients. Therefore quality and risk-management are important measures when treating critically ill patients. A pragmatic approach to support quality and safety in intensive care is peer review. This approach has gained significant acceptance over the past years. It consists of mutual visits by colleagues who conduct standardised peer reviews. These reviews focus on the systematic evaluation of the quality of an ICU's structure, its processes and outcome. Together with different associations, the State Chambers of Physicians and the German Medical Association have developed peer review as a standardized tool for quality improvement. The common goal of all stakeholders is the continuous and sustainable improvement in intensive care with peer reviews significantly increasing and improving communication between professions and disciplines. Peer reviews secure the sustainability of planned change processes and consequently lead the way to an improved culture of quality and safety.

  11. Nuclear Safety Review for the Year 2006

    International Nuclear Information System (INIS)

    2007-07-01

    the various stakeholders effectively and efficiently. Related to this is the need for operators, users and regulatory bodies to communicate with the public effectively and in an open and transparent manner. The global nature of safety is reflected in the relevant international instruments, including conventions and codes of conduct, currently in place. All the international conventions related to safety welcomed additional contracting parties in 2006. During the year, the second review meeting took place for the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management. The newly established Integrated Regulatory Review Service (IRRS) is contributing to the enhancement of Member States' legislative and regulatory infrastructure and the harmonization of regulatory approaches in nuclear, radiation, radioactive waste and transport safety. It is also one of the most effective feedback tools on the application of Agency standards that will be used for the further improvement of existing standards and guidance. In addition, the approach evaluates not only the policies and strategies, but also how efficient and effective they are regarding protection against all types of exposure. Therefore it is also a tool for information sharing and mutual learning on good policies and practices that can be used to reach harmonization step by step. Overall, the safety performance of the nuclear industry is good. However, there continue to be recurring events and there is a need to maintain vigilance. There is also a need for lessons learned to be transferred across the various sectors of the nuclear industry. Strong safety management and safety culture are vitally important for the continuation of this good performance. Leaders must ensure that personnel are properly trained and that adequate resources are available. The nuclear power industry around the world remains a safe and sound one with no worker or member of the public receiving a

  12. Nuclear Safety Review for the Year 2007

    International Nuclear Information System (INIS)

    2008-07-01

    In 2007, the 50th anniversary year of the Agency, the safety performance of the nuclear industry, on the whole, remained high, although incidents and accidents with no significant impact on public health and safety continue to make news headlines and challenge operators and regulators. It is therefore essential to maintain vigilance, continuously improve safety culture and enhance the international sharing and utilization of operating and other safety experience, including that resulting from natural events. The establishment and sustainability of infrastructures for all aspects of nuclear, radiation, transport and waste safety will remain a high priority. Member States embarking on nuclear power programmes will need to be active participants in the global nuclear safety regime. Harmonized safety standards, the peer review mechanism among contracting parties of the safety conventions, and sharing safety knowledge and best practices through networking are key elements for the continuous strengthening of the global nuclear safety regime. Technical and scientific support organizations (TSOs), whether part of the regulatory body or a separate organization, are gaining increased importance by providing the technical and scientific basis for safety related decisions and activities. There is a need for enhanced interaction and cooperation between TSOs. Academic and industrial expert communities also play a vital role in improving safety cooperation and capacity building. Countries embarking on nuclear power programmes, as well as countries expanding existing programmes, have to meet the challenge of building a technically qualified workforce. A vigorous knowledge transfer programme is key to capacity building - particularly in view of the ageing of experienced professionals in the nuclear field. National and regional safety networks, and ultimately a global safety network will greatly help these efforts. Changes in world markets and technology are having an impact on both

  13. The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Chen, Kai; Mi, Hua; Xu, Guangyu; Liu, Lin; Sun, Xiubin; Wang, Shiping; Meng, Qingrong; Lv, Tao

    2015-10-01

    Many studies have been conducted to investigate adjunctive tamsulosin therapy after extracorporeal shockwave lithotripsy (SWL) for urolithiasis. The results from those studies, however, are still inconsistent. Therefore, we performed a meta-analysis to provide an update on the clinical efficacy and safety of tamsulosin combined with SWL for urolithiasis. A systematic search was performed in PubMed, Cochrane Library, and Embase to identify all relevant randomized controlled trials until January 2015. Two reviewers independently assessed trial quality and extracted data. Meta-analysis was conducted with Review Manager (RevMan), version 5.1. Twenty-one studies (2093 subjects in total) were identified in the current meta-analysis. Compared with a control group, the experimental group (tamsulosin combined with SWL) showed an increased overall benefit for stone expulsion, with pooled risk ratio (RR) of 1.20 (95% confidence interval [CI], 1.15-1.26). With respect to the different geographic regions, European and American had a high possibility of improvement in stone expulsion (RR: 1.33, 95% CI, 1.19-1.49). According to the stone locations (renal, upper and lower ureteral) and sizes (4-10 mm and 11-24 mm), tamsulosin is more useful for lower ureteral stone (RR: 1.28; 95% CI, 1.14-1.43) and larger sized stones (RR: 1.49; 95% CI, 1.28-1.75). The effect estimates did not vary markedly when stratified by follow-up durations but varied by dose of tamsulosin. Furthermore, a shorter expulsion time, reduced occurrence of steinstrasse, fewer incidences of colic, and lower analgesic requirements were observed within the experimental group. In addition, tamsulosin is well tolerated, and its adverse events rarely led to dropouts of patients. Overall, evidence suggests that tamsulosin combined with SWL is safe and effective in enhancing stone expulsion for patients with urolithiasis. Furthermore, high-quality, randomized and placebo-controlled trials evaluating the efficacy and

  14. Reactor safety review of permanent changes

    International Nuclear Information System (INIS)

    Lam, K.F.

    1997-01-01

    Operational compliance engineers review all changes as part of a change control process. Each change, permanent or temporary, is required to undergo an intricate review process to ensure that the benefits associated with the change outweigh the risk. For permanent changes, it is necessary to ensure that the proposed design meets the nuclear safety requirements, conforms to the licensing requirements and complies with regulatory requirements. In addition, during installation of the permanent change and prior to in-service, a configuration management process is in place to align the change with operating and maintenance documents. (author)

  15. Probabilistic safety analysis procedures guide

    International Nuclear Information System (INIS)

    Papazoglou, I.A.; Bari, R.A.; Buslik, A.J.

    1984-01-01

    A procedures guide for the performance of probabilistic safety assessment has been prepared for interim use in the Nuclear Regulatory Commission programs. The probabilistic safety assessment studies performed are intended to produce probabilistic predictive models that can be used and extended by the utilities and by NRC to sharpen the focus of inquiries into a range of tissues affecting reactor safety. This guide addresses the determination of the probability (per year) of core damage resulting from accident initiators internal to the plant and from loss of offsite electric power. The scope includes analyses of problem-solving (cognitive) human errors, a determination of importance of the various core damage accident sequences, and an explicit treatment and display of uncertainties for the key accident sequences. Ultimately, the guide will be augmented to include the plant-specific analysis of in-plant processes (i.e., containment performance) and the risk associated with external accident initiators, as consensus is developed regarding suitable methodologies in these areas. This guide provides the structure of a probabilistic safety study to be performed, and indicates what products of the study are essential for regulatory decision making. Methodology is treated in the guide only to the extent necessary to indicate the range of methods which is acceptable; ample reference is given to alternative methodologies which may be utilized in the performance of the study

  16. Efficacy and Safety of Insulin Degludec versus Insulin Glargine: A Systematic Review and Meta-Analysis of Fifteen Clinical Trials

    Directory of Open Access Journals (Sweden)

    Wei Liu

    2018-01-01

    Full Text Available Aims. Insulin degludec (IDeg and insulin glargine (IGlar are both proved to be effective in diabetes. This study aimed to assess the effects and safety of IDeg versus IGlar. Methods. A systematic literature search was conducted using the PubMed, EMBASE, and Cochrane Library electronic databases to identify all randomized controlled trials (RCTs. Results. Fifteen RCTs were identified. The combined data showed that the decrease in the glycosylated hemoglobin (HbA1c level was slightly different, and the proportion of patients who achieved HbA1c < 7% was similar between the IDeg and IGlar groups. Further, a statistically significant decrease in the fasting plasma glucose level was observed in the IDeg group as compared to the IGlar group. In patients with T2DM, IDeg was associated with lower rates of overall hypoglycemia. Nocturnal hypoglycemia was significantly lower in the case of IDeg than in the case of IGlar in both T1DM and T2DM patients. No statistically significant differences were observed between the groups. Conclusions. Compared with IGlar, IDeg is associated with equivalent glycemic control and a statistically significantly lower rate of nocturnal hypoglycemia in patients with T1DM and T2DM. In T2DM patients, IDeg also provides better results in terms of overall hypoglycemia.

  17. Effect and safety of early weight-bearing on the outcome after open-wedge high tibial osteotomy: a systematic review and meta-analysis.

    Science.gov (United States)

    Lee, O-Sung; Ahn, Soyeon; Lee, Yong Seuk

    2017-07-01

    The purpose of this systematic review and meta-analysis was to evaluate the effectiveness and safety of early weight-bearing by comparing clinical and radiological outcomes between early and traditional delayed weight-bearing after OWHTO. A rigorous and systematic approach was used. The methodological quality was also assessed. Results that are possible to be compared in two or more than two articles were presented as forest plots. A 95% confidence interval was calculated for each effect size, and we calculated the I 2 statistic, which presents the percentage of total variation attributable to the heterogeneity among studies. The random-effects model was used to calculate the effect size. Six articles were included in the final analysis. All case groups were composed of early full weight-bearing within 2 weeks. All control groups were composed of late full weight-bearing between 6 weeks and 2 months. Pooled analysis was possible for the improvement in Lysholm score, but there was no statistically significant difference shown between groups. Other clinical results were also similar between groups. Four studies reported mechanical femorotibial angle (mFTA) and this result showed no statistically significant difference between groups in the pooled analysis. Furthermore, early weight-bearing showed more favorable results in some radiologic results (osseointegration and patellar height) and complications (thrombophlebitis and recurrence). Our analysis supports that early full weight-bearing after OWHTO using a locking plate leads to improvement in outcomes and was comparable to the delayed weight-bearing in terms of clinical and radiological outcomes. On the contrary, early weight-bearing was more favorable with respect to some radiologic parameters and complications compared with delayed weight-bearing.

  18. Immunization safety review: influenza vaccines and neurological complications

    National Research Council Canada - National Science Library

    Stratton, Kathleen R

    ..., unlike other vaccines. The Immunization Safety Review committee reviewed the data on influenza vaccine and neurological conditions and concluded that the evidence favored rejection of a causal relationship...

  19. Nuclear Safety Review for the Year 2008

    International Nuclear Information System (INIS)

    2009-07-01

    Nuclear technologies are increasingly seen as important solutions for meeting a number of challenges. Enabling the peaceful use of nuclear technology to support global energy demands and other human needs must be accompanied by deliberate, internationally-coordinated actions to minimize the potential for nuclear accidents and terrorism. While in recent years, the safety performance of the nuclear industry has been good, it is important to avoid any complacency. The Agency continues to support and promote the global nuclear safety and security regime as a framework for worldwide achievement of high levels of safety and security in nuclear activities. In 2008, three general themes can be observed from the global trends, issues and challenges in nuclear safety: the continuous improvements in strengthening safety worldwide through international cooperation; an expected increase of new entrant nuclear power programmes and the expansion of existing programmes; and safety and security synergy. Regarding continuous improvements to strengthen safety worldwide, the focus was on operating experience feedback and knowledge networking; and self-assessment and peer review. In the areas of new entrant nuclear programmes and expansion of existing nuclear programmes, activities centred on national safety infrastructures; human resources and capacity building; regulatory independence; nuclear incident and emergency preparedness and response; spent fuel and radioactive waste management; and multinational aspects of nuclear activities. In the area of safety and security synergy, in 2008 there was increasing awareness that processes need to be in place to ensure that safety activities do not compromise security and vice versa. As outlined in Safety Fundamentals No. SF-1, the prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks. An effective legal and governmental framework for safety

  20. [Patient safety in home care - A review of international recommendations].

    Science.gov (United States)

    Czakert, Judith; Lehmann, Yvonne; Ewers, Michael

    2018-06-08

    In recent years there has been a growing trend towards nursing care at home in general as well as towards intensive home care being provided by specialized home care services in Germany. However, resulting challenges for patient safety have rarely been considered. Against this background we aimed to explore whether international recommendations for patient safety in home care in general and in intensive home care in particular already exist and how they can stimulate further practice development in Germany. A review of online English documents containing recommendations for patient safety in intensive home care was conducted. Available documents were analyzed and compared in terms of their form and content. Overall, a small number of relevant documents could be identified. None of these documents exclusively refer to the intensive home care sector. Despite their differences, however, the analysis of four selected documents showed similarities, e. g., regarding specific topics of patient safety (communication, involvement of patients and their relatives, risk assessment, medication management, qualification). Furthermore, strengths and weaknesses of the documents became apparent: e. g., an explicit understanding of patient safety, a literature-based introduction to safety topics or an adaptation of the recommendations to the specific features of home care were occasionally lacking. This document analysis provides interesting input to the formal and content-related development of specific recommendations and to practice development in Germany to improve patient safety in home care. Copyright © 2018. Published by Elsevier GmbH.

  1. A Systematic Review and Meta-Analysis on the Safety of Vascular Endothelial Growth Factor (VEGF) Inhibitors for the Treatment of Retinopathy of Prematurity

    Science.gov (United States)

    Pertl, Laura; Steinwender, Gernot; Mayer, Christoph; Hausberger, Silke; Pöschl, Eva-Maria; Wackernagel, Werner; Wedrich, Andreas; El-Shabrawi, Yosuf; Haas, Anton

    2015-01-01

    Introduction Laser photocoagulation is the current gold standard treatment for proliferative retinopathy of prematurity (ROP). However, it permanently reduces the visual field and might induce myopia. Vascular endothelial growth factor (VEGF) inhibitors for the treatment of ROP may enable continuing vascularization of the retina, potentially allowing the preservation of the visual field. However, for their use in infants concern remains. This meta-analysis explores the safety of VEGF inhibitors. Methods The Ovid Interface was used to perform a systematic review of the literature in the databases PubMed, EMBASE and the Cochrane Library. Results This meta-analysis included 24 original reports (including 1.457 eyes) on VEGF inhibitor treatment for ROP. The trials were solely observational except for one randomized and two case-control studies. We estimated a 6-month risk of retreatment per eye of 2.8%, and a 6-month risk of ocular complication without the need of retreatment of 1.6% per eye. Systemic complications were only reported as isolated incidents. Discussion VEGF inhibitors seem to be associated with low recurrence rates and ocular complication rates. They may have the benefit of potentially allowing the preservation of visual field and lower rates of myopia. Due to the lack of data, the risk of systemic side effects cannot be assessed. PMID:26083024

  2. Lessons learned from the Galileo and Ulysses flight safety review experience

    International Nuclear Information System (INIS)

    Bennett, Gary L.

    1998-01-01

    In preparation for the launches of the Galileo and Ulysses spacecraft, a very comprehensive aerospace nuclear safety program and flight safety review were conducted. A review of this work has highlighted a number of important lessons which should be considered in the safety analysis and review of future space nuclear systems. These lessons have been grouped into six general categories: (1) establishment of the purpose, objectives and scope of the safety process; (2) establishment of charters defining the roles of the various participants; (3) provision of adequate resources; (4) provision of timely peer-reviewed information to support the safety program; (5) establishment of general ground rules for the safety review; and (6) agreement on the kinds of information to be provided from the safety review process

  3. Reload safety analysis automation tools

    International Nuclear Information System (INIS)

    Havlůj, F.; Hejzlar, J.; Vočka, R.

    2013-01-01

    Performing core physics calculations for the sake of reload safety analysis is a very demanding and time consuming process. This process generally begins with the preparation of libraries for the core physics code using a lattice code. The next step involves creating a very large set of calculations with the core physics code. Lastly, the results of the calculations must be interpreted, correctly applying uncertainties and checking whether applicable limits are satisfied. Such a procedure requires three specialized experts. One must understand the lattice code in order to correctly calculate and interpret its results. The next expert must have a good understanding of the physics code in order to create libraries from the lattice code results and to correctly define all the calculations involved. The third expert must have a deep knowledge of the power plant and the reload safety analysis procedure in order to verify, that all the necessary calculations were performed. Such a procedure involves many steps and is very time consuming. At ÚJV Řež, a.s., we have developed a set of tools which can be used to automate and simplify the whole process of performing reload safety analysis. Our application QUADRIGA automates lattice code calculations for library preparation. It removes user interaction with the lattice code and reduces his task to defining fuel pin types, enrichments, assembly maps and operational parameters all through a very nice and user-friendly GUI. The second part in reload safety analysis calculations is done by CycleKit, a code which is linked with our core physics code ANDREA. Through CycleKit large sets of calculations with complicated interdependencies can be performed using simple and convenient notation. CycleKit automates the interaction with ANDREA, organizes all the calculations, collects the results, performs limit verification and displays the output in clickable html format. Using this set of tools for reload safety analysis simplifies

  4. Nuclear safety in Slovak Republic. Safety analysis reports for WWER 440 reactors

    International Nuclear Information System (INIS)

    Rohar, S.

    1999-01-01

    Implementation of nuclear power program is connected to establishment of regulatory body for safe regulation of siting, construction, operation and decommissioning of nuclear installations. Licensing being one of the most important regulatory surveillance activity is based on independent regulatory review and assessment of information on nuclear safety for particular nuclear facility. Documents required to be submitted to the regulatory body by the licensee in Slovakia for the review and assessment usually named Safety Analysis Report (SAR) are presented in detail in this paper. Current status of Safety Analysis Reports for Bohunice V-1, Bohunice V-2 and Mochovce NPP is shown

  5. Efficacy and safety of angiogenesis inhibitors in advanced gastric cancer: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Jing Yu

    2016-10-01

    Full Text Available Abstract Monoclonal antibodies and small molecule tyrosine kinase inhibitors (TKIs directed against the vascular endothelial growth factor (VEGF or its receptors have been investigated in several studies for the treatment of advanced gastric cancer (GC. In the present study, we aimed to evaluate the efficacy and safety of angiogenesis inhibitors in advanced GC. We searched published randomized controlled trials (RCTs comparing angiogenesis inhibitors with non-angiogenesis inhibitors for the treatment of GC. MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched. The extracted data on progression-free survival (PFS and overall survival (OS were measured in terms of hazard ratios (HR and corresponding 95 % confidence intervals (CIs. In addition, risk ratios (RR and corresponding 95 % CIs were pooled for objective response rate (ORR, disease control rate (DCR, and risk of adverse events (AEs. Ten RCTs involving 2786 patients were included. Compared with non-angiogenesis inhibitor-containing regimens, angiogenesis inhibitor-containing regimens resulted in a significant improvement in OS (HR 0.80, 95 % CI 0.69–0.93, P = 0.004, prolonged PFS (HR 0.66, 95 % CI 0.51–0.86, P = 0.002, and superior ORR (RR 1.34, 95 % CI 1.09–1.65, P = 0.005 and DCR (RR 1.37, 95 % CI 1.17–1.61, P = 0.0001. Angiogenesis inhibitors were associated with a greater number of AEs, but most of these were predictable and manageable. However, hand-foot syndrome, diarrhea, and gastrointestinal (GI perforation were significantly increased in patients treated with angiogenesis inhibitors. In summary, angiogenesis inhibitor-containing regimens were superior to non-angiogenesis inhibitor-containing regimens in terms of OS, PFS, RR, and DCR in patients with advanced GC.

  6. Research on review technology for three key safety factors of periodic safety review (PSR) and its application to Qinshan Nuclear Power Plant

    International Nuclear Information System (INIS)

    Xu Shoulv; Yao Weida; Dou Yikang; Lin Shaoxuan; Cao Yenan; Zhou Quanfu; Zheng Jiong; Zhang Ming

    2009-04-01

    In 2001, after 10 years' operation, Qinshan Nuclear Power Plant (Q1) started to carry out periodic safety review (PSR) based on a nuclear safety guideline, Periodic Safety Review for Operational Nuclear Power Plants (HAF0312), issued by National Nuclear Safety Administration of China (NNSA). Entrusted by the owner of Q1, Shanghai Nuclear Engineering Research and Design Institute (SNERDI) implemented reviews of three key safety factors including safety analysis, equipment qualification and ageing. PSR was a challenging work in China at that time and through three years' research and practice, SNERDI summarized a systematic achievement for the review including review methodology, scoping, review contents and implementation steps, etc.. During the process of review for the three safety factors, totally 148 review reports and 341 recommendations for corrections were submitted to Q1. These reports and recommendations have provided guidance for correction actions as follow-up of PSR. This paper focuses on technical aspects to carry out PSR for the above-mentioned three safety factors, including review scoping, contents, methodology and main steps. The review technology and relevant experience can be taken for reference for other NPPs to carry out PSR. (authors)

  7. Systems engineered health and safety criteria for safety analysis reports

    International Nuclear Information System (INIS)

    Beitel, G.A.; Morcos, N.

    1993-01-01

    The world of safety analysis is filled with ambiguous words: codes and standards, consequences and risks, hazard and accident, and health and safety. These words have been subject to disparate interpretations by safety analysis report (SAR) writers, readers, and users. open-quotes Principal health and safety criteriaclose quotes has been one of the most frequently misused phrases; rarely is it used consistently or effectively. This paper offers an easily understood definition for open-quotes principal health and safety criteriaclose quotes and uses systems engineering to convert an otherwise mysterious topic into the primary means of producing an integrated SAR. This paper is based on SARs being written for environmental restoration and waste management activities for the U.S. Department of Energy (DOE). Requirements for these SARs are prescribed in DOE Order 5480-23, open-quotes Nuclear Safety Analysis Reports.close quotes

  8. Efficacy, safety and effectiveness of licensed rotavirus vaccines: a systematic review and meta-analysis for Latin America and the Caribbean.

    Science.gov (United States)

    Velázquez, Raúl F; Linhares, Alexandre C; Muñoz, Sergio; Seron, Pamela; Lorca, Pedro; DeAntonio, Rodrigo; Ortega-Barria, Eduardo

    2017-01-13

    RotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. As many countries in Latin America and the Caribbean have included either RV5 or RV1 in their routine childhood vaccination programs, we conducted a systematic review and meta-analysis to analyze efficacy, safety and effectiveness data from the region. We conducted a systematic search in PubMed, EMBASE, Scielo, Lilacs and the Cochrane Central Register, for controlled efficacy, safety and effectiveness studies published between January 2000 until December 2011, on RV5 and RV1 across Latin America (where both vaccines are available since 2006). The primary outcome measures were: rotavirus-related gastroenteritis of any severity; rotavirus emergency department visits and hospitalization; and severe adverse events. The results of the meta-analysis for efficacy show that RV1 reduced the risk of any-severity rotavirus-related gastroenteritis by 65% (relative risk (RR) 0.35, 95% confidence interval (CI) 0.25; 0.50), and of severe gastroenteritis by 82% (RR 0.18, 95%CI 0.12; 0.26) versus placebo. In trials, both vaccines significantly reduced the risk of hospitalization and emergency visits by 85% (RR 0.15, 95%CI 0.09; 0.25) for RV1 and by 90% (RR 0.099, 95%CI 0.012; 0.77) for RV5. Vaccination with RV5 or RV1 did not increase the risk of death, intussusception, or other severe adverse events which were previously associated with the first licensed rotavirus vaccine. Real-world effectiveness studies showed that both vaccines reduced rotavirus hospitalization in the region by around 45-50% for RV5 (for 1 to 3 doses, respectively), and, by around 50-80% for RV1 (for 1 to 2 doses, respectively). For RV1, effectiveness against hospitalization was highest (around 80-96%) for children vaccinated before 12 months of age, compared with 5

  9. Safety evaluation report of the Waste Isolation Pilot Plant safety analysis report: Contact-handled transuranic waste disposal operations

    International Nuclear Information System (INIS)

    1997-02-01

    DOE 5480.23, Nuclear Safety Analysis Reports, requires that the US Department of Energy conduct an independent, defensible, review in order to approve a Safety Analysis Report (SAR). That review and the SAR approval basis is documented in this formal Safety Evaluation Report (SER). This SER documents the DOE's review of the Waste Isolation Pilot Plant SAR and provides the Carlsbad Area Office Manager, the WIPP SAR approval authority, with the basis for approving the safety document. It concludes that the safety basis documented in the WIPP SAR is comprehensive, correct, and commensurate with hazards associated with planned waste disposal operations

  10. Establishment of Safety Analysis System and Technology for CANDU Reactors

    International Nuclear Information System (INIS)

    Park, Joo Hwan; Rhee, B. W.; Min, B. J.; Kim, H. T.; Kim, W. Y.; Yoon, C.; Chun, J. S.; Cho, M. S.; Jeong, J. Y.; Kang, H. S.

    2007-06-01

    The following 4 research items have been studied to establish a CANDU safety analysis system and to develop the relevant elementary technology for CANDU reactors. First, to improve and validate the CANDU design and operational safety analysis codes, the CANDU physics cell code WIMS-CANDU was improved, and validated, and an analysis of the moderator subcooling and pressure tube integrity has been performed for the large break LOCAs without ECCS. Also a CATHENA model and a CFD model for a post-blowdown fuel channel analysis have been developed and validated against two high temperature thermal-chemical experiments, CS28-1 and 2. Second, to improve the integrated operating system of the CANDU safety analysis codes, an extension has been made to them to include the core and fuel accident analyses, and a web-based CANDU database, CANTHIS version 2.0 was completed. Third, to assess the applicability of the ACR-7 safety analysis methodology to CANDU-6 the ACR-7 safety analysis methods were reviewed and the safety analysis methods of ACR-7 applicable to CANDU-6 were recommended. Last, to supplement and improve the existing CANDU safety analysis procedures, detailed analysis procedures have been prepared for individual accident scenarios. The results of this study can be used to resolve the CANDU safety issues, to improve the current design and operational safety analysis codes, and to technically support the Wolsong site to resolve their problems

  11. ESRS guidelines for software safety reviews. Reference document for the organization and conduct of Engineering Safety Review Services (ESRS) on software important to safety in nuclear power plants

    International Nuclear Information System (INIS)

    2000-01-01

    The IAEA provides safety review services to assist Member States in the application of safety standards and, in particular, to evaluate and facilitate improvements in nuclear power plant safety performance. Complementary to the Operational Safety Review Team (OSART) and the International Regulatory Review Team (IRRT) services are the Engineering Safety Review Services (ESRS), which include reviews of siting, external events and structural safety, design safety, fire safety, ageing management and software safety. Software is of increasing importance to safety in nuclear power plants as the use of computer based equipment and systems, controlled by software, is increasing in new and older plants. Computer based devices are used in both safety related applications (such as process control and monitoring) and safety critical applications (such as reactor protection). Their dependability can only be ensured if a systematic, fully documented and reviewable engineering process is used. The ESRS on software safety are designed to assist a nuclear power plant or a regulatory body of a Member State in the review of documentation relating to the development, application and safety assessment of software embedded in computer based systems important to safety in nuclear power plants. The software safety reviews can be tailored to the specific needs of the requesting organization. Examples of such reviews are: project planning reviews, reviews of specific issues and reviews prior final acceptance. This report gives information on the possible scope of ESRS software safety reviews and guidance on the organization and conduct of the reviews. It is aimed at Member States considering these reviews and IAEA staff and external experts performing the reviews. The ESRS software safety reviews evaluate the degree to which software documents show that the development process and the final product conform to international standards, guidelines and current practices. Recommendations are

  12. Efficacy and safety of meditative movement therapies in fibromyalgia syndrome: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Langhorst, Jost; Klose, Petra; Dobos, Gustav J; Bernardy, Kathrin; Häuser, Winfried

    2013-01-01

    A systematic review with meta-analysis of the efficacy and safety of meditative movement therapies (Qigong, Tai Chi and Yoga) in fibromyalgia syndrome (FMS) was carried out. We screened Clinicaltrials.Gov, Cochrane Library, PsycINFO, PubMed and Scopus (through December 2010) and the reference sections of original studies for meditative movement therapies (MMT) in FMS. Randomized controlled trials (RCT) comparing MMT to controls were analysed. Outcomes of efficacy were pain, sleep, fatigue, depression and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD [95% confidence interval]). Outcomes of safety were drop out because of adverse events and serious adverse events. A total of 7 out of 117 studies with 362 subjects and a median of 12 sessions (range 8-24) were included. MMT reduced sleep disturbances (-0.61 [-0.95, -0.27]; 0.0004), fatigue (-0.66 [-0.99, -0.34]; <0.0001), depression (-0.49 [-0.76, -0.22]; 0.0004) and limitations of HRQOL (-0.59 [-0.93, -0.24]; 0.0009), but not pain (-0.35 [-0.80, 0.11]; 0.14) compared to controls at final treatment. The significant effects on sleep disturbances (-0.52 [-0.97, -0.07]; 0.02) and HRQOL (-0.66 [-1.31, -0.01]; 0.05) could be maintained after a median of 4.5 (range 3-6) months. In subgroup analyses, only Yoga yielded significant effects on pain, fatigue, depression and HRQOL at final treatment. Drop out rate because of adverse events was 3.1%. No serious adverse events were reported. MMT are safe. Yoga had short-term beneficial effects on some key domains of FMS. There is a need for high-quality studies with larger sample sizes to confirm the results.

  13. Integrated program of using of Probabilistic Safety Analysis in Spain

    International Nuclear Information System (INIS)

    1998-01-01

    Since 25 June 1986, when the CSN (Nuclear Safety Conseil) approve the Integrated Program of Probabilistic Safety Analysis, this program has articulated the main activities of CSN. This document summarize the activities developed during these years and reviews the Integrated programme

  14. Safety of human papillomavirus vaccines: a review.

    Science.gov (United States)

    Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

    2015-05-01

    Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

  15. Plant safety review from mass criticality accident

    International Nuclear Information System (INIS)

    Susanto, B.G.

    2000-01-01

    The review has been done to understand the resent status of the plant in facing postulated mass criticality accident. From the design concept of the plant all the components in the system including functional groups have been designed based on favorable mass/geometry safety principle. The criticality safety for each component is guaranteed because all the dimensions relevant to criticality of the components are smaller than dimensions of 'favorable mass/geometry'. The procedures covering all aspects affecting quality including the safety related are developed and adhered to at all times. Staff are indoctrinated periodically in short training session to warn the important of the safety in process of production. The plant is fully equipped with 6 (six) criticality detectors in strategic places to alert employees whenever the postulated mass criticality accident occur. In the event of Nuclear Emergency Preparedness, PT BATAN TEKNOLOGI has also proposed the organization structure how promptly to report the crisis to Nuclear Energy Control Board (BAPETEN) Indonesia. (author)

  16. 10 CFR 70.62 - Safety program and integrated safety analysis.

    Science.gov (United States)

    2010-01-01

    ...; (iv) Potential accident sequences caused by process deviations or other events internal to the... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process... this safety program; namely, process safety information, integrated safety analysis, and management...

  17. Nuclear Safety Review for the Year 2005

    International Nuclear Information System (INIS)

    2006-01-01

    In 2005, the Agency and its Director General were awarded the Nobel Peace Prize. The Nobel Committee statement recognizes the Agency's 'efforts to prevent nuclear energy from being used for military purposes and to ensure that nuclear energy for peaceful purposes is used in the safest possible way.' The global nature of safety is reflected in the relevant international legal instruments, both binding conventions and the non-binding codes of conduct currently in place. During the year, the third review meeting of the Contracting Parties to the Convention on Nuclear Safety as well as the third meeting of the representatives of the competent authorities under the Convention on Early Notification of a Nuclear Accident and Convention on Assistance in the Case of a Nuclear Accident or a Radiological Emergency took place. Improvements have been made in national legislation and regulatory infrastructure in many Member States in 2005. However, inadequate safety management and regulatory supervision of nuclear installations and use of ionizing radiation is a continuing issue in many Member States. A continuing challenge is to collect, analyse and disseminate safety experience and knowledge. Nuclear power plant (NPP) operational safety performance remained high throughout the world in 2005. Radiation doses to workers and members of the public due to NPP operation are well below regulatory limits. Personal injury accidents and incidents are among the lowest in industry. There were no accidents that resulted in the release of radiation that could adversely impact the environment. NPPs in many parts of the world have successfully coped with severe natural disaster conditions such as earthquakes, tsunamis, widespread river flooding and hurricanes. However, operational safety performance has been on a plateau for several years and concern has been expressed in many forums regarding the need to guard against complacency in the industry. Research reactors also maintained a good

  18. Safety analysis report for the Waste Storage Facility. Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Bengston, S.J.

    1994-05-01

    This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

  19. Interagency Nuclear Safety Review Panel Power System Subpanel review for the Ulysses mission

    International Nuclear Information System (INIS)

    McCulloch, W.H.

    1991-01-01

    As part of the Interagency Nuclear Safety Review Panel's assessment of the nuclear safety of NASA's Ulysses Mission to investigate properties of the sun, the Power System Subpanel has reviewed the safety analyses and risk evaluations done for the General Purpose Heat Source-Radioisotope Thermoelectric Generator which provides on-board electrical power for the spacecraft. This paper summarizes the activities and results of that review. In general, the approach taken in the primary analysis, executed by the General Electric Company under contract to the Department of Energy, and the resulting conclusions were confirmed by the review. However, the Subpanel took some exceptions and modified the calculations accordingly, producing an independent evaluation of potential releases of radioactive fuel in launch and reentry accidents. Some of the more important of these exceptions are described briefly

  20. Analysis of high burnup fuel safety issues

    International Nuclear Information System (INIS)

    Lee, Chan Bock; Kim, D. H.; Bang, J. G.; Kim, Y. M.; Yang, Y. S.; Jung, Y. H.; Jeong, Y. H.; Nam, C.; Baik, J. H.; Song, K. W.; Kim, K. S

    2000-12-01

    Safety issues in steady state and transient behavior of high burnup LWR fuel above 50 - 60 MWD/kgU were analyzed. Effects of burnup extension upon fuel performance parameters was reviewed, and validity of both the fuel safety criteria and the performance analysis models which were based upon the lower burnup fuel test results was analyzed. It was found that further tests would be necessary in such areas as fuel failure and dispersion for RIA, and high temperature cladding corrosion and mechanical deformation for LOCA. Since domestic fuels have been irradiated in PWR up to burnup higher than 55 MWD/kgU-rod. avg., it can be said that Korea is in the same situation as the other countries in the high burnup fuel safety issues. Therefore, necessary research areas to be performed in Korea were derived. Considering that post-irradiation examination(PIE) for the domestic fuel of burnup higher than 30 MWD/kgU has not been done so far at all, it is primarily necessary to perform PIE for high burnup fuel, and then simulation tests for RIA and LOCA could be performed by using high burnup fuel specimens. For the areas which can not be performed in Korea, international cooperation will be helpful to obtain the test results. With those data base, safety of high burnup domestic fuels will be confirmed, current fuel safety criteria will be re-evaluated, and finally transient high burnup fuel behavior analysis technology will be developed through the fuel performance analysis code development

  1. Analysis of high burnup fuel safety issues

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Chan Bock; Kim, D. H.; Bang, J. G.; Kim, Y. M.; Yang, Y. S.; Jung, Y. H.; Jeong, Y. H.; Nam, C.; Baik, J. H.; Song, K. W.; Kim, K. S

    2000-12-01

    Safety issues in steady state and transient behavior of high burnup LWR fuel above 50 - 60 MWD/kgU were analyzed. Effects of burnup extension upon fuel performance parameters was reviewed, and validity of both the fuel safety criteria and the performance analysis models which were based upon the lower burnup fuel test results was analyzed. It was found that further tests would be necessary in such areas as fuel failure and dispersion for RIA, and high temperature cladding corrosion and mechanical deformation for LOCA. Since domestic fuels have been irradiated in PWR up to burnup higher than 55 MWD/kgU-rod. avg., it can be said that Korea is in the same situation as the other countries in the high burnup fuel safety issues. Therefore, necessary research areas to be performed in Korea were derived. Considering that post-irradiation examination(PIE) for the domestic fuel of burnup higher than 30 MWD/kgU has not been done so far at all, it is primarily necessary to perform PIE for high burnup fuel, and then simulation tests for RIA and LOCA could be performed by using high burnup fuel specimens. For the areas which can not be performed in Korea, international cooperation will be helpful to obtain the test results. With those data base, safety of high burnup domestic fuels will be confirmed, current fuel safety criteria will be re-evaluated, and finally transient high burnup fuel behavior analysis technology will be developed through the fuel performance analysis code development.

  2. Review of current status of LWR safety research in Japan

    International Nuclear Information System (INIS)

    Yamada, Tasaburo; Mishima, Yoshitsugu; Ando, Yoshio; Miyazono, Shohachiro; Takashima, Yoichi.

    1977-01-01

    The Japan Atomic Energy Commission has exerted efforts on the research of the safety of nuclear plants in Japan, and ''Nuclear plant safety research committees'' was established in August 1974, which is composed of the government and the people. The philosophy of safety research, research and development plan, the forwarding procedure of the plan, international cooperation, for example LOFT program, and the effective feed back of the experimental results concerning nuclear safety are reviewed in this paper at first. As for the safety of nuclear reactors the basic philosophy that radio active fission products are contained in fuel or reactors with multiple barriers, (defence in depth) and almost no fission product is released outside reactor plants even at the time of hypothetical accident, is kept, and the research and development history and the future plan are described in this paper with the related technical problems. The structural safety is also explained, for example, on the philosophy ''leak before break'', pipe rupture, pipe restraint and stress analysis. The release of radioactive gas and liquid is decreased as the philosophy ''ALAP''. And probability safety evaluation method, LOCA, reactivity, accident and aseismatic design in nuclear plants in Japan are described. (Nakai, Y.)

  3. Patterns of Harmful Alcohol Consumption among Truck Drivers: Implications for Occupational Health and Work Safety from a Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Nicola Luigi Bragazzi

    2018-05-01

    Full Text Available Alcohol consumption is one of the main causes of productivity losses arising from absenteeism, presenteeism, and workplace injuries. Among occupational categories most affected by the use of this substance, truck drivers are subject to risk factors and risky behaviors that can have a serious impact on their health, their work, and the general road safety. The use of alcohol during truck-driving activities is, indeed, an important risk factor for traffic accidents. The present systematic review and meta-analysis aims at synthesizing the literature regarding harmful alcohol consumption patterns among truck drivers in a rigorous way. A ‘binge drinking’ prevalence of 19.0%, 95% confidence interval or CI (13.1, 26.9 was present. An ‘everyday drinking’ pattern rate of 9.4%, 95% CI (7.0, 12.4 was found, while the rate of alcohol misuse according to the “Alcohol Use Disorders Identification Test” (AUDIT—“Cut down-Annoyed-Guilty-Eye opener questionnaire” (CAGE instruments was computed to be of 22.7%, 95% CI (14.8, 33.0. No evidence of publication bias could be found. However, there is the need to improve the quality of published research, utilizing standardized reliable instruments. The knowledge of these epidemiological data can be useful for decision makers in order to develop, design, and implement ad hoc adequate policies.

  4. Comparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia: protocol for a systematic review and individual patient data network meta-analysis

    Science.gov (United States)

    Veroniki, Areti Angeliki; Straus, Sharon E; Ashoor, Huda M; Hamid, Jemila S; Hemmelgarn, Brenda R; Holroyd-Leduc, Jayna; Majumdar, Sumit R; McAuley, Glenn; Tricco, Andrea C

    2016-01-01

    Introduction Alzheimer's dementia (AD) is the most common cause of dementia, and several organisations, such as the National Institute for Health and Care Excellence, suggest that management of patients with AD should be tailored to their needs. To date, little research has been conducted on the treatment effect in different subgroups of patients with AD. The aim of this study is to examine the comparative effectiveness and safety of cognitive enhancers for different patient characteristics. Methods and analysis We will update our previous literature search from January 2015 forward, using the same terms and electronic databases (eg, MEDLINE) from our previous review. We will additionally search grey literature and scan the reference lists of the included studies. Randomised clinical trials of any duration conducted at any time comparing cognitive enhancers alone or in any combination against other cognitive enhancers, or placebo in adults with AD will be eligible. The outcomes of interest are cognition according to the Mini-Mental State Examination, and overall serious adverse events. For each outcome and treatment comparison, we will perform a Bayesian hierarchical random-effects meta-analysis combining the individual patient data (IPD) from each eligible study. If the identified treatment comparisons form a connected network diagram, we will perform an IPD network meta-analysis (NMA) to estimate subgroup effects for patients with different characteristics, such as AD severity and sex. We will combine aggregated data from studies that we will not be able to obtain IPD, with the IPD provided by the original authors, in a single model. We will use the PRISMA-IPD and PRISMA-NMA statements to report our findings. Ethics and dissemination The findings of this study will be of interest to stakeholders, including decision makers, guideline developers, clinicians, methodologists and patients, and they will help to improve guidelines for the management of patients with AD

  5. Transient analysis for resolving safety issues

    International Nuclear Information System (INIS)

    Chao, J.; Layman, W.

    1987-01-01

    The Nuclear Safety Analysis Center (NSAC) has a Generic Safety Analysis Program to help resolve high priority generic safety issues. This paper describes several high priority safety issues considered at NSAC and how they were resolved by transient analysis using thermal hydraulics and neutronics codes. These issues are pressurized thermal shock (PTS), anticipated transients without scram (ATWS), steam generator tube rupture (SGTR), and reactivity transients in light of the Chernobyl accident

  6. Comparison of the effectiveness and safety of formoterol versus salmeterol in the treatment of patients with asthma: A systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Ashraf Velayati

    2015-01-01

    Full Text Available Background: Formoterol and salmeterol are two long-acting β2-agonists given by inhalation, with bronchodilating effects lasting for at least 12 h after a single administration. Formoterol has a faster onset of action compared with salmeterol. The aim of this study was to perform a systematic review and meta-analysis on the data published from previous review in order to calculate pooled estimates of effectiveness and safety assessment of formoterol and salmeterol in treatment of patients with asthma. Materials and Methods: In this study, we conducted an electronic search for medical citation databases including Cochrane, PubMed, Scopus, PsycInfo, and IranMedex. Besides manual search of the databases that record randomized clinical trials, conference proceedings, and journals related to asthma were included. Studies were evaluated by two independent people based on inclusion and exclusion criteria, and the common outcomes of studies were entered into the RevMan 5.0.1 software, after evaluation of studies and extraction of data from them; and in cases where there were homogeneous studies, meta-analysis was performed, and for heterogeneous studies, the results were reported qualitatively. Results: Of the 1539 studies initially found, 13 were included in the study. According to the meta-analysis conducted, no significant difference was found between the inhalation of formoterol 12 μg and salmeterol 50 μg in the two outcomes of mean forced expiratory volume 1 s (FEV1, 12 h after inhalation of medication and Borg score (A frequently used scale for quantifying breathlessness after inhalation of medication. In addition, salmeterol was more effective than formoterol in the two outcomes of percent decrease in FEV1 after inhalation of methacholine and the number of days without an attack. Since the two outcomes of FEV1 30-60 min after inhalation of medication and morning peak expiratory flow after inhalation of medication were heterogeneous, they had no

  7. Guidance for preparation of safety analysis reports for nonreactor facilities and operations

    International Nuclear Information System (INIS)

    1992-01-01

    Department of Energy (DOE) Orders 5480.23, ''Nuclear Safety Analysis Reports,'' and 5481.1B, ''Safety Analysis and Review System'' require the preparation of appropriate safety analyses for each DOE operation and subsequent significant modifications including decommissioning, and independent review of each safety analysis. The purpose of this guide is to assist in the preparation and review of safety documentation for Oak Ridge Field Office (OR) nonreactor facilities and operation. Appendix A lists DOE Orders, NRC Regulatory Guides and other documents applicable to the preparation of safety analysis reports

  8. Nuclear Safety Review for the Year 2009

    International Nuclear Information System (INIS)

    2010-07-01

    . A growing number of Member States are considering or have expressed interest in developing nuclear power programmes for the first time. Several countries have also embarked on ambitious plans for expanding their current programmes. The Agency's latest projections for the future of nuclear power by 2030 are higher than they were last year. Emerging international cooperative efforts in support of new and expanding nuclear power programmes have focused on many key issues. Such issues include gaps in national safety infrastructures, safety and security synergy and integration, and safety responsibilities and capacities for the various participants in a nuclear power programme, which include operators, regulators, government, suppliers, technical support organizations and relevant international organizations. Continued focus on cooperation for new and expanding nuclear power programmes is underscored by the fact that in some cases plans for nuclear programme development are moving faster than the establishment of the necessary safety infrastructure and capacity. Therefore, it is important that those countries of new and expanding nuclear power programmes actively participate in the global nuclear safety and security regime. As a result of the increasingly multinational nature of today's nuclear business and activities and associated technical and economic benefits, suppliers, operators, regulators and experts communities are making significant efforts towards the standardization and harmonization of equipment, components, methods and processes. As an example, the adoption by the European Union of a nuclear towards a harmonized approach to sustainable nuclear safety infrastructure worldwide. Similarly, international cooperation through conventions and codes of conduct, including associated peer review mechanisms, also provide for harmonized approaches to safety. Establishing and maintaining a regulatory body which is effectively independent in its decision making

  9. 324 building safety analysis report supplement

    International Nuclear Information System (INIS)

    Dodd, A.O.; Wittenbrock, N.G.

    1977-01-01

    Process engineering designs, major equipment and plant facilities to be utilized in commercial nuclear waste preparation and vitrification in the 324 Radiochemical Engineering Building are reviewed with regard to accident potential and consequences. This Safety Analysis Report Supplement compares calculated environmental doses anticipated from the Commercial Nuclear Waste Vitrification Project (CNWVP) routine operations with the average doses from past waste management operations conducted at the Hanford Project and finds them to be significantly less. The calculated CNWVP environmental doses are found to be far below presently applicable ERDA standards and standards proposed by the EPA for nuclear power operations

  10. Status of generic actions items and safety analysis system of PHWR

    Energy Technology Data Exchange (ETDEWEB)

    Park, Joo Hwan; Min, Byung Joo

    2001-05-01

    This report described the review results of a GAIs(Generic Action Item) currently issued on safety analysis of PHWR(Pressurized Heavy Water Reactor) and the research activities and positions to solve the GAIs in each country which possess PHWRs. eviewing the Final Safety Analysis Report for Wolsong-2/3/4 Units, the safety analysis methodology, classification for accident scenarios, safety analysis codes, their interface, etc.. were described. From the present review report, it is intended to establish the CANDU safety analysis system by providing the better understandings and development plans for the safety analysis of PHWR. esults.

  11. The efficacy and safety of triple inhaled treatment in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis using Bayesian methods

    Directory of Open Access Journals (Sweden)

    Kwak MS

    2015-11-01

    Full Text Available Min-Sun Kwak,1 Eunyoung Kim,2 Eun Jin Jang,3 Hyun Jung Kim,4 Chang-Hoon Lee5 1Department of Internal Medicine, Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital, Seoul, Republic of Korea; 2Department of Statistics, Kyungpook National University, Daegu, Republic of Korea; 3Department of Information Statistics, Andong National University, Andong, Republic of Korea; 4Department of Preventive Medicine, College of Medicine, Korea University, Seoul, Republic of Korea; 5Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea Purpose: Although tiotropium (TIO and inhaled corticosteroid (ICS/long-acting β-agonists are frequently prescribed together, the efficacy of “triple therapy” has not been scientifically demonstrated. We conducted a systematic review and meta-analysis using Bayesian methods to compare triple therapy and TIO monotherapy.Methods: We searched the MEDLINE, EMBASE, and Cochrane Library databases for randomized controlled trials comparing the efficacy and safety of triple therapy and TIO monotherapy in patients with chronic obstructive pulmonary disease (COPD. We conducted a meta-analysis to compare the effectiveness and safety of triple therapy and TIO monotherapy using Bayesian random effects models.Results: Seven trials were included, and the risk of bias in the majority of the studies was acceptable. There were no statistically significant differences in the incidence of death and acute exacerbation of disease in the triple therapy and TIO monotherapy groups. Triple therapy improved the prebronchodilator forced expiratory volume in 1 second (mean difference [MD], 63.68 mL; 95% credible interval [CrI], 45.29–82.73, and patients receiving triple therapy showed more improvement in St George Respiratory Questionnaire scores (MD, -3.11 points; 95% Cr

  12. Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

    Science.gov (United States)

    Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

    2017-08-01

    Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from

  13. Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review

    Directory of Open Access Journals (Sweden)

    Wang Z

    2016-09-01

    Full Text Available Zhiqiang Wang,1 Lei Yuan,1 Yongchuan Wang,2 Baizhi Yang,1 Xiaohong Dong,1 Zhaowang Gao3 1Department of Urology, Shouguang Hospital of Traditional Chinese Medicine, Shouguang, 2Department of Urology, Weifang Traditional Chinese Hospital, Weifang, 3Department of Urology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Shandong, People’s Republic of China Objective: The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM for chronic prostatitis (CP associated with damp-heat and blood-stasis syndromes.Methods: An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software.Results: Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78–9.48, P<0.00001 and reducing the SI-CM scores (standardized mean difference: -1.08, 95% CI: -1.35 to -0.81, P<0.00001. Oral CHMs were significantly more effective than placebo at reducing NIH-CPSI scores, with a mean difference of -1.39 (95% CI: -1.87 to -0.92, P<0.00001. Nevertheless, no significant differences were found between Prostant and placebo (standardized mean difference: -0.23, 95% CI: -0.46 to 0.01, P=0.06. The frequency of adverse events associated with oral CHM was similar to that associated with placebo (risk ratio: 1.36, 95% CI: 0.72–2.55, P=0.34 and less than that

  14. The efficiency and safety of fibrin sealant for reducing blood loss in primary total hip arthroplasty: A systematic review and meta-analysis.

    Science.gov (United States)

    Wang, Zhiyuan; Xiao, Lin; Guo, Hao; Zhao, Guanghui; Ma, Jianbing

    2017-01-01

    Total hip arthroplasty (THA) is associated with substantial blood loss. The objective of present systematic review and meta-analysis is to provide evidence from randomized controlled trials (RCTs) on the efficiency and safety of administration of fibrin sealant (FS) for reducing blood loss in patients undergoing primary THA. Potential relevant studies were identified from electronic databases including Medline, PubMed, Embase, ScienceDirect, web of science and Cochrane Library. Gray academic studies were also identified from the reference list of included studies. There was no language restriction. Pooling of data was carried out by using RevMan 5.1. Six randomized controlled trials (RCTs) met the inclusion criteria. Current meta-analysis indicated that there were significant differences in terms of total blood loss (MD = -153.77, 95% CI: -287.21 to -20.34, P = 0.02), postoperative hemoglobin level (MD = -0.25, 95% CI: -0.46 to -0.05, P = 0.02) and transfusion rate (RD = -0.12, 95% CI: -0.22 to -0.03, P = 0.01) between groups. No significant differences were found regarding the incidence of deep venous thrombosis (DVT) (RD = 0.00, 95% CI: -0.01to 0.01, P = 0.51) or other side effects. Administration of fibrin sealant in total hip arthroplasty may reduce total blood loss, postoperative hemoglobin decline and transfusion requirements. Moreover, no adverse effect was related to FS. Due to the limited quality of the evidence currently available, higher quality RCTs are required. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  15. Systematic review and meta-analysis of feasibility, safety, and efficacy of a novel procedure: associating liver partition and portal vein ligation for staged hepatectomy.

    Science.gov (United States)

    Schadde, Erik; Schnitzbauer, Andreas A; Tschuor, Christoph; Raptis, Dimitri A; Bechstein, Wolf O; Clavien, Pierre-Alain

    2015-09-01

    Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a novel strategy to resect liver tumors despite the small size of the liver remnant. It is an hepatectomy in two stages, with PVL and parenchymal transection during the first stage, which induces rapid growth of the remnant liver exceeding any other technique. Despite high postoperative morbidity and mortality in most reports, the technique was adopted by a number of surgeons. This systematic review explores current data regarding the feasibility, safety, and oncologic efficacy of ALPPS; the search strategy has been published online. A meta-analysis of hypertrophy, feasibility (ALPPS stage 2 performed), mortality, complications, and R0 (complete) resection was performed. A literature search revealed a total of 13 publications that met the search criteria, reporting data from 295 patients. Evidence levels were low, with the highest Oxford evidence level being 2c. The most common indication was colorectal liver metastasis in 203 patients. Hypertrophy in the meta-analysis was 84 %, feasibility (ALPPS stage 2 performed) 97 % (CI 94-99 %), 90-day mortality 11 % (CI 8-16 %), and complications grade IIIa or higher occured in 44 % (CI 38-50 %) of patients. A standardized reporting format for complications is lacking despite the widespread use of the Clavien-Dindo classification. Oncological outcome is not well-documented. The most common topics in the selected studies published were technical feasibility and indications for the procedures. Publication bias due to case-series and single-center reports is common. A systematic exploration of this novel operation with a rigid methodology, such as registry analyses and a randomized controlled trial, is highly advised.

  16. Utility and Safety of Endoscopic Ultrasound With Bronchoscope-Guided Fine-Needle Aspiration in Mediastinal Lymph Node Sampling: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Dhooria, Sahajal; Aggarwal, Ashutosh N; Gupta, Dheeraj; Behera, Digambar; Agarwal, Ritesh

    2015-07-01

    The use of endoscopic ultrasound with bronchoscope-guided fine-needle aspiration (EUS-B-FNA) has been described in the evaluation of mediastinal lymphadenopathy. Herein, we conduct a meta-analysis to estimate the overall diagnostic yield and safety of EUS-B-FNA combined with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), in the diagnosis of mediastinal lymphadenopathy. The PubMed and EmBase databases were searched for studies reporting the outcomes of EUS-B-FNA in diagnosis of mediastinal lymphadenopathy. The study quality was assessed using the QualSyst tool. The yield of EBUS-TBNA alone and the combined procedure (EBUS-TBNA and EUS-B-FNA) were analyzed by calculating the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio for each study, and pooling the study results using a random effects model. Heterogeneity and publication bias were assessed for individual outcomes. The additional diagnostic gain of EUS-B-FNA over EBUS-TBNA was calculated using proportion meta-analysis. Our search yielded 10 studies (1,080 subjects with mediastinal lymphadenopathy). The sensitivity of the combined procedure was significantly higher than EBUS-TBNA alone (91% vs 80%, P = .004), in staging of lung cancer (4 studies, 465 subjects). The additional diagnostic gain of EUS-B-FNA over EBUS-TBNA was 7.6% in the diagnosis of mediastinal adenopathy. No serious complication of EUS-B-FNA procedure was reported. Clinical and statistical heterogeneity was present without any evidence of publication bias. Combining EBUS-TBNA and EUS-B-FNA is an effective and safe method, superior to EBUS-TBNA alone, in the diagnosis of mediastinal lymphadenopathy. Good quality randomized controlled trials are required to confirm the results of this systematic review. Copyright © 2015 by Daedalus Enterprises.

  17. Effectiveness and safety of acupuncture in the treatment of Parkinson's disease: A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Noh, Hyeonseok; Kwon, Seungwon; Cho, Seung-Yeon; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

    2017-10-01

    This study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson's disease (PD). English, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using RevMan 5.3. In total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported. We found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Aging evaluation methodology of periodic safety review in Korea

    International Nuclear Information System (INIS)

    Park, Heung-Bae; Jung, Sung-Gyu; Jin, Tae-Eun; Jeong, Ill-Seok

    2002-01-01

    In Korea plant lifetime management (PLIM) study for Kori Unit 1 has been performed since 1993. Meanwhile, periodic safety review (PSR) for all operating nuclear power plants (NPPs) has been started with Kori Unit 1 since 2000 per IAEA recommendation. The evaluation period is 10 years, and safety (evaluation) factors are 11 per IAEA guidelines as represented in table 1. The relationship between PSR factors and PLIM is also represented. Among these factors evaluation of 'management of aging' is one of the most important and difficult factor. This factor is related to 'actual condition of the NPP', 'use of experience from other nuclear NPPs and of research findings', and 'management of aging'. The object of 'management of aging' is to obtain plant safety through identifying actual condition of system, structure and components (SSCs) and evaluating aging phenomena and residual life of SSCs using operating experience and research findings. The paper describes the scope and procedure of valuation of 'management of aging', such as, screening criteria of SSCs, Code and Standards, evaluation of SSCs and safety issues as represented. Evaluating SSCs are determined using final safety analysis report (FSAR) and power unit maintenance system for Nuclear Ver. III (PUMAS/N-III). The screening criteria of SSCs are safety-related items (quality class Q), safety-impact items (quality class T), backfitting rule items (fire protection (10CFR50.48), environmental qualification (10CFR50.49), pressurized thermal shock (10CFR50.61), anticipated transient without scram (10CFR50.62), and station blackout (10CFR50.63)) and regulating authority requiring items[1∼3]. The purpose of review of Code and Standards is identifying actual condition of the NPP and evaluating aging management using effective Code and Standards corresponding to reactor facilities. Code and Standards is composed of regulating laws, FSAR items, administrative actions, regulating actions, agreement items, and other

  19. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  20. Passenger safety, health, and comfort: a review.

    Science.gov (United States)

    Rayman, R B

    1997-05-01

    Since the birth of aviation medicine approximately 80 yrs ago, practitioners and scientists have given their attention primarily to flight deck crew, cabin crew, and ground support personnel. However, in more recent years we have broadened our horizons to include the safety, health, and comfort of passengers flying commercial aircraft. This will be even more compelling as more passengers take to the air in larger aircraft and flying longer hours to more distant destinations. Further, we can expect to see more older passengers because people in many countries are living longer, healthier lives. The author first discusses the stresses imposed by ordinary commercial flight upon travelers such as airport tumult, barometric pressure changes, immobility, jet lag, noise/ vibration, and radiation. Medical considerations are next addressed describing inflight illness and medical care capability aboard U.S. air carriers. Passenger safety, cabin air quality, and the preventive medicine aspects of air travel are next reviewed in the context of passenger safety, health, and comfort. Recommendations are addressed to regulator agencies, airlines aircraft manufacturers, and the aerospace medicine community.

  1. A systematic review and meta-analysis of the effect and safety of ginger in the treatment of pregnancy-associated nausea and vomiting.

    Science.gov (United States)

    Viljoen, Estelle; Visser, Janicke; Koen, Nelene; Musekiwa, Alfred

    2014-03-19

    Nausea and vomiting during pregnancy (NVP) occur commonly. Possible harmful side-effects of conventional medicine to the fetus create the need for alternative options to relieve NVP. This systematic review (SR) investigated current evidence regarding orally administered ginger for the treatment of NVP. The primary objective was to assess the effectiveness of ginger in treating NVP. The secondary objective was to assess the safety of ginger during pregnancy. A comprehensive electronic bibliographic database search was carried out. Randomized controlled trials (RCTs) of the efficacy of orally administered ginger, as treatment for NVP in pregnant women at any stage of pregnancy, published in English, were included. Two researchers independently extracted data and assessed trial quality. RevMan5 software (Cochrane Collaboration) was used for data analysis. p Ginger significantly improved the symptoms of nausea when compared to placebo (MD 1.20, 95% CI 0.56-1.84, p = 0.0002, I² = 0%). Ginger did not significantly reduce the number of vomiting episodes during NVP, when compared to placebo, although there was a trend towards improvement (MD 0.72, 95% CI -0.03-1.46, p = 0.06, I² = 71%). Subgroup analyses seemed to favor the lower daily dosage of ginger for nausea relief. Ginger did not pose a significant risk for spontaneous abortion compared to placebo (RR 3.14, 95% CI 0.65-15.11, p = 0.15; I² = 0%), or to vitamin B₆ (RR 0.49, 95% CI 0.17-1.42, p = 0.19, I² = 40%). Similarly, ginger did not pose a significant risk for the side-effects of heartburn or drowsiness. This review suggests potential benefits of ginger in reducing nausea symptoms in pregnancy (bearing in mind the limited number of studies, variable outcome reporting and low quality of evidence). Ginger did not significantly affect vomiting episodes, nor pose a risk for side-effects or adverse events during pregnancy. Based on evidence from this SR, ginger could be considered a harmless and possibly

  2. Efficacy and safety of aldose reductase inhibitor for the treatment of diabetic cardiovascular autonomic neuropathy: systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Xin Hu

    Full Text Available BACKGROUND: Aldose reductase inhibitors (ARIs can block the metabolism of the polyol pathway, and have been used to slow or reverse the progression of diabetic cardiovascular autonomic neuropathy (DCAN. The purpose of this study was to review the effectiveness and safety of ARIs in the treatment of DCAN as determined by five cardiac autonomic neuropathy function tests. METHODS: CENTRAL, MEDLINE, EMBASE, Scopus databases (inception to May 2012 were searched to identify randomized controlled trials (RCTs and non-randomized controlled trials (non-RCTs investigating ARIs for the treatment of DCAN with an English-language restriction. The data were analyzed using RevMan 5.0, and the heterogeneity between the trials was evaluated using the Cochrane's Q-test as well as the I² test. The type of model (random or fixed used for analysis was based on heterogeneity. Weighted mean differences (WMD with 95% confidence intervals (CI were computed for the five cardiac automatic neuropathy function tests to evaluate the effects. RESULTS: Ten articles met the prerequisites for this review. Analysis of the results showed that ARIs significantly improved function in at least three of the five automatic neuropathy tests, including the resting heart rate variation coefficients (WMD = 0.25, 95%CI 0.02 to 0.48, P = 0.040; the 30∶15 ratio (WMD = 0.06, 95%CI 0.01 to 0.10, P = 0.010 and the postural systolic blood pressure change (WMD = -5.94, 95%CI -7.31 to -4.57, P = 0.001. The expiration/inspiration ratio showed a marginally significant benefit (WMD = 0.05, 95%CI 0.00 to 0.09, P = 0.040. Glycaemic control was not significantly affected by ARIs. Adverse effects of ARIs except for Tolerestat were minimal. CONCLUSIONS: Based on these results, we conclude that ARIs could ameliorate cardiac automatic neuropathy especially mild or asymptomatic DCAN but need further investigation.

  3. SIMMER as a safety analysis tool

    International Nuclear Information System (INIS)

    Smith, L.L.; Bell, C.R.; Bohl, W.R.; Bott, T.F.; Dearing, J.F.; Luck, L.B.

    1982-01-01

    SIMMER has been used for numerous applications in fast reactor safety, encompassing both accident and experiment analysis. Recent analyses of transition-phase behavior in potential core disruptive accidents have integrated SIMMER testing with the accident analysis. Results of both the accident analysis and the verification effort are presented as a comprehensive safety analysis program

  4. Solid waste burial grounds interim safety analysis

    International Nuclear Information System (INIS)

    Saito, G.H.

    1994-01-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment

  5. Solid waste burial grounds interim safety analysis

    Energy Technology Data Exchange (ETDEWEB)

    Saito, G.H.

    1994-10-01

    This Interim Safety Analysis document supports the authorization basis for the interim operation and restrictions on interim operations for the near-surface land disposal of solid waste in the Solid Waste Burial Grounds. The Solid Waste Burial Grounds Interim Safety Basis supports the upgrade progress for the safety analysis report and the technical safety requirements for the operations in the Solid Waste Burial Grounds. Accident safety analysis scenarios have been analyzed based on the significant events identified in the preliminary hazards analysis. The interim safety analysis provides an evaluation of the operations in the Solid Waste Burial Grounds to determine if the radiological and hazardous material exposures will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, the public, and the environment.

  6. Review and analysis of potential safety impacts of and regulatory barriers to fuel efficiency technologies and alternative fuels in medium- and heavy-duty vehicles

    Science.gov (United States)

    2015-06-01

    This report summarizes a safety analysis of medium- and heavy-duty vehicles (MD/HDVs) equipped with fuel efficiency (FE) technologies and/or using alternative fuels (natural gas-CNG and LNG, propane, biodiesel and power train electrification). The st...

  7. Shielding modefication and safety review on Mutsu

    International Nuclear Information System (INIS)

    Osanai, Masao

    1978-01-01

    The Japan Atomic Energy Commission requests strongly to repair the shielding and make general safety inspection on Mutsu after an accident of radiation leakage from the reactor. The content and procedure of this repair of shielding and general safety inspection are outlined. The neutron leakage location in the reactor proper, technical shielding investigation, conceptual design of relating shielding repair, the mock up test of the shielding on the neutron streaming, the final conceptual design of repair, the relating research and development experiment and the detailed basic design of repair are explained, comparing the original design and the modified one. The modified design depends on the experimental results of neutron streaming test between the reactor vessel and the primary shield. As for the general safety inspection, the functional test of control rod driving mechanism and other main components, the flaw detection for heat transfer tubes of the steam generator and primary cooling pipings are carried out in hardwares, and the integrity analysis of fuel assemblies, stress corrosion cracking of fuel claddings and primary cooling pipings, the natural circulation analysis of primary cooling system, and integrity check of the heat transfer tubes of steam generator are carried out in softwares. The burst test and the strength test after high temperature oxidation for fuel claddings made of stainless steel were carried out. (Nakai, Y.)

  8. Efficacy and safety profile of linezolid in the treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis: a systematic review and meta-analysis.

    Science.gov (United States)

    Agyeman, Akosua Adom; Ofori-Asenso, Richard

    2016-06-22

    Treatment options for drug-resistant tuberculosis are still limited. Linezolid has been recommended for treatment of patients with multidrug-resistant (MDR) or extensively-drug-resistant (XDR) tuberculosis, although uncertainties remain regarding its safety and tolerability in these circumstances. To systematically evaluate the existing evidence regarding the efficacy and tolerability of linezolid in the treatment of MDR or XDR tuberculosis. We conducted a systematic review and meta-analysis in accordance with the PRISMA guidelines. Searches were conducted in PubMed, Web of Science and EMBASE followed by direct search of abstracts in the International Journal of Tuberculosis and Lung Disease to retrieve primary studies published between January 2000 and January 2016 assessing linezolid efficacy and safety in the treatment of drug-resistant TB. We evaluated the occurrence of outcomes including culture conversion, treatment success and incidence of adverse events such as myelosuppression and neuropathy. Twenty-three (23) studies conducted in fourteen (14) countries and involving 507 patients were retrieved. Only 1 randomized controlled trial was identified and none of the identified studies involved participants from Africa. The pooled proportion for treatment success was 77.36 % (95 % CI = 71.38-82.83 %, I(2) = 37.6 %) with culture conversion rate determined as 88.45 % (95 % CI = 83.82-92.38 %, I(2) = 45.4 %). There was no strong evidence for both culture conversion (p = 0.0948) and treatment success (p = 0.0695) between linezolid daily doses ≤ 600 and > 600 mg. Only myelosuppression showed a strong statistical significance (p linezolid also showed no significance upon dose comparisons (p = 0.3213, p = 0.9050 respectively). Available evidence presents Linezolid as a viable option in the treatment of MDR/XDR TB although patients ought to be monitored closely for the incidence of major adverse events such as myelosuppression and

  9. Galileo and Ulysses missions safety analysis and launch readiness status

    International Nuclear Information System (INIS)

    Cork, M.J.; Turi, J.A.

    1989-01-01

    The Galileo spacecraft will explore the Jupiter system and Ulysses will fly by Jupiter en route to a polar orbit of the sun. Both spacecraft are powered by general purpose heat source radioisotope thermoelectric generators (RTGs). As a result of the Challenger accident and subsequent mission reprogramming, the Galileo and Ulysses missions' safety analysis had to be repeated. In addition to presenting an overview of the safety analysis status for the missions, this paper presents a brief review of the missions' objectives and design approaches, RTG design characteristics and development history, and a description of the safety analysis process. (author)

  10. Assessment of technologies for hazardous waste site remediation: Non-treatment technologies and pilot scale facility implementation -- excavation -- storage technology -- safety analysis and review statement. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, H.R.; Overbey, W.K. Jr.; Koperna, G.J. Jr.

    1994-02-01

    The purpose of this study is to assess the state-of-the-art of excavation technology as related to environmental remediation applications. A further purpose is to determine which of the excavation technologies reviewed could be used by the US Corp of Engineers in remediating contaminated soil to be excavated in the near future for construction of a new Lock and Dam at Winfield, WV. The study is designed to identify excavation methodologies and equipment which can be used at any environmental remediation site but more specifically at the Winfield site on the Kanawha River in Putnam County, West Virginia. A technical approach was determined whereby a functional analysis was prepared to determine the functions to be conducted during the excavation phase of the remediation operations. A number of excavation technologies were identified from the literature. A set of screening criteria was developed that would examine the utility and ranking of the technologies with respect to the operations that needed to be conducted at the Winfield site. These criteria were performance, reliability, implementability, environmental safety, public health, and legal and regulatory compliance. The Loose Bulk excavation technology was ranked as the best technology applicable to the Winfield site. The literature was also examined to determine the success of various methods of controlling fugitive dust. Depending upon any changes in the results of chemical analyses, or prior remediation of the VOCs from the vadose zone, consideration should be given to testing a new ``Pneumatic Excavator`` which removes the VOCs liberated during the excavation process as they outgas from the soil. This equipment however would not be needed on locations with low levels of VOC emissions.

  11. Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Megan R Stafford

    Full Text Available Studies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults.Systematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results.Twenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26, and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60 and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31. There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98.For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

  12. Assessment of technologies for hazardous waste site remediation: Non-treatment technologies and pilot scale facility implementation -- excavation -- storage technology -- safety analysis and review statement

    International Nuclear Information System (INIS)

    Johnson, H.R.; Overbey, W.K. Jr.; Koperna, G.J. Jr.

    1994-02-01

    The purpose of this study is to assess the state-of-the-art of excavation technology as related to environmental remediation applications. A further purpose is to determine which of the excavation technologies reviewed could be used by the US Corp of Engineers in remediating contaminated soil to be excavated in the near future for construction of a new Lock and Dam at Winfield, WV. The study is designed to identify excavation methodologies and equipment which can be used at any environmental remediation site but more specifically at the Winfield site on the Kanawha River in Putnam County, West Virginia. A technical approach was determined whereby a functional analysis was prepared to determine the functions to be conducted during the excavation phase of the remediation operations. A number of excavation technologies were identified from the literature. A set of screening criteria was developed that would examine the utility and ranking of the technologies with respect to the operations that needed to be conducted at the Winfield site. These criteria were performance, reliability, implementability, environmental safety, public health, and legal and regulatory compliance. The Loose Bulk excavation technology was ranked as the best technology applicable to the Winfield site. The literature was also examined to determine the success of various methods of controlling fugitive dust. Depending upon any changes in the results of chemical analyses, or prior remediation of the VOCs from the vadose zone, consideration should be given to testing a new ''Pneumatic Excavator'' which removes the VOCs liberated during the excavation process as they outgas from the soil. This equipment however would not be needed on locations with low levels of VOC emissions

  13. Retrograde Wiring of Collateral Channels of the Heart in Chronic Total Occlusions: A Systematic Review and Meta-Analysis of Safety, Feasibility, and Incremental Value in Achieving Revascularization.

    Science.gov (United States)

    Khand, Aleem; Patel, Bilal; Palmer, Nicholas; Jones, Julia; Andron, Mohammed; Perry, Raph; Mehrotra, Sanjay; Mitsudo, Kazuaki

    2015-11-01

    To conduct a systematic review and meta-analysis on retrograde wiring in chronic total occlusions (CTOs) with focus on its safety and feasibility. We searched publications from 1990 to December 2013 in PubMed, Ovid, EMBASE, and the Cochrane database inserting a number of terms relating to the collateral circulation of the heart in CTOs. A total of 18 case series (n range17-462) with a total of 2280 CTO revascularization attempts fulfilled criteria for a study of retrograde wiring of collateral channels in CTOs. There were no randomized studies comparing a primary antegrade with a primary retrograde approach. Procedural CTO revascularization rates ranged from 67% to 90.6% with a large proportion having previously failed an "antegrade" approach. The septal perforator collaterals and epicardial channels were used in 73.2% (n = 1670) and 21.7% (n = 495) of cases. Although collateral/coronary perforation was not infrequent (n = 90, 5%), serious acute complications were uncommon; in the combined population 18 cases of cardiac tamponade (0.8%) and 3 deaths (0.1%). Septal perforating wiring (79.3%) was significantly more likely to be successful compared to epicardial coronary artery wiring (72.5%) when chosen by the operator as a route of retrograde access to the CTO body (relative risk 1.11 [95% confidence interval: 1.02-1.20; P = .013]). Successful retrograde wiring of collateral channels in selected patients undertaken by "CTO dedicated" operators can significantly enhance the chances of revascularization of complex CTOs with a low risk of acute serious complications. Septal perforator channels are significantly more likely to be successfully retrogradely wired compared to epicardial vessels when either is selected, by reference to their anatomical suitability by the operator, as a route of access. © The Author(s) 2015.

  14. Development of Safety Review Guidance for Research and Training Reactors

    International Nuclear Information System (INIS)

    Oh, Kju-Myeng; Shin, Dae-Soo; Ahn, Sang-Kyu; Lee, Hoon-Joo

    2007-01-01

    The KINS already issued the safety review guidance for pressurized LWRs. But the safety review guidance for research and training reactors were not developed. So, the technical standard including safety review guidance for domestic research and training reactors has been applied mutates mutandis to those of nuclear power plants. It is often difficult for the staff to effectively perform the safety review of applications for the permit by the licensee, based on peculiar safety review guidance. The NRC and NSC provide the safety review guidance for test and research reactors and European countries refer to IAEA safety requirements and guides. The safety review guide (SRG) of research and training reactors was developed considering descriptions of the NUREG- 1537 Part 2, previous experiences of safety review and domestic regulations for related facilities. This study provided the safety review guidance for research and training reactors and surveyed the difference of major acceptance criteria or characteristics between the SRG of pressurized light water reactor and research and training reactors

  15. Fuel safety criteria and review by OECD / CSNI task force

    International Nuclear Information System (INIS)

    Van Doesburg, W.

    1999-01-01

    Full text of publication follows: with the advent of advanced fuel and core designs, and the implementation of more accurate (best estimate or statistical) design and analysis methods, there is a general feeling that safety margins have been or are being reduced. Historically, fuel safety margins were defined by adding conservatism to the safety limits, which in turn were also fixed in a conservative manner, here, the expression 'conservatism' expresses the fact that bounding or limiting numbers were chosen for model parameters, plant and fuel design data, and fuel operating history values. Unfortunately, as these conservatisms were not quantified (or quantifiable), the amount of safety available or the reduction thereof is difficult to substantiate. For the regulator, it is important to know the margin available with the utilities' request for approval of new fuel or methods; likewise, for the utility and vendor it is important to know what margins exist and what they are based on, to identify in which direction they can make further progress and optimize fuel and fuel cycle cost. Naturally, each party involved will have to decide on how much margin should be in place, to establish operational criteria and ensure that these can actually be met during operation. To assess the margins issue, safety criteria themselves need to be reviewed first. Most - if not all - of the currently existing safety criteria were established during the 60's and early 70's, and verified against experiments with fuel available at that time - mostly at zero exposure. Of course, verification was performed as designs progressed in later years, primarily with the aim to be able to prove that safety criteria were adequate as long as the said conservatisms would be retained, and not with the aim to reestablish limits. The mandate to the OECD/CSNI/PWG2 Task Force on Fuel Safety Criteria (TFFSC) is to assess the adequacy of existing fuel safety criteria, in view of the 'new design' elements (new

  16. Automation for System Safety Analysis

    Science.gov (United States)

    Malin, Jane T.; Fleming, Land; Throop, David; Thronesbery, Carroll; Flores, Joshua; Bennett, Ted; Wennberg, Paul

    2009-01-01

    This presentation describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

  17. The safety of endothelin receptor antagonists in the treatment of pulmonary arterial hypertension: Protocol for a systemic review and network meta-analysis.

    Science.gov (United States)

    Gu, Zhi-Chun; Zhang, Yi-Jing; Pan, Mang-Mang; Zhang, Chi; Liu, Xiao-Yan; Wei, An-Hua; Su, Ying-Jie

    2018-03-01

    Pulmonary arterial hypertension (PAH) is a progressive disease and ultimately leads to right heart failure. Endothelin receptor antagonists (ERAs) have been demonstrated to significantly improve prognosis in PAH. However, ERAs-induced side effects can result in poor patient tolerance. Thus, we aim to evaluate current safety evidence of ERAs in PAH. An electronic search will be performed for randomized controlled trials (RCTs) that reported the interested safety data (abnormal liver function, peripheral edema, and anemia) of ERAs in PAH. Risk ratios (RRs) with their confidence intervals (CIs) and the surface under the cumulative ranking curve (SUCRA) will be calculated using a network analysis. This study will provide the safety evidence of ERAs in PAH by combining the results of individual studies based on direct- and network comparison, and to rank ERAs in the evidence network. The results will supplement missing evidence of head-to-head comparisons between different ERAs and guide both clinical decision-making and future research.

  18. Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

    Science.gov (United States)

    2017-01-01

    A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes

  19. Safety evaluation status report for the prototype license application safety analysis report

    International Nuclear Information System (INIS)

    1989-07-01

    The US Nuclear Regulatory Commission (NRC) staff and consultants reviewed a Prototype License Application Safety Analysis Report (PLASAR) submitted by the US Department of Energy (DOE) for the earth-mounded concrete bunker (EMCB) alternative method of low-level radioactive waste disposal. The NRC reviewers relied extensively on the Standard Review Plan (SRP), Rev.1 (NUREG-1200), to evaluate the acceptability of the information provided in the EMCB PLASAR. The NRC staff selected certain review areas in the PLASAR for development of safety evaluation report input to provide examples of safety assessments that are necessary as part of a licensing review. Because of the fictitious nature of the assumed disposal site, and the decision to limit the review to essentially first-round review status, the NRC staff report is labeled a ''Safety Evaluation Status Report'' (SESR). Appendix A comprises the NRC review comments and questions on the information that DOE submitted in the PLASAR. The NRC concentrated its review on the design and operations-related portions of the EMCB PLASAR

  20. Comparative safety of antiepileptic drugs for neurological development in children exposed during pregnancy and breast feeding: a systematic review and network meta-analysis

    Science.gov (United States)

    Veroniki, Areti Angeliki; Rios, Patricia; Cogo, Elise; Straus, Sharon E; Finkelstein, Yaron; Kealey, Ryan; Reynen, Emily; Soobiah, Charlene; Thavorn, Kednapa; Hutton, Brian; Hemmelgarn, Brenda R; Yazdi, Fatemeh; D'Souza, Jennifer; MacDonald, Heather; Tricco, Andrea C

    2017-01-01

    Objectives Compare the safety of antiepileptic drugs (AEDs) on neurodevelopment of infants/children exposed in utero or during breast feeding. Design and setting Systematic review and Bayesian random-effects network meta-analysis (NMA). MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched until 27 April 2017. Screening, data abstraction and quality appraisal were completed in duplicate by independent reviewers. Participants 29 cohort studies including 5100 infants/children. Interventions Monotherapy and polytherapy AEDs including first-generation (carbamazepine, clobazam, clonazepam, ethosuximide, phenobarbital, phenytoin, primidone, valproate) and newer-generation (gabapentin, lamotrigine, levetiracetam, oxcarbazepine, topiramate, vigabatrin) AEDs. Epileptic women who did not receive AEDs during pregnancy or breast feeding served as the control group. Primary and secondary outcome measures Cognitive developmental delay and autism/dyspraxia were primary outcomes. Attention-deficit hyperactivity disorder, language delay, neonatal seizures, psychomotor developmental delay and social impairment were secondary outcomes. Results The NMA on cognitive developmental delay (11 cohort studies, 933 children, 18 treatments) suggested that among all AEDs only valproate was statistically significantly associated with more children experiencing cognitive developmental delay compared with control (OR=7.40, 95% credible interval (CrI) 3.00 to 18.46). The NMA on autism (5 cohort studies, 2551 children, 12 treatments) suggested that oxcarbazepine (OR 13.51, CrI 1.28 to 221.40), valproate (OR 17.29, 95% CrI 2.40 to 217.60), lamotrigine (OR 8.88, CrI 1.28 to 112.00) and lamotrigine+valproate (OR 132.70, CrI 7.41 to 3851.00) were associated with significantly greater odds of developing autism compared with control. The NMA on psychomotor developmental delay (11 cohort studies, 1145 children, 18 treatments) found that valproate (OR 4.16, CrI 2.04 to 8

  1. Rituximab Effectiveness and Safety for Treating Primary Sjögren's Syndrome (pSS: Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Francine Bertolais do Valle Souza

    Full Text Available Primary Sjögren's Syndrome (pSS is a systemic autoimmune disease that involves the exocrine glands and internal organs. pSS leads to destruction and loss of secretory function due to intense lymphoplasmacytic infiltration. Therapeutic options include mainly symptomatic and supportive measures, and traditional immunosuppressant drugs have shown no effectiveness in randomized trials. Rituximab (RTX is a chimeric antibody anti-CD20 that leads to B cell depletion by diverse mechanisms. There is evidence that this drug may be effective for treating pSS. The objective of this systematic review was to evaluate Rituximab effectiveness and safety for treating pSS.We conducted a systematic review of RCTs published until December 2015, with no language restriction. We registered a protocol on Plataforma Brasil (40654814.6.0000.5505 and developed search strategies for the following scientific databases: MEDLINE, EMBASE, CENTRAL and LILACS. We included adults with established pSS diagnosis and considered the use of Rituximab as intervention and the use of other drugs or placebo as control. Four studies met our eligibility criteria: three with low risk of bias and one with uncertain risk of bias. The total number of participants was 276 (145 RTX, 131 placebo. We assessed the risk of bias of each included study and evaluated the following as primary outcomes: lacrimal gland function, salivary gland function, fatigue improvement and adverse events. We found no significant differences between the groups in the Schirmer test at week 24 meta-analysis (MD 3.59, 95% CI -2.89 to 10.07. Only one study evaluated the lissamine green test and reported a statistically significant difference between the groups at week 24 (MD -2.00, 95% CI -3.52 to -0.48. There was a significant difference between the groups regarding salivary flow rate (MD 0.09, 95% CI 0.02 to 0.16 and improvement in fatigue VAS at weeks 6 (RR 3.98, 95% CI 1.61 to 9.82 and week 16 (RR 3.08, 95% CI 1.21 to

  2. Safety reviews of the Brazilian multipurpose reactor

    International Nuclear Information System (INIS)

    Soares, Humberto Vitor

    2014-01-01

    This work presents a model developed for thermal hydraulic (TH) simulation of the Multipurpose Brazilian Reactor (RMB), whose Brazilian proposal for design, construction and operation was established in 2007. This reactor has as main proposed the production of radioisotopes for use in exams of nuclear medicine, material tests and utilization of neutrons beams. Besides of the TH modeling and safety analysis of the reactor, the application of a methodology to perform coupled calculation thermal-hydraulic/neutron kinetic (TH/NK) is also presented. Initially, the RMB was modeled in the safety analysis RELAP5 code. This code performs the thermal hydraulic calculation using point kinetics. Subsequently, the model was adapted and verified to the RELAP5-3D© code. This code performs the process of internal coupling through the option of nodal neutron kinetics calculation using the NESTLE code which solves the neutron diffusion equation. To generate the neutronic group constants, which are macroscopic cross sections that serve as input data for the neutronic codes, it was used the WIMSD-5B cell calculation code. The neutron analysis code PARCS was also used to model the 3D RMB core in order to compare the results of radial and axial average power distribution with the results generated by RELAP5-3D© code and with the available results of the CITATION neutron kinetic code. The safety analyses demonstrated safe behavior of the reactor through situations of possible transients. The 3D coupled calculations to the steady state operation also showed expected behavior, as well as the RMB neutronic analyzes performed with the codes NESTLE and PARCS.(author)

  3. 14 CFR 33.75 - Safety analysis.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Safety analysis. 33.75 Section 33.75... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... consequences of all failures that can reasonably be expected to occur. This analysis will take into account, if...

  4. 14 CFR 35.15 - Safety analysis.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Safety analysis. 35.15 Section 35.15... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the.... This analysis will take into account, if applicable: (i) The propeller system in a typical installation...

  5. Efficacy and Safety of rh-Endostatin Combined with Chemotherapy 
versus Chemotherapy Alone for Advanced NSCLC: A Meta-analysis Review

    Directory of Open Access Journals (Sweden)

    Jinzhong ZHANG

    2011-05-01

    Full Text Available Background and objective In recent years, there has been a large number of studies and reports about the efficacy and safety of recombinant human endostatin (rh-endostatin, an anti-angiogenic drug, in treatment of advanced lung cancer. Authentic assessment of rh-endostatin treatment in lung cancer is important. The aim of this study is to assess the clinical efficacy and safety of rh-endostatin combined with chemotherapy in the treatment of patients with non-small cell lung cancer (NSCLC. Methods Cochrane systematic review methods were used in the data selection, and data were selected from the Cochrane Library, EMBASE, Medline, SCI, CBM, CNKI, and etc electronic database to get all clinical controlled trials. The retrieval time was March 2010. The objects of these randomized controlled trials were advanced NSCLC patients and in the experimental group was rh-endostatin combination chemotherapy, in the control group was chemotherapy alone to compare the efficacy of two groups. The quality of included trials were evaluated by two reviewers independently. The software RevMan 5.0 was used for meta-analyses. Results Fifteen trials with 1,326 patients were included according to the including criterion. All trials were randomized controlled trials, and two trials were adequate in reporting randomization. Thirteen trials didn’t mention the blinding methods. Meta analysis indicated that the NPE arm (Vinorelbine+cisplatin+rh-endostatin had a different response rate compared with NP (Vinorelbine+cisplatin arm (OR=2.16, 95%CI: 1.57-2.99. The incidences of severe leukopenia (OR=0.94, 95%CI: 0.66-1.32 and severe thrombocytopenia (OR=1.00, 95%CI: 0.64-1.57 and nausea and vomiting (OR=0.85, 95%CI: 0.61-1.20 were similar in the NPE arm compared with those in the NP arm. The NPE plus radiotherapy (RT arm had a similar response rate compared with NP plus RT arm (OR=2.39, 95%CI: 0.99-5.79. The incidences of leukopenia (OR=0.83, 95%CI: 0.35-1.94 and

  6. Probabilistic safety analysis and human reliability analysis. Proceedings. Working material

    International Nuclear Information System (INIS)

    1996-01-01

    An international meeting on Probabilistic Safety Assessment (PSA) and Human Reliability Analysis (HRA) was jointly organized by Electricite de France - Research and Development (EDF DER) and SRI International in co-ordination with the International Atomic Energy Agency. The meeting was held in Paris 21-23 November 1994. A group of international and French specialists in PSA and HRA participated at the meeting and discussed the state of the art and current trends in the following six topics: PSA Methodology; PSA Applications; From PSA to Dependability; Incident Analysis; Safety Indicators; Human Reliability. For each topic a background paper was prepared by EDF/DER and reviewed by the international group of specialists who attended the meeting. The results of this meeting provide a comprehensive overview of the most important questions related to the readiness of PSA for specific uses and areas where further research and development is required. Refs, figs, tabs

  7. Probabilistic safety analysis and human reliability analysis. Proceedings. Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    An international meeting on Probabilistic Safety Assessment (PSA) and Human Reliability Analysis (HRA) was jointly organized by Electricite de France - Research and Development (EDF DER) and SRI International in co-ordination with the International Atomic Energy Agency. The meeting was held in Paris 21-23 November 1994. A group of international and French specialists in PSA and HRA participated at the meeting and discussed the state of the art and current trends in the following six topics: PSA Methodology; PSA Applications; From PSA to Dependability; Incident Analysis; Safety Indicators; Human Reliability. For each topic a background paper was prepared by EDF/DER and reviewed by the international group of specialists who attended the meeting. The results of this meeting provide a comprehensive overview of the most important questions related to the readiness of PSA for specific uses and areas where further research and development is required. Refs, figs, tabs.

  8. Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders

    National Research Council Canada - National Science Library

    Stratton, Kathleen; Gable, Alicia; McCormick, Marie C

    2001-01-01

    In this report, the Immunization Safety Review committee examines the hypothesis of whether or not the use of vaccines containing the preservative thimerosal can cause neurodevelopmental disorders (NDDs...

  9. Comparative efficacy and safety of first-line antiretroviral therapy for the treatment of HIV infection: a systematic review and network meta-analysis.

    Science.gov (United States)

    Kanters, Steve; Vitoria, Marco; Doherty, Meg; Socias, Maria Eugenia; Ford, Nathan; Forrest, Jamie I; Popoff, Evan; Bansback, Nick; Nsanzimana, Sabin; Thorlund, Kristian; Mills, Edward J

    2016-11-01

    New antiretroviral therapy (ART) regimens for HIV could improve clinical outcomes for patients. To inform global guidelines, we aimed to assess the comparative effectiveness of recommended ART regimens for HIV in ART-naive patients. For this systematic review and network meta-analysis, we searched for randomised clinical trials published up to July 5, 2015, comparing recommended antiretroviral regimens in treatment-naive adults and adolescents (aged 12 years or older) with HIV. We extracted data on trial and patient characteristics, and the following primary outcomes: viral suppression, mortality, AIDS defining illnesses, discontinuations, discontinuations due to adverse events, and serious adverse events. We synthesised data using network meta-analyses in a Bayesian framework and included older treatments, such as indinavir, to serve as connecting nodes. We defined network nodes in terms of specific antivirals rather than specific ART regimens. We categorised backbone regimens and adjusted for them through group-specific meta-regression. We used the GRADE framework to interpret the strength of inference. We identified 5865 citations through database searches and other sources, of which, 126 articles related to 71 unique trials were included in the network analysis, including 34 032 patients randomly assigned to 161 treatment groups. For viral suppression at 48 weeks, compared with efavirenz, the odds ratio (OR) for viral suppression was 1·87 (95% credible interval [CrI] 1·34-2·64) with dolutegravir and 1·40 (1·02-1·96) with raltegravir; with respect to viral suppression, low-dose efavirenz was similar to all other treatments. Both low-dose efavirenz and integrase strand transfer inhibitors tended to be protective of discontinuations due to adverse events relative to normal-dose efavirenz. The most protective effect relative to efavirenz in network meta-analyses was that of dolutegravir (OR 0·26, 95% CrI 0·14-0·47), followed by low-dose efavirenz (0·39

  10. AST-500 safety analysis experience

    Energy Technology Data Exchange (ETDEWEB)

    Falikov, A A; Bakhmetiev, A M; Kuul, V S; Samoilov, O B [OKBM, Nizhny Novgorod (Russian Federation)

    1997-09-01

    Characteristic AST-type NHR safety features and requirements are described briefly. The main approaches and results of design and beyond-design accidents analyses for the AST-500 NHR, and the results of probabilistic safety assessments are considered. It is concluded that the AST-500 possesses a high safety level in virtue of the development and realization in the design of self-protection, passivity and defence-in-depth principles. (author). 9 refs, 2 figs.

  11. The efficiency and safety of local liposomal bupivacaine infiltration for pain control in total hip arthroplasty: A systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Xin; Yang, Qing; Zhang, Zhi

    2017-12-01

    This meta-analysis aimed to compare the efficiency and safety of local liposomal bupivacaine infiltration and traditional cocktail analgesia for pain management in total hip arthroplasty (THA). PubMed, Embase, Web of science, Medline, and Cochrane library databases were systematically searched. Participants: patients planned for a THA with a diagnosis of hip osteoarthritis. liposomal bupivacaine was administrated in the experimental groups for pain control. Comparisons: the control groups received local infiltration of traditional analgesics. pain scores, opioids consumption, and postoperative complications among the patients. randomized control trials (RCTs) and non-RCTs. Methodological Index for Non-Randomized Studies scale was used to assess the methodological quality of the included studies. Meta-analysis was conducted by Stata 11.0 software. Systematic review registration number is CRD42017120981. Four articles involving 308 participants were included. Current meta-analysis revealed that there were significant differences regarding postoperative pain score at 12 hours (standard mean difference [SMD] = -0.496, 95% CI: -0.717 to -0.275, P = .000), 24 hours (SMD = -0.537, 95% CI: -0.760 to -0.313, P = .000), and 48 hours (SMD = -0.802, 95% CI: -1.029 to -0.576, P = .000). Liposomal bupivacaine intervention was found to significantly decrease opioid consumption at 12 hours (SMD = -0.544, 95% CI: -0.766 to -0.323, P = .000), 24 hours (SMD = -0.357, 95% CI: -0.577 to -0.138, P = .001), and 48 hours (SMD = -0.370, 95% CI: -0.589 to -0.151, P = .001). Local liposomal bupivacaine infiltration could significantly reduce visual analogue scale (VAS) scores and opioid consumption within the first 48 hours following THA surgery. In addition, there was a decreased risk of nausea and vomiting in liposomal bupivacaine groups. The overall evidence level was low, which means that further research is likely to

  12. IAEA Operational Safety Team Reviews Cattenom Nuclear Power Plant

    International Nuclear Information System (INIS)

    2011-01-01

    , transport and storage of the source; Redundant and diversified telecommunication means are deployed in the various on-site emergency response facilities; and In the event of a severe accident, the support which can be provided to plant staff through a wide range of expertise and analytical tools is commendable. The team has made recommendations and suggestions related to areas where operational safety of Cattenom NPP could be improved. Examples include: Ensuring that all management information, directives and expectations are clearly communicated to all staff and fully implemented; Enhancing the organization of the training programme in the areas of assessment, objectives and competencies; Improving the control of the plant surveillance test programme regarding scheduling and acceptance criteria; and Improving the effectiveness of the plant's Root Cause Analysis process. Cattenom management expressed a determination to address all the areas identified for improvement and requested the IAEA to schedule a follow-up mission in approximately 18 months' time. The team handed over a draft of their recommendations, suggestions and good practices to the plant management in the form of ''Technical Notes'' for factual comments. The technical notes will be reviewed at IAEA headquarters including any comments from Cattenom NPP and the French Safety Authority (ASN). The final report will be submitted to the Government of France within three months. This was the 166th mission of the OSART programme, which began in 1982, and the 23rd such mission in France. General information about OSART missions can be found on the IAEA website OSART Missions. Background An OSART mission is designed as a review of programmes and activities essential to operational safety. It is not a regulatory inspection, nor is it a design review or a substitute for an exhaustive assessment of the plant's overall safety status. Experts participating in the IAEA's June 2010 International Conference on Operational

  13. NPP Temelin safety analysis reports and PSA status

    International Nuclear Information System (INIS)

    Mlady, O.

    1999-01-01

    To enhance the safety level of Temelin NPP, recommendations of the international reviews were implemented into the design as well as into organization of the plant construction and preparation for operation. The safety assessment of these design changes has been integrated and reflected in the Safety Analysis Reports, which follow the internationally accepted guidelines. All safety analyses within Safety Analysis Reports were repeated carefully considering technical improvements and replacements to complement preliminary safety documentation. These analyses were performed by advanced western computer codes to the depth and in the structure required by western standards. The Temelin NPP followed a systematic approach in the functional design of the Reactor Protection System and related safety analyses. Modifications of reactor protection system increase defense in depth and facilitate demonstrating that LOCA and radiological limits are met for non-LOCA events. The rigorous safety analysis methodology provides assurance that LOCA and radiological limits are met. Established and accepted safety analysis methodology and accepted criteria were applied to Temelin NPP meeting US NRC and Czech Republic requirements. IAEA guidelines and recommendations

  14. Domestic Regulation for Periodic Safety Review of Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kim, Daesik; Ahn, Seunghoon; Auh, Geunsun; Lee, Jonghyeok

    2015-01-01

    The so-called Periodic Safety Review (PSR) has been carried out such safety assessment throughout its life, on a periodic basis. In January 2001, the Atomic Energy Act and related regulations were amended to adopt the PSR institutional scheme from IAEA Nuclear Safety Guide 50-SG-O12. At that time the safety assessment was made to review the plant safety on 10 safety factors, such as aging management and emergency planning, where the safety factor indicates the important aspects of safety of an operating NPP to be addressed in the PSR. According to this legislation, the domestic utility, the KHNP has conducted the PSR for the operating NPP of 10 years coming up from operating license date, starting since May 2000. Some revisions in the PSR rule were made to include the additional safety factors last year. This paper introduces the current status of the PSR review and regulation, in particular new safety factors and updated technical regulation. Comprehensive safety assessment for Korea Nuclear Power Plants have performed a reflecting design and procedure changes and considering the latest technology every 10 years. This paper also examined the PSR system changes in Korea. As of July 2015, reviews for PSR of 18 units have been completed, with 229 nuclear safety improvement items. And implementation have been completed for 165 of them. PSR system has been confirmed that it has contributed to improvement of plant safety. In addition, this paper examined the PSR system change in Korea

  15. Computational methods for criticality safety analysis within the scale system

    International Nuclear Information System (INIS)

    Parks, C.V.; Petrie, L.M.; Landers, N.F.; Bucholz, J.A.

    1986-01-01

    The criticality safety analysis capabilities within the SCALE system are centered around the Monte Carlo codes KENO IV and KENO V.a, which are both included in SCALE as functional modules. The XSDRNPM-S module is also an important tool within SCALE for obtaining multiplication factors for one-dimensional system models. This paper reviews the features and modeling capabilities of these codes along with their implementation within the Criticality Safety Analysis Sequences (CSAS) of SCALE. The CSAS modules provide automated cross-section processing and user-friendly input that allow criticality safety analyses to be done in an efficient and accurate manner. 14 refs., 2 figs., 3 tabs

  16. Preliminary safety analysis of the Gorleben site

    International Nuclear Information System (INIS)

    Bracke, G.; Fischer-Appelt, K.

    2014-01-01

    The safety requirements governing the final disposal of heat-generating radioactive waste in Germany were implemented by the Federal Ministry of Environment, Natural Conservation and Nuclear Safety (BMU) in 2010. The Ministry considers as a fundamental objective the protection of man and the environment against the hazards of radioactive waste. Unreasonable burdens and obligation for future generations shall be avoided. The main safety principles are concentration and inclusion of radioactive and other pollutants in a containment-providing rock zone. Any release of radioactive nuclides may increase the risk for men and the environment only negligibly compared to natural radiation exposure. No intervention or maintenance work shall be necessary in the post-closure phase. Retrieval/recovery of the waste shall be possible up to 500 years after closure. The Gorleben salt dome has been discussed since the 1970's as a possible repository site for heat-generating radioactive waste in Germany. The objective of the project preliminary safety analysis of the Gorleben site (VSG) was to assess if repository concepts at the Gorleben site or other sites with a comparable geology could comply with these requirements based on currently available knowledge (Fischer-Appelt, 2013; Bracke, 2013). In addition to this it was assessed if methodological approaches can be used for a future site selection procedure and which technological and conceptual considerations can be transferred to other geological situations. The objective included the compilation and review of the available exploration data of the Gorleben site and on disposal in salt rock, the development of repository designs, and the identification of the needs for future R and D work and further site investigations. (authors)

  17. Preliminary Integrated Safety Analysis Status Report

    International Nuclear Information System (INIS)

    Gwyn, D.

    2001-01-01

    This report provides the status of the potential Monitored Geologic Repository (MGR) Integrated Safety Analysis (EA) by identifying the initial work scope scheduled for completion during the ISA development period, the schedules associated with the tasks identified, safety analysis issues encountered, and a summary of accomplishments during the reporting period. This status covers the period from October 1, 2000 through March 30, 2001

  18. 78 FR 11902 - Review of Gun Safety Technologies

    Science.gov (United States)

    2013-02-20

    ... DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (NIJ) Docket No. 1615] Review of Gun Safety...'s Plan to reduce gun violence released on January 16, 2013, the U.S. Department of Justice, Office... emerging gun safety technologies and plans to issue a report on the availability and use of those...

  19. Efficacy and safety of bevacizumab plus chemotherapy compared to chemotherapy alone in previously untreated advanced or metastatic colorectal cancer: a systematic review and meta-analysis

    International Nuclear Information System (INIS)

    Botrel, Tobias Engel Ayer; Clark, Luciana Gontijo de Oliveira; Paladini, Luciano; Clark, Otávio Augusto C.

    2016-01-01

    Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of neoplasm-related death in the United States. Several studies analyzed the efficacy of bevacizumab combined with different chemotherapy regimens consisting on drugs such as 5-FU, capecitabine, irinotecan and oxaliplatin. This systematic review aims to evaluate the effectiveness and safety of chemotherapy plus bevacizumab versus chemotherapy alone in patients with previously untreated advanced or metastatic colorectal cancer (mCRC). Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoints were overall survival and progression-free survival. Data extracted from the studies were combined by using hazard ratio (HR) or risk ratio (RR) with their corresponding 95 % confidence intervals (95 % CI). The final analysis included 9 trials comprising 3,914 patients. Patients who received the combined treatment (chemotherapy + bevacizumab) had higher response rates (RR = 0.89; 95 % CI: 0.82 to 0.96; p = 0.003) with heterogeneity, higher progression-free survival (HR = 0.69; 95 % CI: 0.63 to 0.75; p < 0.00001) and also higher overall survival rates (HR = 0.87; 95 % CI: 0.80 to 0.95; p = 0.002) with moderate heterogeneity. Regarding adverse events and severe toxicities (grade ≥ 3), the group receiving the combined therapy had higher rates of hypertension (RR = 3.56 95 % CI: 2.58 to 4.92; p < 0.00001), proteinuria (RR = 1.89; 95 % CI: 1.26 to 2.84; p = 0.002), gastrointestinal perforation (RR = 3.63; 95 % CI: 1.31 to 10.09; p = 0.01), any thromboembolic events (RR = 1.44; 95 % CI: 1.20 to 1.73; p = 0.0001), and bleeding (RR = 1.81; 95 % CI: 1.22 to 2.67; p = 0.003). The combination of chemotherapy with bevacizumab increased the response rate, progression-free survival and overall survival of patients with mCRC without prior chemotherapy. The results of progression-free survival (PFS) and overall survival (OS) were comparatively higher

  20. NRU licence extension via integrated safety review

    Energy Technology Data Exchange (ETDEWEB)

    Mantifel, N. [Atomic Energy of Canada Limited, Chalk River, ON (Canada)

    2014-07-01

    The National Research Reactor, NRU at AECL Chalk River Laboratories achieved first criticality in November 1957. The completion of an Integrated Safety Review (ISR) in 2011, and subsequent Global Assessment Report (GAR), and Integrated Implementation Plan (IIP) has given confidence in the safe and reliable operation of NRU, therefore extending the licensing case to safely and reliably operate NRU until 2021 and beyond (64+ years of operation). The key vehicle to achieve this confidence is the IIP, that resulted from the ISR. NRU's IIP is a 10 year plan that addresses the gaps identified in the ISR between modern codes and standards in a prioritized approach. AECL is currently in year 3 of the IIP execution, is on or ahead of schedule to complete the identified improvements. The IIP in conjunction with a License Condition Handbook has replaced the licensing protocol with the Canadian Nuclear Safety Commission, (CNSC). Execution of the IIP to plan supports the continued safe operation of NRU. The ISR was carried out with the recognition that the NRU reactor is a research and isotope producing reactor approaching license renewal and not a power reactor undergoing refurbishment and life extension. Therefore, the IIP is being executed while NRU continues to deliver on its three missions: production of medical isotopes, support for fuels and materials research, and serving as a high flux neutron source in support of research relying on neutron scattering. The IIP is grouped into 5 Global Issue Groups, (GIGs) to support focused execution. The activities and tasks within the five GIGs are being executed via a matrix organization through the use of the Chalk River Laboratories Corrective Action Program to ensure the assignment of actions, completion and evidence to support closure is documented and retained. This paper discusses the approach taken by AECL to license and ensure safe, reliable operation of NRU until 2021 and beyond. (author)

  1. Hot Cell Facility (HCF) Safety Analysis Report

    Energy Technology Data Exchange (ETDEWEB)

    MITCHELL,GERRY W.; LONGLEY,SUSAN W.; PHILBIN,JEFFREY S.; MAHN,JEFFREY A.; BERRY,DONALD T.; SCHWERS,NORMAN F.; VANDERBEEK,THOMAS E.; NAEGELI,ROBERT E.

    2000-11-01

    This Safety Analysis Report (SAR) is prepared in compliance with the requirements of DOE Order 5480.23, Nuclear Safety Analysis Reports, and has been written to the format and content guide of DOE-STD-3009-94 Preparation Guide for U. S. Department of Energy Nonreactor Nuclear Safety Analysis Reports. The Hot Cell Facility is a Hazard Category 2 nonreactor nuclear facility, and is operated by Sandia National Laboratories for the Department of Energy. This SAR provides a description of the HCF and its operations, an assessment of the hazards and potential accidents which may occur in the facility. The potential consequences and likelihood of these accidents are analyzed and described. Using the process and criteria described in DOE-STD-3009-94, safety-related structures, systems and components are identified, and the important safety functions of each SSC are described. Additionally, information which describes the safety management programs at SNL are described in ancillary chapters of the SAR.

  2. Hot Cell Facility (HCF) Safety Analysis Report

    International Nuclear Information System (INIS)

    MITCHELL, GERRY W.; LONGLEY, SUSAN W.; PHILBIN, JEFFREY S.; MAHN, JEFFREY A.; BERRY, DONALD T.; SCHWERS, NORMAN F.; VANDERBEEK, THOMAS E.; NAEGELI, ROBERT E.

    2000-01-01

    This Safety Analysis Report (SAR) is prepared in compliance with the requirements of DOE Order 5480.23, Nuclear Safety Analysis Reports, and has been written to the format and content guide of DOE-STD-3009-94 Preparation Guide for U. S. Department of Energy Nonreactor Nuclear Safety Analysis Reports. The Hot Cell Facility is a Hazard Category 2 nonreactor nuclear facility, and is operated by Sandia National Laboratories for the Department of Energy. This SAR provides a description of the HCF and its operations, an assessment of the hazards and potential accidents which may occur in the facility. The potential consequences and likelihood of these accidents are analyzed and described. Using the process and criteria described in DOE-STD-3009-94, safety-related structures, systems and components are identified, and the important safety functions of each SSC are described. Additionally, information which describes the safety management programs at SNL are described in ancillary chapters of the SAR

  3. Approach to uncertainty evaluation for safety analysis

    International Nuclear Information System (INIS)

    Ogura, Katsunori

    2005-01-01

    Nuclear power plant safety used to be verified and confirmed through accident simulations using computer codes generally because it is very difficult to perform integrated experiments or tests for the verification and validation of the plant safety due to radioactive consequence, cost, and scaling to the actual plant. Traditionally the plant safety had been secured owing to the sufficient safety margin through the conservative assumptions and models to be applied to those simulations. Meanwhile the best-estimate analysis based on the realistic assumptions and models in support of the accumulated insights could be performed recently, inducing the reduction of safety margin in the analysis results and the increase of necessity to evaluate the reliability or uncertainty of the analysis results. This paper introduces an approach to evaluate the uncertainty of accident simulation and its results. (Note: This research had been done not in the Japan Nuclear Energy Safety Organization but in the Tokyo Institute of Technology.) (author)

  4. Review of Public Safety in Viewpoint of Complex Networks

    International Nuclear Information System (INIS)

    Gai Chengcheng; Weng Wenguo; Yuan Hongyong

    2010-01-01

    In this paper, a brief review of public safety in viewpoint of complex networks is presented. Public safety incidents are divided into four categories: natural disasters, industry accidents, public health and social security, in which the complex network approaches and theories are need. We review how the complex network methods was developed and used in the studies of the three kinds of public safety incidents. The typical public safety incidents studied by the complex network methods in this paper are introduced, including the natural disaster chains, blackouts on electric power grids and epidemic spreading. Finally, we look ahead to the application prospects of the complex network theory on public safety.

  5. Safety analysis methodologies for radioactive waste repositories in shallow ground

    International Nuclear Information System (INIS)

    1984-01-01

    The report is part of the IAEA Safety Series and is addressed to authorities and specialists responsible for or involved in planning, performing and/or reviewing safety assessments of shallow ground radioactive waste repositories. It discusses approaches that are applicable for safety analysis of a shallow ground repository. The methodologies, analysis techniques and models described are pertinent to the task of predicting the long-term performance of a shallow ground disposal system. They may be used during the processes of selection, confirmation and licensing of new sites and disposal systems or to evaluate the long-term consequences in the post-sealing phase of existing operating or inactive sites. The analysis may point out need for remedial action, or provide information to be used in deciding on the duration of surveillance. Safety analysis both general in nature and specific to a certain repository, site or design concept, are discussed, with emphasis on deterministic and probabilistic studies

  6. Risk analysis and safety rationale

    International Nuclear Information System (INIS)

    Bengtsson, G.

    1989-01-01

    Decision making with respect to safety is becoming more and more complex. The risk involved must be taken into account together with numerous other factors such as the benefits, the uncertainties and the public perception. Can the decision maker be aided by some kind of system, general rules of thumb, or broader perspective on similar decisions? This question has been addressed in a joint Nordic project relating to nuclear power. Modern techniques for risk assessment and management have been studied, and parallels drawn to such areas as offshore safety and management of toxic chemicals in the environment. The report summarises the finding of 5 major technical reports which have been published in the NORD-series. The topics includes developments, uncertainties and limitations in probabilistic safety assessments, negligible risks, risk-cost trade-offs, optimisation of nuclear safety and radiation protection, and the role of risks in the decision making process. (author) 84 refs

  7. Infusing Reliability Techniques into Software Safety Analysis

    Science.gov (United States)

    Shi, Ying

    2015-01-01

    Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

  8. Tolerability of risk, safety assessment principles and their implications for probabilistic safety analysis

    International Nuclear Information System (INIS)

    Ewing, D.J.F.; Campbell, J.F.

    1994-01-01

    This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)

  9. Critical review of safety performance metrics

    NARCIS (Netherlands)

    Karanikas, Nektarios

    2016-01-01

    Various tools for safety performance measurement have been introduced in order to fulfil the need for safety monitoring in organisations, which is tightly related to their overall performance and achievement of their business goals. Such tools include accident rates, benchmarking, safety culture and

  10. Uncertainty analysis in safety assessment

    International Nuclear Information System (INIS)

    Lemos, Francisco Luiz de; Sullivan, Terry

    1997-01-01

    Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author)

  11. Systems Analysis of NASA Aviation Safety Program: Final Report

    Science.gov (United States)

    Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

    2013-01-01

    A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

  12. Conducting organizational safety reviews - requirements, methods and experience

    International Nuclear Information System (INIS)

    Reiman, T.; Oedewald, P.; Wahlstroem, B.; Rollenhagen, C.; Kahlbom, U.

    2008-03-01

    Organizational safety reviews are part of the safety management process of power plants. They are typically performed after major reorganizations, significant incidents or according to specified review programs. Organizational reviews can also be a part of a benchmarking between organizations that aims to improve work practices. Thus, they are important instruments in proactive safety management and safety culture. Most methods that have been used for organizational reviews are based more on practical considerations than a sound scientific theory of how various organizational or technical issues influence safety. Review practices and methods also vary considerably. The objective of this research is to promote understanding on approaches used in organizational safety reviews as well as to initiate discussion on criteria and methods of organizational assessment. The research identified a set of issues that need to be taken into account when planning and conducting organizational safety reviews. Examples of the issues are definition of appropriate criteria for evaluation, the expertise needed in the assessment and the organizational motivation for conducting the assessment. The study indicates that organizational safety assessments involve plenty of issues and situations where choices have to be made regarding what is considered valid information and a balance has to be struck between focus on various organizational phenomena. It is very important that these choices are based on a sound theoretical framework and that these choices can later be evaluated together with the assessment findings. The research concludes that at its best, the organizational safety reviews can be utilised as a source of information concerning the changing vulnerabilities and the actual safety performance of the organization. In order to do this, certain basic organizational phenomena and assessment issues have to be acknowledged and considered. The research concludes with recommendations on

  13. Conducting organizational safety reviews - requirements, methods and experience

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, T.; Oedewald, P.; Wahlstroem, B. [Technical Research Centre of Finland, VTT (Finland); Rollenhagen, C. [Royal Institute of Technology, KTH, (Sweden); Kahlbom, U. [RiskPilot (Sweden)

    2008-03-15

    Organizational safety reviews are part of the safety management process of power plants. They are typically performed after major reorganizations, significant incidents or according to specified review programs. Organizational reviews can also be a part of a benchmarking between organizations that aims to improve work practices. Thus, they are important instruments in proactive safety management and safety culture. Most methods that have been used for organizational reviews are based more on practical considerations than a sound scientific theory of how various organizational or technical issues influence safety. Review practices and methods also vary considerably. The objective of this research is to promote understanding on approaches used in organizational safety reviews as well as to initiate discussion on criteria and methods of organizational assessment. The research identified a set of issues that need to be taken into account when planning and conducting organizational safety reviews. Examples of the issues are definition of appropriate criteria for evaluation, the expertise needed in the assessment and the organizational motivation for conducting the assessment. The study indicates that organizational safety assessments involve plenty of issues and situations where choices have to be made regarding what is considered valid information and a balance has to be struck between focus on various organizational phenomena. It is very important that these choices are based on a sound theoretical framework and that these choices can later be evaluated together with the assessment findings. The research concludes that at its best, the organizational safety reviews can be utilised as a source of information concerning the changing vulnerabilities and the actual safety performance of the organization. In order to do this, certain basic organizational phenomena and assessment issues have to be acknowledged and considered. The research concludes with recommendations on

  14. Efficiency and safety of laser photocoagulation with or without intravitreal ranibizumab for treatment of diabetic macular edema: a systematic review and Meta-analysis

    Directory of Open Access Journals (Sweden)

    Tian-Wei Qian

    2017-07-01

    Full Text Available AIM: To compare the therapeutic effect and safety of laser photocoagulation along with intravitreal ranibizumab (IVR versus laser therapy in treatment of diabetic macular edema (DME. METHODS: Pertinent publications were identified through comprehensive searches of PubMed, EMBASE, Web of Science, Cochrane Library, and ClinicalTrials.gov to identify randomized clinical trials (RCTs comparing IVR+laser to laser monotherapy in patients with DME. Therapeutic effect estimates were determined by weighted mean differences (WMD of change from baseline in best corrected visual acuity (BCVA and central retinal thickness (CRT at 6, 12, or 24mo after initial treatment, and the risk ratios (RR for the proportions of patients with at least 10 letters of improvement or reduction at 12mo. Data regarding major ocular and nonocular adverse events (AEs were collected and analyzed. The Review Manager 5.3.5 was used. RESULTS: Six RCTs involving 2069 patients with DME were selected for this Meta-analysis. The results showed that IVR+laser significantly improved BCVA compared with laser at 6mo (WMD: 6.57; 95% CI: 4.37-8.77; P<0.00001, 12mo (WMD: 5.46; 95% CI: 4.35-6.58; P<0.00001, and 24mo (WMD: 3.42; 95% CI: 0.84-5.99; P=0.009 in patients with DME. IVR+laser was superior to laser in reducing CRT at 12mo from baseline with statistical significance (WMD: -63.46; 95% CI: -101.19 to -25.73; P=0.001. The pooled RR results showed that the proportions of patients with at least 10 letters of improvement or reduction were in favor of IVR+laser arms compared with laser (RR: 2.13; 95% CI: 1.77-2.57; P<0.00001 and RR: 0.37; 95% CI: 0.22-0.62; P=0.0002, respectively. As for AEs, the pooled results showed that a significantly higher proportion of patients suffering from conjunctival hemorrhage (study eye and diabetic retinal edema (fellow eye in IVR+laser group compared to laser group (RR: 3.29; 95% CI: 1.53-7.09; P=0.002 and RR: 3.02; 95% CI: 1.24-7.32; P=0.01, respectively. The

  15. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  16. Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-analysis

    NARCIS (Netherlands)

    Jaspers, Loes; Feys, Frederik; Bramer, Wichor M.; Franco, Oscar H.; Leusink, Peter; Laan, Ellen T. M.

    2016-01-01

    In August 2015, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs. To conduct a systematic review and meta-analysis of randomized clinical trials

  17. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  18. The Efficacy and Safety of the Combination of Total Glucosides of Peony and Leflunomide for the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Zhitao Feng

    2016-01-01

    Full Text Available Objective. To evaluate the efficacy and safety of the total glucosides of peony (TGP and leflunomide (LEF for the treatment of rheumatoid arthritis (RA. Methods. Randomized controlled trials (RCTs on the efficacy and safety of the combination of TGP and LEF versus LEF alone for the treatment of RA were retrieved by searching PubMed, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, and Wanfang database. Results. Eight RCTs including 643 RA patients were included in the present meta-analysis. The quality of included studies was poor. The levels of ESR (P<0.0001, CRP (P<0.0001, and RF (P<0.0001 in RA patients who received the combination of TGP and LEF were significantly lower than RA patients who received LEF therapy alone. The pooled results suggest that the combination of TGP and LEF caused less abnormal liver function than LEF alone (P=0.02. No significant difference in the gastrointestinal discomfort was identified between the combination of TGP and LEF and LEF alone groups (P=0.18. Conclusion. The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

  19. The Efficacy and Safety of the Combination of Total Glucosides of Peony and Leflunomide for the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis.

    Science.gov (United States)

    Feng, Zhitao; Xu, Juan; He, Guochao; Cao, Meiqun; Duan, Lihong; Chen, Liguo; Wu, Zhengzhi

    2016-01-01

    Objective. To evaluate the efficacy and safety of the total glucosides of peony (TGP) and leflunomide (LEF) for the treatment of rheumatoid arthritis (RA). Methods. Randomized controlled trials (RCTs) on the efficacy and safety of the combination of TGP and LEF versus LEF alone for the treatment of RA were retrieved by searching PubMed, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, and Wanfang database. Results. Eight RCTs including 643 RA patients were included in the present meta-analysis. The quality of included studies was poor. The levels of ESR (P TGP and LEF were significantly lower than RA patients who received LEF therapy alone. The pooled results suggest that the combination of TGP and LEF caused less abnormal liver function than LEF alone (P = 0.02). No significant difference in the gastrointestinal discomfort was identified between the combination of TGP and LEF and LEF alone groups (P = 0.18). Conclusion. The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

  20. The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis

    DEFF Research Database (Denmark)

    Hristovska, A-M; Duch, P; Allingstrup, M

    2018-01-01

    We compared the efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. Our outcomes were: recovery time from second twitch to train-of-four ratio > 0.9; recovery time from post-tetanic count 1-5 to train-of-four ratio > 0.9; and risk of composite adverse.......0 min with sugammadex 2 mg.kg-1 and 12.9 min with neostigmine 0.05 mg.kg-1 , with a mean difference (MD) (95%CI)) of 10.2 (8.5-12.0) (I2 = 84%, 10 studies, n = 835, Grades of Recommendation, Assessment, Development and Evaluation (GRADE): moderate quality). Time to reversal of neuromuscular blockade...... from a post-tetanic count of 1-5 to a train-of-four ratio > 0.9 was 2.9 min with sugammadex 4 mg.kg-1 and 48.8 min with neostigmine 0.07 mg.kg-1 , with a MD (95%CI) of 45.8 (39.4-52.2) (I2 = 0%, 2 studies, n = 114, GRADE: low quality). There were significantly fewer composite adverse events...

  1. Safety and efficacy of direct oral anticoagulants compared to warfarin for extended treatment of venous thromboembolism -a systematic review and meta-analysis

    DEFF Research Database (Denmark)

    Sindet-Pedersen, Caroline; Pallisgaard, Jannik Langtved; Olesen, Jonas Bjerring

    2015-01-01

    OBJECTIVE: To examine and compare the safety and efficacy of extended treatment with dabigatran, apixaban, rivaroxaban and warfarin in patients with unprovoked venous thromboembolism. METHODS: PubMed and Embase were searched for randomized clinical trials reporting on the use of direct oral...... anticoagulants (DOACs) and warfarin for the extended treatment of VTE. Meta-analysis was performed on studies reporting similar study design and comparator. RESULTS: A total of 729 articles were identified and 5 studies covering 6 randomized clinical trials met the eligibility criteria and were included...... in the study. 5 studies were included in the meta-analysis. Results from the meta-analysis showed that the extended use of DOACs and warfarin significantly decreased the risk of recurrent VTE with 83 % when compared placebo. Warfarin (RR: 0.03, CI: 0.00-0.49) and dabigatran (RR: 0.08, CI: 0.03-0.27) showed...

  2. IRSN safety research carried out for reviewing safety cases

    International Nuclear Information System (INIS)

    Serres, Ch.

    2010-01-01

    Christophe Serres from IRSN (France) described the independent role of the IRSN regarding research related to nuclear safety in the context of the French Planning Act of 28 June 2006 foreseeing a licence application to be submitted in 2015 for the creation of a deep geological repository. IRSN research programme is organised along research activities devoted to addressing independently-identified k ey safety issues . These 'key issues' should also be of prime concern for the implementer since they relate to the demonstration of the overall safety of the repository, and the level of funding that the implementer should afford to research activities of concern for safety. He explained that the quality and independency of the research programme carried out by IRSN allow building and improving a set of scientific knowledge and technical skills that serves the public mission of delivering technical appraisal and advice, e.g., on behalf of the national safety authority. In particular they contribute to improving the decisional process by making possible scientific dialogue with stakeholders independently from regulator or implementer. The current IRSN R and D programme is developed along the following lines: - Test the adequacy of experimental methods for which feedback is not sufficient. - Develop basic scientific knowledge in the fields where there is a need for better understanding of complex phenomena and interactions. - Develop and use numerical modelling tools to support studies on complex phenomena and interactions. - Perform specific experimental tests aiming at assessing the key parameters that may warrant the performances of the different components of the repository. These studies are carried out by means of experiments performed either at IRSN surface laboratories, or in the Tournemire Experimental Station (TES), an underground facility operated by IRSN in the south-east of France. Targeted actions on research related to operational safety and reversibility

  3. Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

    Science.gov (United States)

    Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

    2017-08-30

    Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

  4. Shielding modification and safety review on the nuclear ship 'Mutsu'

    International Nuclear Information System (INIS)

    Osanai, Masao

    1978-01-01

    The Japan Atomic Energy Commission (JAEC) called on the Japan Nuclear Ship Development Agency (JNSDA) for shielding modification and safety review on the nuclear ship ''Mutsu'', and JNSDA has conducted the research and development (R and D) to meet the request of JAEC for the above two items. Concerning the shield modification, the following matters are described: the study on the cause of radiation leakage which was concluded to the fast neutron streaming, the conceptual design for this modification, the mock up experiment for shielding utilizing JRR-4, the basic design following on the conceptual design, including the detailed drawings of the modified construction and the shielding analysis using RADHEAT-V3 code, and the relating experiments such as the heat transfer test of the primary shielding structure and the test of strength in stranding. As for the safety review, the survey of the troubles and the technical problems having been experienced in the light water reactor plants of land use, for example, fuel integrity, stress corrosion cracking and the leakage of steam generator tubes, the revision of the design so as to adapt to current safety standards and regulations, for example, in-service inspection, the setting of additional leak detectors in the primary cooling system, the modification of emergeney filters, etc., and the review of the design and construction corresponding to recent R and D works, such as re-evaluation of the core design, cooling capability of natural circulation, thermal stress analysis of main pipings, and the evaluation of ECCS performance are presented . (Nakai, Y.)

  5. Ignalina NPP Safety Analysis: Models and Results

    International Nuclear Information System (INIS)

    Uspuras, E.

    1999-01-01

    Research directions, linked to safety assessment of the Ignalina NPP, of the scientific safety analysis group are presented: Thermal-hydraulic analysis of accidents and operational transients; Thermal-hydraulic assessment of Ignalina NPP Accident Localization System and other compartments; Structural analysis of plant components, piping and other parts of Main Circulation Circuit; Assessment of RBMK-1500 reactor core and other. Models and main works carried out last year are described. (author)

  6. Preliminary safety analysis report for the Waste Characterization Facility

    International Nuclear Information System (INIS)

    1994-10-01

    This safety analysis report outlines the safety concerns associated with the Waste Characterization Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are to: define and document a safety basis for the Waste Characterization Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume. 142 refs., 38 figs., 39 tabs

  7. Autoclave nuclear criticality safety analysis

    Energy Technology Data Exchange (ETDEWEB)

    D`Aquila, D.M. [Martin Marietta Energy Systems, Inc., Piketon, OH (United States); Tayloe, R.W. Jr. [Battelle, Columbus, OH (United States)

    1991-12-31

    Steam-heated autoclaves are used in gaseous diffusion uranium enrichment plants to heat large cylinders of UF{sub 6}. Nuclear criticality safety for these autoclaves is evaluated. To enhance criticality safety, systems are incorporated into the design of autoclaves to limit the amount of water present. These safety systems also increase the likelihood that any UF{sub 6} inadvertently released from a cylinder into an autoclave is not released to the environment. Up to 140 pounds of water can be held up in large autoclaves. This mass of water is sufficient to support a nuclear criticality when optimally combined with 125 pounds of UF{sub 6} enriched to 5 percent U{sup 235}. However, water in autoclaves is widely dispersed as condensed droplets and vapor, and is extremely unlikely to form a critical configuration with released UF{sub 6}.

  8. National Waste Repository Novi Han operational safety analysis report. Safety assessment methodology

    International Nuclear Information System (INIS)

    2003-01-01

    The scope of the safety assessment (SA), presented includes: waste management functions (acceptance, conditioning, storage, disposal), inventory (current and expected in the future), hazards (radiological and non-radiological) and normal and accidental modes. The stages in the development of the SA are: criteria selection, information collection, safety analysis and safety assessment documentation. After the review the facilities functions and the national and international requirements, the criteria for safety level assessment are set. As a result from the 2nd stage actual parameters of the facility, necessary for safety analysis are obtained.The methodology is selected on the base of the comparability of the results with the results of previous safety assessments and existing standards and requirements. The procedure and requirements for scenarios selection are described. A radiological hazard categorisation of the facilities is presented. Qualitative hazards and operability analysis is applied. The resulting list of events are subjected to procedure for prioritization by method of 'criticality analysis', so the estimation of the risk is given for each event. The events that fall into category of risk on the boundary of acceptability or are unacceptable are subjected to the next steps of the analysis. As a result the lists with scenarios for PSA and possible design scenarios are established. PSA logical modeling and quantitative calculations of accident sequences are presented

  9. Uncertainty analysis in safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Lemos, Francisco Luiz de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN), Belo Horizonte, MG (Brazil); Sullivan, Terry [Brookhaven National Lab., Upton, NY (United States)

    1997-12-31

    Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author) 13 refs.; e-mail: lemos at bnl.gov; sulliva1 at bnl.gov

  10. Design review report for modifications to RMCS safety class equipment

    International Nuclear Information System (INIS)

    Corbett, J.E.

    1997-01-01

    This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable

  11. Design review report for modifications to RMCS safety class equipment

    Energy Technology Data Exchange (ETDEWEB)

    Corbett, J.E.

    1997-05-30

    This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable.

  12. Safety analysis of spent fuel packaging

    International Nuclear Information System (INIS)

    Akamatsu, Hiroshi; Taniuchi, Hiroaki; Tai, Hideto

    1987-01-01

    Many types of spent fuel packagings have been manufactured and been used for transport of spent fuels discharged from nuclear power plant. These spent fuel packagings need to be assesed thoroughly about safety transportation because spent fuels loaded into the packaging have high radioactivity and generation of heat. This paper explains the outline of safety analysis of a packaging, Safety analysis is performed for structural, thermal, containment, shielding and criticality factors, and MARC-CDC, TRUMP, ORIGEN, QAD, ANISN, KENO, etc computer codes are used for such analysis. (author)

  13. US nuclear safety. Review and experience

    International Nuclear Information System (INIS)

    Hanauer, S.H.

    1977-01-01

    The paper deals with the evolution of reactor safety principles, design bases, regulatory requirements, and experience in the United States. Safety concerns have evolved over the years, from reactivity transients and shut-down systems, to blowdowns and containment, to severe design basis accidents and mitigating systems, to the performance of actual materials, systems and humans. The primary safety concerns of one epoch have been superseded in considerable measure by those of later times. Successive plateaus of technical understanding are achieved by solutions being found to earlier problems. Design studies, research, operating experience and regulatory imperatives all contribute to the increased understanding and thus to the safety improvements adopted and accepted. The improvement of safety with time, and the ability of existing reactors to operate safely in the face of new concerns, has confirmed the correctness and usefulness of the defence-in-depth approach and safety margins used in safety design in the United States of America. A regulatory programme such as the one in the United States justifies its great cost by its important contributions to safety. Yet only the designers, constructors and operators of nuclear power plants can actually achieve public safety. The regulatory programme audits, assesses and spot-checks the actual work. Since neither materials nor human beings are flawless, mistakes will be made; that is why defence-in-depth and safety margins are provided. The regulatory programme should enhance safety by decreasing the frequency of uncorrected mistakes. Maintenance of public safety also requires technical and managerial competence and attention in the organizations responsible for nuclear plants as well as regulatory organizations. (author)

  14. Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-11-15

    The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

  15. Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

    International Nuclear Information System (INIS)

    2011-01-01

    The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

  16. Safety analysis in subsurface repositories

    International Nuclear Information System (INIS)

    1985-06-01

    The development of mathematical models to represent the repository-geosphere-biosphere system, and the development of a structure for data acquisition, processing, and use to analyse the safety of subsurface repositories, are presented. To study the behavior of radionuclides in geosphere a laboratory to determine the hydrodynamic dispersion coefficient was constructed. (M.C.K.) [pt

  17. HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

    Energy Technology Data Exchange (ETDEWEB)

    EVANS, C B

    2004-12-21

    The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.

  18. Safety analysis report 231-Z Building

    Energy Technology Data Exchange (ETDEWEB)

    Powers, C.S.

    1989-03-01

    This report provides an intensive review of the nuclear safety of the operation of the 231-Z Building. For background information complete descriptions of the floor plan, building services, alarm systems, and glove box systems are included in this report. In addition, references are included to The Plutonium Laboratory Radiation Work Procedures, Safety Guides, 231-Z Operating Procedures Manual and Nuclear Materials accountability Procedures. Engineered and administrative features contribute to the overall safety of personnel, the building, and environs. The consequences of credible incidents were considered and are discussed.

  19. Safety Review Committee - Annual Report 1991-1992

    International Nuclear Information System (INIS)

    1993-01-01

    During the year under review. The Safety Review Committee (SRC) assessed the safety of ANSTO's operations. This was done by site visits, examination of documentation and briefing by ANSTO officers responsible for particular operations, and includes HIFAR and Moata reactors, radioisotope production, packing and dispatch, radioactive waste management practices, occupational health and safety activities and ANSTO's arrangements for public health and safety beyond the site. This report describes the activities and findings of the SRC during the year ending 30 June 1992. 8 figs., ills

  20. The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis.

    Science.gov (United States)

    Hristovska, A-M; Duch, P; Allingstrup, M; Afshari, A

    2018-05-01

    We compared the efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. Our outcomes were: recovery time from second twitch to train-of-four ratio > 0.9; recovery time from post-tetanic count 1-5 to train-of-four ratio > 0.9; and risk of composite adverse and serious adverse events. We searched for randomised clinical trials irrespective of publication status and date, blinding status, outcomes reported or language. We included 41 studies with 4206 participants. Time to reversal of neuromuscular blockade from second twitch to a train-of-four ratio > 0.9 was 2.0 min with sugammadex 2 mg.kg -1 and 12.9 min with neostigmine 0.05 mg.kg -1 , with a mean difference (MD) (95%CI)) of 10.2 (8.5-12.0) (I 2  = 84%, 10 studies, n = 835, Grades of Recommendation, Assessment, Development and Evaluation (GRADE): moderate quality). Time to reversal of neuromuscular blockade from a post-tetanic count of 1-5 to a train-of-four ratio > 0.9 was 2.9 min with sugammadex 4 mg.kg -1 and 48.8 min with neostigmine 0.07 mg.kg -1 , with a MD (95%CI) of 45.8 (39.4-52.2) (I 2  = 0%, 2 studies, n = 114, GRADE: low quality). There were significantly fewer composite adverse events in the sugammadex group compared with neostigmine, with a risk ratio (95%CI) of 0.60 (0.49-0.74) (I 2  = 40%, 28 studies, n = 2298, number needed to treat (NNT): 8, GRADE: moderate quality). Specifically, the risk of bradycardia (RR (95%CI) 0.16 (0.07-0.34), n = 1218, NNT: 14, GRADE: moderate quality), postoperative nausea and vomiting (RR (95%CI) 0.52 (0.28-0.97), n = 389, NNT: 16, GRADE: low quality) and overall signs of postoperative residual paralysis (RR (95%CI) 0.40 (0.28-0.57), n = 1474, NNT: 13, GRADE: moderate quality) were all reduced. There was no significant difference regarding the risk of serious adverse events (RR 0.54, 95%CI 0.13-2.25, I 2  = 0%, n = 959, GRADE: low quality). Sugammadex reverses neuromuscular blockade more rapidly

  1. The Efficacy and Clinical Safety of Various Analgesic Combinations for Post-Operative Pain after Third Molar Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Alvin Ho Yeung Au

    Full Text Available To run a systematic review and meta-analysis of randomized clinical trials aiming to answer the clinical question "which analgesic combination and dosage is potentially the most effective and safe for acute post-operative pain control after third molar surgery?".A systematic search of computer databases and journals was performed. The search and the evaluations of articles were performed by 2 independent reviewers in 3 rounds. Randomized clinical trials related to analgesic combinations for acute post-operative pain control after lower third molar surgery that matched the selection criteria were evaluated to enter in the final review.Fourteen studies with 3521 subjects, with 10 groups (17 dosages of analgesic combinations were included in the final review. The analgesic efficacy were presented by the objective pain measurements including sum of pain intensity at 6 hours (SPID6 and total pain relief at 6 hours (TOTPAR6. The SPID6 scores and TOTPAR6 scores of the reported analgesic combinations were ranged from 1.46 to 6.44 and 3.24 - 10.3, respectively. Ibuprofen 400mg with oxycodone HCL 5mg had superior efficacy (SPID6: 6.44, TOTPAR6: 9.31. Nausea was the most common adverse effect, with prevalence ranging from 0-55%. Ibuprofen 200mg with caffeine 100mg or 200mg had a reasonable analgesic effect with fewer side effects.This systematic review and meta-analysis may help clinicians in their choices of prescribing an analgesic combination for acute post-operative pain control after lower third molar surgery. It was found in this systematic review Ibuprofen 400mg combined with oxycodone HCL 5mg has superior analgesic efficacy when compared to the other analgesic combinations included in this study.

  2. Software safety analysis practice in installation phase

    Energy Technology Data Exchange (ETDEWEB)

    Huang, H. W.; Chen, M. H.; Shyu, S. S., E-mail: hwhwang@iner.gov.t [Institute of Nuclear Energy Research, No. 1000 Wenhua Road, Chiaan Village, Longtan Township, 32546 Taoyuan County, Taiwan (China)

    2010-10-15

    This work performed a software safety analysis in the installation phase of the Lung men nuclear power plant in Taiwan, under the cooperation of Institute of Nuclear Energy Research and Tpc. The US Nuclear Regulatory Commission requests licensee to perform software safety analysis and software verification and validation in each phase of software development life cycle with Branch Technical Position 7-14. In this work, 37 safety grade digital instrumentation and control systems were analyzed by failure mode and effects analysis, which is suggested by IEEE standard 7-4.3.2-2003. During the installation phase, skew tests for safety grade network and point to point tests were performed. The failure mode and effects analysis showed all the single failure modes can be resolved by the redundant means. Most of the common mode failures can be resolved by operator manual actions. (Author)

  3. Software safety analysis practice in installation phase

    International Nuclear Information System (INIS)

    Huang, H. W.; Chen, M. H.; Shyu, S. S.

    2010-10-01

    This work performed a software safety analysis in the installation phase of the Lung men nuclear power plant in Taiwan, under the cooperation of Institute of Nuclear Energy Research and Tpc. The US Nuclear Regulatory Commission requests licensee to perform software safety analysis and software verification and validation in each phase of software development life cycle with Branch Technical Position 7-14. In this work, 37 safety grade digital instrumentation and control systems were analyzed by failure mode and effects analysis, which is suggested by IEEE standard 7-4.3.2-2003. During the installation phase, skew tests for safety grade network and point to point tests were performed. The failure mode and effects analysis showed all the single failure modes can be resolved by the redundant means. Most of the common mode failures can be resolved by operator manual actions. (Author)

  4. Time Based Workload Analysis Method for Safety-Related Operator Actions in Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Yun Goo; Oh, Eung Se [Korea Hydro and Nuclear Power Co., Daejeon (Korea, Republic of)

    2016-05-15

    During the design basis event, the safety system performs safety functions to mitigate the event. The most of safety system is actuated by automatic system however, there are operator manual actions that are needed for the plant safety. These operator actions are classified as important human actions in human factors engineering design. The human factors engineering analysis and evaluation is needed for these important human actions to assure that operator successfully perform their tasks for plant safety and operational goals. The work load analysis is one of the required analysis for the important human actions.

  5. Time Based Workload Analysis Method for Safety-Related Operator Actions in Safety Analysis

    International Nuclear Information System (INIS)

    Kim, Yun Goo; Oh, Eung Se

    2016-01-01

    During the design basis event, the safety system performs safety functions to mitigate the event. The most of safety system is actuated by automatic system however, there are operator manual actions that are needed for the plant safety. These operator actions are classified as important human actions in human factors engineering design. The human factors engineering analysis and evaluation is needed for these important human actions to assure that operator successfully perform their tasks for plant safety and operational goals. The work load analysis is one of the required analysis for the important human actions.

  6. On some aspects of nuclear safety surveillance and review

    International Nuclear Information System (INIS)

    Li Ganjie; Zhu Hong; Zhou Shanyuan

    2004-01-01

    Five aspects of the nuclear safety surveillance and review are discussed: Strict implementation of nuclear safety regulation, making the nuclear safety surveillance and review more normalization, procedurization, scientific decision-making; Strictly requiring the applicant to comply with the requirements of codes, do not allowing the utilization of mixing of codes; Properly controlling the strictness for the review on significant non-conformance; Strengthening the co-operation between regional offices and technical support units, Properly treat the relations between administrational management unit and technical support units. (authors)

  7. Airline Safety: A Comparative Analysis.

    Science.gov (United States)

    1987-01-01

    shrinking FAA inspector force handling a rapidly growing number of air carriers. These studies have always shown an improvement in airline safety in the...EhCLhEmohhhhhhhEoo EhhshhEEmhhhhE EhhEohhEshhhhE EhhhEEEohEohEE EohEEEmhshEmhE IEEE...mmmo 1-2. jI. Mi6 NEW - secuRily CLASSIFICATION OF THIS PAGE (When De

  8. Safety analysis and related studies

    International Nuclear Information System (INIS)

    Lelievre, J.

    1979-12-01

    Several examples of reactor safety studies are given. For light water reactors, the consequences of loss of coolant, the disposition of the fuel elements and the behaviour under irradiation of the steels used for containment are described. For fast reactors, the disposition of fuel elements in the case of cooling accidents and sodium fies are described. Examples given of studies not specific to a particular reactor type include studies of non-destructive testing and those of reliability

  9. Using Addenda in Documented Safety Analysis Reports

    International Nuclear Information System (INIS)

    Swanson, D.S.; Thieme, M.A.

    2003-01-01

    This paper discusses the use of addenda to the Radioactive Waste Management Complex (RWMC) Documented Safety Analysis (DSA) located at the Idaho National Engineering and Environmental Laboratory (INEEL). Addenda were prepared for several systems and processes at the facility that lacked adequate descriptive information and hazard analysis in the DSA. They were also prepared for several new activities involving unreviewed safety questions (USQs). Ten addenda to the RWMC DSA have been prepared since the last annual update

  10. MSSV Modeling for Wolsong-1 Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Moon, Bok Ja; Choi, Chul Jin; Kim, Seoung Rae [KEPCO EandC, Daejeon (Korea, Republic of)

    2010-10-15

    The main steam safety valves (MSSVs) are installed on the main steam line to prevent the overpressurization of the system. MSSVs are held in closed position by spring force and the valves pop open by internal force when the main steam pressure increases to open set pressure. If the overpressure condition is relieved, the valves begin to close. For the safety analysis of anticipated accident condition, the safety systems are modeled conservatively to simulate the accident condition more severe. MSSVs are also modeled conservatively for the analysis of over-pressurization accidents. In this paper, the pressure transient is analyzed at over-pressurization condition to evaluate the conservatism for MSSV models

  11. Development of regulatory technology for thermal-hydraulic safety analysis

    International Nuclear Information System (INIS)

    Bang, Young Seok; Lee, S. H.; Ryu, Y. H.

    2001-02-01

    The present study aims to develop the regulation capability in thermal-hydraulic safety analysis which was required for the reasonable safety regulation in the current NPP, the next generation reactors, and the future-type reactors. The fourth fiscal year of the first phase of the research was focused on the following research topics: Investigation on the current status of the thermal-hydraulic safety analysis technology outside and inside of the country; Review on the improved features of the thermal-hydraulic safety analysis regulatory audit code, RELAP5/MOD3; Assessments of code with LOFT L9-3 ATWS experiment and LSTF SB-SG-10 multiple SGTR experiment; Application of the RELAP5/CANDU code to analyses of SLB and LBLOCA and evaluation of its effect on safety; Application of the code to IAEA PHWR ISP analysis; Assessments of RELAP5 and TRAC with UPTF downcomer injection test and Analysis of LBLOCA with RELAP5 for the performance evaluation of KNGR DVI; Setup of a coupled 3-D kinetics and thermal-hydraulics and application it to a reactivity accident analysis; and Extension of database and improvement of plant input decks. For supporting the resolution of safety issues, loss of RHR event during midloop operation was analyzed for Kori Unit 3, issues on high burnup fuel were reviewed and performance of FRAPCON-3 assessed. Also MSLB was analyzed to figure out the sensitivity of downcomer temperature supporting the PTS risk evaluation of Kori Unit 1. Thermal stratification in pipe was analyzed using the method proposed. And a method predicting the thermal-hydraulic performance of IRWST of KNGR was explored. The PWR ECCS performance criteria was issued as a MOST Article 200-19.and a regulatory guide on evaluation methodology was improved to cover concerns raised from the related licensing review process

  12. Safety analysis of autonomous excavator functionality

    International Nuclear Information System (INIS)

    Seward, D.; Pace, C.; Morrey, R.; Sommerville, I.

    2000-01-01

    This paper presents an account of carrying out a hazard analysis to define the safety requirements for an autonomous robotic excavator. The work is also relevant to the growing generic class of heavy automated mobile machinery. An overview of the excavator design is provided and the concept of a safety manager is introduced. The safety manager is an autonomous module responsible for all aspects of system operational safety, and is central to the control system's architecture. Each stage of the hazard analysis is described, i.e. system model creation, hazard definition and hazard analysis. Analysis at an early stage of the design process, and on a system that interfaces directly to an unstructured environment, exposes certain issues relevant to the application of current hazard analysis methods. The approach taken in the analysis is described. Finally, it is explained how the results of the hazard analysis have influenced system design, in particular, safety manager specifications. Conclusions are then drawn about the applicability of hazard analysis of requirements in general, and suggestions are made as to how the approach can be taken further

  13. Software safety analysis application in installation phase

    International Nuclear Information System (INIS)

    Huang, H. W.; Yih, S.; Wang, L. H.; Liao, B. C.; Lin, J. M.; Kao, T. M.

    2010-01-01

    This work performed a software safety analysis (SSA) in the installation phase of the Lungmen nuclear power plant (LMNPP) in Taiwan, under the cooperation of INER and TPC. The US Nuclear Regulatory Commission (USNRC) requests licensee to perform software safety analysis (SSA) and software verification and validation (SV and V) in each phase of software development life cycle with Branch Technical Position (BTP) 7-14. In this work, 37 safety grade digital instrumentation and control (I and C) systems were analyzed by Failure Mode and Effects Analysis (FMEA), which is suggested by IEEE Standard 7-4.3.2-2003. During the installation phase, skew tests for safety grade network and point to point tests were performed. The FMEA showed all the single failure modes can be resolved by the redundant means. Most of the common mode failures can be resolved by operator manual actions. (authors)

  14. Detailed Safety Review of Anthrax Vaccine Adsorbed

    National Research Council Canada - National Science Library

    2001-01-01

    To date, 18 human studies have assessed the safety of anthrax vaccination. These studies, some stretching back almost 50 years, reported adverse events after vaccination in varying degrees of detail...

  15. Patient safety in otolaryngology: a descriptive review.

    Science.gov (United States)

    Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

    2017-03-01

    Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within

  16. Probabilistic safety analysis using microcomputer

    International Nuclear Information System (INIS)

    Futuro Filho, F.L.F.; Mendes, J.E.S.; Santos, M.J.P. dos

    1990-01-01

    The main steps of execution of a Probabilistic Safety Assessment (PSA) are presented in this report, as the study of the system description, construction of event trees and fault trees, and the calculation of overall unavailability of the systems. It is also presented the use of microcomputer in performing some tasks, highlightning the main characteristics of a software to perform adequately the job. A sample case of fault tree construction and calculation is presented, using the PSAPACK software, distributed by the IAEA (International Atomic Energy Agency) for training purpose. (author)

  17. A review of the nuclear safety activities in Italy

    International Nuclear Information System (INIS)

    Merelli, A.

    1989-01-01

    A review of research programs carried out in Italy in the field of nuclear reactor safety was done in 1986, in the frame of the activities of the Commission of the European Communities, the International Energy Agency and the Nuclear Energy Agency of the Organization for Economic Cooperation and Development. The report contains information on these programs, as well as information on the organization of safety research in Italy and the evolution of safety research programs

  18. Tank waste remediation system nuclear criticality safety program management review

    International Nuclear Information System (INIS)

    BRADY RAAP, M.C.

    1999-01-01

    This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999

  19. Efficacy and safety of flurbiprofen axetil in the prevention of pain on propofol injection: a systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Lieliang; Zhu, Juan; Xu, Lei; Zhang, Xunlei; Wang, Hongyu; Luo, Zhonghua; Zhao, Yamei; Yu, Yi; Zhang, Yong; Shi, Hongwei; Bao, Hongguang

    2014-06-17

    Pain on injection is an acknowledged adverse effect (AE) of propofol administration for the induction of general anesthesia. Flurbiprofen axetil has been reported to reduce the pain of injection. However, results of published papers on the efficacy of flurbiprofen axetil in managing pain on injection of propofol are inconsistent. We conducted a comprehensive meta-analysis of studies to appraise the efficacy and safety of flurbiprofen axetil for controlling pain induced by propofol injection. The pooled risk ratio (RR) with corresponding 95% confidence intervals (CI) was calculated employing fixed- or random-effects models, depending upon the heterogeneity of the included trials. Compared with the placebo group, flurbiprofen axetil allows more patients to have no pain (RR 3.51, 95% CI 2.22-5.55, p=0.000), and decreases the cumulative number of patients with mild, moderate, and severe pain on injecting propofol (RR 0.70, 95% CI 0.58-0.86, p=0.000; RR 0.59, 95% CI 0.46-0.75, p=0.000; RR 0.25, 95% CI 0.16-0.38, p=0.000, respectively). In the stratified analysis by the doses, flurbiprofen axetil at a dose of over 50 mg was found to be effective in reducing propofol-induced pain on injection; however, there were no significant differences in relieving pain between treatment and placebo groups with flurbiprofen axetil at a dose of 25 mg. In terms of drug safety, there were no adverse effects (AEs) reported between flurbiprofen axetil-based regimens and placebo regimens. Flurbiprofen axetil, an injectable prodrug of flurbiprofen, can significantly prevent or relieve the pain induced by propofol injection. More studies are required to assess its adverse effects.

  20. LMFBR safety experiment facility planning and analysis

    International Nuclear Information System (INIS)

    Stevenson, M.G.; Scott, J.H.

    1976-01-01

    In the past two years considerable effort has been placed on the planning and design of new facilities for the resolution of LMFBR safety issues. The paper reviews the key issues, the experiments needed to resolve them, and the design aspects of proposed new facilities. In addition, it presents a decision theory approach to selecting an optimal combination of modified and new facilities

  1. Procurement strategic analysis of nuclear safety equipment

    International Nuclear Information System (INIS)

    Wu Caixia; Yang Haifeng; Li Xiaoyang; Li Shixin

    2013-01-01

    The nuclear power development plan in China puts forward a challenge on procurement of nuclear safety equipment. Based on the characteristics of the procurement of nuclear safety equipment, requirements are raised for procurement process, including further clarification of equipment technical specification, establishment and improvement of the expert database of the nuclear power industry, adoption of more reasonable evaluation method and establishment of a unified platform for nuclear power plants to procure nuclear safety equipment. This paper makes recommendation of procurement strategy for nuclear power production enterprises from following aspects, making a plan of procurement progress, dividing procurement packages rationally, establishing supplier database through qualification review and implementing classified management, promoting localization process of key equipment continually and further improving the system and mechanism of procurement of nuclear safety equipment. (authors)

  2. Nuclear Safety Review for the Year 2004

    International Nuclear Information System (INIS)

    2005-08-01

    In the nuclear area, challenges continue to emerge from the globalization of issues related to safety, technology, business, information, communication and security. Scientific advances and operational experience in nuclear, radiation, waste and transport technology are providing new opportunities to continuously improve safety and security by utilizing synergies between safety and security. The prime responsibility for nuclear, radiation, waste and transport safety rests with users and national governments. The Agency continues to support a Global Nuclear Safety Regime based on strong national safety infrastructures and widespread subscription to international legal instruments to maintain high levels of safety worldwide. Central to the Agency's role are the establishment of international safety standards and the provision for applying these standards, as well as the promotion of sharing information through managing the knowledge base. Nuclear power plant operational safety performance remains high throughout the world. Challenges facing the nuclear power industry include avoiding complacency, maintaining the necessary infrastructure, nuclear power plant ageing and long-term operation, as well as new reactor designs and construction. The research reactor community has a long history of safe operation. However nearly two-thirds of the world's operating research reactors are now over 30 years old and face safety and security challenges. In 2004, the Board of Governors approved the Code of Conduct on the Safety of Research Reactors to help address these challenges. In 2004, there was international consensus on radionuclide activity concentrations in materials below which regulatory controls need not apply. Key occupational radiation protection performance indicators continued to improve in 2004. Challenges include new medical practices where workers can receive high exposures, industrial radiography and worker exposure to naturally occurring radioactive material. New

  3. Patient Safety and Workplace Bullying: An Integrative Review.

    Science.gov (United States)

    Houck, Noreen M; Colbert, Alison M

    Workplace bullying is strongly associated with negative nursing outcomes, such as work dissatisfaction, turnover, and intent to leave; however, results of studies examining associations with specific patient safety outcomes are limited or nonspecific. This integrative review explores and synthesizes the published articles that address the impact of workplace nurse bullying on patient safety.

  4. Efficacy and Safety of the TCM Qi-Supplementing Therapy in Patients with Myasthenia Gravis: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Xi-qian Yang

    2017-01-01

    Full Text Available Background. The Traditional Chinese Medicine (TCM Qi-supplementing therapy has been used widely for treating myasthenia gravis (MG in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of Qi-supplementing therapy as an adjunctive therapy in MG patients. Methods. Seven electronic databases were searched through June 2016. Randomized controlled trials (RCTs evaluating the add-on effect of Qi-supplementing therapy in MG patients were included. The outcome measures were the total effective rate, relapse rate, and adverse events. Results. Twenty-three RCTs involving 1,691 MG patients were included. The included studies were of low-to-moderate quality. Meta-analysis showed that Qi-supplementing therapy combined with Western medicine (WM significantly improved the total response rate and reduced the relapse risk during 6–24 months of follow-up. Subgroup analysis showed that Qi-supplementing therapy only affected the total response rate within the first 6 months of treatment. Moreover, the rate of adverse events was lower with the addition of Qi-supplementing therapy to WM than with WM only. Conclusions. Short-term Qi-supplementing therapy combined with WM appears to be superior to WM for improving the total response rate and reducing the relapse rate. However, more high-quality RCTs are warranted owing to methodological flaws of previous trials.

  5. A review of models relevant to road safety.

    Science.gov (United States)

    Hughes, B P; Newstead, S; Anund, A; Shu, C C; Falkmer, T

    2015-01-01

    It is estimated that more than 1.2 million people die worldwide as a result of road traffic crashes and some 50 million are injured per annum. At present some Western countries' road safety strategies and countermeasures claim to have developed into 'Safe Systems' models to address the effects of road related crashes. Well-constructed models encourage effective strategies to improve road safety. This review aimed to identify and summarise concise descriptions, or 'models' of safety. The review covers information from a wide variety of fields and contexts including transport, occupational safety, food industry, education, construction and health. The information from 2620 candidate references were selected and summarised in 121 examples of different types of model and contents. The language of safety models and systems was found to be inconsistent. Each model provided additional information regarding style, purpose, complexity and diversity. In total, seven types of models were identified. The categorisation of models was done on a high level with a variation of details in each group and without a complete, simple and rational description. The models identified in this review are likely to be adaptable to road safety and some of them have previously been used. None of systems theory, safety management systems, the risk management approach, or safety culture was commonly or thoroughly applied to road safety. It is concluded that these approaches have the potential to reduce road trauma. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Deterministic Safety Analysis for Nuclear Power Plants. Specific Safety Guide (Russian Edition)

    International Nuclear Information System (INIS)

    2014-01-01

    The objective of this Safety Guide is to provide harmonized guidance to designers, operators, regulators and providers of technical support on deterministic safety analysis for nuclear power plants. It provides information on the utilization of the results of such analysis for safety and reliability improvements. The Safety Guide addresses conservative, best estimate and uncertainty evaluation approaches to deterministic safety analysis and is applicable to current and future designs. Contents: 1. Introduction; 2. Grouping of initiating events and associated transients relating to plant states; 3. Deterministic safety analysis and acceptance criteria; 4. Conservative deterministic safety analysis; 5. Best estimate plus uncertainty analysis; 6. Verification and validation of computer codes; 7. Relation of deterministic safety analysis to engineering aspects of safety and probabilistic safety analysis; 8. Application of deterministic safety analysis; 9. Source term evaluation for operational states and accident conditions; References

  7. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis

    Science.gov (United States)

    Lai, Tianwen; Wang, Shaobin; Xu, Zhiwei; Zhang, Chao; Zhao, Yun; Hu, Yue; Cao, Chao; Ying, Songmin; Chen, Zhihua; Li, Wen; Wu, Bin; Shen, Huahao

    2015-01-01

    Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ≥52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749). Omalizumab was associated with significant improvements in quality of life and the Global Evaluation of Treatment Effectiveness. Omalizumab also allowed patients to completely withdraw from inhaled corticosteroid therapy and did not increase the overall incidence of adverse events. However, there was insufficient evidence that omalizumab reduced the incidence of exacerbations, and the cost-effectiveness of omalizumab varied across studies. Our data indicated that omalizumab use for at least 52 weeks in patients with persistent uncontrolled allergic asthma was accompanied by an acceptable safety profile, but it lacked effect on the asthma exacerbations. Use of omalizumab was associated with a higher cost than conventional therapy, but these increases may be cost-effective if the medication is used in patients with severe allergic asthma. PMID:25645133

  8. Gas-cooled reactor safety and accident analysis

    International Nuclear Information System (INIS)

    1985-12-01

    The Specialists' Meeting on Gas-Cooled Reactor Safety and Accident Analysis was convened by the International Atomic Energy Agency in Oak Ridge on the invitation of the Department of Energy in Washington, USA. The meeting was hosted by the Oak Ridge National Laboratory. The purpose of the meeting was to provide an opportunity to compare and discuss results of safety and accident analysis of gas-cooled reactors under development, construction or in operation, to review their lay-out, design, and their operational performance, and to identify areas in which additional research and development are needed. The meeting emphasized the high safety margins of gas-cooled reactors and gave particular attention to the inherent safety features of small reactor units. The meeting was subdivided into four technical sessions: Safety and Related Experience with Operating Gas-Cooled Reactors (4 papers); Risk and Safety Analysis (11 papers); Accident Analysis (9 papers); Miscellaneous Related Topics (5 papers). A separate abstract was prepared for each of these papers

  9. Safety relief valve alternate analysis method

    International Nuclear Information System (INIS)

    Adams, R.H.; Javid, A.; Khatua, T.P.

    1981-01-01

    An experimental test program was started in the United States in 1976 to define and quantify Safety Relief Valve (SRV) phenomena in General Electric Mark I Suppression Chambers. The testing considered several discharged devices and was used to correlate SRV load prediction models. The program was funded by utilities with Mark I containments and has resulted in a detailed SRV load definition as a portion of the Mark I containment program Load Definition Report (LDR). The (USNRC) has reviewed and approved the LDR SRV load definition. In addition, the USNRC has permitted calibration of structural models used for predicting torus response to SRV loads. Model calibration is subject to confirmatory in-plant testing. The SRV methodology given in the LDR requires that transient dynamic pressures be applied to a torus structural model that includes a fluid added mass matrix. Preliminary evaluations of torus response have indicated order of magnitude conservatisms, with respect to test results, which could result in unrealistic containment modifications. In addition, structural response trends observed in full-scale tests between cold pipe, first valve actuation and hot pipe, subsequent valve actuation conditions have not been duplicated using current analysis methods. It was suggested by others that an energy approach using current fluid models be utilized to define loads. An alternate SRV analysis method is defined to correct suppression chamber structural response to a level that permits economical but conservative design. Simple analogs are developed for the purpose of correcting the analytical response obtained from LDR analysis methods. Analogs evaluated considered forced vibration and free vibration structural response. The corrected response correlated well with in-plant test response. The correlation of the analytical model at test conditions permits application of the alternate analysis method at design conditions. (orig./HP)

  10. Comparative efficacy and safety of treatment options for MDR and XDR Acinetobacter baumannii infections: a systematic review and network meta-analysis.

    Science.gov (United States)

    Kengkla, Kirati; Kongpakwattana, Khachen; Saokaew, Surasak; Apisarnthanarak, Anucha; Chaiyakunapruk, Nathorn

    2018-01-01

    To comprehensively compare and rank the efficacy and safety of available treatment options for patients with MDR and XDR Acinetobacter baumannii (AB) infection. We searched PubMed, Embase and the Cochrane register of trials systematically for studies that examined treatment options for patients with MDR- and XDR-AB infections until April 2016. Network meta-analysis (NMA) was performed to estimate the risk ratio (RR) and 95% CI from both direct and indirect evidence. Primary outcomes were clinical cure and microbiological cure. Secondary outcomes were all-cause mortality and nephrotoxic and non-nephrotoxic adverse events. A total of 29 studies with 2529 patients (median age 60 years; 65% male; median APACHE II score 19.0) were included. Although there were no statistically significant differences between treatment options, triple therapy with colistin, sulbactam and tigecycline had the highest clinical cure rate. Colistin in combination with sulbactam was associated with a significantly higher microbiological cure rate compared with colistin in combination with tigecycline (RR 1.23; 95% CI 1.03-1.47) and colistin monotherapy (RR 1.21; 95% CI 1.06-1.38). No significant differences in all-cause mortality were noted between treatment options. Tigecycline-based therapy also appeared less effective for achieving a microbiological cure and is not appropriate for treating bloodstream MDR- and XDR-AB infections. Combination therapy of colistin with sulbactam demonstrates superiority in terms of microbiological cure with a safety profile similar to that of colistin monotherapy. Thus, our findings support the use of this combination as a treatment for MDR- and XDR-AB infections. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Safety and efficacy of the perioperative administration of recombinant human brain natriuretic peptide (rhBNP: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Hua P

    2018-02-01

    Full Text Available Ping Hua,1 Jianyang Liu,2 Jun Tao,1 Xifeng Lin,1 Rongjun Zou,1 Dingwen Zhang,1 Songran Yang3,4 1Department of Cardiovascular Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 2Department of Vascular Surgery, Henan Provincial People’s Hospital, Zhengzhou, 3The Biobank of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 4Guangdong Province Key Laboratory of Brain Function and Disease, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, China Objective: Retrospective studies and a meta-analysis were performed to evaluate the safety and effectiveness of the perioperative administration of recombinant human brain natriuretic peptide (rhBNP during cardiac surgery under extracorporeal circulation. Methods: Computerized literature searches were performed in Medline, Embase, The Cochrane Library, CNKI, CBM, and WANFANG to find randomized controlled trials (RCTs related to the perioperative administration of rhBNP during cardiac surgery starting from the database inception until December 2016. Two researchers independently performed study screening, information extraction, and quality evaluation according to the inclusion/exclusion criteria, and a meta-analysis was performed using RevMan 5.2 software. Results: A total of 12 studies were analyzed, including 12 RCTs and 727 patients. The meta-analysis results indicated that the perioperative administration of rhBNP could reduce the occurrence rate of postoperative complications, length of intensive care unit (ICU stay, length of hospital stay, and serum creatinine (Scr levels, and increase the 24-hour urine volume; however, it did not affect the postoperative mortality rate. Conclusion: The perioperative administration of rhBNP during cardiac surgery was safe and effective, and could improve the prognosis of the patients. Keywords: recombinant human brain natriuretic peptide, perioperative administration, meta-analysis

  12. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

  13. Feasibility and safety of robot-assisted thoracic surgery for lung lobectomy in patients with non-small cell lung cancer: a systematic review and meta-analysis.

    Science.gov (United States)

    Wei, Shiyou; Chen, Minghao; Chen, Nan; Liu, Lunxu

    2017-05-08

    The aim of this study is to evaluate the feasibility and safety of robot-assisted thoracic surgery (RATS) lobectomy versus video-assisted thoracic surgery (VATS) for lobectomy in patients with non-small cell lung cancer (NSCLC). An electronic search of six electronic databases was performed to identify relevant comparative studies. Meta-analysis was performed by pooling the results of reported incidence of overall morbidity, mortality, prolonged air leak, arrhythmia, and pneumonia between RATS and VATS lobectomy. Subgroup analysis was also conducted based on matched and unmatched cohort studies, if possible. Relative risks (RR) with their 95% confidence intervals (CI) were calculated by means of Revman version 5.3. Twelve retrospective cohort studies were included, with a total of 60,959 patients. RATS lobectomy significantly reduced the mortality rate when compared with VATS lobectomy (RR = 0.54, 95% CI 0.38-0.77; P = 0.0006), but this was not consistent with the pooled result of six matched studies (RR = 0.12, 95% CI 0.01-1.07; P = 0.06). There was no significant difference in morbidity between the two approaches (RR = 0.97, 95% CI 0.85-1.12; P = 0.70). RATS lobectomy is a feasible and safe technique and can achieve an equivalent short-term surgical efficacy when compared with VATS, but its cost effectiveness also should be taken into consideration.

  14. Reliability analysis of Angra I safety systems

    International Nuclear Information System (INIS)

    Oliveira, L.F.S. de; Soto, J.B.; Maciel, C.C.; Gibelli, S.M.O.; Fleming, P.V.; Arrieta, L.A.

    1980-07-01

    An extensive reliability analysis of some safety systems of Angra I, are presented. The fault tree technique, which has been successfully used in most reliability studies of nuclear safety systems performed to date is employed. Results of a quantitative determination of the unvailability of the accumulator and the containment spray injection systems are presented. These results are also compared to those reported in WASH-1400. (E.G.) [pt

  15. Application of Software Safety Analysis Methods

    International Nuclear Information System (INIS)

    Park, G. Y.; Hur, S.; Cheon, S. W.; Kim, D. H.; Lee, D. Y.; Kwon, K. C.; Lee, S. J.; Koo, Y. H.

    2009-01-01

    A fully digitalized reactor protection system, which is called the IDiPS-RPS, was developed through the KNICS project. The IDiPS-RPS has four redundant and separated channels. Each channel is mainly composed of a group of bistable processors which redundantly compare process variables with their corresponding setpoints and a group of coincidence processors that generate a final trip signal when a trip condition is satisfied. Each channel also contains a test processor called the ATIP and a display and command processor called the COM. All the functions were implemented in software. During the development of the safety software, various software safety analysis methods were applied, in parallel to the verification and validation (V and V) activities, along the software development life cycle. The software safety analysis methods employed were the software hazard and operability (Software HAZOP) study, the software fault tree analysis (Software FTA), and the software failure modes and effects analysis (Software FMEA)

  16. From Safety Analysis to Formal Specification

    DEFF Research Database (Denmark)

    Hansen, Kirsten Mark; Ravn, Anders P.; Stavridou, Victoria

    1998-01-01

    Software for safety critical systems must deal with the hazards identified bysafety analysis. This paper investigates, how the results of onesafety analysis technique, fault trees, are interpreted as software safetyrequirements to be used in the program design process. We propose thatfault tree...... analysis and program development use the samesystem model. This model is formalized in areal-time, interval logic, based on a conventional dynamic systems modelwith state evolving over time. Fault trees are interpreted astemporal formulas, and it is shown how such formulas can be usedfor deriving safety...

  17. Swimming pool reactor reliability and safety analysis

    International Nuclear Information System (INIS)

    Li Zhaohuan

    1997-01-01

    A reliability and safety analysis of Swimming Pool Reactor in China Institute of Atomic Energy is done by use of event/fault tree technique. The paper briefly describes the analysis model, analysis code and main results. Meanwhile it also describes the impact of unassigned operation status on safety, the estimation of effectiveness of defense tactics in maintenance against common cause failure, the effectiveness of recovering actions on the system reliability, the comparison of occurrence frequencies of the core damage by use of generic and specific data

  18. Lithium-thionyl chloride cell system safety hazard analysis

    Science.gov (United States)

    Dampier, F. W.

    1985-03-01

    This system safety analysis for the lithium thionyl chloride cell is a critical review of the technical literature pertaining to cell safety and draws conclusions and makes recommendations based on this data. The thermodynamics and kinetics of the electrochemical reactions occurring during discharge are discussed with particular attention given to unstable SOCl2 reduction intermediates. Potentially hazardous reactions between the various cell components and discharge products or impurities that could occur during electrical or thermal abuse are described and the most hazardous conditions and reactions identified. Design factors influencing the safety of Li/SOCl2 cells, shipping and disposal methods and the toxicity of Li/SOCl2 battery components are additional safety issues that are also addressed.

  19. Safety review of experiments at Albuquerque Operations Office

    International Nuclear Information System (INIS)

    Elliott, K.

    1984-01-01

    The Department of Energy (DOE) Albuquerque Operations Office is responsible for the safety overview of nuclear reactor and critical assembly facilities at Sandia National Laboratories, Los Alamos National Laboratory, and the Rocky Flats Plant. The important safety concerns with these facilities involve the complex experiments that are performed, and that is the area emphasized. A determination is made by the Albuquerque Office (AL) with assistance from DOE/OMA whether or not a proposed experiment is an unreviewed safety question. Meetings are held with the contractor to resolve and clarify questions that are generated during the review of the proposed experiment. The AL safety evaluation report is completed and any recommendations are discussed. Prior to the experiment a preoperational appraisal is performed to assure that personnel, procedures, and equipment are in readiness for operations. During the experiment, any abnormal condition is reviewed in detail to determine any safety concerns

  20. Russian Minatom nuclear safety research strategic plan. An international review

    International Nuclear Information System (INIS)

    Royen, J.

    1999-01-01

    An NEA study on safety research needs of Russian-designed reactors, carried out in 1996, strongly recommended that a strategic plan for safety research be developed with respect to Russian nuclear power plants. Such a plan was developed at the Russian International Nuclear Safety Centre (RINSC) of the Russian Ministry of Atomic Energy (Minatom). The Strategic Plan is designed to address high-priority safety-research needs, through a combination of domestic research, the application of appropriate foreign knowledge, and collaboration. It represents major progress toward developing a comprehensive and coherent safety-research programme for Russian nuclear power plants (NPPs). The NEA undertook its review of the Strategic Plan with the objective of providing independent verification on the scope, priority, and content of the research described in the Plan based upon the experience of the international group of experts. The principal conclusions of the review and the general comments of the NEA group are presented. (K.A.)

  1. The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis.

    Science.gov (United States)

    Hou, Min; Xing, Haiyan; Cai, Yongqing; Li, Bin; Wang, Xianfeng; Li, Pan; Hu, Xiaolin; Chen, Jianhong

    2017-12-01

    Migraine has been recognized as one of the leading causes of disability in the 2013 Global Burden of Disease Study and seriously affects the quality of patients' life, current treatment options are not ideal. Monoclonal antibodies to calcitonin gene-related peptide and its receptor (CGRP-mAbs) appear more promising for migraine because of considerably better effect and safety profiles. The objective of this study is to systematically assess the clinical efficacy and safety of CGRP-mAbs for migraine therapy. A systematic literature search in PubMed, Cochrane Library and Baidu Scholar was performed to identify randomized controlled trials (RCTs), which compared the effect and safety of CGRP-mAbs with placebo on migraine. Regarding the efficacy, the reduction of monthly migraine days from baseline to weeks 1-4, 5-8, and 9-12; responder rates were extracted as the outcome measures of the effects of CGRP-mAbs. Regarding the safety, total adverse events, the main adverse events, and other adverse events were evaluated. We found significant reduction of monthly migraine days in CGRP-mAbs vs. placebo (weeks 1-4: SMD -0.49, 95% CI -0.61 to -0.36; weeks 5-8: SMD -0.43, 95% CI -0.56 to -0.30; weeks 9-12: SMD -0.37, 95% CI -0.49 to -0.24). 50% and 75% responder rates (OR 2.59, 95% CI 1.99 to 3.37; and OR 2.91, 95% CI 2.06 to 4.10) were significantly increased compared with placebo. There was no significant difference in total adverse events (OR 1.17, 95% CI 0.91 to 1.51), and the main adverse events including upper respiratory tract infection (OR 1.44, 95% CI 0.82 to 2.55), nasopharyngitis (OR 0.59, 95% CI 0.30 to 1.16), nausea (OR 0.61, 95% CI 0.29 to 1.32), injection-site pain (OR 1.73, 95% CI 0.95 to 3.16) and back pain (OR 0.97, 95% CI 0.49 to 1.90) were not obviously changed compared with placebo control, but the results showed significant increase of dizziness in CGRP-mAbs vs. placebo (OR 3.22, 95% CI 1.09 to 9.45). This meta-analysis suggests that CGRP-mAbs are

  2. Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis.

    Science.gov (United States)

    Miller, Larry E; Zimmermann, Angela K; Herbert, William G

    2016-01-01

    Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. A total of 14 studies (eight ReWalk™, three Ekso™, two Indego(®), and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60-120 minutes per session, for 1-24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6-20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to

  3. Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis

    Science.gov (United States)

    Miller, Larry E; Zimmermann, Angela K; Herbert, William G

    2016-01-01

    Background Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results A total of 14 studies (eight ReWalk™, three Ekso™, two Indego®, and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60–120 minutes per session, for 1–24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6–20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Conclusion Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at

  4. Efficacy and safety of atazanavir/ritonavir-based antiretroviral therapy for HIV-1 infected subjects: a systematic review and meta-analysis.

    Science.gov (United States)

    Menshawy, Amr; Ismail, Ammar; Abushouk, Abdelrahman Ibrahim; Ahmed, Hussien; Menshawy, Esraa; Elmaraezy, Ahmed; Gadelkarim, Mohamed; Abdel-Maboud, Mohamed; Attia, Attia; Negida, Ahmed

    2017-08-01

    Atazanavir (ATZ) is a well-tolerated protease inhibitor that can be boosted with ritonavir (r) to treat infection with resistant strains of human immunodeficiency virus 1 (HIV-1). The aim of this meta-analysis was to compare the efficacy, safety, and metabolic effects of ATZ/r regimen versus commonly used antiretroviral drugs such as lopinavir (LPV) and darunavir (DRV) in HIV-1-infected patients. We searched PubMed, Scopus, Embase and Cochrane CENTRAL, using relevant keywords. Data were extracted from eligible randomized trials and pooled as risk ratios (RR) or standardized mean differences (SMD) in a meta-analysis model using RevMan software. Nine randomized controlled trials (RCTs) (3292 patients) were eligible for the final analysis. After 96 weeks of treatment, the pooled effect estimate did not favor either ATZ/r or LPV/r in terms of virological failure rate (RR 1.11, 95% CI [0.74, 1.66]). However, ATZ/r was marginally superior to LPV/r in terms of increasing the proportion of patients with HIV RNA SMD -0.06, 95%CI [-0.33, 0.21]) or subcutaneous adipose tissue (SMD 0.12, 95% CI [-0.15, 0.39]). The ATZ/r regimen was generally as effective and well-tolerated as the LPV/r regimen for the treatment of HIV-1 patients. Compared to the DRV/r regimen, ATZ/r has no favorable effect on the plasma lipid profile or adipose tissue distribution.

  5. The practical implementation of integrated safety management for nuclear safety analysis and fire hazards analysis documentation

    International Nuclear Information System (INIS)

    COLLOPY, M.T.

    1999-01-01

    In 1995 Mr. Joseph DiNunno of the Defense Nuclear Facilities Safety Board issued an approach to describe the concept of an integrated safety management program which incorporates hazard and safety analysis to address a multitude of hazards affecting the public, worker, property, and the environment. Since then the U S . Department of Energy (DOE) has adopted a policy to systematically integrate safety into management and work practices at all levels so that missions can be completed while protecting the public, worker, and the environment. While the DOE and its contractors possessed a variety of processes for analyzing fire hazards at a facility, activity, and job; the outcome and assumptions of these processes have not always been consistent for similar types of hazards within the safety analysis and the fire hazard analysis. Although the safety analysis and the fire hazard analysis are driven by different DOE Orders and requirements, these analyses should not be entirely independent and their preparation should be integrated to ensure consistency of assumptions, consequences, design considerations, and other controls. Under the DOE policy to implement an integrated safety management system, identification of hazards must be evaluated and agreed upon to ensure that the public. the workers. and the environment are protected from adverse consequences. The DOE program and contractor management need a uniform, up-to-date reference with which to plan. budget, and manage nuclear programs. It is crucial that DOE understand the hazards and risks necessarily to authorize the work needed to be performed. If integrated safety management is not incorporated into the preparation of the safety analysis and the fire hazard analysis, inconsistencies between assumptions, consequences, design considerations, and controls may occur that affect safety. Furthermore, confusion created by inconsistencies may occur in the DOE process to grant authorization of the work. In accordance with

  6. Activity of safety review for the facilities using nuclear material (2). Safety review results and maintenance experiences for hot laboratories

    International Nuclear Information System (INIS)

    Amagai, Tomio; Fujishima, Tadatsune; Mizukoshi, Yasutaka; Sakamoto, Naoki; Ohmori, Tsuyoshi

    2009-01-01

    In the site of O-arai Research and Development Center of Japan Atomic Energy Agency (JAEA), five hot laboratories for post-irradiation examination and development of plutonium fuels are operated more than 30 years. A safety review method for preventive maintenance on these hot laboratories includes test facilities and devices are established in 2003. After that, the safety review of these facilities and devices are done and taken the necessary maintenance based on the results in each year. In 2008, 372 test facilities and devices in these hot laboratories were checked and reviewed by this method. As a results of the safety review, repair issues of 38 facilities of above 372 facilities were resolved. This report shows the review results and maintenance experiences based on the results. (author)

  7. A study on safety analysis methodology in spent fuel dry storage facility

    Energy Technology Data Exchange (ETDEWEB)

    Che, M. S.; Ryu, J. H.; Kang, K. M.; Cho, N. C.; Kim, M. S. [Hanyang Univ., Seoul (Korea, Republic of)

    2004-02-15

    Collection and review of the domestic and foreign technology related to spent fuel dry storage facility. Analysis of a reference system. Establishment of a framework for criticality safety analysis. Review of accident analysis methodology. Establishment of accident scenarios. Establishment of scenario analysis methodology.

  8. Status of SPACE Safety Analysis Code Development

    International Nuclear Information System (INIS)

    Lee, Dong Hyuk; Yang, Chang Keun; Kim, Se Yun; Ha, Sang Jun

    2009-01-01

    In 2006, the Korean the Korean nuclear industry started developing a thermal-hydraulic analysis code for safety analysis of PWR(Pressurized Water Reactor). The new code is named as SPACE(Safety and Performance Analysis Code for Nuclear Power Plant). The SPACE code can solve two-fluid, three-field governing equations in one dimensional or three dimensional geometry. The SPACE code has many component models required for modeling a PWR, such as reactor coolant pump, safety injection tank, etc. The programming language used in the new code is C++, for new generation of engineers who are more comfortable with C/C++ than old FORTRAN language. This paper describes general characteristics of SPACE code and current status of SPACE code development

  9. A systemic review and meta-analysis of the clinical efficacy and safety of total glucosides of peony combined with methotrexate in rheumatoid arthritis.

    Science.gov (United States)

    Feng, Zhi-Tao; Xu, Juan; He, Guo-Chao; Cai, San-Jin; Li, Juan; Mei, Zhi-Gang

    2018-01-01

    To assess the efficacy and safety of the combination of total glucoside of peony (TGP) and methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). Randomized controlled trial (RCT) data on the traditional Chinese active component TGP combined with MTX vs. MTX alone for the treatment of RA was collected by searching the Pubmed, Embase, Cochrane Library, CNKI, VIP Journals database, and Wanfang database up to February 2017. Study selection, data extraction, data synthesis, and data analyses were performed according to the Cochrane standards. A total of eight RCTs involving 522 participants were included in this meta-analysis. Compared with MTX alone, the use of TGP combined with MTX exhibited better therapeutic effects for the treatment of RA (P = 0.004). In addition, TGP combined with MTX caused a more significant decrease in erythrocyte sedimentation rate (ESR) (P TGP and MTX combination group (P = 0.0007). Our study demonstrates that TGP combined with MTX is more effective than MTX alone for the treatment of RA. Nevertheless, the adverse effects of the combination of TGP and MTX need to be further assessed. Due to the poor methodological quality of included trials, well-designed, multi-center, and large-scale RCTs are necessary to draw a more definitive conclusion.

  10. Review of methodologies for analysis of safety incidents at NPPs. Final report of a co-ordinated research project 1998-2001

    International Nuclear Information System (INIS)

    2002-03-01

    The safe operation of nuclear power plants around the world and the prevention of incidents in these installations remain key concerns for the nuclear community. In this connection, the feedback of operating experience plays a major role: every nuclear power plant or nuclear utility needs to have a system in place for collecting information on unusual events, whether these are incidents or merely deviations from normal operation. Reporting to the regulatory body of important events and lessons learned is normally carried out through the national reporting schemes based on regulatory reporting requirements. The most important lessons learned are further shared internationally, through, for example, the Joint IAEA/NEA Incident Reporting System (IRS) or the event information exchange of the World Association of Nuclear Operators (WANO). In order to properly assess the event, an adequate event investigation methodology has to be applied, which leads to the identification of correct root causes. Once these root causes have been ascertained, appropriate corrective actions can be established and corresponding lessons can be drawn. The overall goal of root cause analysis is the prevention of events or their recurrence and thus the overall improvement in plant safety. In 1998, the IAEA established a co-ordinated research project with the objective of exploring root cause methodologies and techniques currently in use in Member States, evaluating their strengths and limitations and developing criteria for appropriate event investigation methodologies. This report is the outcome of four years of co-ordinated research which involved 15 national and international research organizations

  11. Accident consequence calculations for project W-058 safety analysis

    International Nuclear Information System (INIS)

    Van Keuren, J.C.

    1997-01-01

    This document describes the calculations performed to determine the accident consequences for the W-058 safety analysis. Project W-058 is the replacement cross site transfer system (RCSTS), which is designed to transort liquid waste between the 200 W and 200 E areas. Calculations for RCSTS safety analyses used the same methods as the calculations for the Tank Waste Remediation System (TWRS) Basis for Interim Operation (BIO) and its supporting calculation notes. Revised analyses were performed for the spray and pool leak accidents since the RCSTS flows and pressures differ from those assumed in the TWRS BIO. Revision 1 of the document incorporates review comments

  12. Using systematic review in occupational safety and health.

    Science.gov (United States)

    Howard, John; Piacentino, John; MacMahon, Kathleen; Schulte, Paul

    2017-11-01

    Evaluation of scientific evidence is critical in developing recommendations to reduce risk. Healthcare was the first scientific field to employ a systematic review approach for synthesizing research findings to support evidence-based decision-making and it is still the largest producer and consumer of systematic reviews. Systematic reviews in the field of occupational safety and health are being conducted, but more widespread use and adoption would strengthen assessments. In 2016, NIOSH asked RAND to develop a framework for applying the traditional systematic review elements to the field of occupational safety and health. This paper describes how essential systematic review elements can be adapted for use in occupational systematic reviews to enhance their scientific quality, objectivity, transparency, reliability, utility, and acceptability. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  13. IRSN safety research carried out for reviewing geological disposal safety case

    International Nuclear Information System (INIS)

    Serres, Christophe; Besnus, Francois; Gay, Didier

    2010-01-01

    The Radiation Protection and Nuclear Safety Institute develops a research programme on scientific issues related to geological disposal safety in order to supporting the technical assessment carried out in the framework of the regulatory review process. This research programme is organised along key safety questions that deal with various scientific disciplines as geology, hydrogeology, mechanics, geochemistry or physics and is implemented in national and international partnerships. It aims at providing IRSN with sufficient independent knowledge and scientific skills in order to be able to assess whether the scientific results gained by the waste management organisation and their integration for demonstrating the safety of the geological disposal are acceptable with regard to the safety issues to be dealt with in the Safety Case. (author)

  14. Risk of wound infection and safety profile of amoxicillin in healthy patients which required third molar surgery: a systematic review and meta-analysis.

    Science.gov (United States)

    Isiordia-Espinoza, M A; Aragon-Martinez, O H; Martínez-Morales, J F; Zapata-Morales, J R

    2015-11-01

    The aim of this systematic review and meta-analysis was to assess the risk of surgical wound infection and the adverse effects of amoxicillin in healthy patients who required excision of third molars. We identified eligible reports from searches of PubMed, Medline®, the Cochrane Library, Imbiomed, LILACS, and Google Scholar. Studies that met our minimum requirements were evaluated using inclusion and exclusion criteria and the Oxford Quality Scale. Those with a score of 3 or more on this Scale were included and their data were extracted and analysed. For evaluation of the risk of infection the absolute risk reduction, number needed to treat, and 95% CI were calculated. For evaluation of the risk of an adverse effect the absolute risk increase, number needed to harm, and 95% CI were calculated using the Risk Reduction Calculator. Each meta-analysis was made with the help of the Mantel-Haenszel random effects model, and estimates of risk (OR) and 95% CI were calculated using the Review Manager 5.3, from the Cochrane Library. A significant risk was assumed when the lower limit of the 95% CI was greater than 1. Probabilities of less than 0.05 were accepted as significant. The results showed that there was no reduction in the risk of infection when amoxicillin was given before or after operation compared with an untreated group or placebo. In conclusion, this study suggests that amoxicillin given prophylactically or postoperatively does not reduce the risk of infection in healthy patients having their third molars extracted. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  15. Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: a systematic review and meta-analysis.

    Science.gov (United States)

    Bera, Ebrahim; Mia, Rafiq

    2012-10-08

    The package insert for nevirapine (NVP) cautions use in HIV-infected women (including pregnant women) with CD4 counts ≥250 cells/µl. However, recent studies showed that the CD4 count of pregnant women receiving antiretroviral therapy (ART) was not predictive of NVP toxicity. To determine whether ART-naive pregnant women initiating NVP-based ART at higher CD4 counts experience greater toxicity compared with pregnant women at lower CD4 counts. We reviewed studies comparing serious adverse NVP-related events among ART-naive pregnant women who commenced therapy at higher v. lower CD4 counts. Relevant studies were extracted from PubMed, SCOPUS and EMBASE, major journals and conference proceedings prior to December 2011. Authors were contacted for additional data. Data were independently extracted and entered into Review Manager. Fourteen studies (2 663 participants) were included for analysis. The odds ratio (OR) for overall NVP toxicity among pregnant women with CD4 <250 cells/µl was 0.61 (95% confidence interval (CI) 0.43 - 0.85). When analysis was restricted to prospective studies only (7 studies, 1 318 participants), the results were consistent for overall NVP toxicity (OR 0.43; 95% CI 0.25 - 0.73) and severe hepatotoxicity (OR 0.45; 95% CI 0.22 - 0.90), but not for severe cutaneous reaction (OR 0.53; 95% CI 0.26 - 1.10). Initiating NVP-based ART during pregnancy at CD4 ≥250 cells/µl increases toxicity risk and should be avoided, necessitating urgent revision of current guidelines supporting this practice.

  16. Efficacy and safety of extracorporeal shock wave therapy for acute and chronic soft tissue wounds: A systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, Li; Fu, Xiao-Bing; Chen, Shuo; Zhao, Zhan-Bo; Schmitz, Christoph; Weng, Chang-Shui

    2018-04-19

    This study aimed to evaluate and compare the effects of extracorporeal shock wave therapy (ESWT) and conventional wound therapy (CWT) for acute and chronic soft tissue wounds. All English-language articles on ESWT for acute and chronic soft tissue wounds indexed in PubMed, Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, Physiotherapy Evidence Database, and HealthSTAR published prior to June 2017 were included, as well as corresponding articles cited in reference lists of related review articles. The methodological quality of the selected studies was assessed with the Cochrane Collaboration's "risk of bias" tool. Study design, subject demographics, wound aetiology, treatment protocols, assessment indexes, and follow-up duration were extracted. The fixed or random-effects model was used to calculate the pooled effect sizes according to studies' heterogeneity. Ten randomised controlled trials (RCTs) involving 473 patients were included in this systematic review and meta-analysis. The meta-analysis showed that ESWT statistically significantly increased the healing rate of acute and chronic soft tissue wounds 2.73-fold (odds ratio, OR = 3.73, 95% confidence interval, CI: 2.30-6.04, P SMD) = 30.45; 95% CI: 23.79-37.12; P SMD = -2.86, 95% CI:-3.78 to -1.95, P SMD = -19.11, 95% CI: -23.74 to -14.47, P infection by 53% (OR = 0.47, 95% CI: 0.24-0.92, P = .03) when compared with CWT alone. Serious adverse effects were not reported. ESWT showed better therapeutic effects on acute and chronic soft tissue wounds compared with CWT alone. However, higher-quality and well-controlled RCTs are needed to further assess the role of ESWT for acute and chronic soft tissue wounds. © 2018 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

  17. Evaluation of safety assessment methodologies in Rocky Flats Risk Assessment Guide (1985) and Building 707 Final Safety Analysis Report (1987)

    International Nuclear Information System (INIS)

    Walsh, B.; Fisher, C.; Zigler, G.; Clark, R.A.

    1990-01-01

    FSARs. Rockwell International, as operating contractor at the Rocky Flats plant, conducted a safety analysis program during the 1980s. That effort resulted in Final Safety Analysis Reports (FSARs) for several buildings, one of them being the Building 707 Final Safety Analysis Report, June 87 (707FSAR) and a Plant Safety Analysis Report. Rocky Flats Risk Assessment Guide, March 1985 (RFRAG85) documents the methodologies that were used for those FSARs. Resources available for preparation of those Rocky Flats FSARs were very limited. After addressing the more pressing safety issues, some of which are described below, the present contractor (EG ampersand G) intends to conduct a program of upgrading the FSARs. This report presents the results of a review of the methodologies described in RFRAG85 and 707FSAR and contains suggestions that might be incorporated into the methodology for the FSAR upgrade effort

  18. Safety balance: Analysis of safety systems; Bilans de surete: analyse par les organismes de surete

    Energy Technology Data Exchange (ETDEWEB)

    Delage, M; Giroux, C

    1990-12-01

    Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses.

  19. Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Harsha Shanthanna

    2017-08-01

    Full Text Available Chronic Low Back Pain (CLBP is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG and Gabapentin (GB are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS, England, expressed concerns on their off-label use, in addition to the risk of misuse. We aimed to assess the effectiveness and safety of gabapentinoids in adult CLBP patients.Electronic databases of MEDLINE, EMBASE, and Cochrane were searched from their inception until December 20th, 2016. We included randomized control trials reporting the use of gabapentinoids for the treatment of CLBP of >3 months duration, in adult patients. Study selection and data extraction was performed independently by paired reviewers. Outcomes were guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief and safety as the primary outcomes. Meta-analyses were performed for outcomes reported in 3 or more studies. Outcomes were reported as mean differences (MDs or risk ratios (RRs with their corresponding 95% confidence intervals (CIs, and I2 in percentage representing the percentage variability in effect estimates that could be explained by heterogeneity. GRADE (Grading of Recommendations Assessment, Development, and Evaluation was used to assess the quality of evidence.Out of 1,385 citations, eight studies were included. Based on the interventions and comparators, studies were analyzed in 3 different groups. GB compared with placebo (3 studies, n = 185 showed minimal improvement of pain (MD = 0.22 units, 95% CI [-0.5 to 0.07] I2 = 0%; GRADE: very low. Three studies compared PG with other types of analgesic medication

  20. Accident Analysis and Highway Safety

    Directory of Open Access Journals (Sweden)

    Omar Noorliyana

    2017-01-01

    Full Text Available Since 2010, Federal Route FT050 (Jalan Batu Pahat-Kluang has undergone many changes, including the improvement of geometric features (i.e., construction of median, dedicated U-turns and additional lanes and upgrading the quality of the road surface. Unfortunately, even with these enhancements, accidents continue to occur along this route. This study covered both accident analysis and blackspot study. Accident point weightage was used to identify blackspot locations. The results reveal hazardous road locations and blackspot ranking along the route.

  1. Safety analysis methodology for OPR 1000

    International Nuclear Information System (INIS)

    Hwang-Yong, Jun

    2005-01-01

    Full text: Korea Electric Power Research Institute (KEPRI) has been developing inhouse safety analysis methodology based on the delicate codes available to KEPRI to overcome the problems arising from currently used vendor oriented methodologies. For the Loss of Coolant Accident (LOCA) analysis, the KREM (KEPRI Realistic Evaluation Methodology) has been developed based on the RELAP-5 code. The methodology was approved for the Westinghouse 3-loop plants by the Korean regulatory organization and the project to extent the methodology to the Optimized Power Reactor 1000 (OPR1000) has been ongoing since 2001. Also, for the Non-LOCA analysis, the KNAP (Korea Non-LOCA Analysis Package) has been developed using the UNICORN-TM code system. To demonstrate the feasibility of these codes systems and methodologies, some typical cases of the design basis accidents mentioned in the final safety analysis report (FSAR) were analyzed. (author)

  2. Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis

    Directory of Open Access Journals (Sweden)

    Miller LE

    2016-03-01

    Full Text Available Larry E Miller,1 Angela K Zimmermann,1 William G Herbert,1,2 1Miller Scientific Consulting, Inc., Asheville, NC, 2Department of Human Nutrition, Foods, and Exercise, Virginia Tech, Blacksburg, VA, USA Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI. We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods: MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results: A total of 14 studies (eight ReWalk™, three Ekso™, two Indego®, and one unspecified exoskeleton representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60–120 minutes per session, for 1–24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6–20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3

  3. Nuclear Safety: Technical progress review, January-March 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    This journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  4. Reviewing real-time performance of nuclear reactor safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Preckshot, G.G. [Lawrence Livermore National Lab., CA (United States)

    1993-08-01

    The purpose of this paper is to recommend regulatory guidance for reviewers examining real-time performance of computer-based safety systems used in nuclear power plants. Three areas of guidance are covered in this report. The first area covers how to determine if, when, and what prototypes should be required of developers to make a convincing demonstration that specific problems have been solved or that performance goals have been met. The second area has recommendations for timing analyses that will prove that the real-time system will meet its safety-imposed deadlines. The third area has description of means for assessing expected or actual real-time performance before, during, and after development is completed. To ensure that the delivered real-time software product meets performance goals, the paper recommends certain types of code-execution and communications scheduling. Technical background is provided in the appendix on methods of timing analysis, scheduling real-time computations, prototyping, real-time software development approaches, modeling and measurement, and real-time operating systems.

  5. Reviewing real-time performance of nuclear reactor safety systems

    International Nuclear Information System (INIS)

    Preckshot, G.G.

    1993-08-01

    The purpose of this paper is to recommend regulatory guidance for reviewers examining real-time performance of computer-based safety systems used in nuclear power plants. Three areas of guidance are covered in this report. The first area covers how to determine if, when, and what prototypes should be required of developers to make a convincing demonstration that specific problems have been solved or that performance goals have been met. The second area has recommendations for timing analyses that will prove that the real-time system will meet its safety-imposed deadlines. The third area has description of means for assessing expected or actual real-time performance before, during, and after development is completed. To ensure that the delivered real-time software product meets performance goals, the paper recommends certain types of code-execution and communications scheduling. Technical background is provided in the appendix on methods of timing analysis, scheduling real-time computations, prototyping, real-time software development approaches, modeling and measurement, and real-time operating systems

  6. Reliability analysis of software based safety functions

    International Nuclear Information System (INIS)

    Pulkkinen, U.

    1993-05-01

    The methods applicable in the reliability analysis of software based safety functions are described in the report. Although the safety functions also include other components, the main emphasis in the report is on the reliability analysis of software. The check list type qualitative reliability analysis methods, such as failure mode and effects analysis (FMEA), are described, as well as the software fault tree analysis. The safety analysis based on the Petri nets is discussed. The most essential concepts and models of quantitative software reliability analysis are described. The most common software metrics and their combined use with software reliability models are discussed. The application of software reliability models in PSA is evaluated; it is observed that the recent software reliability models do not produce the estimates needed in PSA directly. As a result from the study some recommendations and conclusions are drawn. The need of formal methods in the analysis and development of software based systems, the applicability of qualitative reliability engineering methods in connection to PSA and the need to make more precise the requirements for software based systems and their analyses in the regulatory guides should be mentioned. (orig.). (46 refs., 13 figs., 1 tab.)

  7. WNP-2 outage safety review methodology

    International Nuclear Information System (INIS)

    Chiang, Albert; Fu, James

    2004-01-01

    A practical and versatile method was developed in the flow chart and checklist forms to show the defense-in-depth for various key safety functions of a nuclear power plant during shutdown. Using four different colors (green, yellow, orange, and red) for indication of levels of defense-in-depth is visually impressive, easy to understand, and was adopted by the outage management personnel as a convenient reference tool for maintenance activity planning before the outage, and schedule changes during the outage. This paper describes the method and its application at Washington Public Power Supply System's Nuclear Project 2 (WNP-2). (author)

  8. Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Xiaoxuan Li

    2018-05-01

    Full Text Available Background: Teneligliptin is a 3rd-generation dipeptidyl peptidase-4 (DPP-4 inhibitor. There is a limited evidence regarding the effect of teneligliptin. Therefore, this study is to assess the efficacy and safety of teneligliptin in type 2 diabetes mellitus (T2DM patients with inadequately glycemic controlled.Methods: A search of PubMed, Medline, Embase, and The Cochrane Library during 2000.01–2018.03 was performed for randomized controlled trials of teneligliptin compared to placebo in patients with T2DM with monotherapy or add-on treatment.Results: Ten trials with 2119 patients were analyzed. Teneligliptin produced absolute reductions in glycated hemoglobin A1c (HbA1c levels (weighted mean difference (WMD 0.82%, 95% confidence interval (CI [−0.91 to −0.72], p < 0.00001 compared with placebo. However, after 36–42 weeks of follow-up (open-label, HbA1c level rise higher than duration (double-blind in teneligliptin group. Teneligliptin led to greater decrease of fasting plasma glucose (FPG level (vs. placebo, WMD −18.32%, 95% CI [−21.05 to −15.60], p < 0.00001. Teneligliptin also significantly decreased the 2 h post-prandial plasma glucose (2 h PPG (WMD −46.94%, 95% CI [−51.58 to −42.30], p < 0.00001 and area under the glucose plasma concentration-time curve from 0 to 2 h (AUC0−2h for PPG (WMD −71.50%, 95% CI [−78.09 to −64.91], p < 0.00001 compared with placebo. Patients treated with teneligliptin achieved increased homeostasis model assessment of β cell function (HOMA-β with 9.31 (WMD, 95% CI [7.78–10.85], p < 0.00001. However, there was no significant difference between teneligliptin and placebo in overall adverse effects (0.96 risk ratio (RR, 95% CI [0.87, 1.06], p = 0.06. The risks of hypoglycemia were not significantly different between teneligliptin and placebo (1.16 RR, 95% CI [0.59, 2.26], p = 0.66.Conclusions: Teneligliptin improved blood glucose levels and β-cells function with low risk of hypoglycemia

  9. K West integrated water treatment system subproject safety analysis document

    International Nuclear Information System (INIS)

    SEMMENS, L.S.

    1999-01-01

    This Accident Analysis evaluates unmitigated accident scenarios, and identifies Safety Significant and Safety Class structures, systems, and components for the K West Integrated Water Treatment System

  10. K West integrated water treatment system subproject safety analysis document

    Energy Technology Data Exchange (ETDEWEB)

    SEMMENS, L.S.

    1999-02-24

    This Accident Analysis evaluates unmitigated accident scenarios, and identifies Safety Significant and Safety Class structures, systems, and components for the K West Integrated Water Treatment System.

  11. Safety Review related to Commercial Grade Digital Equipment in Safety System

    International Nuclear Information System (INIS)

    Yu, Yeongjin; Park, Hyunshin; Yu, Yeongjin; Lee, Jaeheung

    2013-01-01

    The upgrades or replacement of I and C systems on safety system typically involve digital equipment developed in accordance with non-nuclear standards. However, the use of commercial grade digital equipment could include the vulnerability for software common-mode failure, electromagnetic interference and unanticipated problems. Although guidelines and standards for dedication methods of commercial grade digital equipment are provided, there are some difficulties to apply the methods to commercial grade digital equipment for safety system. This paper focuses on regulatory guidelines and relevant documents for commercial grade digital equipment and presents safety review experiences related to commercial grade digital equipment in safety system. This paper focuses on KINS regulatory guides and relevant documents for dedication of commercial grade digital equipment and presents safety review experiences related to commercial grade digital equipment in safety system. Dedication including critical characteristics is required to use the commercial grade digital equipment on safety system in accordance with KEPIC ENB 6370 and EPRI TR-106439. The dedication process should be controlled in a configuration management process. Appropriate methods, criteria and evaluation result should be provided to verify acceptability of the commercial digital equipment used for safety function

  12. Desonide: a review of formulations, efficacy and safety.

    Science.gov (United States)

    Kahanek, Nr; Gelbard, Cg; Hebert, Aa

    2008-07-01

    Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

  13. Preliminary safety analysis report for the TFTR

    International Nuclear Information System (INIS)

    Lind, K.E.; Levine, J.D.; Howe, H.J.

    A Preliminary Safety Analysis Report has been prepared for the Tokamak Fusion Test Reactor. No accident scenarios have been identified which would result in exposures to on-site personnel or the general public in excess of the guidelines defined for the project by DOE

  14. Safety analysis of accident localization system

    International Nuclear Information System (INIS)

    1999-01-01

    A complex safety analysis of accident localization system of Ignalina NPP was performed. Calculation results obtained, results of non-destruct ing testing and experimental data of reinforced concrete testing of buildings does not revealed deficiencies of buildings of accident localization system at unit 1 of Ignalina NPP. Calculations were performed using codes NEPTUNE, ALGOR, CONTAIN

  15. DESIGN PACKAGE 1E SYSTEM SAFETY ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    M. Salem

    1995-06-23

    The purpose of this analysis is to systematically identify and evaluate hazards related to the Yucca Mountain Project Exploratory Studies Facility (ESF) Design Package 1E, Surface Facilities, (for a list of design items included in the package 1E system safety analysis see section 3). This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the Design Package 1E structures/systems/components(S/S/Cs) in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the structure/system/component design, (2) add safety devices and capabilities to the designs that reduce risk, (3) provide devices that detect and warn personnel of hazardous conditions, and (4) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions.

  16. Cost benefit analysis of reactor safety systems

    International Nuclear Information System (INIS)

    Maurer, H.A.

    1984-01-01

    Cost/benefit analysis of reactor safety systems is a possibility appropriate to deal with reactor safety. The Commission of the European Communities supported a study on the cost-benefit or cost effectiveness of safety systems installed in modern PWR nuclear power plants. The following systems and their cooperation in emergency cases were in particular investigated in this study: the containment system (double containment), the leakage exhaust and control system, the annulus release exhaust system and the containment spray system. The benefit of a safety system is defined according to its contribution to the reduction of the radiological consequences for the environment after a LOCA. The analysis is so far performed in two different steps: the emergency core cooling system is considered to function properly, failure of the emergency core cooling system is assumed (with the possible consequence of core melt-down) and the results may demonstrate the evidence that striving for cost-effectiveness can produce a safer end result than the philosophy of safety at any cost. (orig.)

  17. Integrated framework for dynamic safety analysis

    International Nuclear Information System (INIS)

    Kim, Tae Wan; Karanki, Durga R.

    2012-01-01

    In the conventional PSA (Probabilistic Safety Assessment), detailed plant simulations by independent thermal hydraulic (TH) codes are used in the development of accident sequence models. Typical accidents in a NPP involve complex interactions among process, safety systems, and operator actions. As independent TH codes do not have the models of operator actions and full safety systems, they cannot literally simulate the integrated and dynamic interactions of process, safety systems, and operator responses. Offline simulation with pre decided states and time delays may not model the accident sequences properly. Moreover, when stochastic variability in responses of accident models is considered, defining all the combinations for simulations will be cumbersome task. To overcome some of these limitations of conventional safety analysis approach, TH models are coupled with the stochastic models in the dynamic event tree (DET) framework, which provides flexibility to model the integrated response due to better communication as all the accident elements are in the same model. The advantages of this framework also include: Realistic modeling in dynamic scenarios, comprehensive results, integrated approach (both deterministic and probabilistic models), and support for HRA (Human Reliability Analysis)

  18. Safety reviews of next-generation light-water reactors

    International Nuclear Information System (INIS)

    Kudrick, J.A.; Wilson, J.N.

    1997-01-01

    The Nuclear Regulatory Commission (NRC) is reviewing three applications for design certification under its new licensing process. The U.S. Advanced Boiling Water Reactor (ABWR) and System 80+ designs have received final design approvals. The AP600 design review is continuing. The goals of design certification are to achieve early resolution of safety issues and to provide a more stable and predictable licensing process. NRC also reviewed the Utility Requirements Document (URD) of the Electric Power Research Institute (EPRI) and determined that its guidance does not conflict with NRC requirements. This review led to the identification and resolution of many generic safety issues. The NRC determined that next-generation reactor designs should achieve a higher level of safety for selected technical and severe accident issues. Accordingly, NRC developed new review standards for these designs based on (1) operating experience, including the accident at Three Mile Island, Unit 2; (2) the results of probabilistic risk assessments of current and next-generation reactor designs; (3) early efforts on severe accident rulemaking; and (4) research conducted to address previously identified generic safety issues. The additional standards were used during the individual design reviews and the resolutions are documented in the design certification rules. 12 refs

  19. Systematic review and meta-analysis of the efficacy and safety of leflunomide and methotrexate in the treatment of rheumatoid arthritis.

    Science.gov (United States)

    Alfaro-Lara, Roberto; Espinosa-Ortega, Hector Fabricio; Arce-Salinas, César Alejandro

    2017-08-31

    To assess the efficacy and side effects of methotrexate and leflunomide in patients with rheumatoid arthritis (RA) as the first disease-modifying antirheumatic drug (DMARD). We performed a systematic review and meta-analysis of clinical studies that included patients who took methotrexate, leflunomide, placebo or another DMARD for RA treatment. A systematic review yielded 1971 articles from databases; once completely reviewed, 73 trials that completed inclusion criteria were selected. In structured workshops for discussion and assessment of each article, 6 could be meta-analyzed for the primary and secondary outcomes: achievement of American College of Rheumatology (ACR) 20 and its core set components; and change of serum C-reactive protein (CRP) levels, Health Assessment Questionnaire Disability Index (HAQ-Di), liver enzyme aspartate transaminase/alanine transaminase ratio, new gastrointestinal (GI) side effects and infections. A total of 1984 patients were included: 986 took leflunomide and 998 methotrexate. The probability of achieving ACR 20 had an odds ratio (OR) of 0.88 (95% confidence interval [CI] 0.74, 1.06) with a trend toward favoring methotrexate; reduction of the swollen joint count was greater for methotrexate: mean difference=0.82 (95%CI 0.24, 1.39); tender joint count, physician global assessment, HAQ-Di, and serum CRP levels revealed no significant difference between groups. Increased liver enzymes were more frequent in the leflunomide group, OR=0.38 (95%CI 0.27, 0.53), and new GI complaints were more common with methotrexate (OR=1.44; 95%CI 1.17, 1.79). There was no difference in the incidence of non-severe infections. Leflunomide used as the first DMARD in RA seemed to be as efficacious as methotrexate; only the reduction of swollen joint count was more marked for methotrexate. Leflunomide was linked to a greater increase in liver enzymes, but there were fewer GI complaints. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de

  20. Review of the German Reactor Safety Study

    International Nuclear Information System (INIS)

    Bayer, A.

    1980-01-01

    The accident risks in German nuclear power plants are reviewed. Parameters influencing the extent and consequences of an accident are differentiated. Risks of normal operation, war, and sabotage have not been considered. Measures taken by the operating shaft in the course of an accident are taken into account. The knowledge thus gained can be applied in the planning of emergency measures. (DG) [de

  1. The Safety of Artemisinin Derivatives for the Treatment of Malaria in the 2nd or 3rd Trimester of Pregnancy: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Stephanie D Kovacs

    Full Text Available Given the high morbidity for mother and fetus associated with malaria in pregnancy, safe and efficacious drugs are needed for treatment. Artemisinin derivatives are the most effective antimalarials, but are associated with teratogenic and embryotoxic effects in animal models when used in early pregnancy. However, several organ systems are still under development later in pregnancy. We conducted a systematic review and meta-analysis of the occurrence of adverse pregnancy outcomes among women treated with artemisinins monotherapy or as artemisinin-based combination therapy during the 2nd or 3rd trimesters relative to pregnant women who received non-artemisinin antimalarials or none at all. Pooled odds ratio (POR were calculated using Mantel-Haenszel fixed effects model with a 0.5 continuity correction for zero events. Eligible studies were identified through Medline, Embase, and the Malaria in Pregnancy Consortium Library. Twenty studies (11 cohort studies and 9 randomized controlled trials contributed to the analysis, with 3,707 women receiving an artemisinin, 1,951 a non-artemisinin antimalarial, and 13,714 no antimalarial. The PORs (95% confidence interval (CI for stillbirth, fetal loss, and congenital anomalies when comparing artemisinin versus quinine were 0.49 (95% CI 0.24-0.97, I2 = 0%, 3 studies; 0.58 (95% CI 0.31-1.16, I2 = 0%, 6 studies; and 1.00 (95% CI 0.27-3.75, I2 = 0%, 3 studies, respectively. The PORs comparing artemisinin users to pregnant women who received no antimalarial were 1.13 (95% CI 0.77-1.66, I2 = 86.7%, 3 studies; 1.10 (95% CI 0.79-1.54, I2 = 0%, 4 studies; and 0.79 (95% CI 0.37-1.67, I2 = 0%, 3 studies for miscarriage, stillbirth and congenital anomalies respectively. Treatment with artemisinin in 2nd and 3rd trimester was not associated with increased risks of congenital malformations or miscarriage and may be was associated with a reduced risk of stillbirths compared to quinine. This study updates the reviews

  2. Review of Risk Reduction Methods using Probabilistic Safety Assessment Insights and Improved Technology

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun-Chan; Choi, Byung-Pil [Korea Hydro and Nuclear Power Co., Daejeon (Korea, Republic of)

    2016-10-15

    As seen in the process of the periodic safety review of domestic nuclear power plants, the risk management objectives such as core damage frequency and large early release frequency are not easy to be met without continuous safety improvements and the integratoin of the improved technologies into the PSA evaluation methodologies. Because external event analyses have a protion of uncertainty factors in the current analysis methodologies, the technical efforts in various perspectives.

  3. Deterministic and probabilistic approach to safety analysis

    International Nuclear Information System (INIS)

    Heuser, F.W.

    1980-01-01

    The examples discussed in this paper show that reliability analysis methods fairly well can be applied in order to interpret deterministic safety criteria in quantitative terms. For further improved extension of applied reliability analysis it has turned out that the influence of operational and control systems and of component protection devices should be considered with the aid of reliability analysis methods in detail. Of course, an extension of probabilistic analysis must be accompanied by further development of the methods and a broadening of the data base. (orig.)

  4. Safety review on unit testing of safety system software of nuclear power plant

    International Nuclear Information System (INIS)

    Liu Le; Zhang Qi

    2013-01-01

    Software unit testing has an important place in the testing of safety system software of nuclear power plants, and in the wider scope of the verification and validation. It is a comprehensive, systematic process, and its documentation shall meet the related requirements. When reviewing software unit testing, attention should be paid to the coverage of software safety requirements, the coverage of software internal structure, and the independence of the work. (authors)

  5. Review of actinide nitride properties with focus on safety aspects

    Energy Technology Data Exchange (ETDEWEB)

    Albiol, Thierry [CEA Cadarache, St Paul Lez Durance Cedex (France); Arai, Yasuo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    This report provides a review of the potential advantages of using actinide nitrides as fuels and/or targets for nuclear waste transmutation. Then a summary of available properties of actinide nitrides is given. Results from irradiation experiments are reviewed and safety relevant aspects of nitride fuels are discussed, including design basis accidents (transients) and severe (core disruptive) accidents. Anyway, as rather few safety studies are currently available and as many basic physical data are still missing for some actinide nitrides, complementary studies are proposed. (author)

  6. Survey of systems safety analysis methods and their application to nuclear waste management systems

    International Nuclear Information System (INIS)

    Pelto, P.J.; Winegardner, W.K.; Gallucci, R.H.V.

    1981-11-01

    This report reviews system safety analysis methods and examines their application to nuclear waste management systems. The safety analysis methods examined include expert opinion, maximum credible accident approach, design basis accidents approach, hazard indices, preliminary hazards analysis, failure modes and effects analysis, fault trees, event trees, cause-consequence diagrams, G0 methodology, Markov modeling, and a general category of consequence analysis models. Previous and ongoing studies on the safety of waste management systems are discussed along with their limitations and potential improvements. The major safety methods and waste management safety related studies are surveyed. This survey provides information on what safety methods are available, what waste management safety areas have been analyzed, and what are potential areas for future study

  7. Survey of systems safety analysis methods and their application to nuclear waste management systems

    Energy Technology Data Exchange (ETDEWEB)

    Pelto, P.J.; Winegardner, W.K.; Gallucci, R.H.V.

    1981-11-01

    This report reviews system safety analysis methods and examines their application to nuclear waste management systems. The safety analysis methods examined include expert opinion, maximum credible accident approach, design basis accidents approach, hazard indices, preliminary hazards analysis, failure modes and effects analysis, fault trees, event trees, cause-consequence diagrams, G0 methodology, Markov modeling, and a general category of consequence analysis models. Previous and ongoing studies on the safety of waste management systems are discussed along with their limitations and potential improvements. The major safety methods and waste management safety related studies are surveyed. This survey provides information on what safety methods are available, what waste management safety areas have been analyzed, and what are potential areas for future study.

  8. A review of the probabilistic safety assessment application to the TR-2 research reactor

    International Nuclear Information System (INIS)

    Goektepe, G.; Adalioglu, U.; Anac, H.; Sevdik, B.; Menteseoglu, S.

    2001-01-01

    A review