WorldWideScience

Sample records for evaluate blood safety

  1. Evaluation of fluid warmer safety using hemorheologic analysis with outdated human blood.

    Science.gov (United States)

    Kim, Hee Jung; Yoo, Sung Mook; Chung, Jae Ho; Kim, Tae Sik; Lee, Sung Ho; Son, Ho Sung

    2016-01-01

    A newly developed fluid warmer (ThermoSens®) has a direct blood warming plate, which can result in hemolysis or red blood cell injury during heating. Therefore, to evaluate the safety of heating blood products with a fluid warmer, we conducted laboratory tests to study hemolysis and erythrocyte rheology. We used outdated human blood taken from a Korean blood bank. Packed red blood cells mixed with 100 mL isotonic saline was passed through the fluid warmer. Blood flow was achieved by either gravity or 300 mmHg pressure. Blood samples were analyzed before and after heating for hemolysis marker and erythrocyte rheology parameters. The temperatures at the outlet were higher than 38°C at gravity and 300 mmHg pressure, respectively. There were no significant differences in hemolysis markers (hemoglobin, hematocrit, lactate dehydrogenase, and plasma free hemoglobin) or erythrocyte rheology (deformability, disaggregating shear stress, and aggregation index) between before and after heating (p >  0.05) except LDH at gravity (p = 0.0001). The ThermoSens® fluid warmer caused no erythrocyte injury or negative effects on rheology during heating. Regarding medical device development, hemorheologic analysis can be useful for safety evaluation of medical devices that directly contact blood for temperature modulation.

  2. Globalisation and blood safety.

    Science.gov (United States)

    Farrugia, Albert

    2009-05-01

    Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to

  3. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.

    Directory of Open Access Journals (Sweden)

    Rolf Burghaus

    Full Text Available Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist, enoxaparin (an indirect thrombin/Factor Xa inhibitor and dabigatran (a direct thrombin inhibitor. A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies.

  4. Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation

    Science.gov (United States)

    Burghaus, Rolf; Coboeken, Katrin; Gaub, Thomas; Kuepfer, Lars; Sensse, Anke; Siegmund, Hans-Ulrich; Weiss, Wolfgang; Mueck, Wolfgang; Lippert, Joerg

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration–effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

  5. Health economics of blood transfusion safety

    NARCIS (Netherlands)

    Hulst, Marinus van

    2008-01-01

    The HIV/AIDS disaster in transfusion medicine shaped the future agendas for blood transfusion safety. More than ever before, the implementation of interventions which could improve blood transfusion safety was driven merely by availability of technology. The introduction of new expensive

  6. Blood transfusion safety: a new philosophy.

    Science.gov (United States)

    Franklin, I M

    2012-12-01

    Blood transfusion safety has had a chequered history, and there are current and future challenges. Internationally, there is no clear consensus for many aspects of the provision of safe blood, although pan-national legislation does provide a baseline framework in the European Union. Costs are rising, and new safety measures can appear expensive, especially when tested against some other medical interventions, such as cancer treatment and vaccination programmes. In this article, it is proposed that a comprehensive approach is taken to the issue of blood transfusion safety that considers all aspects of the process rather than considering only new measures. The need for an agreed level of safety for specified and unknown risks is also suggested. The importance of providing care and support for those inadvertently injured as a result of transfusion problems is also made. Given that the current blood safety decision process often uses a utilitarian principle for decision making--through the calculation of Quality Adjusted Life Years--an alternative philosophy is proposed. A social contract for blood safety, based on the principles of 'justice as fairness' developed by John Rawls, is recommended as a means of providing an agreed level of safety, containing costs and providing support for any adverse outcomes. © 2012 The Author. Transfusion Medicine © 2012 British Blood Transfusion Society.

  7. [Haemovigilance and blood safety in overseas military].

    Science.gov (United States)

    Sailliol, A; Plang, S; Martinaud, C; Pouget, T; Vedy, S; Clavier, B; Cellarier, V; Roche, C; Civadier, C; Ausset, S

    2014-11-01

    The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. Challenges of safety evaluation.

    Science.gov (United States)

    Wiesner, Jacqueline

    2014-12-02

    Each application for authorisation of a medicinal product must be accompanied by the particulars and documents referred to in Directive 2001/83/EC on the Community code relating to medicinal products for human use. Details on the documentation needed for traditional herbal medicinal products (THMP) are given in article 16c of the above mentioned Directive. It is pointed out that a bibliographic review of safety data together with an expert report and additional data, if necessary, are required. The Committee on Herbal Medicinal Products (HMPC) provides in its "Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products" (EMA/HMPC/71049/2007 Rev. 1) guidance on how to present the information and the dossier needed for an application. There, in agreement with the Directive 2001/83/EC, a bibliographical review of safety data is required within the "Non-clinical Overview". However, it is assumable that for such products, with a long tradition of usage bibliographical information relating to non-clinical safety are available, even if incomplete or not in accordance with today׳s state of the art. In the "Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration" (EMEA/HMPC/32116/2005) it is reflected how to deal with such an incomplete set of data for traditional herbal medicinal products and crucial information are highlighted. This article will focus on the explanation of the requirements needed for the non-clinical safety evaluation of THMPs and some detailed explanations of the performance and interpretation of the mutagenicity studies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. Safety evaluation of daidzein in laying hens: Effects on laying performance, hatchability, egg quality, clinical blood parameters, and organ development.

    Science.gov (United States)

    Lu, J; Qu, L; Shen, M M; Li, S M; Dou, T C; Hu, Y P; Wang, K H

    2017-07-01

    Daidzein has become increasingly popular as a dietary supplement, particularly for postpeak-estrus animals, as a safe and natural alternative estrogen-like compound. However, there is little available safety data of daidzein in laying hens. A study was conducted to examine if high-dose daidzein affected the safety of hens, including mortality, laying performance, egg quality, hematological parameters, clinical chemical parameters, organ development parameters, and hatchability. A total of 2,448 42-wk-old Rugao laying hens were randomly assigned to 4 groups with 6 replicates of 102 birds each (612 laying hens per group). After a 2-wk acclimation period, the birds were fed diets supplemented with 0, 10, 100, or 200 mg/kg of daidzein for 12 wk. The hatchability of setting eggs increased linearly with increasing dietary daidzein supplementation (P = 0.034), while the hatchability of fertile eggs also tended to increase linearly (P = 0.069). The red cell distribution width (RCDW) and coefficient variation of RCDW showed an increasing and then decreasing quadratic response to increasing dietary daidzein supplementation (P = 0.001 and 0.002, respectively). No statistically significant changes were observed in mortality, laying performance, egg quality, clinical chemistry parameters, or organ development parameters (P > 0.05). The magnitude of these hematological changes was such that they were considered to be of no toxicological significance. Therefore, a nominal daidzein concentration of 200 mg/kg is not expected to cause adverse effects following daily administration to laying hens for 84 d. © 2017 Poultry Science Association Inc.

  10. [Blood transfusion and supply chain management safety].

    Science.gov (United States)

    Quaranta, Jean-François; Caldani, Cyril; Cabaud, Jean-Jacques; Chavarin, Patricia; Rochette-Eribon, Sandrine

    2015-02-01

    The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  11. A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

    Science.gov (United States)

    McCarthy, James S; Rückle, Thomas; Djeriou, Elhadj; Cantalloube, Cathy; Ter-Minassian, Daniel; Baker, Mark; O'Rourke, Peter; Griffin, Paul; Marquart, Louise; Hooft van Huijsduijnen, Rob; Möhrle, Jörg J

    2016-09-13

    Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers. Male and non-pregnant female aged 18-50 years were screened for this phase II, controlled, single-centre clinical trial. Subjects were inoculated with ~1800 viable Plasmodium falciparum 3D7A-infected human erythrocytes, and treated with a single-dose of 800 mg ferroquine. Blood samples were taken at defined time-points to measure PK and PD parameters. The blood concentration of ferroquine and its active metabolite, SSR97213, were measured on dry blood spot samples by ultra-performance liquid chromatography with tandem mass spectrometry (LC-MS/MS). Parasitaemia and emergence of gametocytes were monitored by quantitative PCR. Safety was determined by recording adverse events and monitoring clinical laboratory assessments during the course of the study. Eight subjects were enrolled into the study, inoculated with infected erythrocytes and treated with 800 mg ferroquine. Ferroquine was rapidly absorbed with maximal exposure after 4-8 and 4-12 h exposure for SSR97213. Non-compartmental PK analysis resulted in estimates for half-lives of 10.9 and 23.8 days for ferroquine and SSR97213, respectively. Parasite clearance as reported by parasite reduction ratio was 162.9 (95 % CI 141-188) corresponding to a parasite clearance half-life of 6.5 h (95 % CI: 6.4-6.7 h). PK/PD modelling resulted in a predicted minimal parasiticidal concentration of 20 ng/mL, and the single dosing tested in this study was predicted to maintain an exposure above this threshold for 454 h (37.8 days). Although ferroquine was overall well tolerated, transient elevated transaminase levels were observed in three subjects. Paracetamol was the only concomitant treatment among the two out of these three subjects

  12. LNG Safety Assessment Evaluation Methods

    Energy Technology Data Exchange (ETDEWEB)

    Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Angela Christine [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-05-01

    Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods were evaluated for their potential applicability for use in the LNG railroad application. After reviewing the documents included in this report, as well as others not included because of repetition, the Department of Energy (DOE) Hydrogen Safety Plan Checklist is most suitable to be adapted to the LNG railroad application. This report was developed to survey industries related to rail transportation for methodologies and tools that can be used by the FRA to review and evaluate safety assessments submitted by the railroad industry as a part of their implementation plans for liquefied or compressed natural gas storage ( on-board or tender) and engine fueling delivery systems. The main sections of this report provide an overview of various methods found during this survey. In most cases, the reference document is quoted directly. The final section provides discussion and a recommendation for the most appropriate methodology that will allow efficient and consistent evaluations to be made. The DOE Hydrogen Safety Plan Checklist was then revised to adapt it as a methodology for the Federal Railroad Administration’s use in evaluating safety plans submitted by the railroad industry.

  13. Approaches to advancing blood safety through haemovigilance: A ...

    African Journals Online (AJOL)

    Background: Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. Objective: To examine the contribution of haemovigilance to blood safety, ...

  14. The infectious disease blood safety risk of Australian hemochromatosis donations.

    Science.gov (United States)

    Hoad, Veronica; Bentley, Peter; Bell, Barbara; Pathak, Praveen; Chan, Hiu Tat; Keller, Anthony

    2016-12-01

    It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile. © 2016 AABB.

  15. Blood transfusion safety; current status and challenges in Nigeria

    Science.gov (United States)

    Aneke, John C.; Okocha, Chide E.

    2017-01-01

    The attainment of blood transfusion safety in Nigeria (and probably the rest of Sub-Saharan Africa) remains an uphill task due to a number of factors, ranging from shortage of blood, poor implementation of blood transfusion guidelines, infrastructural deficits to high prevalence of transfusion-transmissible infections (TTIs), particularly hepatitis and human immune deficiency viruses. We reviewed available data on blood transfusion practices and safety in Nigeria using the PubMed, PubMed Central, Google Scholar, and African Index Medicus search engines, through a combination of word and phrases relevant to the subject. The World Health Organization has been in the forefront of efforts to establish safe, available, and affordable blood transfusion services in most parts of Africa through encouraging adequate blood donor recruitment, donor blood testing, and collection as well developing strategies for the rational use of blood. Even though modest improvement has been recorded, particularly with regards to donor blood screening for common TTIs, considerable efforts are needed in the form of robust public enlightenment campaigns (on blood donation) and continuous system improvement to drive the current transfusion practices in the country toward safety and self-sustenance. PMID:28316432

  16. Approaches to advancing blood safety through haemovigilance: A ...

    African Journals Online (AJOL)

    Approaches to advancing blood safety through haemovigilance: A review. ... Abstract. Background: Blood transfusion is always associated with some level of risk. Haemovigilance ... Data sources: The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language.

  17. Safety climate and attitude as evaluation measures of organizational safety.

    Science.gov (United States)

    Isla Díaz, R; Díaz Cabrera, D

    1997-09-01

    The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

  18. [Blood transfusion - safety of the inventory].

    Science.gov (United States)

    Tissot, Jean-Daniel; Danic, Bruno; Schneider, Thierry

    2015-02-01

    Over the years, transfusion medicine has been faced to many different problems, notably those related to transmission of pathogens. Major progresses have been accomplished in terms of security. However, nowadays, the discipline is confronted to the day-to-day variability and availability of blood products. More and more donors are excluded from blood donation due to various reasons, and the donor selection criteria have increased over the years, influencing the number of donors able to give blood. This paradox represents one of the constraints that transfusion medicine should resolve in the future. This paper presents some aspects either common or different between France and Switzerland. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  19. Blood safety and availability: continuing challenges in China's blood banking system.

    Science.gov (United States)

    Shi, Ling; Wang, Jing-Xing; Stevens, Lori; Ness, Paul; Shan, Hua

    2014-02-01

    Social and economic development, along with increased health care coverage, has caused a sharp increase in the clinical demand for blood in China. Whole blood collection has increased rapidly in the past decade but has failed to keep pace with the ever-increasing demand. Overall, the country's blood safety has been improved with 99% of whole blood donations collected from voluntary unpaid donors. However, the unmet clinical demand for blood and the increasing incidence of human immunodeficiency virus and syphilis in the general population pose new challenges to China's blood banking system. To ensure a safe and adequate blood supply, continued efforts are required to recruit and retain a sufficient number of low-risk voluntary blood donors, improve donor prescreening and blood testing process, ease donor restrictions, and strengthen patient blood management. © 2013 American Association of Blood Banks.

  20. Approaches to advancing blood safety through haemovigilance: a review.

    Science.gov (United States)

    Mwangi, J W; Kimani, D; Oduor, M

    2009-12-01

    Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. To examine the contribution of haemovigilance to blood safety, including the approaches that some countries have taken to institute haemovigilance, and explore routes through which countries without such systems can achieve them. The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language. Reputable journals on the topic of haemovigilance were examined for abstracts and papers. Abstracts based on known credible and distinguished sources were selected. Information on haemovigilance and the processes of developing haemovigilance in various countries was reviewed. The information from selected papers and abstracts was used for writing this paper. Varying processes for haemovigilance have been adopted by different countries. The more advanced systems have national/regional coordinating mechanisms. Availability of haemovigilance data has given transfusion services a clear understanding of problems associated with transfusion that need to be solved so as to improve transfusion safety. Although countries in sub-Saharan Africa have made considerable progress in enhancing blood safety in the recent past, nationally coordinated haemovigilance systems are lacking. Focus on haemovigilance systems is considered the next frontier to be conquered in enhancing blood safety in the region.

  1. Can a decentralized blood system ensure self-sufficiency and blood safety? The Lebanese experience.

    Science.gov (United States)

    Haddad, Antoine; Bou Assi, Tarek; Garraud, Olivier

    2017-08-01

    Lebanon has adopted a liberal economic system that also applies to healthcare procurement. There is no national Lebanese blood transfusion service and the blood supply is divided between a large number of licensed (45 per cent) and unlicensed (55 per cent) blood banks, many of them issuing a very limited number of blood components. All blood banks are hospital based and operate the entire transfusion chain, from collection to the release of blood units. Blood donation is voluntary and non-remunerated in 20-25 per cent of donations; it relies principally on replacement donations. Recently, Lebanon has faced political instability and war, and now welcomes an enormous number of refugees from neighboring countries at war. This has had an important impact on heath care and on the transfusion supply. We discuss the impact of the blood donation organization on the transfusion safety and ethics, to set the foundation for a more developed and safer transfusion programs.

  2. Arthroscopic latarjet procedure: safety evaluation in cadavers

    National Research Council Canada - National Science Library

    Gracitelli, Mauro Emilio Conforto; Ferreira, Arnaldo Amado; Benegas, Eduardo; Malavolta, Eduardo Angeli; Sunada, Edwin Eiji; Assunção, Jorge Henrique

    2013-01-01

    To evaluate the safety of arthroscopic Latarjet procedure in cadavers. : Twelve cadaveric shoulders underwent arthroscopic Latarjet procedure in our laboratory for arthroscopy, by four different surgeons...

  3. Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors.

    Directory of Open Access Journals (Sweden)

    Susanne H Sheehy

    Full Text Available Traditionally, vaccine development against the blood-stage of Plasmodium falciparum infection has focused on recombinant protein-adjuvant formulations in order to induce high-titer growth-inhibitory antibody responses. However, to date no such vaccine encoding a blood-stage antigen(s alone has induced significant protective efficacy against erythrocytic-stage infection in a pre-specified primary endpoint of a Phase IIa/b clinical trial designed to assess vaccine efficacy. Cell-mediated responses, acting in conjunction with functional antibodies, may be necessary for immunity against blood-stage P. falciparum. The development of a vaccine that could induce both cell-mediated and humoral immune responses would enable important proof-of-concept efficacy studies to be undertaken to address this question.We conducted a Phase Ia, non-randomized clinical trial in 16 healthy, malaria-naïve adults of the chimpanzee adenovirus 63 (ChAd63 and modified vaccinia virus Ankara (MVA replication-deficient viral vectored vaccines encoding two alleles (3D7 and FVO of the P. falciparum blood-stage malaria antigen; apical membrane antigen 1 (AMA1. ChAd63-MVA AMA1 administered in a heterologous prime-boost regime was shown to be safe and immunogenic, inducing high-level T cell responses to both alleles 3D7 (median 2036 SFU/million PBMC and FVO (median 1539 SFU/million PBMC, with a mixed CD4(+/CD8(+ phenotype, as well as substantial AMA1-specific serum IgG responses (medians of 49 µg/mL and 41 µg/mL for 3D7 and FVO AMA1 respectively that demonstrated growth inhibitory activity in vitro.ChAd63-MVA is a safe and highly immunogenic delivery platform for both alleles of the AMA1 antigen in humans which warrants further efficacy testing. ChAd63-MVA is a promising heterologous prime-boost vaccine strategy that could be applied to numerous other diseases where strong cellular and humoral immune responses are required for protection.ClinicalTrials.gov NCT01095055.

  4. Improving blood safety: Errors management in transfusion medicine

    Directory of Open Access Journals (Sweden)

    Bujandrić Nevenka

    2014-01-01

    Full Text Available Introduction. The concept of blood safety includes the entire transfusion chain starting with the collection of blood from the blood donor, and ending with blood transfusion to the patient. The concept involves quality management system as the systematic monitoring of adverse reactions and incidents regarding the blood donor or patient. Monitoring of near-miss errors show the critical points in the working process and increase transfusion safety. Objective. The aim of the study was to present the analysis results of adverse and unexpected events in transfusion practice with a potential risk to the health of blood donors and patients. Methods. One-year retrospective study was based on the collection, analysis and interpretation of written reports on medical errors in the Blood Transfusion Institute of Vojvodina. Results. Errors were distributed according to the type, frequency and part of the working process where they occurred. Possible causes and corrective actions were described for each error. The study showed that there were not errors with potential health consequences for the blood donor/patient. Errors with potentially damaging consequences for patients were detected throughout the entire transfusion chain. Most of the errors were identified in the preanalytical phase. The human factor was responsible for the largest number of errors. Conclusion. Error reporting system has an important role in the error management and the reduction of transfusion-related risk of adverse events and incidents. The ongoing analysis reveals the strengths and weaknesses of the entire process and indicates the necessary changes. Errors in transfusion medicine can be avoided in a large percentage and prevention is costeffective, systematic and applicable.

  5. EVALUATION OF MICROBIOLOGICAL SAFETY OF

    African Journals Online (AJOL)

    user

    (in Hausa), Moringa Oleifera or “Zogale” (in Hausa). Indigofera astragalina or .... material during collection, drying, processing and dispensing. ... (Garlic seed oil). Pure and natural garlic seed oil. Artery expansion, blood pressure, cholesterol control, skin disease, anti- malaria. Oral. 8. YK2. Black seed oil. Black seed oil.

  6. Mucocutaneous blood contact: blood release behavior of safety peripheral intravenous catheters.

    Science.gov (United States)

    Wittmann, Andreas; Köver, Jan; Kralj, Nenad; Gasthaus, Klaus; Tosch, Marco; Hofmann, Friedrich

    2013-12-01

    Protection against needlestick injuries has significantly improved in recent years thanks to so-called "safety devices." However, a potential drawback occasionally reported by users is a risk of blood splashing. If this blood comes in contact with the mucous membranes, it could lead to an infection. Five safety peripheral intravenous catheter brands were examined in a laboratory test. To simulate the extreme situations, which may arise through human use, the introducer needle was withdrawn from the catheter at 2 different angles whereby an industrial robot was used to simulate the sequence of this movement. Each brand was tested 30 times. The experiment was carried out using radioactively labeled human whole blood. The measurements for the transmitted volume of blood was taken both from an artificial head and from a surface measuring 18.5 cm by 26.5 cm at a height of 30 cm above the catheter; scintigraphy was used to take the measurements. The volume of blood droplets potentially splashing into the mucous membranes was in the range of 1 nL. For normal virus concentrations in the blood of sick patients, this dose is too small to cause hepatitis C and HIV. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  7. SAFETY CONSIDERATIONS WITH BLOOD FLOW RESTRICTED RESISTANCE TRAINING

    Directory of Open Access Journals (Sweden)

    Alan Kacin

    2015-11-01

    Full Text Available Blood flow restricted resistance (BFRR training with pneumatic tourniquet has been suggested as an alternative for conventional weight training due to the proven benefits for muscle strength and hypertrophy using relatively low resistance, hence reducing the mechanical stress across a joint. As such, it has become an important part of rehabilitation programs used in either injured or operated athletes. Despite a general consensus on effectiveness of BFRR training for muscle conditioning, there are several uncertainties regarding the interplay of various extrinsic and intrinsic factors on its safety and efficiency, which are being reviewed from a clinical perspective. Among extrinsic factors tourniquet cuff pressure, size and shape have been identified as key for safety and efficiency. Among intrinsic factors, limb anthropometrics, patient history and presence of cardiac, vascular, metabolic or peripheral neurologic conditions have been recognized as most important. Though there are a few potential safety concerns connected to BFRR training, the following have been identified as the most probable and health-hazardous: (a mechanical injury to the skin, muscle, and peripheral nerves, (b venous thrombosis due to vascular damage and disturbed hemodynamics and (c augmented arterial blood pressure responses due to combined high body exertion and increased peripheral vascular resistance. Based on reviewed literature and authors’ personal experience with the use of BFRR training in injured athletes, some guidelines for its safe application are outlined. Also, a comprehensive risk assessment tool for screening of subjects prior to their inclusion in a BFRR training program is being introduced.

  8. Prospective safety performance evaluation on construction sites.

    Science.gov (United States)

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Pathogen Inactivation Technologies: The Advent of Pathogen-Reduced Blood Components to Reduce Blood Safety Risk.

    Science.gov (United States)

    Devine, Dana V; Schubert, Peter

    2016-06-01

    Pathogen inactivation technologies represent a shift in blood safety from a reactive approach to a proactive protective strategy. Commercially available technologies demonstrate effective killing of most viruses, bacteria, and parasites and are capable of inactivating passenger leukocytes in blood products. The use of pathogen inactivation causes a decrease in the parameters of products that can be readily measured in laboratory assays but that do not seem to cause any alteration in hemostatic effect of plasma or platelet transfusions. Effort needs to be made to further develop these technologies so that the negative quality impact is ameliorated without reducing the pathogen inactivation effectiveness. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Plutonium Finishing Plant safety evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1995-01-01

    The Plutonium Finishing Plant (PFP) previously known as the Plutonium Process and Storage Facility, or Z-Plant, was built and put into operation in 1949. Since 1949 PFP has been used for various processing missions, including plutonium purification, oxide production, metal production, parts fabrication, plutonium recovery, and the recovery of americium (Am-241). The PFP has also been used for receipt and large scale storage of plutonium scrap and product materials. The PFP Final Safety Analysis Report (FSAR) was prepared by WHC to document the hazards associated with the facility, present safety analyses of potential accident scenarios, and demonstrate the adequacy of safety class structures, systems, and components (SSCs) and operational safety requirements (OSRs) necessary to eliminate, control, or mitigate the identified hazards. Documented in this Safety Evaluation Report (SER) is DOE`s independent review and evaluation of the PFP FSAR and the basis for approval of the PFP FSAR. The evaluation is presented in a format that parallels the format of the PFP FSAR. As an aid to the reactor, a list of acronyms has been included at the beginning of this report. The DOE review concluded that the risks associated with conducting plutonium handling, processing, and storage operations within PFP facilities, as described in the PFP FSAR, are acceptable, since the accident safety analyses associated with these activities meet the WHC risk acceptance guidelines and DOE safety goals in SEN-35-91.

  11. Safety evaluation of synthetic β-carotene

    NARCIS (Netherlands)

    Woutersen, R.A.; Wolterbeek, A.P.M.; Appel, M.J.; Berg, H. van den; Goldbohm, R.A.; Feron, V.J.

    1999-01-01

    The safety of β-carotene was reassessed by evaluating the relevant literature on the beneficial and adverse effects of β-carotene on cancer and, in particular, by evaluating the results of toxicity studies. β- Carotene appeared neither genotoxic nor reprotoxic or teratogenic, and no signs of organ

  12. Safety evaluation of superabsorbent baby diapers.

    Science.gov (United States)

    Kosemund, Kirstin; Schlatter, Harald; Ochsenhirt, Jennifer L; Krause, Edburga L; Marsman, Daniel S; Erasala, Geetha N

    2009-03-01

    Superabsorbent disposable baby diapers are sophisticated, well-engineered products that provide many benefits including convenience, comfort, exceptional leakage protection, improved hygiene and skin care benefits compared with cloth diapers. Safety assurance is an integral part of the diaper development process at Procter & Gamble, with the goal of ensuring safety for both caregivers and babies. A systematic, stepwise approach to safety assessment starts with a thorough evaluation of new design features and materials, using the principles of general risk assessment including, as appropriate, controlled trials to assess clinical endpoints or independent scientific review of safety data. The majority of the diaper materials are polymers that are safe and do not have inherent toxicity issues. Trace amounts of non-polymeric materials, such as colorants, are assessed based on their skin contact potential. New materials or design features are introduced in marketed products only if they have been shown to be safe under the conditions of recommended or foreseeable use. The product safety continues to be confirmed after launch by means of in-market monitoring. This article provides a broad overview of human safety exposure-based risk assessment used at Procter & Gamble for absorbent hygiene products.

  13. Expensive blood safety initiatives may offer less benefit than we think

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Hjalgrim, Henrik; Edgren, Gustaf

    2010-01-01

    Various blood safety initiatives have ensured a historically low risk of infection transmission through blood transfusion. Although further prevention of infection transmission is possible through, for example, nucleic acid testing and future introduction of pathogen inactivation, such initiatives...

  14. Safety insights from forensics evaluations at Daiichi

    Directory of Open Access Journals (Sweden)

    J. Rempe

    2017-01-01

    Information obtained from Daiichi is required to inform Decontamination and Decommissioning activities, improving the ability of the Tokyo Electric Power Company (TEPCO to characterize potential hazards and to ensure the safety of workers involved with cleanup activities. This paper reports initial results from the US Forensics Effort to utilize examination information obtained by TEPCO to enhance the safety of existing and future nuclear power plant designs. In this paper, three examples are presented in which examination information, such as visual images, dose surveys, sample evaluations, and muon tomography examinations, along with data from plant instrumentation, are used to obtain significant safety insights in the areas of component performance, fission product release and transport, debris end-state location, and combustible gas generation and transport. In addition to reducing uncertainties related to severe accident modeling progression, these insights confirm actions, such as the importance of water addition and containment venting, that are emphasized in updated guidance for severe accident prevention, mitigation, and emergency planning.

  15. United States pharmacopeia safety evaluation of spirulina.

    Science.gov (United States)

    Marles, Robin J; Barrett, Marilyn L; Barnes, Joanne; Chavez, Mary L; Gardiner, Paula; Ko, Richard; Mahady, Gail B; Low Dog, Tieraona; Sarma, Nandakumara D; Giancaspro, Gabriel I; Sharaf, Maged; Griffiths, James

    2011-08-01

    The Dietary Supplements Information Expert Committee (DSI-EC) of the United States Pharmacopeial Convention (USP) reviews the safety of dietary supplements and dietary supplement ingredients for the purpose of determining whether they should be admitted as quality monographs into the United States Pharmacopeia and National Formulary (USP-NF). The United States Food and Drug Administration (FDA) has enforcement authority to pursue a misbranding action in those instances where a dietary supplement product indicates that it conforms to USP standards but fails to so conform. Recently DSI-EC undertook a safety evaluation of spirulina, a widely used dietary ingredient. DSI-EC reviewed information from human clinical trials, animal studies, and regulatory and pharmacopeial sources and analyzed 31 adverse event reports regarding spirulina to assess potential health concerns. At the conclusion of this review, DSI-EC assigned a Class A safety rating for Spirulina maxima and S. platensis, thereby permitting the admission of quality monographs for these dietary supplement ingredients in USP-NF. DSI-EC continually monitors reports concerning the safety of dietary supplements and dietary supplement ingredients for which USP dietary supplement monographs are developed. The DSI-EC may revisit the safety classification of spirulina as new information on this dietary ingredient becomes available.

  16. Processing and storage of blood components: strategies to improve patient safety

    Directory of Open Access Journals (Sweden)

    Pietersz RNI

    2015-08-01

    Full Text Available Ruby NI Pietersz, Pieter F van der Meer Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, the Netherlands Abstract: This review focuses on safety improvements of blood processing of various blood components and their respective storage. A solid quality system to ensure safe and effective blood components that are traceable from a donor to the patient is the foundation of a safe blood supply. To stimulate and guide this process, National Health Authorities should develop guidelines for blood transfusion, including establishment of a quality system. Blood component therapy enabled treatment of patients with blood constituents that were missing, only thus preventing reactions to unnecessarily transfused elements. Leukoreduction prevents many adverse reactions and also improves the quality of the blood components during storage. The safety of red cells and platelets is improved by replacement of plasma with preservative solutions, which results in the reduction of isoantibodies and plasma proteins. Automation of blood collection, separation of whole blood into components, and consecutive processing steps, such as preparation of platelet concentrate from multiple donations, improves the consistent composition of blood components. Physicians can better prescribe the number of transfusions and therewith reduce donor exposure and/or the risk of pathogen transmission. Pathogen reduction in cellular blood components is the latest development in improving the safety of blood transfusions for patients. Keywords: blood components, red cell concentrates, platelet concentrates, plasma, transfusion, safety 

  17. Inactivation of TSE agents: safety of blood and blood-derived products.

    Science.gov (United States)

    Taylor, D M

    2003-02-01

    Evidence relating to whether the blood of individuals with sporadic Creutzfeldt-Jakob disease is infectious is discussed. The conclusion is that this is unproven. Similar consideration is given to the blood of individuals with variant Creutzfeldt-Jakob disease; it is concluded that there is no convincing evidence that the blood is infectious but reasons for caution are presented. There is discussion regarding factors that add to the safety of plasma-derived therapeutic products, including the capacity of the manufacturing processes to inactivate or remove infectivity by the chemical and physical processes involved. There is extended discussion regarding the inactivation of these types of agents and the few reliable options available in worst-case scenarios such as the processing of instruments used neurosurgically on known or suspected cases. The most effective method is exposure to 1 M sodium hydroxide during autoclaving at 121 degrees C. The inappropriateness of applying any of the most effective methods to blood and blood-products because they are harsh and denaturing is discussed. Nevertheless, such procedures have potential application to the plant used in the manufacture of plasma-products. Evidence is presented which suggests that even more modest treatments (the use of lower concentrations of sodium hydroxide at lower temperatures) are effective when applied to surfaces that are free from any tissue contamination, as is the case with plant used to manufacture plasma-derived products. This evidence has come from studies carried out by the gelatin manufacturers of Europe regarding the capability of their manufacturing systems to inactivate the causal agent of bovine spongiform encephalopathy.

  18. Safety evaluation of the extract from the shoots of Arctotis arctotoides ...

    African Journals Online (AJOL)

    Safety evaluation of the extract from the shoots of Arctotis arctotoides in rats and mice. ... It did cause a significance increase in white blood cell count and its differentials. The extract caused a significant decrease in the levels of some liver enzymes, blood urea nitrogen, potassium, total and conjugated bilirubin. Changes ...

  19. NHS Blood Tracking Pilot: City University Evaluation Project

    Science.gov (United States)

    Goddard, Kate; Shabestari, Omid; Adriano, Juan; Kay, Jonathan; Roudsari, Abdul

    Automation of healthcare processes is an emergent theme in the drive to increase patient safety. The Mayday Hospital has been chosen as the pilot site for the implementation of the Electronic Clinical Transfusion Management System to track blood from the point of ordering to the final transfusion. The Centre for Health Informatics at City University is carrying out an independent evaluation of the system implementation using a variety of methodologies to both formatively inform the implementation process and summatively provide an account of the lessons learned for future implementations.

  20. Processing and storage of blood components: strategies to improve patient safety

    OpenAIRE

    Pietersz RNI; van der Meer PF

    2015-01-01

    Ruby NI Pietersz, Pieter F van der Meer Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, the Netherlands Abstract: This review focuses on safety improvements of blood processing of various blood components and their respective storage. A solid quality system to ensure safe and effective blood components that are traceable from a donor to the patient is the foundation of a safe blood supply. To stimulate and guide this process, National Health Authorities should d...

  1. ENVIRONMENTAL SAFETY INDEX: THE CONCEPT AND EVALUATION

    Directory of Open Access Journals (Sweden)

    G. Kharlamova

    2014-06-01

    Full Text Available Ecological security of the state – is a complex and multifaceted category that requires deep study. A comprehensive assessment of environmental security in terms of national security in Ukraine is not exercised. The paper summarizes the theoretical aspects of ecological safety of Ukraine and its components, contains the analysis of environmental safety indexes compiled by international organizations, including the Commission on Sustainable Development UN, the International Institute for Sustainable Development (IISD, the Scientific Committee on Problems of the Environment (SCOPE, Yale University. Analyses of such indexes as Environmental Sustainability Index, Environmental Performance Index, Human Development Index, Environmental Vulnerability Index, Enabling Environment Index had shown that despite all of them represent the level of ecological security, there is a lack of adapted for Ukraine method to assess domestic ecological situation and to compare it with global tendencies. On the basis of statistical data, a concept of evaluation of Environmental Safety Index (ESfIof Ukraine is proposed for subsequent adequate science-based assessment of the current level of ecological situation in Ukraine in comparison with other countries. Its main feature is that it takes into account in addition to the most important environmental indicators also economic and demographic indicators as threats/risks components. The rating of more than 150 countries according to ESfI is evaluated.

  2. A probabilistic bridge safety evaluation against floods.

    Science.gov (United States)

    Liao, Kuo-Wei; Muto, Yasunori; Chen, Wei-Lun; Wu, Bang-Ho

    2016-01-01

    To further capture the influences of uncertain factors on river bridge safety evaluation, a probabilistic approach is adopted. Because this is a systematic and nonlinear problem, MPP-based reliability analyses are not suitable. A sampling approach such as a Monte Carlo simulation (MCS) or importance sampling is often adopted. To enhance the efficiency of the sampling approach, this study utilizes Bayesian least squares support vector machines to construct a response surface followed by an MCS, providing a more precise safety index. Although there are several factors impacting the flood-resistant reliability of a bridge, previous experiences and studies show that the reliability of the bridge itself plays a key role. Thus, the goal of this study is to analyze the system reliability of a selected bridge that includes five limit states. The random variables considered here include the water surface elevation, water velocity, local scour depth, soil property and wind load. Because the first three variables are deeply affected by river hydraulics, a probabilistic HEC-RAS-based simulation is performed to capture the uncertainties in those random variables. The accuracy and variation of our solutions are confirmed by a direct MCS to ensure the applicability of the proposed approach. The results of a numerical example indicate that the proposed approach can efficiently provide an accurate bridge safety evaluation and maintain satisfactory variation.

  3. Program evaluation of FHWA pedestrian and bicycle safety activities.

    Science.gov (United States)

    2011-03-01

    "Introduction : FHWAs Office of Highway Safety (HSA) initiated a program evaluation by Booz Allen Hamilton to assess the overall effectiveness of the Agencys Pedestrian and Bicycle Safety Program. The evaluation covers pedestrian and bicycle sa...

  4. Contribution of the Retrovirus Epidemiology Donor Study (REDS to research on blood transfusion safety in Brazil

    Directory of Open Access Journals (Sweden)

    Paula Loureiro

    2014-04-01

    Full Text Available The Retrovirus Epidemiology Donor Study (REDS program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

  5. Safety evaluation for packaging (onsite) SERF cask

    Energy Technology Data Exchange (ETDEWEB)

    Edwards, W.S.

    1997-10-24

    This safety evaluation for packaging (SEP) documents the ability of the Special Environmental Radiometallurgy Facility (SERF) Cask to meet the requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for transfer of Type B quantities (up to highway route controlled quantities) of radioactive material within the 300 Area of the Hanford Site. This document shall be used to ensure that loading, tie down, transport, and unloading of the SERF Cask are performed in accordance with WHC-CM-2-14. This SEP is valid until October 1, 1999. After this date, an update or upgrade to this document is required.

  6. Robustness of arterial blood gas analysis for assessment of respiratory safety pharmacology in rats.

    Science.gov (United States)

    Whiteside, Garth T; Hummel, Michele; Boulet, Jamie; Beyenhof, Jessica D; Strenkowski, Bryan; John, Janet Dell; Knappenberger, Terri; Maselli, Harry; Koetzner, Lee

    2016-01-01

    Whole body plethysmography using unrestrained animals is a common technique for assessing the respiratory risk of new drugs in safety pharmacology studies in rats. However, wide variations in experimental technique make cross laboratory comparison of data difficult and raise concerns that non-appropriate conditions may mask the deleterious effects of test compounds - in particular with suspected respiratory depressants. Therefore, the objective of this study was to evaluate the robustness of arterial blood gas analysis as an alternative to plethysmography in rats. We sought to do this by assessing the effect of different vehicles and times post-surgical catheterization on blood gas measurements, in addition to determining sensitivity to multiple opioids. Furthermore, we determined intra-lab variability from multiple datasets utilizing morphine and generated within a single lab and lastly, inter-lab variability was measured by comparing datasets generated in two separate labs. Overall, our data show that arterial blood gas analysis is a measure that is both flexible in terms of experimental conditions and highly sensitive to respiratory depressants, two key limitations when using plethysmography. As such, our data strongly advocate the adoption of arterial blood gas analysis as an investigative approach to reliably examine the respiratory depressant effects of opioids. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. BLOOD BIOMARKERS FOR EVALUATION OF PERINATAL ENCEPHALOPATHY

    Directory of Open Access Journals (Sweden)

    Ernest Marshall Graham

    2016-07-01

    Full Text Available Recent research in identification of brain injury after trauma shows many possible blood biomarkers that may help identify the fetus and neonate with encephalopathy. Traumatic brain injury shares many common features with perinatal hypoxic-ischemic encephalopathy. Trauma has a hypoxic component, and one of the 1st physiologic consequences of moderate-severe traumatic brain injury is apnea. Trauma and hypoxia-ischemia initiate an excitotoxic cascade and free radical injury followed by the inflammatory cascade, producing injury in neurons, glial cells and white matter. Increased excitatory amino acids, lipid peroxidation products and alteration in microRNAs and inflammatory markers are common to both traumatic brain injury and perinatal encephalopathy. The blood-brain barrier is disrupted in both leading to egress of substances normally only found in the central nervous system. Brain exosomes may represent ideal biomarker containers, as RNA and protein transported within the vesicles are protected from enzymatic degradation. Evaluation of fetal or neonatal brain derived exosomes that cross the blood-brain barrier and circulate peripherally has been referred to as the liquid brain biopsy. A multiplex of serum biomarkers could improve upon the current imprecise methods of identifying fetal and neonatal brain injury such as fetal heart rate abnormalities, meconium, cord gases at delivery, and Apgar scores. Quantitative biomarker measurements of perinatal brain injury and recovery could lead to operative delivery only in the presence of significant fetal risk, triage to appropriate therapy after birth and measure the effectiveness of treatment.

  8. A Methodology for Evaluating Quantitative Nuclear Safety Culture Impact

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kiyoon; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of)

    2015-05-15

    Through several accidents of NPPs including the Fukushima Daiichi in 2011 and Chernobyl accidents in 1986, nuclear safety culture has been emphasized in reactor safety world-widely. In Korea, KHNP evaluates the safety culture of NPP itself. KHNP developed the principles of the safety culture in consideration of the international standards. A questionnaire and interview questions are also developed based on these principles and it is used for evaluating the safety culture. However, existing methodology to evaluate the safety culture has some disadvantages. First, it is difficult to maintain the consistency of the assessment. Second, the period of safety culture assessment is too long (every two years) so it has limitations in preventing accidents occurred by a lack of safety culture. Third, it is not possible to measure the change in the risk of NPPs by weak safety culture since it is not clearly explains the effect of safety culture on the safety of NPPs. In this study, Safety Culture Impact Assessment Model (SCIAM) is developed overcoming these disadvantages. In this study, SCIAM which overcoming disadvantages of exiting safety culture assessment method is developed. SCIAM uses SCII to monitor the statues of the safety culture periodically and also uses RCDF to quantify the safety culture impact on NPP's safety. It is significant that SCIAM represents the standard of the healthy nuclear safety culture, while the exiting safety culture assessment presented only vulnerability of the safety culture of organization. SCIAM might contribute to monitoring the level of safety culture periodically and, to improving the safety of NPP.

  9. [Self-sufficiency, needs, prescription and safety of blood products].

    Science.gov (United States)

    Folléa, G; Monsellier, M; Grimfeld, A; Pelletier, B; Lassale, B; Morel, P; Samama, C M; Hermine, O; Lefrère, J-J

    2013-05-01

    The current issues debate will bring together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products will be confronted. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  10. Managing blood pressure control in Asian patients: safety and efficacy of losartan

    Science.gov (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

    Hypertension is common in Asian populations and is a major cause of cardiovascular diseases. The prevalence of hypertension is increasing in many Asian countries. The overall prevalence of hypertension in India and the People’s Republic of China has been estimated to be 20.6% in men and 22.6% in women. However, the rates of detection, treatment, and control of hypertension remain low in Asia. This reflects a low level of literacy and education, as well as a low level of access to medical care. To overcome these obstacles, strategies targeted at education, promotion, and optimization of medical care, are crucial to achieve target blood pressure control. Angiotensin receptor blockers are one of the first-line treatments for essential hypertension because they confer better cardiovascular outcomes. Losartan has been widely evaluated for the management of hypertension. Although some studies suggested that the blood pressure-lowering effect of losartan is perhaps lower than for other angiotensin receptor blockers, losartan has been demonstrated to be beneficial in terms of renal protection in patients with diabetes, heart failure resulting from either systolic or diastolic dysfunction, and diuretic-induced hyperuricemia. However, most of these data were obtained from Caucasian populations. The efficacy and safety of losartan in Asian populations may be different because of genetic and ethnic variations. Therefore, the efficacy and safety of losartan in Asian patients with hypertension warrant further study. PMID:24672231

  11. Blood protein derivative viral safety: observations and analysis.

    OpenAIRE

    Horowitz, B.

    1990-01-01

    The well-documented viral safety of albumin arises from several factors operating in concert, including virus removal during preparation, immune neutralization, serendipitous inactivation, virus sterilization through pasteurization. Safety with respect to HBV transmission was achieved even prior to the development of sensitive screening tests for HBsAg, as can be predicted given the initial virus load and the influence of factors affecting removal and inactivation. Coagulation factor concentr...

  12. Safety evaluation of saffron (Crocus sativus) tablets in healthy volunteers.

    Science.gov (United States)

    Modaghegh, Mohammad-Hadi; Shahabian, Masoud; Esmaeili, Habib-Allah; Rajbai, Omid; Hosseinzadeh, Hossein

    2008-12-01

    Saffron (Crocus sativus) stigma tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. The study was a double-blind, placebo-controlled design consisting of a 1 week treatment of saffron tablets. Volunteers were divided into 3 groups of 10 each (5 males and 5 females). Group I received placebo; groups 2 and 3 received 200 and 400mg saffron tablets, respectively, for 7 days. General measures of health were recorded during the study such as hematological, biochemical and electrocardiographic parameters done in pre- and post-treatment periods. Clinical examination showed no gross changes in all volunteers after intervention. Saffron with higher dose (400mg) decreased standing systolic blood pressure and mean arterial pressures significantly. Saffron decreased slightly some hematological parameters such as red blood cells, hemoglobin, hematocrit and platelets. Saffron increased sodium, blood urea nitrogen and creatinine. This study showed that saffron tablets may change some hematological and biochemical parameters. However, these alterations were in normal ranges and they were not important clinically.

  13. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    Science.gov (United States)

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  14. Evaluation of red blood cell stability during immersion blood warming

    African Journals Online (AJOL)

    Temperature increase within the blood unit being warmed by immersion in warm water is non-uniform, with the outer part showing the largest temperature increases. This was examined at waterbath temperatures of 45°C and 47°C and represented graphically. Temperature decrease in a stainless steel bucket filled with 10 ...

  15. Improving health profile of blood donors as a consequence of transfusion safety efforts

    DEFF Research Database (Denmark)

    Edgren, Gustaf; Tran, Trung Nam; Hjalgrim, Henrik

    2007-01-01

    BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted...... in improvements. Mortality and cancer incidence among blood donors in Sweden and Denmark was investigated. STUDY DESIGN AND METHODS: All computerized blood bank databases were compiled into one database, which was linked to national population and health data registers. With a retrospective cohort study design, 1......,110,329 blood donors were followed for up to 35 years from first computer-registered blood donation to death, emigration, or December 31, 2002. Standardized mortality and incidence ratios expressed relative risk of death and cancer comparing blood donors to the general population. RESULTS: Blood donors had...

  16. Delta check for blood groups: A step ahead in blood safety

    Directory of Open Access Journals (Sweden)

    Raj Nath Makroo

    2017-01-01

    Conclusion: Delta checks proved to be an effective tool for detecting blood group errors and prevention of accidental mismatched blood transfusions. Preanalytical errors in patient identification or sample labeling were the most frequent.

  17. A modified isometric test to evaluate blood pressure control with ...

    African Journals Online (AJOL)

    SAMJ. VOL 83. NOV 1993. A modified isometric test to evaluate blood pressure control with once-daily slow-release verapamil. A. CANTOR, H. GILUTZ, T. MEYER. Abstract Blood pressure at rest is not predictive of round- the-clock values. Blood pressure should therefore be measured during effort to evaluate hypertension.

  18. Blood Safety Status in WHO African Region Countries: Lessons Learnt from Mauritius

    Science.gov (United States)

    Sonoo, Janaki; Musango, Laurent; Nikiema, Jean Baptiste; Lapnet-Moustapha, Thomas

    2017-01-01

    In 2001, the WHO Office for Africa adopted a strategy for blood safety defining four targets. This paper describes the progress made by Mauritius in the implementation of this strategy. The blood safety indicators were collected and compared with the norms recommended by WHO. The country has formulated its blood policy and developed a strategic plan for its implementation since 2004. The total number of blood donations increased from 31,228 in 2002 to 43,742 in 2016, giving an annual blood collection rate evolving from 26.3 per 1000 inhabitants in 2002 to 34.2 per 1000 inhabitants in 2016. The percentage of voluntary donations rose from 60% to 82.5%. Since 2002, all the blood units collected have been tested for the mandatory infectious markers. The Blood Transfusion Service has been certified ISO2008-9001 and nucleic acid testing has been introduced. The preparation of blood components increased from 60% to 98.2%. The most transfused blood components were red cell concentrates, platelet concentrates, and fresh frozen plasma. In addition to transfusion activities, there were other departments performing antenatal serology, tissue typing, special investigations, and reagent preparation. Despite the progress made, some challenges remain, namely, legal framework and haemovigilance system. A regulatory system for blood needs to be established. PMID:29181226

  19. Blood Safety Status in WHO African Region Countries: Lessons Learnt from Mauritius

    Directory of Open Access Journals (Sweden)

    André Loua

    2017-01-01

    Full Text Available In 2001, the WHO Office for Africa adopted a strategy for blood safety defining four targets. This paper describes the progress made by Mauritius in the implementation of this strategy. The blood safety indicators were collected and compared with the norms recommended by WHO. The country has formulated its blood policy and developed a strategic plan for its implementation since 2004. The total number of blood donations increased from 31,228 in 2002 to 43,742 in 2016, giving an annual blood collection rate evolving from 26.3 per 1000 inhabitants in 2002 to 34.2 per 1000 inhabitants in 2016. The percentage of voluntary donations rose from 60% to 82.5%. Since 2002, all the blood units collected have been tested for the mandatory infectious markers. The Blood Transfusion Service has been certified ISO2008-9001 and nucleic acid testing has been introduced. The preparation of blood components increased from 60% to 98.2%. The most transfused blood components were red cell concentrates, platelet concentrates, and fresh frozen plasma. In addition to transfusion activities, there were other departments performing antenatal serology, tissue typing, special investigations, and reagent preparation. Despite the progress made, some challenges remain, namely, legal framework and haemovigilance system. A regulatory system for blood needs to be established.

  20. Insight into "Calculated Risk" : An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety

    NARCIS (Netherlands)

    Neslo, R. E J; Oei, W.; Janssen, M. P.|info:eu-repo/dai/nl/304818208

    Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or

  1. Nanoparticles and the blood coagulation system. Part II: safety concerns

    Science.gov (United States)

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2014-01-01

    Nanoparticle interactions with the blood coagulation system can be beneficial or adverse depending on the intended use of a nanomaterial. Nanoparticles can be engineered to be procoagulant or to carry coagulation-initiating factors to treat certain disorders. Likewise, they can be designed to be anticoagulant or to carry anticoagulant drugs to intervene in other pathological conditions in which coagulation is a concern. An overview of the coagulation system was given and a discussion of a desirable interface between this system and engineered nanomaterials was assessed in part I, which was published in the May 2013 issue of Nanomedicine. Unwanted pro- and anti-coagulant properties of nanoparticles represent significant concerns in the field of nanomedicine, and often hamper the development and transition into the clinic of many promising engineered nanocarriers. This part will focus on the undesirable effects of engineered nanomaterials on the blood coagulation system. We will discuss the relationship between the physicochemical properties of nanoparticles (e.g., size, charge and hydrophobicity) that determine their negative effects on the blood coagulation system in order to understand how manipulation of these properties can help to overcome unwanted side effects. PMID:23730696

  2. [Economic analysis versus the principle of guaranteed safety in blood transfusion].

    Science.gov (United States)

    Moatti, J P; Loubière, S; Rotily, M

    2000-06-01

    This article shows that policies aimed at reducing risks of infectious agents transmissible through blood unfortunately follow a law of 'diminishing returns': increasing marginal costs have to be devoted for limited reductions in the risks of contamination through blood donations. Therefore, the economic cost-effectiveness analysis is appropriate to identify screening strategies which may minimize costs to reach a certain level of safety. Moreover, economic analysis can contribute to public debates about the level of residual risk that society is willing to accept. Empirical results from French studies about screening for hepatitis C virus (HCV) in individuals who have received blood transfusions and in blood donations are presented to illustrate these points.

  3. Evaluation of homocysteine in blood bank donors

    Directory of Open Access Journals (Sweden)

    Luiz Antonio Rosa

    2005-03-01

    Full Text Available Objective: To investigate the use of plasma homocysteine levelsin blood bank donors as a risk marker for the development ofcardiovascular diseases in healthy individuals. Methods: Thirtynineblood donors were evaluated and a correlation was establishedbetween the plasma homocysteine levels and the different ageand gender groups. Results: The values of homocysteine levelswere found to be within the normal range, as expected for a healthypopulation. Only three male donors, aged between 40 and 60years, presented hyperhomocysteinemia within the risk rangefor developing cardiovascular disease. Comparing females andmales with regard to homocysteine levels, the values presentedstatistically significant differences, however of little relevance.Variance analysis did not show significant differences betweenthe considered age groups, regardless of gender, but there was aclear increase in homocysteine concentration in males betweenthe 5th and 6th decades of life. Conclusions: It was not possible tosuggest the use of plasma homocysteine levels as an early markerfor the development of cardiovascular diseases in healthy bloodbank donors, but one can speculate about a critical homocysteinelevel to be defined as a cutoff point, above which there wouldbe an increased risk of developing cardiovascular disease.

  4. To evaluate the extent of awareness about hazards of blood transfusion among the blood recipients.

    Science.gov (United States)

    Shah, M S; Islam, A; Rahman, A; Rahman, M M; Akter, D; Afrin, S

    2012-10-01

    This cross-sectional, observational study was carried out among the blood receiving patients conducted in the Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University from April 2008 to August 2009, over 126 purposively selected, to evaluate the extent of awareness about hazards of blood transfusion among the blood recipient. In this study 74.1% of male and 73.3% of female respondents had correct knowledge of blood transfusion (p>0.05). In literate group 85(91.4%) had knowledge about blood donation and transfusion compared to 8(8.6%) in illiterate group with significant statistical difference (p=0.001). Different misconception and lack of awareness about safe blood transfusion is present among people receiving blood and blood products. Illiterate persons have significant less level of knowledge about safe blood transfusion. So the number of educational programs on blood-donation should be expanded and transmitted to encourage possible receivers to take blood from nonprofessional volunteer donor and to carry out relevant screening tests before receiving blood products. Furthermore, they should know that all measures besides screening tests are implemented by blood banks to ensure that blood donation is safe for donors and that transfusion of the donated blood is safe for recipients.

  5. A modified isometric test to evaluate blood pressure control with ...

    African Journals Online (AJOL)

    Blood pressure at rest is not predictive of roundthe- clock values. Blood pressure should therefore be measured during effort to evaluate hypertension and its response to treatment. The effect of sustained-release verapamil (240 mg taken once a day) on blood pressure at rest and during isometric effort was therefore ...

  6. Evaluation of safety management in an Appliances manufacturing company

    Directory of Open Access Journals (Sweden)

    F. Golbabaei

    2015-01-01

    Full Text Available Introduction: Prevention of accidents and work related diseases, are not allowed regardless of the safety of employees, customers, contractors and other persons. Assessment of individual safety management activities could reduce many losses. Present study aimed to evaluate the safety management of a household appliance manufacturing company.  .Material and Method: This study has done in a household appliance manufacturing company in Damavand city. Two questionnaires were firstly designed based on the weighted scores. The questionnaire 1 consisted of 4 indicators: Safety of machinery, Electrical safety, Risk assessment and Fire safety. Questionnaire 2 consisted of 11 sub indicators. Both questionnaires were completed by 30 HSE experts and supervisors. Reliability of questionnaires was based on cronbachs alpha coefficient. the safety status of each unit was determined and scored using information acquired by the questionnaires. Lastly, the safety of the entire company was determined.  .Result: Results showed that in safety management: the pressing and store house were in a good range of 66.66 and 60.12 points. Powder painting, enameling, laboratory were in a average range of 56.25, 55.92 and 54.15 points. Assembling and door storage were in a week range of 46.06 points.  .Conclusion: The findings showed that the safety status in the studied appliances company is in average range with 55.45 points. Therefore, it is recommended that the safety indicators should be improved for the betterment of the safety management in the company.

  7. The Evaluation of the Safety Benefits of Combined Passive and On-Board Active Safety Applications

    Science.gov (United States)

    Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

    2009-01-01

    One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006–2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectivenessof the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries. PMID:20184838

  8. The evaluation of the safety benefits of combined passive and on-board active safety applications.

    Science.gov (United States)

    Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

    2009-10-01

    One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006-2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectiveness of the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries.

  9. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids.

    Science.gov (United States)

    Sweat, J M; Abdy, M; Weniger, B G; Harrington, R; Coyle, B; Abuknesha, R A; Gibbs, E P

    2000-01-01

    Needle free jet injection guns have been used extensively in both veterinary and human health to deliver both vaccine and drugs, but in recent years, concerns have mounted for their potential to transmit blood borne disease agents among consecutive vaccinates. A Ped-O-Jet type jet injection device was used to deliver serial subcutaneous injections of 0.5 mL saline (as a surrogate for vaccine) into calves and pigs, with intervening ejectates collected in vials to represent what the next vaccinate would have received. An enzyme linked immunosorbant assay was developed to detect species specific albumin as a marker for blood, using calibration standards from known dilutions of bovine or porcine blood. Assay sensitivity of 20 pL/mL corresponded to the estimated minimal chimpanzee infectious dose of 10 pL for hepatitis B virus. The methodology and available results for evaluating the safety of jet injector devices are reported.

  10. PREVENTIVE MEASURES FOR THE IMPROVEMENT OF THE SAFETY OF BLOOD TRANSFUSION AND VIRTUAL TRANSFUSION LABORATORY

    Directory of Open Access Journals (Sweden)

    Primož Rožman

    2002-04-01

    Full Text Available Background. Even though blood transfusion is a relatively safe form of therapy, because of the eventual administrative errors in the transfusion chain between the blood donor and the recipient of blood, transfusion errors still occur. Therefore, it is imperative to ensure an utmost extent of safety and reliability of all transfusion related procedures. The safety of blood transfusion can be improved by preventive actions, i.e. implementation of the total quality management concept, haemovigilance and virtual transfusion laboratory. In the resulting system, the information web, robotics, computer sciences and communication technologies ensure safe and reliable identification of the patients, blood donors, corresponding test samples and blood products. Apart form this; the modern technologies enable the automation of laboratory testing, the integrity of laboratory results and enable an optimal use of blood.Conclusions. For an improved transfusion safety in Slovenia, adoption of corresponding prevention as well as haemovigilance is necessary. Identification errors can be prevented by implementation of the wristbands systems with the code bars for the tagging of the patient and his biological samples, whereas the administrative errors in the blood bank and transfusion laboratory can be prevented by implementation of information systems and automation.We assume that the virtual transfusion laboratory will become an integral part of the new Slovenian transfusion web and will speed up, unify and simplify today’s methods of ordering and administering blood products. To the attending physician, it will enable the choice of optimal transfusion therapy schedule and at the same time, it will enable the supervision of individual orders, deviations and indications, all of which is needed in order to analyse and improve the quality and the costs of the treatment. These services represent the first obligatory step for the modernisation of the transfusion

  11. Dengue viremia in blood donors in Northern India: Challenges of emerging dengue outbreaks to blood transfusion safety

    Directory of Open Access Journals (Sweden)

    Sadhana Mangwana

    2015-01-01

    Full Text Available Backdround: Emerging infectious diseases pose threats to the general human population; including recipients of blood transfusions. Dengue is spreading rapidly to new areas and with increasing frequency of major outbreaks. Screening blood for dengue antigens in dengue-endemic countries would be costly and should, therefore, be recommended only after careful assessment of risk for infection and cost. Aim: A prospective study was conducted to establish the magnitude of the threat that dengue poses to blood safety where it is sporadic with seasonal variations, to quantify risk and to assess that whether screening is feasible and cost-effective. Materials and Methods: Nonstructural protein 1 (NS1 antigen test was done on 1709 donations during dengue outbreak in the months August to November 2013 as an additional test using Bio-Rad Platelia Dengue NS1AG test kit which is one step sandwich format microplate enzyme immunoassay using murine monoclonal antibodies for capture and revelation. Chi-square test was used to find statistical significance. Results and Conclusions: Majority cases were whole blood, replacement, male donors with 76.10% donors in <35 years age group. About 17.85% were single donor platelet donations. NS1 antigen in all donors was negative. In the past, dengue affected mainly children who do not donate blood. With the changing trend, mean age of infection increased affecting the population that does donate blood, further reducing blood donation pool. Further studies need to be done in different geographic regions of the country during dengue transmission season to establish maximum incidence of viremic donations, rates of transfusion transmission and clinical consequences in recipients. If risk is found to be substantial, decision will be taken by the policymakers at what threshold screening should be instituted to ensure safe blood transfusion.

  12. Criticality safety benchmark evaluation project: Recovering the past

    Energy Technology Data Exchange (ETDEWEB)

    Trumble, E.F.

    1997-06-01

    A very brief summary of the Criticality Safety Benchmark Evaluation Project of the Westinghouse Savannah River Company is provided in this paper. The purpose of the project is to provide a source of evaluated criticality safety experiments in an easily usable format. Another project goal is to search for any experiments that may have been lost or contain discrepancies, and to determine if they can be used. Results of evaluated experiments are being published as US DOE handbooks.

  13. A paradigm shift in organisational safety culture evaluation and training

    OpenAIRE

    Cram, Robert

    2015-01-01

    The focus of this research is to explore the issues surrounding traditional approaches towards understanding the safety culture of an organisation operating in a high risk environment and to identify an effective technique to educate corporate management in how to measure and evaluate the underlying safety culture of their own organisations. The results of the first part of the research highlight the concerns being expressed by both academic and industrial communities that current safety cult...

  14. Analytic choices in road safety evaluation

    DEFF Research Database (Denmark)

    Elvik, Rune

    2012-01-01

    Conducting rigorous before-and-after studies is essential for improving knowledge regarding the effects of road safety measures. However, state-of-the-art approaches like the empirical Bayes or fully Bayesian techniques cannot always be applied, as the data required by these approaches may...

  15. Evaluating bicyclists comfort and safety perception

    NARCIS (Netherlands)

    Jain, Himani; Tiwari, Geetam; Zuidgeest, M.H.P.; Viegas, J.M.; Macario, R.

    2010-01-01

    Perception of safety and comfort of bicycle infrastructure is an important factor influencing the use of bicycles. Cyclists can be found all over India. In urban areas presently, mostly captive riders choose to bicycle as no other viable options of travel are available to them. This study discusses

  16. Criticality Safety Evaluation of Hanford Tank Farms Facility

    Energy Technology Data Exchange (ETDEWEB)

    WEISS, E.V.

    2000-12-15

    Data and calculations from previous criticality safety evaluations and analyses were used to evaluate criticality safety for the entire Tank Farms facility to support the continued waste storage mission. This criticality safety evaluation concludes that a criticality accident at the Tank Farms facility is an incredible event due to the existing form (chemistry) and distribution (neutron absorbers) of tank waste. Limits and controls for receipt of waste from other facilities and maintenance of tank waste condition are set forth to maintain the margin subcriticality in tank waste.

  17. Leucoreduction of blood components: an effective way to increase blood safety?

    Science.gov (United States)

    Bianchi, Maria; Vaglio, Stefania; Pupella, Simonetta; Marano, Giuseppe; Facco, Giuseppina; Liumbruno, Giancarlo M.; Grazzini, Giuliano

    2016-01-01

    Over the past 30 years, it has been demonstrated that removal of white blood cells from blood components is effective in preventing some adverse reactions such as febrile non-haemolytic transfusion reactions, immunisation against human leucocyte antigens and human platelet antigens, and transmission of cytomegalovirus. In this review we discuss indications for leucoreduction and classify them into three categories: evidence-based indications for which the clinical efficacy is proven, indications based on the analysis of observational clinical studies with very consistent results and indications for which the clinical efficacy is partial or unproven. PMID:26710353

  18. The National Heart, Lung, and Blood Institute retrovirus epidemiology donor studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): twenty years of research to advance blood product safety and availability.

    Science.gov (United States)

    Kleinman, Steven; King, Melissa R; Busch, Michael P; Murphy, Edward L; Glynn, Simone A

    2012-10-01

    The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute-funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as xenotropic murine leukemia virus-related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma cruzi infections. Other analyses have characterized blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors' perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, 2 large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting and adds a third country, South Africa

  19. Fire safety evaluation system for NASA office/laboratory buildings

    Science.gov (United States)

    Nelson, H. E.

    1986-11-01

    A fire safety evaluation system for office/laboratory buildings is developed. The system is a life safety grading system. The system scores building construction, hazardous areas, vertical openings, sprinklers, detectors, alarms, interior finish, smoke control, exit systems, compartmentation, and emergency preparedness.

  20. Economic evaluation of home blood pressure telemonitoring

    DEFF Research Database (Denmark)

    Madsen, Line Bille; Christiansen, Terkel; Kirkegaard, Peder

    2011-01-01

    Aims. The purpose of the present study was to compare the costs of home blood pressure (BP) telemonitoring (HBPM) with the costs of conventional office BP monitoring. In a randomized controlled trial, 105 hypertensive patients performed HBPM and 118 patients received usual care with conventional...

  1. Availability, safety, and quality of blood for transfusion in the Americas

    Directory of Open Access Journals (Sweden)

    José Ramiro Cruz

    2003-03-01

    Full Text Available OBJECTIVES: This article has two objectives: (1 to present for countries and territories of the Region of the Americas data on the number of blood donations, proportion of voluntary blood donors versus remunerated blood donors, coverage of screening for infectious agents, and separation of donated blood into its components and (2 to explore the relationships of those characteristics with economic and organizational factors in the countries and territories. METHODS: We carried out comparative analyses using population and health information gathered annually by the Pan American Health Organization (PAHO from national health officials from the countries in the Americas, as well as economic information (gross national product (GNP per capita obtained from publications of the World Bank. RESULTS: There is a direct correlation between the availability of blood for transfusion and GNP per capita. Seven countries with a GNP per capita above US$ 10 000 per year account for 38% of the Regional population but 68% of the Regional blood donations. Voluntary blood donation is more common in the countries with better blood availability. There is no association between GNP per capita and coverage of screening for infectious agents. Nevertheless, of the six countries with a GNP per capita below US$ 1 000, only one of the six screens all units for human immunodeficiency virus (HIV, hepatitis C virus (HCV, and hepatitis B surface antigen (HBsAg. Countries with a higher proportion of voluntary blood donors tend to have lower prevalence rates of infectious markers. Separation of blood into its components is also more common in countries with higher blood donation rates. CONCLUSIONS: The availability, safety, and quality of blood for transfusion in the Americas needs to be improved. As part of that effort, national policies and strategies must be put into place so that the resources already allocated for blood services are better utilized.

  2. Using basic ethical principles to evaluate safety efforts in transfusion medicine.

    Science.gov (United States)

    Brooks, Jay P

    2012-01-01

    Pursuit of pharmaceutical purity of the blood in the bag has led to a shrinking donor base and a significantly more expensive product. Decisions regarding new infectious marker testing and donor deferrals have typically been made emphasizing decreasing one specific risk without considering the effect the intervention will have on the overall safety and availability of blood transfusion. Regulations have been formulated by governmental agencies with limited input from the medical community. The decision making process has lacked risk benefit analyses and has not had the robustness associated with spirited discussions. Policies made in this manner may result in certain risks being decreased but can also have adverse unintended consequences. Being guided by the ethical principles of nonmaleficence, beneficence, autonomy, and justice, we need to evaluate our actions in the context of overall blood safety rather than narrowly focusing on any one area.

  3. Using Basic Ethical Principles to Evaluate Safety Efforts in Transfusion Medicine

    Directory of Open Access Journals (Sweden)

    Jay P. Brooks

    2012-01-01

    Full Text Available Pursuit of pharmaceutical purity of the blood in the bag has led to a shrinking donor base and a significantly more expensive product. Decisions regarding new infectious marker testing and donor deferrals have typically been made emphasizing decreasing one specific risk without considering the effect the intervention will have on the overall safety and availability of blood transfusion. Regulations have been formulated by governmental agencies with limited input from the medical community. The decision making process has lacked risk benefit analyses and has not had the robustness associated with spirited discussions. Policies made in this manner may result in certain risks being decreased but can also have adverse unintended consequences. Being guided by the ethical principles of nonmaleficence, beneficence, autonomy, and justice, we need to evaluate our actions in the context of overall blood safety rather than narrowly focusing on any one area.

  4. CRITICALITY SAFETY LIMIT EVALUATION PROGRAM (CSLEP) & QUICK SCREENS, ANSWERS TO EXPEDITED PROCESSING LEGACY CRITICALITY SAFETY LIMITS & EVALUATIONS

    Energy Technology Data Exchange (ETDEWEB)

    TOFFER, H.

    2006-02-21

    Since the end of the cold war, the need for operating weapons production facilities has faded. Criticality Safety Limits and controls supporting production modes in these facilities became outdated and furthermore lacked the procedure based rigor dictated by present day requirements. In the past, in many instances, the formalism of present day criticality safety evaluations was not applied. Some of the safety evaluations amounted to a paragraph in a notebook with no safety basis and questionable arguments with respect to double contingency criteria. When material stabilization, clean out, and deactivation activities commenced, large numbers of these older criticality safety evaluations were uncovered with limits and controls backed up by tenuous arguments. A dilemma developed: on the one hand, cleanup activities were placed on very aggressive schedules; on the other hand, a highly structured approach to limits development was required and applied to the cleanup operations. Some creative approaches were needed to cope with the limits development process.

  5. Evaluation of bypass lane safety, operations, and design in Kansas.

    Science.gov (United States)

    2015-08-01

    The construction of bypass lanes at rural intersections has typically been considered a low-cost highway safety : improvement by the transportation community. However, this needs to be quantitatively evaluated so that decisions can be made : on wheth...

  6. LNG safety assessment evaluation methods : task 3 letter report.

    Science.gov (United States)

    2016-07-01

    Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

  7. [Evaluation of non-compliance of transfusion requests of packed red blood cells].

    Science.gov (United States)

    Ben Romdhane, Asma Rym; Ben Ayoub, Wided; Gouider, Emna

    2015-06-01

    Despite legislative acts develloped, many deficiencies were identified in blood requests at the National Blood TransfusionCenter impedding board and blood safety. to evaluate the conformity of the different topics of packed red blood cells requests to the legislation. Our study was prospective descriptive lasting six months (March-August 2011). It assessed all packed red blood cells requests which reached the national blood transfusion center. 16064 packed red blood cells requests from 21 public institutions and 28 private institutions were studied. There was different deficiencies in each item.The absence of birth date in 67.18% of request represented the largest non-compliance within administrative information. A predominance of shortcomings related to transfusion and obstetric history was recorded for clinical information with absence of date of the last transfusion in 91.72% cases, lack of accuracy of any previous transfusion reactions in 88.63% cases and absence of the number of previous pregnancies in 93.15% of transfusion requests prescribed to women. Non-conformities related to the prescribing physician concerned mainly the phone number which was absent in 55.82% of cases. This study revealed a significant lack of awareness of physicians in relation to the law governing transfusion. It is therefore essential to develop training for prescribers to improve transfusion safety.

  8. A comprehensive protocol to evaluate the use of blood and its components in Latin America and the Caribbean

    Directory of Open Access Journals (Sweden)

    Ana E. del Pozo

    2015-06-01

    Full Text Available Blood transfusion safety is a critical part of appropriate health care. Considering the limited information available on the use of blood and its components in Latin America and the Caribbean, the Grupo Cooperativo iberoamericano de Medicina Transfusional (Ibero-American Cooperative Group for Transfusion Medicine; GCIAMT, through its Research and International Affairs committees, carried out a project to develop a protocol that would facilitate the evaluation of blood usage at the country, jurisdiction, and institutional levels in varied country contexts. Experts in blood safety from the Pan American Health Organization (Washington, DC, United States, the University of São Paulo (São Paulo, Brazil, the Hemocentro of São Paulo (São Paulo, Brazil, and GCIAMT designed a 2-step comprehensive blood-use evaluation protocol: step 1 collects data from blood requests, and step 2, from medical charts. At a minimum, 1 000 analyzed requests are necessary; as such, study periods vary depending on the number of transfusion requests issued. An Internet-based application, the Modular Research System-Study Management System (MRS-SMS, houses the data and produces reports on how hospitals request blood, how blood is issued, who requires blood and blood components, and as an added benefit, how many blood units are wasted and what the real demand for blood is.

  9. Revaluing donor and recipient bodies in the globalised blood economy: transitions in public policy on blood safety in the United Kingdom.

    Science.gov (United States)

    Busby, Helen; Kent, Julie; Farrell, Anne-Maree

    2014-01-01

    The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on 'tissue economies'. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies.

  10. Evaluation of the AHRQ patient safety initiative: framework and approach.

    Science.gov (United States)

    Farley, Donna O; Battles, James B

    2009-04-01

    Describe the evaluation performed of the patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). AHRQ PATIENT SAFETY INITIATIVE When patient safety became a national priority in 2000, Congress charged and funded AHRQ to improve health care safety. Over the next 6 years, AHRQ funded more than 300 research projects and other activities, addressing diverse patient safety issues and practices. AHRQ contracted with RAND in 2002 to perform a 4-year evaluation of the initiative, which was completed in 2006. This formative evaluation used the CIPP program evaluation model, which emphasizes multiple stakeholders' interests (e.g., patients, providers, funded researchers). We monitored the progress of the patient safety initiative and provided AHRQ annual feedback that assessed each year's activities, identifying issues and offering suggestions for actions by AHRQ. Given the size and complexity of the initiative, the evaluation needed to examine key individual components and synthesize results across them, and it also had to be responsive to changes in the initiative over time. We used a conceptual framework to bring together the disparate pieces to synthesize overall findings. The remaining articles in this issue describe selected results from this evaluation.

  11. Development of safety analysis technology for integral reactor; evaluation on safety concerns of integral reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hee Chul; Kim, Woong Sik; Lee, J. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

    2002-03-01

    The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in this study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They include the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. The study presents the general safety requirements applicable to licensing of an integral reactor and suggests additional regulatory requirements, which need to be developed, based on the direction to resolution of the safety concerns. The efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. Suggestion on the development of additional regulatory requirements will contribute for the regulator to taking actions for licensing of an integral reactor. 66 refs., 5 figs., 24 tabs. (Author)

  12. Evaluating safety-critical organizations - emphasis on the nuclear industry

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, Teemu; Oedewald, Pia (VTT, Technical Research Centre of Finland (Finland))

    2009-04-15

    An organizational evaluation plays a key role in the monitoring, as well as controlling and steering, of the organizational safety culture. If left unattended, organizations have a tendency to gradually drift into a condition where they have trouble identifying their vulnerabilities and mechanisms or practices that create or maintain these vulnerabilities. The aim of an organizational evaluation should be to promote increased understanding of the sociotechnical system and its changing vulnerabilities. Evaluation contributes to organizational development and management. Evaluations are used in various situations, but when the aim is to learn about possible new vulnerabilities, identify organizational reasons for problems, or prepare for future challenges, the organization is most open to genuine surprises and new findings. It is recommended that organizational evaluations should be conducted when - there are changes in the organizational structures - new tools are implemented - when the people report increased workplace stress or a decreased working climate - when incidents and near-misses increase - when work starts to become routine - when weak signals (such as employees voicing safety concerns or other worries, the organization 'feels' different, organizational climate has changed) are perceived. In organizations that already have a high safety level, safety managers work for their successors. This means that they seldom see the results of their successful efforts to improve safety. This is due to the fact that it takes time for the improvement to become noticeable in terms of increased measurable safety levels. The most challenging issue in an organizational evaluation is the definition of criteria for safety. We have adopted a system safety perspective and we state that an organization has a high potential for safety when - safety is genuinely valued and the members of the organization are motivated to put effort on achieving high levels of safety

  13. Safety evaluation of amylomaltase from Thermus aquaticus.

    Science.gov (United States)

    Tafazoli, Shahrzad; Wong, Andrea W; Akiyama, Tsunehisa; Kajiura, Hideki; Tomioka, Eisuke; Kojima, Iwao; Takata, Hiroki; Kuriki, Takashi

    2010-06-01

    A recombinant amylomaltase, MQ-01, obtained by cultivation of Bacillus subtilis expressing the amylomaltase gene from Thermus aquaticus is to be used in the production of enzymatically-synthesized glycogen; which is intended for use as a food ingredient. In order to establish the safety of MQ-01, the enzyme was subjected to standard toxicological testing. In a battery of standard Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) and in Escherichia coli WP2 uvrA, both with and without metabolic activation, MQ-01 failed to exhibit mutagenic activity. Similarly, MQ-01 did not display clastogenic properties in Chinese hamster lung fibroblast cells (CHL/IU), in an in vitro chromosomal aberration assay. In a 13-week subchronic toxicity study in rats, oral administration of MQ-01 at doses of up to 15 mL/kg body weight/day (corresponding to approximately 1230 mg/kg body weight/day) did not produce compound-related clinical signs or toxicity, changes in body weight gain, food consumption, hematology, clinical chemistry, urinalysis, organ weights, or in any gross and microscopic findings. The results of this study support the safety of MQ-01 in food production. (c) 2009 Elsevier Inc. All rights reserved.

  14. Evaluation of the effect of horse blood supplemented with human ...

    African Journals Online (AJOL)

    The study was conducted to evaluate the effect of horse blood supplemented with human blood and vitamin on the performance of Glossina morsitans morsitans colony. Three feeding groups were established and a total of 144 female G. m. morsitans flies were assigned to each group. The first group was entirely ...

  15. The evaluation of interaction between red blood cells in blood coagulation by optical tweezers.

    Science.gov (United States)

    Yang, Bor-Wen; Mu, Yu-Hong; Huang, Kui-Teng; Li, Zhe; Wu, Jie-Lung; Lin, Yu-An

    2010-09-01

    To maintain the life of patients with hemophilia, apoplexy or hemorrhage, appropriate blood coagulation is crucial. To study the microscopic phenomena of blood coagulation and the therapeutic effects of blood medication, optical tweezers were applied to estimate the interaction between red blood cells in the coagulation process. By measuring minimum optical power required to trap the coagulating blood cells, the pN-scale interaction between them can be evaluated. In normal blood sample, the interaction rises in accordance with coagulation time. The addition of heparin attenuates the interaction and postpones the coagulation, whereas the addition of tranexamic acid starts the coagulation early at the beginning and allows the process completed in less time.

  16. Safety evaluation and antimalarial effect of mechanochemically ...

    African Journals Online (AJOL)

    The mechanochemical synthesis and characterization of trimethoprim - copper complex and its antimalarial efficacy on Plasmodium berghei infected mice and toxicity evaluation were investigated by evaluating percentage parasitemia and chemosuppresive effect of the drugs on Plasmodium berghei infected mice, status of ...

  17. Occupational safety of different industrial sectors in Khartoum State, Sudan. Part 1: Safety performance evaluation.

    Science.gov (United States)

    Zaki, Gehan R; El-Marakby, Fadia A; H Deign El-Nor, Yasser; Nofal, Faten H; Zakaria, Adel M

    2012-12-01

    Safety performance evaluation enables decision makers improve safety acts. In Sudan, accident records, statistics, and safety performance were not evaluated before maintenance of accident records became mandatory in 2005. This study aimed at evaluating and comparing safety performance by accident records among different cities and industrial sectors in Khartoum state, Sudan, during the period from 2005 to 2007. This was a retrospective study, the sample in which represented all industrial enterprises in Khartoum state employing 50 workers or more. All industrial accident records of the Ministry of Manpower and Health and those of different enterprises during the period from 2005 to 2007 were reviewed. The safety performance indicators used within this study were the frequency-severity index (FSI) and fatal and disabling accident frequency rates (DAFR). In Khartoum city, the FSI [0.10 (0.17)] was lower than that in Bahari [0.11 (0.21)] and Omdurman [0.84 (0.34)]. It was the maximum in the chemical sector [0.33 (0.64)] and minimum in the metallurgic sector [0.09 (0.19)]. The highest DAFR was observed in Omdurman [5.6 (3.5)] and in the chemical sector [2.5 (4.0)]. The fatal accident frequency rate in the mechanical and electrical engineering industry was the highest [0.0 (0.69)]. Male workers who were older, divorced, and had lower levels of education had the lowest safety performance indicators. The safety performance of the industrial enterprises in Khartoum city was the best. The safety performance in the chemical sector was the worst with regard to FSI and DAFR. The age, sex, and educational level of injured workers greatly affect safety performance.

  18. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Science.gov (United States)

    2012-05-31

    ... summary, radiation protection, nuclear criticality safety, chemical process safety, fire safety, emergency... COMMISSION Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction Process and Depleted Uranium Deconversion Plan, Lea County, NM AGENCY: Nuclear Regulatory Commission...

  19. Safety evaluation of a hydrogen fueled transit bus

    Energy Technology Data Exchange (ETDEWEB)

    Coutts, D.A.; Thomas, J.K.; Hovis, G.L.; Wu, T.T. [Westinghouse Savannah River Co., Aiken, SC (United States)

    1997-12-31

    Hydrogen fueled vehicle demonstration projects must satisfy management and regulator safety expectations. This is often accomplished using hazard and safety analyses. Such an analysis has been completed to evaluate the safety of the H2Fuel bus to be operated in Augusta, Georgia. The evaluation methods and criteria used reflect the Department of Energy`s graded approach for qualifying and documenting nuclear and chemical facility safety. The work focused on the storage and distribution of hydrogen as the bus motor fuel with emphases on the technical and operational aspects of using metal hydride beds to store hydrogen. The safety evaluation demonstrated that the operation of the H2Fuel bus represents a moderate risk. This is the same risk level determined for operation of conventionally powered transit buses in the United States. By the same criteria, private passenger automobile travel in the United States is considered a high risk. The evaluation also identified several design and operational modifications that resulted in improved safety, operability, and reliability. The hazard assessment methodology used in this project has widespread applicability to other innovative operations and systems, and the techniques can serve as a template for other similar projects.

  20. Safety of Disposable Diaper Materials: Extensive Evaluations Validate Use.

    Science.gov (United States)

    Dey, Swatee; Helmes, C Tucker; White, Jeffrey C; Zhou, Shaoying

    2014-08-01

    Disposable diapers are primarily composed of polymers, such as cellulose, polypropylene, polyester, and polyethylene, which are biologically inert and not bioavailable. They are used in clothes, fabrics, personal hygiene products, and other materials that are commonly in contact with the skin. Each component used throughout the production process must undergo rigorous safety evaluations and assessments and are proven to be well tolerated and safe for their intended uses. No materials are incorporated into a diaper until their safety is confirmed through robust assessments, and additional factors are integrated into the process to compensate for the uncertainty associated with extrapolating toxicity data. After a thorough assessment of the materials and final product, extensive skin compatibility evaluations are conducted as appropriate. This rigorous safety process provides reassurance that consumers can rely on the safety of these diapers. © The Author(s) 2014.

  1. Drug safety evaluation of ropinirole prolonged release.

    Science.gov (United States)

    Stocchi, Fabrizio; Radicati, Fabiana G; Torti, Margherita

    2014-03-01

    The need for multiple administrations and a difficult titration schedule has always represented a limit in the use of dopamine agonists in the treatment of early Parkinson's disease. To avoid these problems, Ropinirole prolonged release (RPR), a non-ergoline dopamine receptor agonist that can be taken once a day, has been formulated. The prolonged release formulation has higher patient compliance due to a simpler and fastest titration schedule; the once-a-day administration makes this molecule especially suitable for young Parkinsonian patients who are still working and having an active lifestyle. In this paper, we will review ropinirole's mechanism of action including pharmacokinetics and pharmacodynamic data and the results of the main clinical studies in early and advanced PD patients. We will also discuss safety data shown during the experimental phase and after RPR commercialization. This article reviews the use of RPR in early and advanced Parkinsonian patients. Medical literature on the use of RPR in Parkinson's disease was identified using MEDLINE and the reference lists of published articles. RPR is effective in the treatment of patients with early Parkinson's disease; in advanced Parkinsonian patients, the amount of daily off-time significantly decreases, improving the mean on time. RPR has also demonstrated to be effective in ameliorating the quality of sleep without increasing the occurrence of daily sleepiness and nocturnal psychosis. RPR was generally well tolerated in both early and advanced Parkinsonian patients.

  2. An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

    Science.gov (United States)

    Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

    2016-01-01

    As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

  3. [Comics for traffic education: evaluation of a traffic safety campaign].

    Science.gov (United States)

    Bonfadelli, H

    1989-01-01

    Traffic safety campaigns often are ineffective to change driving behavior because they don't reach the target group or are recognized only by people who are already interested or concerned. The evaluation of a traffic safety campaign called "Leo Lässig", addressed to young new drivers, shows that recognition and acceptance by the target group were stimulated by the age-conform means of comic-strips.

  4. Evaluation of Health, Safety and Environment (HSE) Culture

    OpenAIRE

    Iraj Mohammadfam; Hanie Nikoomaram; Mohammad Faridan

    2013-01-01

    Studies have determined that the application of technical safety measures is not adequate to protect human, economic and environmental assets in industries. Therefore, promoting Health, Safety and Environment (HSE culture), as an alternative approach, is of great importance. The aim of this study was to evaluate and manage HSE culture among employees of an industrial sector in Iran. This descriptive-analytic research was carried out during the years 2009 and 2010. The statistical population i...

  5. Evaluation of capillary haemoglobin determination for anaemia screening in blood donation settings.

    Science.gov (United States)

    Daves, Massimo; Cemin, Roberto; Zagler, Elmar M; Joos, Alexandra; Platzgummer, Stefan; Hueber, Rudolf; Lippi, Giuseppe

    2016-09-01

    An accurate assessment of hemoglobin (Hb) values before donation is unavoidable for safeguarding donors' safety and fulfilling the current specifications of Hb content in blood bags. This study was hence aimed to compare a finger-prick method for Hb measurement in capillary blood with Hb assessment in venous blood using a hematological analyser. The study populations consisted in 1,014 consecutive blood donors, who had paired measurement of Hb values with HemoCue on capillary blood and UniCel DxH800 in venous blood. A significant overestimation was found with HemoCue compared to UniCel DxH800, but the correlation between methods was significant (comprised between 0.600 and 0.759; all p<0.01) and the bias always lower than the quality specifications. The prevalence of Hb values below the gender-specific thresholds for blood donation was also not significantly different (p=0.186). It can hence be concluded that the finger-prick method evaluated is a safe and reliable means for screening blood donors.

  6. Evaluation of Placental Blood Flow in Patients with Placental Insufficiency

    Directory of Open Access Journals (Sweden)

    Julia E. Dobrokhotova

    2017-03-01

    Full Text Available Background: Placental insufficiency is a major problem of modern obstetrics due to its link to maternal and perinatal morbidity and mortality. Placental microcirculatory disorders play a decisive role in the pathogenesis of this condition. Thus, an evaluation of placental blood flow is of particular importance and crucial for appropriate diagnosis. The aim of this study was to evaluate placental blood flow in patients with placental insufficiency. SMI (superb microvascular imaging was compared to color Doppler for that purpose. Materials and Methods: Primigravida patients (n=91 at 15 to 16 weeks of gestation were enrolled. Inclusion criteria were spontaneous singleton pregnancy, age from 18 to 45 years. All participants were divided into 2 groups: Group 1 – control group (n=27 and Group 2 – threatened miscarriage group (n=64. Transvaginal ultrasound and color Doppler were performed to assess uteroplacental circulation. Placental blood flow was evaluated using a Toshiba Aplio™ 500 machine equipped with an SMI tool. Results: Placental blood flow assessment in patients with normal pregnancy revealed homogenous placental tissue, normal distribution of vessels, and active blood flow; in patients with pregnancy complications, we found inhomogeneous placenta, decreased blood flow, sporadic vessels, and avascular areas. SMI demonstrated several benefits compared to color Doppler imaging. Color Doppler allows us to assess superficial vessels only, whereas SMI provides more comprehensive data on the overall vascularization of the placenta. Conclusion: SMI by Aplio™ 500 (Toshiba may be an effective tool in the assessment of placental blood flow and the diagnosis and prognosis of placental insufficiency.

  7. Criticality safety evaluations - a {open_quotes}stalking horse{close_quotes} for integrated safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Williams, R.A. [Westinghouse Electric Corp., Columbia, SC (United States)

    1995-12-31

    The Columbia Fuel Fabrication Facility of the Westinghouse Commercial Nuclear Fuel Division manufactures low-enriched uranium fuel and associated components for use in commercial pressurized water power reactors. To support development of a comprehensive integrated safety assessment (ISA) for the facility, as well as to address increasing U.S. Nuclear Regulatory Commission (NRC) expectations regarding such a facility`s criticality safety assessments, a project is under way to complete criticality safety evaluations (CSEs) of all plant systems used in processing nuclear materials. Each CSE is made up of seven sections, prepared by a multidisciplinary team of process engineers, systems engineers, safety engineers, maintenance representatives, and operators. This paper provides a cursory outline of the type of information presented in a CSE.

  8. Criticality Safety Evaluation for the TACS at DAF

    Energy Technology Data Exchange (ETDEWEB)

    Percher, C. M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Heinrichs, D. P. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2011-06-10

    Hands-on experimental training in the physical behavior of multiplying systems is one of ten key areas of training required for practitioners to become qualified in the discipline of criticality safety as identified in DOE-STD-1135-99, Guidance for Nuclear Criticality Safety Engineer Training and Qualification. This document is a criticality safety evaluation of the training activities and operations associated with HS-3201-P, Nuclear Criticality 4-Day Training Course (Practical). This course was designed to also address the training needs of nuclear criticality safety professionals under the auspices of the NNSA Nuclear Criticality Safety Program1. The hands-on, or laboratory, portion of the course will utilize the Training Assembly for Criticality Safety (TACS) and will be conducted in the Device Assembly Facility (DAF) at the Nevada Nuclear Security Site (NNSS). The training activities will be conducted by Lawrence Livermore National Laboratory following the requirements of an Integrated Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of an LLNL Certified Fissile Material Handler.

  9. Safety evaluation for packaging (onsite) disposable solid waste cask

    Energy Technology Data Exchange (ETDEWEB)

    Flanagan, B.D., Westinghouse Hanford

    1996-12-20

    This safety evaluation for packaging (SEP) evaluates and documents the ability of the Disposable Solid Waste Cask (DSWC) to meet the packaging requirements of HNF-CM-2-14, Hazardous Material Packaging and Shipping, for the onsite transfer of special form, highway route controlled quantity, Type B fissile radioactive material. This SEP evaluates five shipments of DSWCs used for the transport and storage of Fast Flux Test Facility unirradiated fuel to the Plutonium Finishing Plant Protected Area.

  10. Comparative analysis of existing food safety culture evaluation systems

    OpenAIRE

    Jespersen, Lone; Griffiths, Mansel; Wallace, Carol Anne

    2017-01-01

    The purpose of the research was firstly, to analyze existing culture evaluation systems for commonalities and differences in research quality, applied validation strategies, and content. Secondly, to suggest a simple structure of food safety cultural dimensions to help unify the culture evaluation field. To achieve these goals, a comparison of eight culture evaluation models applied to varing degrees in the food industry was conducted. The systems were found to vary significantly in applied v...

  11. Preliminary safety evaluation of the advanced burner test reactor.

    Energy Technology Data Exchange (ETDEWEB)

    Dunn, F. E.; Fanning, T. H.; Cahalan, J. E.; Nuclear Engineering Division

    2006-09-15

    Results of a preliminary safety evaluation of the Advanced Burner Test Reactor (ABTR) pre-conceptual design are reported. The ABTR safety design approach is described. Traditional defense-in-depth design features are supplemented with passive safety performance characteristics that include natural circulation emergency decay heat removal and reactor power reduction by inherent reactivity feedbacks in accidents. ABTR safety performance in design-basis and beyond-design-basis accident sequences is estimated based on analyses. Modeling assumptions and input data for safety analyses are presented. Analysis results for simulation of simultaneous loss of coolant pumping power and normal heat rejection are presented and discussed, both for the case with reactor scram and the case without reactor scram. The analysis results indicate that the ABTR pre-conceptual design is capable of undergoing bounding design-basis and beyond-design-basis accidents without fuel cladding failures. The first line of defense for protection of the public against release of radioactivity in accidents remains intact with significant margin. A comparison and evaluation of general safety design criteria for the ABTR conceptual design phase are presented in an appendix. A second appendix presents SASSYS-1 computer code capabilities and modeling enhancements implemented for ABTR analyses.

  12. Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

    Science.gov (United States)

    Saito, Masami; Iwasaki, Kiyotaka

    2017-03-01

    Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

  13. Evaluating Performance of Safety Management and Occupational Health Using Total Quality Safety Management Model (TQSM

    Directory of Open Access Journals (Sweden)

    E Mohammadfam

    2015-11-01

    Full Text Available Introduction: All organizations, whether public or private, necessitate performance evaluation systems in regard with growth, stability, and development in the competitive fields. One of the existing models for performance evaluation of occupational health and safety management is Total Quality Safety Management model (TQSM. Therefore, the present study aimed to evaluate performance of safety management and occupational health utilizing TQSM model. Methods: In this descriptive-analytic study, the population consisted of 16 individuals, including managers, supervisors, and members of technical protection and work health committee. Then the participants were asked to respond to TQSM questionnaire before and after the implementation of Occupational Health & Safety Advisory Services 18001 (OHSAS18001. Ultimately, the level of each program as well as the TQSM status were determined before and after the implementation of OHSAS18001. Results: The study results showed that the scores obtained by the company before OHSAS 18001’s implementation, was 43.7 out of 312. After implementing OHSAS 18001 in the company and receiving the related certificate, the total score of safety program that company could obtain was 127.12 out of 312 demonstrating a rise of 83.42 scores (26.8%. The paired t-test revealed that mean difference of TQSM scores before and after OHSAS 18001 implementation was proved to be significant (p> 0.05. Conclusion: The study findings demonstrated that TQSM can be regarded as an appropriate model in order to monitor the performance of safety management system and occupational health, since it possesses the ability to quantitatively evaluate the system performance.

  14. Utilizing Radiofrequency Identification Technology to Improve Safety and Management of Blood Bank Supply Chains.

    Science.gov (United States)

    Coustasse, Alberto; Meadows, Pamela; Hall, Robert S; Hibner, Travis; Deslich, Stacie

    2015-11-01

    The importance of efficiency in the supply chain of perishable products, such as the blood products used in transfusion services, cannot be overstated. Many problems can occur, such as the outdating of products, inventory management issues, patient misidentification, and mistransfusion. The purpose of this article was to identify the benefits and barriers associated with radiofrequency identification (RFID) usage in improving the blood bank supply chain. The methodology for this study was a qualitative literature review following a systematic approach. The review was limited to sources published from 2000 to 2014 in the English language. Sixty-five sources were found, and 56 were used in this research study. According to the finding of the present study, there are numerous benefits and barriers to RFID utilization in blood bank supply chains. RFID technology offers several benefits with regard to blood bank product management, including decreased transfusion errors, reduction of product loss, and more efficient inventory management. Barriers to RFID implementation include the cost associated with system implementation and patient privacy issues. Implementation of an RFID system can be a significant investment. However, when observing the positive impact that such systems may have on transfusion safety and inventory management, the cost associated with RFID systems can easily be justified. RFID in blood bank inventory management is vital to ensuring efficient product inventory management and positive patient outcomes.

  15. Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient.

    Science.gov (United States)

    Muñoz Gómez, M; Bisbe Vives, E; Basora Macaya, M; García Erce, J A; Gómez Luque, A; Leal-Noval, S R; Colomina, M J; Comin Colet, J; Contreras Barbeta, E; Cuenca Espiérrez, J; Garcia de Lorenzo Y Mateos, A; Gomollón García, F; Izuel Ramí, M; Moral García, M V; Montoro Ronsano, J B; Páramo Fernández, J A; Pereira Saavedra, A; Quintana Diaz, M; Remacha Sevilla, Á; Salinas Argente, R; Sánchez Pérez, C; Tirado Anglés, G; Torrabadella de Reinoso, P

    2015-12-01

    In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  16. A Guidebook for Evaluating Organizations in the Nuclear Industry - an example of safety culture evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Oedewald, Pia; Pietikaeinen, Elina; Reiman, Teemu [VTT, Technical Research Centre of Finland, Espoo (Finland)

    2011-06-15

    Organizations in the nuclear industry need to maintain an overview on their vulnerabilities and strengths with respect to safety. Systematic periodical self assessments are necessary to achieve this overview. This guidebook provides suggestions and examples to assist power companies but also external evaluators and regulators in carrying out organizational evaluations. Organizational evaluation process is divided into five main steps. These are: 1) planning the evaluation framework and the practicalities of the evaluation process, 2) selecting data collection methods and conducting the data acquisition, 3) structuring and analysing the data, 4) interpreting the findings and 5) reporting the evaluation results with possible recommendations. The guidebook emphasises the importance of a solid background framework when dealing with multifaceted phenomena like organisational activities and system safety. The validity and credibility of the evaluation stem largely from the evaluation team's ability to crystallize what they mean by organization and safety when they conduct organisational safety evaluations - and thus, what are the criteria for the evaluation. Another important and often under-considered phase in organizational evaluation is interpretation of the findings. In this guidebook a safety culture evaluation in a Nordic nuclear power plant is presented as an example of organizational evaluation. With the help of the example, challenges of each step in the organizational evaluation process are described. Suggestions for dealing with them are presented. In the case example, the DISC (Design for Integrated Safety culture) model is used as the evaluation framework. The DISC model describes the criteria for a good safety culture and the organizational functions necessary to develop a good safety culture in the organization.

  17. Evaluation of Verigene Blood Culture Test Systems for Rapid Identification of Positive Blood Cultures

    Directory of Open Access Journals (Sweden)

    Jae-Seok Kim

    2016-01-01

    Full Text Available The performance of molecular tests using the Verigene Gram-Positive and Gram-Negative Blood Culture nucleic acid tests (BC-GP and BC-GN, resp.; Naosphere, Northbrook, IL, USA was evaluated for the identification of microorganisms detected from blood cultures. Ninety-nine blood cultures containing Gram-positive bacteria and 150 containing Gram-negative bacteria were analyzed using the BC-GP and BC-GN assays, respectively. Blood cultures were performed using the Bactec blood culture system (BD Diagnostic Systems, Franklin Lakes, NJ, USA and conventional identification and antibiotic-susceptibility tests were performed using a MicroScan system (Siemens, West Sacramento, CA, USA. When a single strain of bacteria was isolated from the blood culture, Verigene assays correctly identified 97.9% (94/96 of Gram-positive bacteria and 93.8% (137/146 of Gram-negative bacteria. Resistance genes mecA and vanA were correctly detected by the BC-GP assay, while the extended-spectrum β-lactamase CTX-M and the carbapenemase OXA resistance gene were detected from 30 cases cultures by the BC-GN assay. The BC-GP and BC-GN assays showed high agreement with conventional identification and susceptibility tests. These tests are useful for rapid identification of microorganisms and the detection of clinically important resistance genes from positive Bactec blood cultures.

  18. Evaluation of Verigene Blood Culture Test Systems for Rapid Identification of Positive Blood Cultures.

    Science.gov (United States)

    Kim, Jae-Seok; Kang, Go-Eun; Kim, Han-Sung; Kim, Hyun Soo; Song, Wonkeun; Lee, Kyu Man

    2016-01-01

    The performance of molecular tests using the Verigene Gram-Positive and Gram-Negative Blood Culture nucleic acid tests (BC-GP and BC-GN, resp.; Naosphere, Northbrook, IL, USA) was evaluated for the identification of microorganisms detected from blood cultures. Ninety-nine blood cultures containing Gram-positive bacteria and 150 containing Gram-negative bacteria were analyzed using the BC-GP and BC-GN assays, respectively. Blood cultures were performed using the Bactec blood culture system (BD Diagnostic Systems, Franklin Lakes, NJ, USA) and conventional identification and antibiotic-susceptibility tests were performed using a MicroScan system (Siemens, West Sacramento, CA, USA). When a single strain of bacteria was isolated from the blood culture, Verigene assays correctly identified 97.9% (94/96) of Gram-positive bacteria and 93.8% (137/146) of Gram-negative bacteria. Resistance genes mecA and vanA were correctly detected by the BC-GP assay, while the extended-spectrum β-lactamase CTX-M and the carbapenemase OXA resistance gene were detected from 30 cases cultures by the BC-GN assay. The BC-GP and BC-GN assays showed high agreement with conventional identification and susceptibility tests. These tests are useful for rapid identification of microorganisms and the detection of clinically important resistance genes from positive Bactec blood cultures.

  19. Safety evaluation for packaging (onsite) 221 T sodium tanks

    Energy Technology Data Exchange (ETDEWEB)

    McCormick, W.A.

    1998-02-04

    This safety evaluation for packaging (SEP) allows the transport of approximately 820 kg (1800 lb) of solid sodium between the 200 W Area and the 337 Building in the 300 Area of Hanford to be processed for disposal. This SEP authorizes a one-time shipment.

  20. Evaluation of pesticide safety measures adopted by potato farmers ...

    African Journals Online (AJOL)

    In order to increase productivity and quality, farmers use pesticides and other agrochemicals. These pesticides if improperly handled impact negatively on the health of the users. The objective of the study was to evaluate the pesticide safety measures adopted by potato farmers in Chebiemit Division of Elgeyo/Marakwet ...

  1. Safety Evaluation for Packaging (onsite) T Plant Canyon Items

    Energy Technology Data Exchange (ETDEWEB)

    OBRIEN, J.H.

    2000-07-14

    This safety evaluation for packaging (SEP) evaluates and documents the ability to safely ship mostly unique inventories of miscellaneous T Plant canyon waste items (T-P Items) encountered during the canyon deck clean off campaign. In addition, this SEP addresses contaminated items and material that may be shipped in a strong tight package (STP). The shipments meet the criteria for onsite shipments as specified by Fluor Hanford in HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments.

  2. The National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study (REDS-III): A research program striving to improve blood donor and transfusion recipient outcomes

    Science.gov (United States)

    Kleinman, Steven; Busch, Michael P; Murphy, Edward L; Shan, Hua; Ness, Paul; Glynn, Simone A.

    2014-01-01

    Background The Recipient Epidemiology and Donor Evaluation Study -III (REDS-III) is a 7-year multicenter transfusion safety research initiative launched in 2011 by the National Heart, Lung, and Blood Institute. Study design The domestic component involves 4 blood centers, 12 hospitals, a data coordinating center, and a central laboratory. The international component consists of distinct programs in Brazil, China, and South Africa which involve US and in-country investigators. Results REDS-III is using two major methods to address key research priorities in blood banking/transfusion medicine. First, there will be numerous analyses of large “core” databases; the international programs have each constructed a donor/donation database while the domestic program has established a detailed research database that links data from blood donors and their donations, the components made from these donations, and data extracts from the electronic medical records of the recipients of these components. Secondly, there are more than 25 focused research protocols involving transfusion recipients, blood donors, or both that are either in progress or scheduled to begin within the next 3 years. Areas of study include transfusion epidemiology and blood utilization; transfusion outcomes; non-infectious transfusion risks; HIV-related safety issues (particularly in the international programs); emerging infectious agents; blood component quality; donor health and safety; and other donor issues. Conclusions It is intended that REDS-III serve as an impetus for more widespread recipient and linked donor-recipient research in the US as well as to help assure a safe and available blood supply in the US and in international locations. PMID:24188564

  3. Evaluation of the food safety training for food handlers in restaurant operations

    National Research Council Canada - National Science Library

    Sung-Hee Park; Tong-Kyung Kwak; Hye-Ja Chang

    2010-01-01

    .... The training program and questionnaires for evaluating employee knowledge and practices concerning food safety, and a checklist for determining food safety performance of restaurants were developed...

  4. Blood cytokines as biomarkers of in vivo toxicity in preclinical safety assessment: considerations for their use.

    Science.gov (United States)

    Tarrant, Jacqueline M

    2010-09-01

    In the drive to develop drugs with well-characterized and clinically monitorable safety profiles, there is incentive to expand the repertoire of safety biomarkers for toxicities without routine markers or premonitory detection. Biomarkers in blood are pursued because of specimen accessibility, opportunity for serial monitoring, quantitative measurement, and the availability of assay platforms. Cytokines, chemokines, and growth factors (here referred to collectively as cytokines) show robust modulation in proximal events of inflammation, immune response, and repair. These are key general processes in many toxicities; therefore, cytokines are commonly identified during biomarker discovery studies. In addition, multiplexed cytokine immunoassays are easily applied to biomarker discovery and routine toxicity studies to measure blood cytokines. However, cytokines pose several challenges as safety biomarkers because of a short serum half-life; low to undetectable baseline levels; lack of tissue-specific or toxicity-specific expression; complexities related to cytokine expression with multiorgan involvement; and species, strain, and interindividual differences. Additional challenges to their application are caused by analytical, methodological, and study design-related variables. A final consideration is the strength of the relationship between changes in cytokine levels and the development of phenotypic or functional manifestations of toxicity. These factors should inform the integrated judgment-based qualification of novel biomarkers in preclinical, and potentially clinical, risk assessment. The dearth of robust, predictive cytokine biomarkers for specific toxicities is an indication of the significant complexity of these challenges. This review will consider the current state of the science and recommendations for appropriate application of cytokines in preclinical safety assessment.

  5. [Medical safety management in the blood collection center of clinical laboratory].

    Science.gov (United States)

    Yoshida, Hiroshi; Kisugi, Reiko; Koike, Masaru

    2011-03-01

    Safety management is essential for providing patients with medical services. Our hospital, opened at Kashiwa in 1987, has been building up systems and taking a number of steps to reduce the blood collection related problems, including venipuncture-related infection, nerve injury, and vasovagal reflex with syncope in accordance with guidelines for the standard method of venipuncture blood collection. We also have made efforts for improving medical services, including reductions in patient waiting time and prevention of patient misidentification, medical test malpractice, and patient privacy. However, ultimately, it is of obvious significance to educate and train communication skills for humanity and friendly kindness because most of medical accidents are basically attributed to communication errors between patients and medical staff.

  6. Hepatitis E and blood donation safety in selected European countries: a shift to screening?

    Science.gov (United States)

    Domanović, Dragoslav; Tedder, Richard; Blümel, Johannes; Zaaijer, Hans; Gallian, Pierre; Niederhauser, Christoph; Sauleda Oliveras, Silvia; O'Riordan, Joan; Boland, Fiona; Harritshøj, Lene; Nascimento, Maria São José; Ciccaglione, Anna Rita; Politis, Constatina; Adlhoch, Cornelia; Flan, Benoit; Oualikene-Gonin, Wahiba; Rautmann, Guy; Strengers, Paul; Hewitt, Patricia

    2017-04-20

    The public health implications of hepatitis E virus (HEV) in Europe have changed due to increasing numbers of hepatitis E cases and recent reports of chronic, persistent HEV infections associated with progression to cirrhosis in immunosuppressed patients. The main infectious risk for such immunosuppressed patients is exposure to undercooked infected pork products and blood transfusion. We summarised the epidemiology of HEV infections among blood donors and also outlined any strategies to prevent transfusion-transmitted HEV, in 11 European countries. In response to the threat posed by HEV and related public and political concerns, most of the observed countries determined seroprevalence of HEV in donors and presence of HEV RNA in blood donations. France, Germany, Spain and the United Kingdom (UK) reported cases of transfusion-transmitted HEV. Ireland and the UK have already implemented HEV RNA screening of blood donations; the Netherlands will start in 2017. Germany and France perform screening for HEV RNA in several blood establishments or plasma donations intended for use in high-risk patients respectively and, with Switzerland, are considering implementing selective or universal screening nationwide. In Greece, Portugal, Italy and Spain, the blood authorities are evaluating the situation. Denmark decided not to implement the HEV screening of blood donations. This article is copyright of The Authors, 2017.

  7. Patient involvement in blood transfusion safety: patients' and healthcare professionals' perspective.

    Science.gov (United States)

    Davis, R; Murphy, M F; Sud, A; Noel, S; Moss, R; Asgheddi, M; Abdur-Rahman, I; Vincent, C

    2012-08-01

    Blood transfusion is one of the major areas where serious clinical consequences, even death, related to patient misidentification can occur. In the UK, healthcare professional compliance with pre-transfusion checking procedures which help to prevent misidentification errors is poor. Involving patients at a number of stages in the transfusion pathway could help prevent the occurrence of these incidents. To investigate patients' willingness to be involved and healthcare professionals' willingness to support patient involvement in pre-transfusion checking behaviours. A cross-sectional design was employed assessing willingness to participate in pre-transfusion checking behaviours (patient survey) and willingness to support patient involvement (healthcare professional survey) on a scale of 1-7. One hundred and ten patients who had received a transfusion aged between 18 and 93 (60 male) and 123 healthcare professionals (doctors, nurses and midwives) involved in giving blood transfusions to patients. Mean scores for patients' willingness to participate in safety-relevant transfusion behaviours and healthcare professionals' willingness to support patient involvement ranged from 4.96-6.27 to 4.53-6.66, respectively. Both groups perceived it most acceptable for patients to help prevent errors or omissions relating to their hospital identification wristband. Neither prior experience of receiving a blood transfusion nor professional role of healthcare staff had an effect on attitudes towards patient participation. Overall, both patients and healthcare professionals view patient involvement in transfusion-related behaviours quite favourably and appear in agreement regarding the behaviours patients should adopt an active role in. Further work is needed to determine the effectiveness of this approach to improve transfusion safety. © 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.

  8. Integrated and automatic mixing of whole blood: an evaluation of a novel blood gas analyzer.

    Science.gov (United States)

    Grenache, David G; Parker, Christopher

    2007-01-01

    A homogeneous whole blood specimen is essential to produce quality results from blood gas analysis, however achieving an adequately mixed specimen can be difficult due to the absence of any dead space in a blood gas syringe. This study evaluated the efficacy of an automatic mixing feature incorporated into the ABL800 FLEX blood gas analyzer and estimated the systematic error in tests performed by the instrument. Quantitative measurements of pH, PCO(2), PO(2), Na(+), K(+), Ca(+), glucose, lactate, and total hemoglobin were performed on 388 whole blood specimens collected into standard blood gas syringes or specific syringes designed to work in conjunction with the ABL800 FLEX. One hundred eighty specimens were manually or automatically mixed following horizontal storage for 10, 20, or 30 min and total hemoglobin was used as in indicator of specimen homogeneity. Two hundred eight specimens were used to estimate the systematic error of tests performed by the ABL800 FLEX. Manual mixing produced significantly more variation in paired hemoglobin measurements compared to automatic mixing at all three time points (pmixing, automatic mixing by the ABL800 FLEX consistently produces a homogeneous specimen.

  9. Evaluation of a preliminary safety concept for the HPLWR

    Energy Technology Data Exchange (ETDEWEB)

    Andreani, M. [Paul Scherrer Inst., PSI, Villigen (Switzerland); Bittermann, D. [AREVA NP GmbH (Germany); Marsault, Ph.; Antoni, O. [Commisssariat a l' Energie Atomique, CEA (France); Kereszturi, A. [Atomic Energy Research Inst. KFKI (Hungary); Schlagenhaufer, M. [Karlsruhe Inst. of Tech., KIT (Germany); Manera, A. [Paul Scherrer Inst., PSI, Villigen (Switzerland); Seppala, M.; Kurki, J. [VTT Tech. Research Centre (Finland)

    2011-07-01

    The main safety functions considered in the preliminary concept for the HPLWR have been evaluated by means of a comprehensive set of analyses, which have been performed using system and coupled codes. The investigated scenarios addressed a variety of initiating events, including anticipated transients as well as accidents. The simulations performed show that for each class of transients at least one of the computational tools used in this project is adequate for preliminary assessment of the safety concept of the HPLWR. The analyses have shown that the proposed systems can be expected to be capable to provide all the safety functions. The open issues that remain to be addressed in future projects are also discussed. (author)

  10. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA).

    Science.gov (United States)

    Farmer, Shannon L; Towler, Simon C; Leahy, Michael F; Hofmann, Axel

    2013-03-01

    Patient blood management is now high on national and international health-system agendas. Serious supply challenges as a result of changing population dynamics, escalating cost of blood, ongoing safety challenges and questions about transfusion efficacy and outcomes are necessitating change in transfusion practice. Numerous initiatives are underway to bring about change, including the institution of comprehensive patient blood management programmes. In 2008, the Western Australia Department of Health initiated a 5-year project to implement a comprehensive health-system-wide Patient Blood Management Program with the aim of improving patient outcomes while reducing costs. Clinically, the Program was structured on the three pillars of patient blood management, namely (1) optimising the patient's own red cell mass, (2) minimising blood loss and (3) harnessing and optimising the patient-specific anaemia reserve. It employs multiple strategies to bring about a cultural change from a blood-product focus to a patient focus. This Program was undertaken in a State that already had one of the lowest red blood cell issuance rates per 1000 population in the developed world (30.47 red blood cell units per 1000 population). The Program identified reasons and drivers for practice change. From financial years 2008-09 to 2011-12, issuance has progressively decreased in Western Australia to 27.54 units per 1000. During the same years, despite increasing activity, total issuance of red blood cells to the entire State decreased from 70,103 units to 65,742. Nationally and internationally, other initiatives are underway to bring about change and implement patient blood management. The World Health Assembly in May 2010 adopted resolution WHA63.12 endorsing patient blood management and its three-pillar application. The United States Advisory Committee on Blood Safety and Availability met in 2011 to consider the implications of this resolution and its implementation. Copyright © 2012

  11. Evaluation of Relative Blood Viscosity During Menstruation in ...

    African Journals Online (AJOL)

    The changes in blood viscosity, plasma viscosity, haematocrit and erythrocyte sedimentation rate before and during menstruation were evaluated. Forty (40) apparently healthy reproductive female subjects (between 15 and 28 years) and resident in Benin City, Edo State, Nigeria were used for the study. The parameters ...

  12. Safety and operational performance evaluation of four types of exit ramps on Florida's freeways (final report).

    Science.gov (United States)

    2010-12-01

    This project mainly focuses on exit ramp performance analysis of safety and operations. In addition, issues of advance guide sign for exit ramp are also mentioned. : Safety analysis evaluates safety performances of different exit ramps used in Florid...

  13. Investigating the Effects of Safety Management System Practice, Benevolent Leadership and Core Self-evaluations on Cabin Crew Safety Behavior

    National Research Council Canada - National Science Library

    CHEN, Ching-Fu; CHEN, Shu-Chuan

    2014-01-01

    .... Specifically, we specify perceived airlines' Safety Management System practice, department managers' benevolent leadership and individual core self-evaluations as three factors affecting cabin crew...

  14. Evaluating the effectiveness of active vehicle safety systems.

    Science.gov (United States)

    Jeong, Eunbi; Oh, Cheol

    2017-03-01

    Advanced vehicle safety systems have been widely introduced in transportation systems and are expected to enhance traffic safety. However, these technologies mainly focus on assisting individual vehicles that are equipped with them, and less effort has been made to identify the effect of vehicular technologies on the traffic stream. This study proposed a methodology to assess the effectiveness of active vehicle safety systems (AVSSs), which represent a promising technology to prevent traffic crashes and mitigate injury severity. The proposed AVSS consists of longitudinal and lateral vehicle control systems, which corresponds to the Level 2 vehicle automation presented by the National Highway Safety Administration (NHTSA). The effectiveness evaluation for the proposed technology was conducted in terms of crash potential reduction and congestion mitigation. A microscopic traffic simulator, VISSIM, was used to simulate freeway traffic stream and collect vehicle-maneuvering data. In addition, an external application program interface, VISSIM's COM-interface, was used to implement the AVSS. A surrogate safety assessment model (SSAM) was used to derive indirect safety measures to evaluate the effectiveness of the AVSS. A 16.7-km freeway stretch between the Nakdong and Seonsan interchanges on Korean freeway 45 was selected for the simulation experiments to evaluate the effectiveness of AVSS. A total of five simulation runs for each evaluation scenario were conducted. For the non-incident conditions, the rear-end and lane-change conflicts were reduced by 78.8% and 17.3%, respectively, under the level of service (LOS) D traffic conditions. In addition, the average delay was reduced by 55.5%. However, the system's effectiveness was weakened in the LOS A-C categories. Under incident traffic conditions, the number of rear-end conflicts was reduced by approximately 9.7%. Vehicle delays were reduced by approximately 43.9% with 100% of market penetration rate (MPR). These results

  15. Packaging Evaluation Approach to Improve Cosmetic Product Safety

    Directory of Open Access Journals (Sweden)

    Benedetta Briasco

    2016-09-01

    Full Text Available In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the specific product is correctly evaluated. Despite the law requirement, there is too little information about the chemical-physical characteristics of finished packaging and the possible interactions between formulation and packaging; furthermore, different from food packaging, the cosmetic packaging is not regulated and, to date, appropriate guidelines are still missing. The aim of this work was to propose a practical approach to investigate commercial polymeric containers used in cosmetic field, especially through mechanical properties’ evaluation, from a safety point of view. First of all, it is essential to obtain complete information about raw materials. Subsequently, using an appropriate full factorial experimental design, it is possible to investigate the variables, like polymeric density, treatment, or type of formulation involved in changes to packaging properties or in formulation-packaging interaction. The variation of these properties can greatly affect cosmetic safety. In particular, mechanical properties can be used as an indicator of pack performances and safety. As an example, containers made of two types of polyethylene with different density, low-density polyethylene (LDPE and high-density polyethylene (HDPE, are investigated. Regarding the substances potentially extractable from the packaging, in this work the headspace solid-phase microextraction method (HSSPME was used because this technique was reported in the literature as suitable to detect extractables from the polymeric material here employed.

  16. Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk.

    Science.gov (United States)

    Kiely, Philip; Gambhir, Manoj; Cheng, Allen C; McQuilten, Zoe K; Seed, Clive R; Wood, Erica M

    2017-07-01

    While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  17. Development of a Novel Nuclear Safety Culture Evaluation Method for an Operating Team Using Probabilistic Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Han, Sangmin; Lee, Seung Min; Seong, Poong Hyun [KAIST, Daejeon (Korea, Republic of)

    2015-05-15

    IAEA defined safety culture as follows: 'Safety Culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance'. Also, celebrated behavioral scientist, Cooper, defined safety culture as,'safety culture is that observable degree of effort by which all organizational members direct their attention and actions toward improving safety on a daily basis' with his internal psychological, situational, and behavioral context model. With these various definitions and criteria of safety culture, several safety culture assessment methods have been developed to improve and manage safety culture. To develop a new quantitative safety culture evaluation method for an operating team, we unified and redefined safety culture assessment items. Then we modeled a new safety culture evaluation by adopting level 1 PSA concept. Finally, we suggested the criteria to obtain nominal success probabilities of assessment items by using 'operational definition'. To validate the suggested evaluation method, we analyzed the collected audio-visual recording data collected from a full scope main control room simulator of a NPP in Korea.

  18. Safety evaluation of Chinese nickel resources based on analytic hierarchy process and fuzzy comprehensive evaluation

    Science.gov (United States)

    Lin, Zhifeng

    2017-08-01

    China is now the world’s largest producer and consumer of nickel. As an important strategic metal, nickel is widely used in various industries of national economy. Whether the supply of nickel ore resources is sufficient or not directly restricts the development of downstream industries. It is becoming more and more important to evaluate the safety of nickel resources in our country, and to formulate the corresponding safety strategy. This paper uses fuzzy analytic hierarchy process to evaluate the safety of nickel resources in China, and overcomes the subjectivity and singleness of traditional evaluation methods. On the basis of the analytic hierarchy process to determine the weight, the fuzzy comprehensive evaluation is introduced. At present, the safety situation of nickel resources in our country is in a more dangerous level, and we need to take positive measures to improve it.

  19. Evaluation of Four Veterinary Hematology Analyzers for Bovine and Ovine Blood Counts for In Vitro Testing of Medical Devices.

    Science.gov (United States)

    Pieper, Ina Laura; Friedmann, Yasmin; Jones, Alyssa; Thornton, Catherine

    2016-11-01

    Small affordable automated hematology analyzers that produce rapid and accurate complete blood cell counts are a valuable tool to researchers developing blood-handling medical devices, such as ventricular assist devices, for in vitro safety assessments. In such studies, it is common to use the blood of large animals such as cattle and sheep. However, the commercially available instruments have not been evaluated for their ability to measure the blood counts of these animals. In this study, we compare, for the first time, four veterinary analyzers for blood counts on bovine and ovine blood samples. We look at ease of use, repeatability and agreement with a view to inform researchers of the benefits of these instruments in routine measurement of ovine and bovine bloods during in vitro testing. Complete blood cell counts and a three-part differential (granulocytes, monocytes, and lymphocytes) were measured by each of the instruments, and the results compared to those obtained from two additional analyzers used in a reference laboratory. Repeatability and agreement were evaluated using the Bland-Altman method; bias and 95% limits of agreement between the instruments, and between the instruments and two reference instruments, were used to evaluate instrument performance. In summary, there are advantages and disadvantages with all instruments. Of the four instruments tested, the repeatability and agreement was fairly similar for all instruments except one instrument which cannot be recommended for bovine or ovine blood counts. Copyright © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  20. Body fat and blood rheology: Evaluation of the association between different adiposity indices and blood viscosity.

    Science.gov (United States)

    Tripolino, Cesare; Irace, Concetta; Carallo, Claudio; Scavelli, Faustina Barbara; Gnasso, Agostino

    2017-01-01

    In recent years, new measures of body adiposity have been introduced: lipid accumulation product (LAP), body adiposity index (BAI) and body shape index (ABSI). These indices have been demonstrated to better associate with cardiovascular disease than other measures of adiposity. The aim of the present study was to evaluate if LAP or BAI better associate with blood viscosity than other measures of adiposity (body mass index, BMI; waist circumference, WC; waist-to-hip ratio, W/HR; waist-to-height ratio, W/HtR). 344 subjects were recruited for the present investigation. Exclusion criteria were: diabetes, elevated triglycerides, smoking and drug use. Blood lipids and glucose were measured by routine methods. Blood and plasma viscosity were measured by a cone-plate viscometer. Adiposity measures were computed as previously described. In simple correlation analyses, blood viscosity (BV) correlated with BMI, BAI, and LAP in males and with LAP in females. Correlations between plasma viscosity and adiposity indices were weak and not statistically significant. Other variables significantly related with BV were: gender, HDL- and LDL-Cholesterol, and triglycerides (p < 0.05). In multiple regression analysis only LAP was associated with BV. Our data suggest that LAP index is strongly associated to blood viscosity. This result, along with previous evidence, identifies LAP index as a potential cardiovascular risk marker.

  1. Safety evaluation for packaging (onsite) depleted uranium waste boxes

    Energy Technology Data Exchange (ETDEWEB)

    McCormick, W.A.

    1997-08-27

    This safety evaluation for packaging (SEP) allows the one-time shipment of ten metal boxes and one wooden box containing depleted uranium material from the Fast Flux Test Facility to the burial grounds in the 200 West Area for disposal. This SEP provides the analyses and operational controls necessary to demonstrate that the shipment will be safe for the onsite worker and the public.

  2. Blood transfusion exposure in Denmark and Sweden

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Edgren, Gustaf; Rostgaard, Klaus

    2009-01-01

    Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population.......Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population....

  3. Rupatadine: global safety evaluation in allergic rhinitis and urticaria.

    Science.gov (United States)

    González-Núñez, Vanesa; Bachert, Claus; Mullol, Joaquim

    2016-10-01

    Rupatadine is a second-generation H1-antihistamine with dual affinity for histamine H1 and PAF receptors. Rupatadine is indicated for the treatment of allergic rhinitis and urticaria. A Medline search was conducted to identify preclinical and clinical studies of rupatadine. This was supplemented with additional articles obtained from online sources. The focus of this review is on the safety profile of rupatadine. The review of these data indicates that rupatadine is highly selective for histamine H1-receptors, exhibits additional PAF antagonism in in vitro and in vivo studies, does not cross the blood-brain barrier, and has similar adverse events comparable with other second-generation antihistamines. Rupatadine is a safe and well tolerated drug in patients over 2 years old, with no central nervous system or cardiovascular effects and it can be taken with or without foods.

  4. Evaluation of alert-based monitoring in a computerised blood transfusion management system.

    Science.gov (United States)

    Shabestari, Omid; Gooch, Philip; Goddard, Kate; Golchin, Kamran; Kay, Jonathan; Roudsari, Abdul

    2011-01-01

    Blood transfusion is a critical and multi-step process that can be lifesaving. At the same time, any mistakes can be life threatening. An electronic blood transfusion system has been designed to ensure the correctness and safety of the blood transfusion process. The standards for the system include notification mechanisms to inform system managers of any errors in the process. Analysis of system alerts has been used to evaluate the performance of the system. The majority of alerts were classified as 'moderate' in terms of risk (i.e. operational rather than affecting clinical safety) and tended to result from user error. The process of alert acknowledgement and resolution by the system administrator acted as a bottleneck whenever the alerts increased above 100 items per month. Although there was no statistically significant correlation between the number of alerts and the number of transfusions or number of the new users of the system, relatively similar patterns were observable in their charts. A major benefit is that the alerts automatically provided information that would not be captured in a manual transfusion process.

  5. Criticality Safety Evaluation of Standard Criticality Safety Requirements #1-520 g Operations in PF-4

    Energy Technology Data Exchange (ETDEWEB)

    Yamanaka, Alan Joseph Jr. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-10-13

    Guidance has been requested from the Nuclear Criticality Safety Division (NCSD) regarding processes that involve 520 grams of fissionable material or less. This Level-3 evaluation was conducted and documented in accordance with NCS-AP-004 (Ref. 1), formerly NCS-GUIDE-01. This evaluation is being written as a generic evaluation for all operations that will be able to operate using a 520-gram mass limit. Implementation for specific operations will be performed using a Level 1 CSED, which will confirm and document that this CSED can be used for the specific operation as discussed in NCS-MEMO-17-007 (Ref. 2). This Level 3 CSED updates and supersedes the analysis performed in NCS-TECH-14-014 (Ref. 3).

  6. Total pancreatectomy for pancreatic carcinoma: evaluation of safety and efficacy.

    Science.gov (United States)

    Kitagawa, Maki; Ikoma, Hisashi; Ochiai, Toshiya; Ishii, Hiromichi; Shiozaki, Atsushi; Kuriu, Yoshiaki; Nakanishi, Masayoshi; Ichikawa, Daisuke; Okamoto, Kazuma; Fujiwara, Hitoshi; Sakakura, Chohei; Kokuba, Yukihito; Sonoyama, Teruhisa; Otsuji, Eigo

    2012-05-01

    To determine the safety and the efficacy of total pancreatectomy for the curative treatment of pancreatic carcinoma. Retrospective analysis was performed using 10 patients receiving total pancreatectomy. The median duration of the operative procedure was 8.7 hours and the median estimated blood loss was 2,700mL. Seven patients developed postoperative complications, including infections in 5 cases. There was no death associated with the operative procedure itself. Median period of postoperative hospital stay was 55 days. Anastomotic ulcer was prevented by administration of proton- pump inhibitors. Blood glucose level was well controlled by subcutaneous injection of sliding scale insulin during the postoperative period and the dosage of insulin required was 0.45±0.13units/kg body weight/ day at the time of discharge. The mean HbA1c level at 3 months after the operation was 6.1%. Four patients needed medication with anti-diarrheal drugs. Total pancreatectomy could be performed safely and postoperative daily performance was reasonable with effective medication. We suggest that total pancreatectomy should be considered for the treatment of pancreatic carcinoma when the patient status is appropriate for this procedure.

  7. Potassium evaluation in blood of Brazilian athletes using NAA

    Energy Technology Data Exchange (ETDEWEB)

    Kovacs, L.; Zamboni, C.B. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil); Nunes, L.A.S.; Lourenco, T.F.; Macedo, D. Vaz de [Universidade Estadual de Campinas (UNICAMP), SP (Brazil)

    2010-07-01

    Full text: According to nutrition sources an athlete needs per day at least one gram of potassium for keeping the correct mineral balance in the organism. Its deficiency or even instantaneous low concentration in blood can diminish the athlete performance originating nervous irritability, muscular weakness, and mental disorientation and in more several causes cardiac arrhythmias. In this study the K levels in blood were determined in athletes submitted to constant load exercise at treadmill at LABEX (Laboratorio de Bioquimica do Exercicio - UNICAMP, Brazil) using Neutron Activation Analyses (NAA). The blood samples were collected from male athletes, age 18 to 26 years, before and after the physical training. Immediately after the collection an amount of 10 micro liters of whole blood was transferred to the filter paper and dried for a few minutes using an infrared lamp. To determine the concentration of potassium each sample was irradiated in the nuclear reactor (IEA-R1, 2-4MW, pool type) at IPEN and was gamma counted using an HPGe Spectrometer of High Energy Resolution. The concentrations of the selected element, 1525keV related to the potassium activated {sup 42}K, were calculated using in -house software. The potassium levels were evaluated before and after the physical exercise and the data were compared with the normal range. (author)

  8. Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites.

    Science.gov (United States)

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

    Malaria inflicts humankind over centuries, and it remains as a major threat to both clinical medicine and public health worldwide. Though hemotherapy is a life-sustaining modality, it continues to be a possible source of disease transmission. Hence, hemovigilance is a matter of grave concern in the malaria-prone third-world countries. In order to pursue an effective research on hemovigilance, a comprehensive search has been conducted by using the premier academic-scientific databases, WHO documents, and English-language search engines. One hundred two appropriate articles were chosen for data extraction, with a particular reference to emerging pathogens transmitted through blood transfusion, specifically malaria. Blood donation screening is done through microscopic examination and immunological assays to improve the safety of blood products by detection major blood-borne pathogens, viz., HIV, HBV, HCV, syphilis, and malarial parasites. Transfusion therapy significantly dwindles the preventable morbidity and mortality attributed to various illnesses and diseases, particularly AIDS, tuberculosis, and malaria. Examination of thick and thin blood smears are performed to detect positivity and to identify the Plasmodium species, respectively. However, all of these existing diagnostic tools have their own limitations in terms of sensitivity, specificity, cost-effectiveness, and lack of resources and skilled personnel. Globally, despite the mandate need of screening blood and its components according to the blood-establishment protocols, it is seldom practiced in the low-income/poverty-stricken settings. In addition, each and every single phase of transfusion chain carries sizable inherent risks from donors to recipients. Interestingly, opportunities also lie ahead to enhance the safety of blood-supply chain and patients. It can be achieved through sustainable blood-management strategies like (1) appropriate usage of precise diagnostic tools/techniques, (2) promoting

  9. Therapeutic efficacy and safety evaluation of erythrocyte concentrate used in dogs

    Directory of Open Access Journals (Sweden)

    Ildiko Barabasi

    2016-11-01

    Full Text Available Therapeutic efficacy and safety evaluation of erythrocyte concentrate used in dogs 1Ildikó BARABÁSI, 1Cristina ȘTEFǍNUȚ, 1Laurenţ OGNEAN 1University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, 400037, Manastur street, no.3-5, Cluj-Napoca, Romania *Corresponding author: lognean@yahoo.com   Keywords: dogs, erythrocyte concentrate, hematocrit, immune-mediated hemolytic anemia, transfusion therapy Introduction: The minimum dose of whole blood products as well as erythrocyte concentrate has been under a lot of debate, new equations for calculating the optimal dose being made up from a large variety of hematologists (Kisielewicz et al 2014; Helm and Knottenbelt, 2010; Gibson, 2007. Aim: The therapeutical efficacy of erythrocyte concentrates in dogs with different types of anemia by measuring the hematocrit level 6 hours after the transfusion and a complete blood count 5 days post-transfusion therapy. Materials and methods: Blood tests were performed with ADIVA hematological analyzer; the 6 hour post-transfusion hematocrit was determined by a micro hematocrit. On admission every patient received a routine blood test that included 40 hematological parameters and 21 biochemical parameters. In addition, a detailed examination of the blood smears was also performed by the ADIVA hematological analyzer with 26 parameters that mostly referred to red blood cell and white blood cell morphology. Blood typing was done using the RapidVet quick test kit. Patients received only type specific blood and to limit transfusion reaction occurrences, in addition, a crossmatch test was performed before every transfusion. Statistical analysis was accomplished with GraphPadInStat 3.0 and the graphical depiction of the obtained results was made using the Origin 8.5. graphics program. Results: Statistical analysis reveal that the total red blood cell count underwent very significant changes (p=0.0052 as well as the hemoglobin (p=0.0085. The hematocrit

  10. Safety and feasibility of countering neurological impairment by intravenous administration of autologous cord blood in cerebral palsy

    Directory of Open Access Journals (Sweden)

    Lee Young-Ho

    2012-03-01

    Full Text Available Abstract Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB in children with cerebral palsy (CP to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential efficacy over 6 months by brain magnetic resonance imaging (MRI-diffusion tensor imaging (DTI, brain perfusion single-photon emission computed tomography (SPECT, and various evaluation tools for motor and cognitive functions. Results Twenty patients received autologous CB infusion and were evaluated. The types of CP were as follows: 11 quadriplegics, 6 hemiplegics, and 3 diplegics. Infusion was generally well-tolerated, although 5 patients experienced temporary nausea, hemoglobinuria, or urticaria during intravenous infusion. Diverse neurological domains improved in 5 patients (25% as assessed with developmental evaluation tools as well as by fractional anisotropy values in brain MRI-DTI. The neurologic improvement occurred significantly in patients with diplegia or hemiplegia rather than quadriplegia. Conclusions Autologous CB infusion is safe and feasible, and has yielded potential benefits in children with CP.

  11. Evaluation of intelligent transport systems impact on school transport safety

    Directory of Open Access Journals (Sweden)

    Jankowska-Karpa Dagmara

    2017-01-01

    Full Text Available The integrated system of safe transport of children to school using Intelligent Transport Systems was developed and implemented in four locations across Europe under the Safeway2School (SW2S project, funded by the EU. The SW2S system evaluation included speed measurements and an eye-tracking experiment carried out among drivers who used the school bus route, where selected elements of the system were tested. The subject of the evaluation were the following system elements: pedestrian safety system at the bus stop (Intelligent Bus Stop and tags for children, Driver Support System, applications for parents’ and students’ mobile phones, bus stop inventory tool and data server. A new sign designed for buses and bus stops to inform about child transportation/children waiting at the bus stop was added to the system. Training schemes for system users were also provided. The article presents evaluation results of the impact of selected elements of the SW2S system on school transport safety in Poland.

  12. Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

    Energy Technology Data Exchange (ETDEWEB)

    Sygitowicz, L S

    2008-03-20

    A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiation Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a site

  13. An evaluation of safety culture initiatives at BNSF Railway

    Science.gov (United States)

    2015-04-01

    Major safety culture (SC) initiatives initiated in the FRA Office of Research, Technology and Development (RT&D), such as Clear Signal for Action (CSA), the Investigation of Safety Related Occurrences Protocol (ISROP), the Participative Safety Rules ...

  14. Observational Pharmacoepidemiology in the Drug Safety and Effectiveness Evaluation

    Directory of Open Access Journals (Sweden)

    José Cabrita

    2017-04-01

    Full Text Available Observational epidemiological studies have been used in the medicines context for more than 40 years, contributing to characterize drug use patterns and safety, efficacy and effectiveness profiles. Its use has been increased in recognition of the clinical trials limitations to assess the therapeutic and iatrogenic potential of the medicines after its commercialization. The evolution of the regulatory framework for pharmacovigilance, requiring post-marketing studies, post-authorization safety studies (PASS and the post-authorization efficacy studies (PAES to approve certain drugs, reinforced the importance of observational pharmacoepidemiology for the characterization of the medicines safety and effectiveness profiles. Pharmacoepidemiological research can be carried out from field studies designed to obtain the necessary information or in databases with health records of population samples that already contain the information. This 2nd option is more efficient and more and more frequent. Although, observational research from field studies continues to have its space, the increasing availability of databases allowed a new development to observational pharmacoepidemiology. Indeed, access to automated records databases with up-to-date information on medical prescriptions and global health care to representative population samples with long follow-up periods is a valuable tool for the study of drug use patterns and therapeutic and iatrogenic potential in routine clinical practice. In this context, observational pharmacoepidemiology reinforces its role as a scientific area particularly suitable for evaluating the safety and the effectiveness of the medicines in the “real world”, making a relevant contribution to overcome the gap in translating the evidence from the clinical trials for clinical practice.

  15. In vitro and in vivo evaluation of efficacy and safety of photoprotective formulations containing antioxidant extracts

    Directory of Open Access Journals (Sweden)

    Maria Cristina P.P. Reis Mansur

    Full Text Available ABSTRACT Chronic exposure to solar radiation could contribute to premature skin aging and skin cancer. Skin presents its own antioxidant defense, however when defenses are out of balance, reactive oxygen species could damage biological structures. In the present work, an oil-in-water photoprotective emulsion was developed and Bauhinia microstachya var. massambabensis Vaz, Fabaceae, extracts at 1% (obtained by extraction with different solvents were added to this emulsion. In vitro and in vivo efficacy and safety of the formulations were evaluated. Spectrophotometric methods and in vivo Colipa test were performed to evaluated efficacy of the formulations, through sun protection factor (SPF determination and UVA protection factor assessment. To the in vitro safety assessment HET-CAM, CAM-TBS and Red Blood Cell tests were performed. Results showed that both extracts contributed to a higher in vivo photoprotection (SPF 18 when compared to the formulation without extract (SPF 13, this result could be attributed to the antioxidant activity of the plant extracts that act by capturing reactive oxygen species. Concerning safety, all formulations were considered non-irritant according to in vitro tests. Formulations containing extracts could be considered efficient and safe for cosmetic use since they presented higher sun protection factor and passed the toxicity tests.

  16. Usability evaluation of a pilot implementation of the electronic clinical transfusion management system IT specification for blood tracking.

    Science.gov (United States)

    Golchin, Kamran; Gooch, Philip; Shabestari, Omid; Roudsari, Abdul

    2011-01-01

    Safe working practices and patient safety are of critical importance in the administration of blood transfusion. While the use of information technology has been proposed to ensure the safety of this process, the usability of such systems has not previously been studied. We present the results of a usability evaluation of an electronic clinical transfusion management system being piloted by the National Health Service in England. A number of major usability problems were recorded, largely relating to unnecessary action, limiting user control and recovery from user error. Such problems can, however, be resolved by relatively minor changes to system functionality and design.

  17. Meat Safety: An Evaluation of Portuguese Butcher Shops.

    Science.gov (United States)

    Santos, Ana; Cardoso, Margarida Fonseca; Costa, José M Correia da; Gomes-Neves, Eduarda

    2017-07-01

    Butcher shops are end points in the meat chain, and they can have a determinant role in cross-contamination control. This study aims to determine whether Portuguese butcher shops comply with European and Portuguese law regarding the sale of fresh meat and meat products. Butcher shops (n = 73) were assessed for meat handler and facility hygiene and for maintenance of the premises. Handlers (n = 88) were given a questionnaire composed of questions about knowledge and practice, including hazard analysis and critical control point (HACCP) and good practice in food industry, to assess their knowledge of and compliance with food safety practices. A checklist of 27 items was used to evaluate facility and meat handler hygiene and butcher shop maintenance. Our results revealed some lack of compliance in all the areas evaluated. The mean knowledge and practice score among the operators was 68.0%, and the mean "visual inspection" score for the butcher shops was 64.0%. Severe deficiencies were observed in the mandatory implementation of HACCP principles in this type of small food business. These findings indicate a need to modify training to enhance compliance with European food safety regulations at this step of the meat chain.

  18. Criticality safety evaluation report for the multi-canister overpack

    Energy Technology Data Exchange (ETDEWEB)

    KESSLER, S.F.

    1999-05-21

    This criticality evaluation is for Spent N Reactor fuel unloaded from the existing canisters in both KE and KW Basins, and loaded into multiple canister overpack (MCO) containers with specially built baskets containing a maximum of either 54 Mark 1V or 48 Mark IA fuel assemblies. The criticality evaluations include loading baskets into the cask-MCO, operations at the Cold Vacuum Drying Facility, and storage in the Canister Storage Building. Many conservatisms have been built into this analysis, the primary one being the selection of the k{sub eff} = 0.95 criticality safety limit. Additional analyses in this revision include partial fuel basket loadings, loading 26.1 inch Mark IA fuel assemblies into Mark IV fuel baskets, and the revised fuel and scrap basket designs. The MCO MCNP model was revised to include the shield plug assembly.

  19. KHNP Safety Culture Framework based on Global Standard, and Lessons learned from Safety Culture Evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Younggab; Hur, Nam Young; Jeong, Hyeon Jong [KHNP Central Research Institute, Daejeon (Korea, Republic of)

    2015-05-15

    In order to eliminate the vague fears of the people about the nuclear power and operate continuously NPPs, a strong safety culture of NPPs should be demonstrated. Strong safety culture awareness of workers can overcome social distrust about NPPs. KHNP has been a variety efforts to improve and establish safety culture of NPPs. Safety culture framework applying global standards was set up and safety culture assessment has been carried out periodically to enhance safety culture of workers. In addition, KHNP developed various safety culture contents and they are being used in NPPs by workers. As a result of these efforts, safety culture awareness of workers is changed positively and the safety environment of NPPs is expected to be improved. KHNP makes an effort to solve areas for improvement derived from safety culture assessment. However, there are some areas to take a long time in completing the work. Therefore, these actions are necessary to be carried out consistently and continuously. KHNP also developed recently safety culture enhancement system based on web. All information related to safety culture in KHNP will be shared through this web system and this system will be used to safety culture assessment. In addition to, KHNP plans to develop safety culture indicators for monitoring the symptoms of safety culture weakening.

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

    Science.gov (United States)

    Wang, Zhiqiang; Yuan, Lei; Wang, Yongchuan; Yang, Baizhi; Dong, Xiaohong; Gao, Zhaowang

    2016-01-01

    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. 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. 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 damp-heat and blood-stasis syndromes. While Prostant showed some efficacy in this disorder, it was associated with a smaller reduction in NIH-CPSI scores. In conclusion, CHM monotherapy is safe and effective for the treatment of CP associated with damp-heat and blood-stasis syndromes.

  1. Transplantation of autologous peripheral blood mononuclear cells in the subarachnoid space for amyotrophic lateral sclerosis: a safety analysis of 14 patients.

    Science.gov (United States)

    Li, Xiao-Yan; Liang, Zhan-Hua; Han, Chao; Wei, Wen-Juan; Song, Chun-Li; Zhou, Li-Na; Liu, Yang; Li, Ying; Ji, Xiao-Fei; Liu, Jing

    2017-03-01

    There is a small amount of clinical data regarding the safety and feasibility of autologous peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis. The objectives of this retrospective study were to assess the safety and efficacy of peripheral blood mononuclear cell transplantation in 14 amyotrophic lateral sclerosis patients to provide more objective data for future clinical trials. After stem cell mobilization and collection, autologous peripheral blood mononuclear cells (1 × 109) were isolated and directly transplanted into the subarachnoid space of amyotrophic lateral sclerosis patients. The primary outcome measure was incidence of adverse events. Secondary outcome measures were electromyography 1 week before operation and 4 weeks after operation, Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale 1 week preoperatively and 1, 2, 4 and 12 weeks postoperatively. There was no immediate or delayed transplant-related cytotoxicity. The number of leukocytes, serum alanine aminotransferase and creatinine levels, and body temperature were within the normal ranges. Radiographic evaluation showed no serious transplant-related adverse events. Muscle strength grade, results of Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale were not significantly different before and after treatment. These findings suggest that peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis is safe, but its therapeutic effect is not remarkable. Thus, a large-sample investigation is needed to assess its efficacy further.

  2. [Roundtables of SFTS Congress 2013: Needs, indications and safety of blood products; self-sufficiency in blood products].

    Science.gov (United States)

    Hermine, O; Lassale, B; Morel, P; Samama, C M; Folléa, G; Monsellier, M; Noël, S; Tissot, J-D; Lefrère, J-J

    2014-06-01

    The current issues debate brings together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products are confronted. Copyright © 2014. Published by Elsevier SAS.. All rights reserved.

  3. Functional and safety evaluation of transgenic pork rich in omega-3 fatty acids.

    Science.gov (United States)

    Tang, Maoxue; Qian, Lili; Jiang, Shengwang; Zhang, Jian; Song, Pengkun; Chen, Yaoxing; Cui, Wentao; Li, Kui

    2014-08-01

    Genetically modified animals rich in omega-3 unsaturated fatty acid offer a new strategy to improve the human health, but at the same time present a challenge in terms of food safety assessment. In this study, we evaluated the function and safety of sFat-1 transgenic pork rich in omega-3 fatty acids in mice by feeding basic diet and diets that contain wild type pork and sFat-1 transgenic pork. Blood biochemistry, haematology, peripheral T cell distributions, bacterial counts, gross necropsy, histopathology and organ weights were performed in mice fed with different doses of wild type and transgenic pork. Results indicated that both low and high dose of wild type and transgenic pork had no significant effect on blood biochemistry, T cell distribution, immunoglobulins and bacterial counts in intestine and feces. However, it was noted that both low and high dose of transgenic pork improved the liver immune system in mice, which is probably due to the beneficial contribution of high level of the "good" fatty acids in transgenic pork. There is no significant effect of transgenic pork on all other organs in mice. In summary, our study clearly demonstrated that feeding transgenic pork rich in omega-3 fatty acids did not cause any harm to mice, and in fact, improved the liver immune system.

  4. Safety evaluation of neem (Azadirachta indica) derived pesticides.

    Science.gov (United States)

    Boeke, Sara J; Boersma, Marelle G; Alink, Gerrit M; van Loon, Joop J A; van Huis, Arnold; Dicke, Marcel; Rietjens, Ivonne M C M

    2004-09-01

    The neem tree, Azadirachta indica, provides many useful compounds that are used as pesticides and could be applied to protect stored seeds against insects. However in addition to possible beneficial health effects, such as blood sugar lowering properties, anti-parasitic, anti-inflammatory, anti-ulcer and hepatoprotective effects, also toxic effects are described. In this study we present a review of the toxicological data from human and animal studies with oral administration of different neem-based preparations. The non-aqueous extracts appear to be the most toxic neem-based products, with an estimated safe dose (ESD) of 0.002 and 12.5 microg/kg bw/day. Less toxic are the unprocessed materials seed oil and the aqueous extracts (ESD 0.26 and 0.3 mg/kg bw/day, 2 microl/kg bw/day respectively). Most of the pure compounds show a relatively low toxicity (ESD azadirachtin 15 mg/kg bw/day). For all preparations, reversible effect on reproduction of both male and female mammals seem to be the most important toxic effects upon sub-acute or chronic exposure. From the available data, safety assessments for the various neem-derived preparations were made and the outcomes are compared to the ingestion of residues on food treated with neem preparations as insecticides. This leads to the conclusion that, if applied with care, use of neem derived pesticides as an insecticide should not be discouraged.

  5. Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

    Science.gov (United States)

    Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

    2016-12-20

    Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright

  6. Blood

    Science.gov (United States)

    ... organs and show how well treatments are working. Problems with your blood may include bleeding disorders, excessive clotting and platelet disorders. If you lose too much blood, you may need a transfusion. NIH: National Heart, Lung, and Blood Institute

  7. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution.

    Science.gov (United States)

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-03-22

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO₂ concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports.

  8. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

    Energy Technology Data Exchange (ETDEWEB)

    Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

    2008-12-15

    The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments

  9. Normative evaluation of blood banks in the Brazilian Amazon region in respect to the prevention of transfusion-transmitted malaria.

    Science.gov (United States)

    Freitas, Daniel Roberto Coradi; Duarte, Elisabeth Carmen

    2014-01-01

    To evaluate blood banks in the Brazilian Amazon region with regard to structure and procedures directed toward the prevention of transfusion-transmitted malaria (TTM). This was a normative evaluation based on the Brazilian National Health Surveillance Agency (ANVISA) Resolution RDC No. 153/2004. Ten blood banks were included in the study and classified as 'adequate' (≥80 points), 'partially adequate' (from 50 to 80 points), or 'inadequate' (banks were classified as 'inadequate' and five as 'partially adequate'. The median clinical screening score was 26 (minimum=16; maximum=32). The median laboratory screening score was 20 (minimum=0; maximum=32). Eight blood banks performed laboratory tests for malaria; six tested all donations. Seven used thick smears, but only one performed this procedure in accordance with Ministry of Health requirements. One service had a Program of External Quality Evaluation for malaria testing. With regard to hemovigilance, two institutions reported having procedures to detect cases of transfusion-transmitted malaria. Malaria is neglected as a blood-borne disease in the blood banks of the Brazilian Amazon region. None of the institutions were classified as 'adequate' in the overall classification or with regard to clinical screening and laboratory screening. Blood bank professionals, the Ministry of Health and Health Surveillance service managers need to pay more attention to this matter so that the safety procedures required by law are complied with. Copyright © 2014 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. All rights reserved.

  10. Numerical Analysis for Structural Safety Evaluation of Butterfly Valves

    Science.gov (United States)

    Shin, Myung-Seob; Yoon, Joon-Yong; Park, Han-Yung

    2010-06-01

    Butterfly valves are widely used in current industry to control the fluid flow. They are used for both on-off and throttling applications involving large flows at relatively low operating pressure especially in large size pipelines. For the industrial application of butterfly valves, it must be ensured that the valve could be used safety under the fatigue life and the deformations produced by the pressure of the fluid. In this study, we carried out the structure analysis of the body and the valve disc of the butterfly valve and the numerical simulation was performed by using ANSYS v11.0. The reliability of valve is evaluated under the investigation of the deformation, the leak test and the durability of the valve.

  11. Preliminary safety evaluation for the plutonium stabilization and packaging system

    Energy Technology Data Exchange (ETDEWEB)

    Shapley, J.E., Fluor Daniel Hanford

    1997-03-14

    This Preliminary Safety Evaluation (PSE) describes and analyzes the installation and operation of the Plutonium Stabilization and Packaging System (SPS) at the Plutonium Finishing Plant (PFP). The SPS is a combination of components required to expedite the safe and timely storage of Plutonium (Pu) oxide. The SPS program will receive site Pu packages, process the Pu for storage, package the Pu into metallic containers, and safely store the containers in a specially modified storage vault. The location of the SPS will be in the 2736- ZB building and the storage vaults will be in the 2736-Z building of the PFP, as shown in Figure 1-1. The SPS will produce storage canisters that are larger than those currently used for Pu storage at the PFP. Therefore, the existing storage areas within the PFP secure vaults will require modification. Other modifications will be performed on the 2736-ZB building complex to facilitate the installation and operation of the SPS.

  12. Evaluation Of Blood Component Request And Ultrasound In ...

    African Journals Online (AJOL)

    Results: A total of 1097 blood component was requested for transfusion. Out of these, 1066 were used and 31 were returned and later discarded due to contamination. The commonest prescribed blood type was whole blood (81.1%) Blood used was higher for obstetrics and gynaecological cases and least for paediatric ...

  13. Evaluation of the Capillary Blood Glucose Self-monitoring Program

    Directory of Open Access Journals (Sweden)

    Mariana Cristina Augusto

    2014-10-01

    Full Text Available OBJECTIVE: to evaluate the structure, process and results of the Capillary Blood Glucose Self-monitoring Program in a Brazilian city.METHOD: epidemiological, cross-sectional study. The methodological framework of Donabedian was used to construct indicators of structure, process and outcome. A random sample (n = 288 of users enrolled and 96 health professionals who worked in the program was studied. Two questionnaires were used that were constructed for this study, one for professionals and one for users, both containing data for the evaluation of structure, process and outcome. Anthropometric measures and laboratory results were collected by consulting the patients' health records. The analysis involved descriptive statistics.RESULTS: most of the professionals were not qualified to work in the program and were not knowledgeable about the set of criteria for patient registration. None of the patients received complete and correct orientations about the program and the percentage with skills to perform conducts autonomously was 10%. As regards the result indicators, 86.4% of the patients and 81.3% of the professionals evaluated the program positively.CONCLUSION: the evaluation indicators designed revealed that one of the main objectives of the program, self-care skills, has not been achieved.

  14. Evaluation of safety belt education program for employees

    Science.gov (United States)

    1980-06-01

    This research was designed to determine the effectiveness of a nine-month safety belt educational program, utilizing various informational materials developed by NHTSA, in increasing safety belt usage among corporate employees. The materials used inc...

  15. Safety performance evaluation of converging chevron pavement markings : final report.

    Science.gov (United States)

    2014-12-01

    The objectives of this study were (1) to perform a detailed safety analysis of converging chevron : pavement markings, quantifying the potential safety benefits and developing an understanding of the : incident types addressed by the treatment, and (...

  16. Does lean management improve patient safety culture? An extensive evaluation of safety culture in a radiotherapy institute.

    Science.gov (United States)

    Simons, Pascale A M; Houben, Ruud; Vlayen, Annemie; Hellings, Johan; Pijls-Johannesma, Madelon; Marneffe, Wim; Vandijck, Dominique

    2015-02-01

    The importance of a safety culture to maximize safety is no longer questioned. However, achieving sustainable culture improvements are less evident. Evidence is growing for a multifaceted approach, where multiple safety interventions are combined. Lean management is such an integral approach to improve safety, quality and efficiency and therefore, could be expected to improve the safety culture. This paper presents the effects of lean management activities on the patient safety culture in a radiotherapy institute. Patient safety culture was evaluated over a three year period using triangulation of methodologies. Two surveys were distributed three times, workshops were performed twice, data from an incident reporting system (IRS) was monitored and results were explored using structured interviews with professionals. Averages, chi-square, logistical and multi-level regression were used for analysis. The workshops showed no changes in safety culture, whereas the surveys showed improvements on six out of twelve dimensions of safety climate. The intention to report incidents not reaching patient-level decreased in accordance with the decreasing number of reports in the IRS. However, the intention to take action in order to prevent future incidents improved (factorial survey presented β: 1.19 with p: 0.01). Due to increased problem solving and improvements in equipment, the number of incidents decreased. Although the intention to report incidents not reaching patient-level decreased, employees experienced sustained safety awareness and an increased intention to structurally improve. The patient safety culture improved due to the lean activities combined with an organizational restructure, and actual patient safety outcomes might have improved as well. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. MRI Evaluation and Safety in the Developing Brain

    Science.gov (United States)

    Tocchio, Shannon; Kline-Fath, Beth; Kanal, Emanuel; Schmithorst, Vincent J.; Panigrahy, Ashok

    2015-01-01

    Magnetic resonance imaging (MRI) evaluation of the developing brain has dramatically increased over the last decade. Faster acquisitions and the development of advanced MRI sequences such as magnetic resonance spectroscopy (MRS), diffusion tensor imaging (DTI), perfusion imaging, functional MR imaging (fMRI), and susceptibility weighted imaging (SWI), as well as the use of higher magnetic field strengths has made MRI an invaluable tool for detailed evaluation of the developing brain. This article will provide an overview of the use and challenges associated with 1.5T and 3T static magnetic fields for evaluation of the developing brain. This review will also summarize the advantages, clinical challenges and safety concerns specifically related to MRI in the fetus and newborn, including the implications of increased magnetic field strength, logistics related to transporting and monitoring of neonates during scanning, sedation considerations and a discussion of current technologies such as MRI-conditional neonatal incubators and dedicated small-foot print neonatal intensive care unit (NICU) scanners. PMID:25743582

  18. Safety evaluation of Whole Algalin Protein (WAP) from Chlorella protothecoides.

    Science.gov (United States)

    Szabo, Nancy J; Matulka, Ray A; Chan, Teresa

    2013-09-01

    Microalgae such as Chlorella spp., were once consumed as traditional human foods; now they are being developed as ingredients for modern diets. Whole Algalin Protein (WAP) from dried milled Chlorella protothecoides was evaluated for dietary safety in a 13-week feeding trial in rodents with genotoxic potential evaluated using in vitro and in vivo assays and the likelihood of food allergy potential evaluated via human repeat-insult patch test (HRIPT). In the subchronic study, rats consumed feed containing 0, 25,000, 50,000 or 100,000 ppm WAP for 92-93 days. No treatment-related mortalities or effects in general condition, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, gross pathology, organ weights, and histopathology occurred. Several endpoints exhibited statistically significant effects, but none was dose-related. The no-observed-adverse-effect level (NOAEL) was based on the highest WAP concentration consumed by the rats and was equivalent to 4805 mg/kg/day in males and 5518 mg/kg/day in females. No mutagenicity occurred in Salmonella typhimurium or Escherichia coli tester strains (≤5000 μg/plate WAP) with or without mutagenic activation. No clastogenic response occurred in bone marrow from mice administered a single oral dose (2000 mg/kg WAP). Skin sensitization was not induced by WAP via HRIPT, indicating little potential for food allergy. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. Strengthening of the Blood Safety System in the National Blood Transfusion Service - Implementation of the European Union IPA Project - at the Institute for Transfusion Medicine of the Republic of Macedonia

    Directory of Open Access Journals (Sweden)

    Rada M. Grubovic

    2014-09-01

    Full Text Available The Safety of the Blood Supply in any country is of utmost importance to safeguard patients from serious adverse events of blood transfusion. Implementation of a Quality System in the Blood Transfusion Service, with support of Government and Ministry of Health is a key element to guarantee safe blood. The IPA TAIB 2009 project - Strengthening of the Blood Safety System executed in 2013/14 provided the means to start implementing a Quality System in the Institute for Transfusion Medicine of the Republic of Macedonia. This project aimed to ultimately bring the Blood Transfusion Service to European Union standards, allowing the exchange of blood components and all other types of collaboration with other European Union countries in future. The project put the basis for unification of blood transfusion standards and operating procedures in the whole country as well as set up essential education of blood transfusion personnel.

  20. [Detection, evaluation, and treatment of high blood cholesterol in adults].

    Science.gov (United States)

    2001-05-01

    This report is based on the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, which was recently issued by the National Institutes of Health of the United States of America. Also known as the Adult Treatment Panel (ATP) III, this new report updates two earlier such reports on high cholesterol. While continuing to concentrate on treating patients with coronary heart disease, the new report advocates more intensive treatment in order to reduce low-density lipoprotein (LDL) cholesterol in specific groups of individuals, pays special attention to primary prevention among patients with multiple risk factors, and recognizes as a secondary prevention concern a cluster of heart disease risk factors known as "the metabolic syndrome." Other issues that the ATP III report covers include therapeutic lifestyle changes to reduce LDL, LDL-lowering drug therapy, and the management of specific dyslipidemias.

  1. Evaluation of the efficacy and safety of bromocriptine QR in type 2 diabetes.

    Science.gov (United States)

    Ramteke, Karuna Balwant; Ramanand, Sunita Jaiprakash; Ramanand, Jaiprakash B; Jain, Suyog Subhas; Raparti, Girish Tulsidas; Patwardhan, Milind Hari; Murthy, Mangala; Ghanghas, Ravi G

    2011-07-01

    Diabetes mellitus is a chronic metabolic disorder of endocrinal origin with multiorgan involement. Today's physician has a lot many options to choose for treating type 2 diabetes, but does not always manages to achieve optimal glycemic control. The newer drug bromocriptine acts by novel hypothalamic circadian rhythm resetting mechanism. To evaluate the efficacy and safety of bromocriptine QR in type 2 diabetes. 105 patients according to inclusion and exclusion criteria were randomized into three groups by simple randomization. Group 1 received bromocriprine 2.4 mg once daily, group 2 received metformin 500 mg twice daily while group 3 received bromocriprine 1.6 mg daily and metformin 500 mg twice daily. Baseline measurement of fasting and postprandial blood sugar, HbA1(C) and BMI were followed up at 6(th) and 12(th) weeks. Safety evaluation was done by questioning the patient and also through routine hematological and biochemical parameters. Z test was used for analysis. Group 1 showed significant reduction in fasting and postprandial sugar and HbA(1c) at 12 weeks. While groups 2 and 3 showed even higher reduction in these parameters albeit with slightly more adverse drug events like nausea, vomiting compared to group 1. Bromocriptine QR is an effective and safe antidiabetic drug which can be employed as monotherapy or in conjuction with metformin to achieve and maintain optimal glycemic control.

  2. Transfusion safety in francophone African countries: an analysis of strategies for the medical selection of blood donors.

    Science.gov (United States)

    Tagny, Claude Tayou; Kouao, Maxime Diané; Touré, Hamane; Gargouri, Jalel; Fazul, Ahamada Said; Ouattara, Siaka; Anani, Ludovic; Othmani, Habiba; Feteke, Lochina; Dahourou, Honorine; Mbensa, Guy Olivier; Molé, Simplice; Nébié, Yacouba; Mbangue, Madeleine; Toukam, Michel; Boulahi, Mahommed Ould; Andriambelo, Lalatiana Valisoa; Rakoto, Olivat; Baby, Mounirou; Yahaya, Rakia; Bokilo, Amelia; Senyana, Florent; Mbanya, Dora; Shiboski, Caroline; Murphy, Edward L; Lefrère, Jean Jacques

    2012-01-01

    The goal of selecting a healthy blood donor is to safeguard donors and reduce the risks of infections and immunologic complications for recipients. To evaluate the blood donor selection process, a survey was conducted in 28 blood transfusion centers located in 15 francophone African countries. Data collected included availability of blood products, risk factors for infection identified among blood donor candidates, the processing of the information collected before blood collection, the review process for the medical history of blood donor candidates, and deferral criteria for donor candidates. During the year 2009, participating transfusion centers identified 366,924 blood donor candidates. A mean of 13% (range, 0%-36%) of the donor candidates were excluded based solely on their medical status. The main risk factors for blood-borne infections were having multiple sex partners, sexual intercourse with occasional partners, and religious scarification. Most transfusion centers collected this information verbally instead of having a written questionnaire. The topics least addressed were the possible complications relating to the donation, religious scarifications, and history of sickle cell anemia and hemorrhage. Only three centers recorded the temperature of the blood donors. The deferral criteria least reported were sickle cell anemia, piercing, scarification, and tattoo. The medical selection process was not performed systemically and thoroughly enough, given the regional epidemiologic risks. It is essential to identify the risk factors specific to francophone African countries and modify the current medical history questionnaires to develop a more effective and relevant selection process. © 2011 American Association of Blood Banks.

  3. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution

    Directory of Open Access Journals (Sweden)

    Jui-Wen Ma

    2017-03-01

    Full Text Available In this study, a chlorine dioxide solution (UC-1 composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50 of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl-2,5-diphenyltetrazolium bromide (MTT test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO2 concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports.

  4. DNA vaccination for rabies: Evaluation of preclinical safety and toxicology

    Directory of Open Access Journals (Sweden)

    Rajni Garg

    2014-01-01

    Full Text Available The worldwide incidence of rabies and high rates of therapy failure, despite availability of effective vaccines indicate the need for timely and improved prophylactic approaches. DNA vaccination based on optimized formulation of lysosome-targeted glycoprotein of the rabies virus provides potential platform for preventing and controlling rabies. As per the pre-clinical requirements, listed in guidelines of Schedule Y, FDA and that of The European Agency for evaluation of Medicinal Products; we evaluated the acute (single dose – 14 days using three dosing levels, that is, the therapeutic (1×, average (5× and high dose (10× intramuscular toxicity in the rodent model Swiss Albino mice. Furthermore, the chronic intramuscular toxicity (repeated dose – 43 days with another 14 days for satellite groups was investigated using broad dosing levels ranging from low (7×, mid (14× to high (28× in Wistar rats. A range of parameters including physical, physiological, clinical, immunological, hematological along with histopathology profiles of target organs was monitored to assess the impact of vaccination. There were no observational adverse effects despite high dose administration of the DNA vaccine formulation. Thus, this study indicates the safety of next generation of vaccines as well as highlights their potential application.

  5. Safety evaluation of filamentous fungi isolated from industrial doenjang koji.

    Science.gov (United States)

    Lee, Jin Hee; Jo, Eun Hye; Hong, Eun Jin; Kim, Kyung Min; Lee, Inhyung

    2014-10-01

    A few starters have been developed and used for doenjang fermentation but often without safety evaluation. Filamentous fungi were isolated from industrial doenjang koji, and their potential for mycotoxin production was evaluated. Two fungi were isolated; one was more dominantly present (90%). Both greenish (SNU-G) and whitish (SNU-W) fungi showed 97% and 95% internal transcribed spacer sequence identities to Aspergillus oryzae/flavus, respectively. However, the SmaI digestion pattern of their genomic DNA suggested that both belong to A. oryzae. Moreover, both fungi had morphological characteristics similar to that of A. oryzae. SNU-G and SNU-W did not form sclerotia, which is a typical characteristic of A. oryzae. Therefore, both fungi were identified to be A. oryzae. In aflatoxin gene cluster analysis, both fungi had norB-cypA genes similar to that of A. oryzae. Consistent with this, aflatoxins were not detected in SNU-G and SNU-W using ammonia vapor, TLC, and HPLC analyses. Both fungi seemed to have a whole cyclopiazonic acid (CPA) gene cluster based on PCR of the maoA, dmaT, and pks-nrps genes, which are key genes for CPA biosynthesis. However, CPA was not detected in TLC and HPLC analyses. Therefore, both fungi seem to be safe to use as doenjang koji starters and may be suitable fungal candidates for further development of starters for traditional doenjang fermentation.

  6. Safety Evaluation of Cosmetic Ingredients Regarding Their Skin Sensitization Potential

    Directory of Open Access Journals (Sweden)

    Winfried Steiling

    2016-03-01

    Full Text Available Up to today, product safety evaluation in the EU is predominantly based on data/information on their individual ingredients. Consequently, the quality and reliability of individual ingredient data is of vital interest. In this context, the knowledge about skin sensitization potential is an explicit need for both hazard and risk assessment. Proper skin sensitization data of the individual chemicals is essential, especially when dermal contact is intended, like for cosmetics. In some cases, e.g., in the presence of irritating chemicals, the combination of individual ingredients may also need to be evaluated to cover possible mixture effects. Today, it seems unlikely or even impossible that skin sensitization in humans can be adequately described by a single test result or even by a simple combination of a few data points (in vivo or in vitro. It is becoming evident that a set of data (including human data and market data and knowledge about the ingredient’s specific sensitizing potency needs to be taken into account to enable a reliable assessment of skin sensitization. A more in-depth understanding on mechanistic details of the Adverse-Outcome-Pathway of skin sensitization could contribute key data for a robust conclusion on skin sensitization.

  7. Performance and safety of femoral central venous catheters in pediatric autologous peripheral blood stem cell collection.

    Science.gov (United States)

    Cooling, Laura; Hoffmann, Sandra; Webb, Dawn; Yamada, Chisa; Davenport, Robertson; Choi, Sung Won

    2017-12-01

    Autologous peripheral blood hematopoietic progenitor cell collection (A-HPCC) in children typically requires placement of a central venous catheter (CVC) for venous access. There is scant published data regarding the performance and safety of femoral CVCs in pediatric A-HPCC. Seven-year, retrospective study of A-HPCC in pediatric patients collected between 2009 and January 2017. Inclusion criteria were an age ≤ 21 years and A-HPCC using a femoral CVC for venous access. Femoral CVC performance was examined by CD34 collection rate, inlet rate, collection efficiency (MNC-FE, CD34-FE), bleeding, flow-related adverse events (AE), CVC removal, and product sterility testing. Statistical analysis and graphing were performed with commercial software. A total of 75/119 (63%) pediatric patients (median age 3 years) met study criteria. Only 16% of children required a CVC for ≥ 3 days. The CD34 collect rate and CD34-FE was stable over time whereas MNC-FE decreased after day 4 in 80% of patients. CD34-FE and MNC-FE showed inter- and intra-patient variability over time and appeared sensitive to plerixafor administration. Femoral CVC showed fewer flow-related AE compared to thoracic CVC, especially in pediatric patients (6.7% vs. 37%, P = 0.0005; OR = 0.12 (95%CI: 0.03-0.45). CVC removal was uneventful in 73/75 (97%) patients with hemostasis achieved after 20-30 min of pressure. In a 10-year period, there were no instances of product contamination associated with femoral CVC colonization. Femoral CVC are safe and effective for A-HPCC in young pediatric patients. Femoral CVC performance was maintained over several days with few flow-related alarms when compared to thoracic CVCs. © 2017 Wiley Periodicals, Inc.

  8. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  9. Evaluation of the DoD Safety Program: DoD Civilian Safety Survey

    Science.gov (United States)

    2008-12-12

    frame of reference. Since some statements tend to be answered more positively or negatively than others, comparing results against the NSC database...setting a positive safety example 31 . Beier that haZards not foced right away will stil be a!ldressed 36. Safety standard level relabve to standard...Beier that haZards not fiXed light away wiD stil be addressed 36. SupeMsors investigating safety incidents 44. Leadership InCluding safety in job

  10. Consumer and farmer safety evaluation of application of botanical pesticides in black pepper crop protection

    NARCIS (Netherlands)

    Hernandez-Moreno, J.; Soffers, A.E.M.F.; Wiratno,; Falke, H.E.; Rietjens, I.; Murk, A.J.

    2013-01-01

    This study presents a consumer and farmer safety evaluation on the use of four botanical pesticides in pepper berry crop protection. The pesticides evaluated include preparations from clove, tuba root, sweet flag and pyrethrum. Their safety evaluation was based on their active ingredients being

  11. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Evaluation of occupational safety and health performance... AND HEALTH PROGRAMS AND RELATED MATTERS Administration § 1960.11 Evaluation of occupational safety and health performance. Each agency head shall ensure that any performance evaluation of any management...

  12. Patient safety culture in a Dutch pediatric surgical intensive care unit: an evaluation using the Safety Attitudes Questionnaire.

    Science.gov (United States)

    Poley, Marten J; van der Starre, Cynthia; van den Bos, Ada; van Dijk, Monique; Tibboel, Dick

    2011-11-01

    Nowadays, the belief is widespread that a safety culture is crucial to achieving patient safety, yet there has been virtually no analysis of the safety culture in pediatric hospital settings so far. Our aim was to measure the safety climate in our unit, compare it with benchmarking data, and identify potential deficiencies. Prospective longitudinal survey study at two points in time. Pediatric surgical intensive care unit at a Dutch university hospital. All unit personnel. To measure the safety climate, the Safety Attitudes Questionnaire was administered to physicians, nurses, nursing assistants, pharmacists, technicians, and ward clerks in both May 2006 and May 2007. This questionnaire assesses caregiver attitudes through use of the six following scales: teamwork climate, job satisfaction, perceptions of management, safety climate, working conditions, and stress recognition. Earlier research showed that the Safety Attitudes Questionnaire has good psychometric properties and produced benchmarking data that can be used to evaluate strengths and weaknesses in a given clinical unit against peers. The response rates for the Safety Attitudes Questionnaire were 85% (May 2006) and 74% (May 2007). There were mixed findings regarding the difference between physicians and nurses: on three scales (i.e., teamwork climate, safety climate, and stress recognition), physicians scored better than nurses at both points in time. On another two scales (i.e., perceptions of management and working conditions), nurses consistently had higher mean scale scores. Probably due to the small number of physicians, only some of these differences between physicians and nurses reached the level of statistical significance. Compared to benchmarking data, scores on perceptions of management were higher than expected (p safety climate), or somewhat below (working conditions) what was expected on the basis of benchmarking data, but no persistent significant differences were observed on these scales

  13. Evaluation of the effect of horse blood supplemented with human ...

    African Journals Online (AJOL)

    morsitans flies were assigned to each group. The first group was entirely maintained on defibrinated horse blood, while the second and third groups fed horse blood with one feed per week on human blood and vitamin supplement respectively. The result of the study showed no difference in mortality between the flies fed ...

  14. Applying a realistic evaluation model to occupational safety interventions

    DEFF Research Database (Denmark)

    Pedersen, Louise Møller

    2018-01-01

    Background: Recent literature characterizes occupational safety interventions as complex social activities, applied in complex and dynamic social systems. Hence, the actual outcomes of an intervention will vary, depending on the intervention, the implementation process, context, personal...... and qualitative methods. This revised model has, however, not been applied in a real life context. Method: The model is applied in a controlled, four-component, integrated behaviour-based and safety culture-based safety intervention study (2008-2010) in a medium-sized wood manufacturing company. The interventions...... involve the company’s safety committee, safety manager, safety groups and 130 workers. Results: The model provides a framework for more valid evidence of what works within injury prevention. Affective commitment and role behaviour among key actors are identified as crucial for the implementation...

  15. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-05-21

    ... availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related... subgroups, including those whose sex partners have risk behavior(s) associated with a higher prevalence of...

  16. Evaluating an Entertainment–Education Telenovela to Promote Workplace Safety

    National Research Council Canada - National Science Library

    Castaneda, Diego E; Organista, Kurt C; Rodriguez, Leslie; Check, Pietra

    2013-01-01

    Occupational safety and health professionals worked with health communication experts to collaborate with a major Spanish language television network to develop and implement a construction workplace...

  17. Evaluation of the analytical performances of a portable, 18-parameter hemometric system using capillary blood samples for blood donor enrolment.

    Science.gov (United States)

    Pierelli, L; Zennaro, F; Patti, D; Miceli, M; Iudicone, P; Mannella, E

    2010-02-01

    Blood donor enrolment process is frequently based on the sole capillary haemoglobin (Hb) evaluation while platelet donors by apheresis also requires platelet (Plt) count. The 'sole Hb' approach prevents a complete donor evaluation and does not allow Plt donor enrolment. To extend blood counts before donations, we evaluated the performances of a multiparametric counter using capillary blood. The ABX Micros 60 (Micros 60) blood analyzer was employed on capillary blood and compared with venous counts by a reference counter (Coulter AcT 5diff) in a first series of 416 donors and in a second series of 136, after a 3-month period of routine use of this study counter. An average of 50 microl of capillary blood was collected whose 10 microl had been aspirated by Micros 60. High correlations were found between capillary counts using Micros 60 and venous counts using the reference counter. Mean Plt counts differed of 37 x 10(9)/l less for capillary approach in the first series of comparisons, but decreased to 10 x 10(9)/l less in the second series due to a greater expertise of operators in capillary sampling. All other parameters were accurate and never reached clinical relevance albeit they showed statistically significant differences. Data on Micros 60 demonstrated that capillary predonation counts may represent a feasible and effective approach to realize an accurate enrolment process of blood and Plt donors.

  18. [Evaluation of the efficacy of medical screening of blood donors on preventing blood transfusion-transmitted infectious agents].

    Science.gov (United States)

    Seck, M; Dièye, B; Guèye, Y B; Faye, B F; Senghor, A B; Toure, S A; Dieng, N; Sall, A; Toure, A O; Dièye, T N; Diop, S

    2016-05-01

    The aim of this study was to evaluate the efficacy of medical screening to retain blood donors in window period by comparing the seroprevalence of infectious agents (HIV, hepatitis B and C, syphilis) in deferred versus accepted blood donors. This prospective and transversal study was performed during 4 months in the National Blood Transfusion Center in Dakar (Senegal). We conducted a convenience sampling comparing the seroprevalence of infectious agents (HIV, HBsAg, HCV and syphilis) in deferred versus accepted blood donors after medical selection. In total, 8219 blood donors were included. Medical selection had authorized 8048 donors (97.92%) and deferred donors were 171 (2.08%). The prevalence of HIV was higher in the deferred than in accepted blood donors (1.75% vs. 0.05%) (P=0.0003; OR=35.91), as well as for HBsAg (12.87% vs. 7.35%) (P=0.006; OR=1.86). HCV antibodies were present in 0.71% of accepted blood donors and 0.58% in deferred blood donors (P=0.65; OR=0.82). Only accepted donors had brought the infection of syphilis (0.34%) (P=0.56; OR=0). Medical selection is efficient to exclude blood donors at high risk of HIV transmission and to a lesser extent of HBV. However, current medical screening procedures do not allow us to exclude donors asymptomatic carriers of HCV and syphilis. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  19. Blood

    Science.gov (United States)

    ... anemia. Iron deficiency anemia is the most common type of anemia and can affect people who have a diet ... 2015 More on this topic for: Teens Blood Types Donating Blood Blood Transfusions Anemia Sickle Cell Disease Hemophilia When Cancer Keeps You ...

  20. Safety evaluation on MOX new fuel at marine transport

    Energy Technology Data Exchange (ETDEWEB)

    Tsumune, Daisuke; Ito, Chihiro; Saegusa, Toshiari; Maruyama, Koki [Central Research Inst. of Electric Power Industry, Abiko, Chiba (Japan). Abiko Research Lab

    2000-02-01

    In the Central Research Institute of Electric Power Industry, in order to confirm effects of MOX new fuel on the public are as small as possible even when its marine transport goes down, some exposed radiation dose has previously conducted on imaginary shipwreck of marine transport on used nuclear fuel, plutonium dioxide, and high level return glass solid. Under a base of such informations, some investigations on safety on marine transport of the MOX new fuel was conducted. On September, 1999, five transport vessels of the MOX new fuel was at first transported on marine. The value of five times of estimated exposed radiation dose (max. 8.1 x 10{sup -8} mSv/y) corresponds to an evaluation result assumed by shipwreck in marine transport this time. As a result, it was found that the exposed radiation dose estimated on this case would be sufficiently less than an effective dose equivalent limit (1 mSv/y) of public exposure according to the recommendation of ICRP in both coastal and oceanic areas. (G.K.)

  1. Safety evaluation studies of Citrullus colocynthis for diabetes in rats

    Directory of Open Access Journals (Sweden)

    S.K Atole

    Full Text Available An experiment conducted in the department of Pharmacology and Toxicology, Nagpur Veterinary College, Nagpur reported Citrullus colocynthis to posses antidiabetic effect in rats at the rate of 50 mg/kg b.w and 100mg/kg b.w. So it was decided to also evaluate the safety of Citrullus colocynthis in rats at its antidiabetic dose. The experiment was conducted for 28 days .18 wistar rats were divided into three groups containing six rats in each group. Group T1 was maintained as normal control, whereas groups T2 and T3 received aqueous extract of Citrullus colocynthis @ 50 and 100 mg/kg body weight. Haematological and Biochemical estimations were done at the end of experiment i.e. on 29th day by using standard kits. Rats were then sacrificed and histopathological examinations were done. The results obtained showed that Citrullus colocynthis is safe at its antidiabetic dose and is safe for use as an antidiabetic remedy. [Vet World 2009; 2(11.000: 423-425

  2. Krypton-85 hydrofracture engineering feasibility and safety evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Peretz, F.J.; Muller, M.E.; Pan, P.Y.

    1981-07-01

    Engineering studies have been made to determine the hazards associated with the disposal of /sup 85/Kr using the hydrofracture process. To assess the hazards, an effort has been made to identify the equipment required to entrain and dissolve the noble gas into the grout stream at hydrofracture pressure (up to 350 bar). Off-the-shelf or slightly modified equipment has been identified for safe and effective compression and gas-grout mixing. Each monthly injection disposes of 1.6 x 10/sup 6/ Ci of /sup 85/Kr. By connecting only one gas cylinder to the injection system at a time, the maximum amount of krypton likely to be released as a result of equipment failure is limited to 128,000 Ci. An evaluation by Los Alamos Technical Associates shows that releasing this amount of gas in less than one hour under worst-case meteorological conditions through a 30-m stack would result in a whole-body dose of 170 millirem at a distance of 1 km from the facility. A krypton collection and recovery system can further reduce this dose to 17 millirem; increasing the distance to the site boundary to 3 km can also reduce the dose by a factor of ten. Lung and skin dose estimates are 1.6 and 120 times the whole-body dose, respectively. These are all worst-case values; releases under more typical conditions would result in a significantly lower dose. No insurmountable safety or engineering problems have been identified.

  3. Biological safety evaluation of the modified urinary catheter

    Energy Technology Data Exchange (ETDEWEB)

    Kowalczuk, Dorota, E-mail: dorota.kowalczuk@umlub.pl [Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin (Poland); Przekora, Agata; Ginalska, Grazyna [Department of Biochemistry and Biotechnology, Medical University of Lublin, Chodzki 1, 20-093 Lublin (Poland)

    2015-04-01

    The purpose of this study was to evaluate in vitro safety of the novel tosufloxacin (TOS)-treated catheters with the prolonged antimicrobial activity. The test samples of silicone latex catheter were prepared by the immobilization of TOS on chitosan (CHIT)-coated catheter by means of covalent bonds and non-covalent interactions. Each step of the modification process of catheter surface was observed using ATR–Fourier transform infrared spectroscopy. In vitro cytotoxicity of the modified and unmodified catheters was assessed by direct and indirect tests in accordance with ISO standards using green monkey kidney (GMK) cell line. The MTT, lactate dehydrogenase activity (LDH), WST-8, Sulforhodamine B (SRB) test results and microscopic observation clearly indicated that unmodified silicone latex catheters decrease cell metabolic activity, act as a cytotoxic agent causing cell lysis and induce cell death through necrotic or apoptotic process. We suggest that chitosan coat with TOS immobilized limits leaching of harmful agents from silicone latex material, which significantly enhances survivability of GMK cells and therefore is quite a good protection against the cytotoxic effect of this material. - Highlights: • Characterization of the novel antimicrobial urinary catheters • Monitoring of the catheter modification by FTIR analysis • Confirmation of high cytotoxicity of latex-based catheter used in urological practice • Chitosan-coated and tosufloxacin-treated catheter is less toxic than the untreated one. • The proposed surface modification protects cells against latex-induced death.

  4. Safety Evaluation of a Hybrid Substructure for Offshore Wind Turbine

    Directory of Open Access Journals (Sweden)

    Min-Su Park

    2016-01-01

    Full Text Available Towers and rotor-nacelles are being enlarged to respond to the need for higher gross generation of the wind turbines. However, the accompanying enlargement of the substructure supporting these larger offshore wind turbines makes it strongly influenced by the effect of wave forces. In the present study, the hybrid substructure is suggested to reduce the wave forces by composing a multicylinder having different radii near free surface and a gravity substructure at the bottom of the multicylinder. In addition, the reaction forces acting on the substructure due to the very large dead load of the offshore wind turbine require very firm foundations. This implies that the dynamic pile-soil interaction has to be fully considered. Therefore, ENSOFT Group V7.0 is used to calculate the stiffness matrices on the pile-soil interaction conditions. These matrices are then used together with the loads at TP (Transition Piece obtained from GH-Bladed for the structural analysis of the hybrid substructure by ANSYS ASAS. The structural strength and deformation are evaluated to derive an ultimate structural safety of the hybrid substructure for various soil conditions and show that the first few natural frequencies of the substructure are heavily influenced by the wind turbine. Therefore, modal analysis is carried out through GH-Bladed to examine the resonance between the wind turbine and the hybrid substructure.

  5. Evaluation of safety practices and performance in a brewery industry ...

    African Journals Online (AJOL)

    Michael Horsfall

    contribution to GDP and employment remain small, due to “weak safeguards ... performance of safety programme of a brewery firm for a period of eight ... function can be used to analyse the performance of ... safety programme in a manufacturing company is viewed from .... Efficiency index is obtained by dividing Equation 9.

  6. The efficacy and safety of autologous blood transfusion drainage in patients undergoing total knee arthroplasty: a meta-analysis of 16 randomized controlled trials.

    Science.gov (United States)

    Pan, Jian-Ke; Hong, Kun-Hao; Xie, Hui; Luo, Ming-Hui; Guo, Da; Liu, Jun

    2016-11-02

    Autologous blood transfusion drainage (ABTD) has been used for many years to reduce blood loss in total knee arthroplasty (TKA). We evaluate the current evidence concerning the efficiency and safety of ABTD used in TKA compared with conventional suction drainage (CSD). We performed a systematic literature search of the PubMed, Embase, Cochrane Library and four Chinese databases. All randomized controlled trials (RCTs) that compared the effects of ABTD versus CSD in TKA were included in the meta-analysis. Sixteen RCTs involving 1534 patients who compared the effects of ABTD versus CSD were included. Five of the RCTs were performed in Asia, ten in Europe, and one in North America. Patients in the ABTD group had a lower blood transfusion rate (OR: 0.25 [0.13, 0.47]; Z = 4.27, P analysis suggests that ABTD is a safe and effective method that yields a lower blood transfusion rate and fewer units transfused per patient in TKA compared with CSD.

  7. Guidelines for preparing criticality safety evaluations at Department of Energy non-reactor nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-09-01

    This Department of Energy (DOE) is approved for use by all components of DOE. It contains guidelines that should be followed when preparing Criticality Safety Evaluations that will be used to demonstrate the safety of operations performed at DOE Non-Reactor Nuclear Facilities. Adherence with these guidelines will provide consistency and uniformity in Criticality Safety Evaluations (CSEs) across the complex and will document compliance with DOE Order 5480.24 requirements as they pertain to CSEs.

  8. Evaluation of hepatic hemangioma by Tc-99 m red blood cell hepatic blood pool scan

    Energy Technology Data Exchange (ETDEWEB)

    Sohn, Myung Hee [Chonbuk National University Medical School, Chonju (Korea, Republic of)

    2005-02-15

    Hemangioma is the most common benign tumor of the liver, with a prevalence estimated as high as 7%. Tc-99m red blood cell (RBC) hepatic blood pool scan with single photon emission computed tomography (SPECT) imaging is extremely useful for the confirmation or exclusion of hepatic hemangiomas. The classic finding of absent or decreased perfusion and increased blood pooling ('perfusion/blood pool mismatch') is the key diagnostic element in the diagnosis of hemangiomas. The combination of early arterial flow and delayed blood pooling ('perfusion/blood pool match') is shown uncommonly. In giant hemangioma, filling with radioactivity appears first in the periphery, with progressive central fill-in on sequential RBC blood pool scan. However, the reverse filling pattern, which begins first in the center with progressive peripheral filling, is also rarely seen. Studies with false-positive blood pooling have been reported infrequently in nonhemangiomas, including hemangiosarcoma, hepatocellular carcinoma, hepatic adenoma, and metastatic carcinomas (adenocarcinma of the colon, small cell carcinoma of the lung, neruroendocrine carcinoma). False-negative results have been also reported rarely except for small hemagniomas that are below the limits of spatial resolution of gamma camera.

  9. Comparative evaluation of pulpal blood flow during incisor intrusion.

    Science.gov (United States)

    Sabuncuoglu, Fidan Alakus; Ersahan, Seyda

    2015-11-01

    The aim of the present study was to evaluate and compare changes in pulpal blood flow (PBF) as a result of maxillary incisor intrusion achieved by one of two methods (utility arches or mini-implants). Thirty subjects were divided into three groups, the first of which underwent maxillary incisor intrusion using utility arches (UA) and a second group, intrusion via mini-implants (MI). The third group acted as a control. An intrusive force of 100 g was applied to the upper incisors in the treatment groups, whereas no force was applied to the anterior teeth in the control group. A laser Doppler flowmeter (LDF) was used to measure PBF at baseline (T0) and during incisor intrusion at 24 hours (T1), three days (T2), seven days (T3) and three weeks (T4). Statistical changes in PBF were assessed by the Wilcoxon Signed Rank and Mann-Whitney U tests, with significance set at p intrusion at T4. No significant changes in PBF were observed in the control group over the course of the study. The only statistically significant difference between the UA and MI groups were at T1 and T2, at which time the MI group had lower PBF values (p intrusion methods are reversible. Although the changes in PBF could not be directly related to the method of intrusion employed, in general, a more severe drop in PBF was observed in the MI group during the first three days of intrusion.

  10. Evaluation of Safety, Quality and Productivity in Construction

    Science.gov (United States)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

    This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

  11. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

    NARCIS (Netherlands)

    Pane, J. (Josep); P.M. Coloma (Preciosa); K.M.C. Verhamme (Katia); M.C.J.M. Sturkenboom (Miriam); Rebollo, I. (Irene)

    2017-01-01

    textabstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our

  12. The art of appropriate evaluation : a guide for highway safety program managers

    Science.gov (United States)

    2008-08-01

    The guide, updated from its original release in 1999, is intended for project managers who will oversee the evaluation of traffic safety programs. It describes the benefits of evaluation and provides an overview of the steps involved. The guide inclu...

  13. Development of an Evaluation Method for Team Safety Culture Competencies using Social Network Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Han, Sang Min; Kim, Ar Ryum; Seong, Poong Hyun [KAIST, Daejeon (Korea, Republic of)

    2016-05-15

    In this study, team safety culture competency of a team was estimated through SNA, as a team safety culture index. To overcome the limit of existing safety culture evaluation methods, the concept of competency and SNA were adopted. To estimate team safety culture competency, we defined the definition, range and goal of team safety culture competencies. Derivation of core team safety culture competencies is performed and its behavioral characteristics were derived for each safety culture competency, from the procedures used in NPPs and existing criteria to assess safety culture. Then observation was chosen as a method to provide the input data for the SNA matrix of team members versus insufficient team safety culture competencies. Then through matrix operation, the matrix was converted into the two meaningful values, which are density of team members and degree centralities of each team safety culture competency. Density of tem members and degree centrality of each team safety culture competency represent the team safety culture index and the priority of team safety culture competency to be improved.

  14. Evaluation of boldenone as a growth promoter in broilers: safety and meat quality aspects.

    Science.gov (United States)

    Elmajdoub, Abdelrazzag; Garbaj, Aboubaker; Abolghait, Said; El-Mahmoudy, Abubakr

    2016-04-01

    The object of this study was to evaluate the safety and meat quality criteria in broilers following intramuscular injection of boldenone. Twenty-four broiler chicks, divided into two groups, were used in the present study. Boldenone was injected intramuscularly at a single-dose level of 5 mg/kg body weight into 12 broiler chicks at 2 weeks old; the other 12 chicks were injected with sesame oil and kept as controls. Blood samples were collected from the wing and metatarsal veins after 1, 2, and 3 weeks through the experimental course for hematological and clinic-chemical safety parameters. On the last day, chicks were humanely sacrificed and livers and kidneys were removed for histopathological examination. Breast muscles were also removed to assess meat-quality parameters. Boldenone significantly (p Leukogram showed leukopenia, lymphopenia, and granulocytosis (p < 0.05) as compared to control. Hepatorenal biomarkers, including alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, urea, and creatinine were significantly (p < 0.05) higher than the corresponding control values. Additionally, boldenone significantly (p < 0.05) increased metabolic markers, including total protein, globulins, cholesterol, triacylglycerols, and glucose, with parallel decreases in albumin and albumin/globulin ratio. Degenerative changes were recorded in liver and kidney tissues from chicks treated with boldenone. Muscle samples exhibited raised pH values and higher microbial counts as compared to the corresponding control. These data may discourage the use of boldenone as a growth promoter in broilers due to safety and meat quality reasons. Copyright © 2016. Published by Elsevier B.V.

  15. Evaluation of boldenone as a growth promoter in broilers: safety and meat quality aspects

    Directory of Open Access Journals (Sweden)

    Abdelrazzag Elmajdoub

    2016-04-01

    Full Text Available The object of this study was to evaluate the safety and meat quality criteria in broilers following intramuscular injection of boldenone. Twenty-four broiler chicks, divided into two groups, were used in the present study. Boldenone was injected intramuscularly at a single-dose level of 5 mg/kg body weight into 12 broiler chicks at 2 weeks old; the other 12 chicks were injected with sesame oil and kept as controls. Blood samples were collected from the wing and metatarsal veins after 1, 2, and 3 weeks through the experimental course for hematological and clinic-chemical safety parameters. On the last day, chicks were humanely sacrificed and livers and kidneys were removed for histopathological examination. Breast muscles were also removed to assess meat-quality parameters. Boldenone significantly (p < 0.05 increased total erythrocytic count and hemoglobin and hematocrit values, while mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration indices decreased. Leukogram showed leukopenia, lymphopenia, and granulocytosis (p < 0.05 as compared to control. Hepatorenal biomarkers, including alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, urea, and creatinine were significantly (p < 0.05 higher than the corresponding control values. Additionally, boldenone significantly (p < 0.05 increased metabolic markers, including total protein, globulins, cholesterol, triacylglycerols, and glucose, with parallel decreases in albumin and albumin/globulin ratio. Degenerative changes were recorded in liver and kidney tissues from chicks treated with boldenone. Muscle samples exhibited raised pH values and higher microbial counts as compared to the corresponding control. These data may discourage the use of boldenone as a growth promoter in broilers due to safety and meat quality reasons.

  16. Evaluation of Relative Blood Viscosity During Menstruation in ...

    African Journals Online (AJOL)

    USER

    ABSTRACT. The changes in blood viscosity, plasma viscosity, haematocrit and erythrocyte sedimentation rate before ... Blood samples were collected during two ..... Gynaecol., 91(7): 685–. 690. Logan, P. and Carolyn, C.(1997).Take Your. Choice. Counterbalance: Gendered. Perspectives on Writing and Language. Pp. 41.

  17. Evaluation of the efficiency and safety in cosmetic products.

    Science.gov (United States)

    Uckaya, Meryem; Uckaya, Fatih; Demir, Nazan; Demir, Yasar

    2016-02-29

    Chemicals used in cosmetics have to interact with enzymes for beneficial or destroy purpose after they enter in our body. Active sections of enzymes that catalyze reactions have three dimensions and they are active optically. When these limitations of catalytic sections are considered, it may be considered that defining geometric specifications of chemical materials and functional groups they contain may contribute on safety evaluations of cosmetic products. In this study, defining similarities and differences of geometric structures of chemicals that are prohibited to be used in cosmetic products and chemical that are allowed to be used by using group theory and analyze of functional groups that are often encountered in these chemicals are aimed. Molecule formulas related to chemical material of, 276 pieces chemicals that are prohibited to be used in cosmetic products and 65 pieces chemicals that are allowed, are used as the material. Two and three-dimension structures of these formulas are drawn and types and quantity of functional groups they contain are defined. And as a method, freeware (Free Trial) version of "Chem-BioOffice Ultra 13.0 Suite" chemical drawing program to draw two and three-dimension of formulas, "Campus-Licensed" version that are provided for use by our university of "Autodesk 3DS Max" for three-dimension drawings are used. In order to analyze geometric specifications of drawn molecules according to Group Theory and define type and quantity of available functional groups, Excel applications developed by Prof. Dr. Yaşar Demir are used. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. A Case Series: Evaluation of the Metabolic Safety of Aripiprazole

    Science.gov (United States)

    De Hert, Marc; Hanssens, Linda; van Winkel, Ruud; Wampers, Martien; Van Eyck, Dominique; Scheen, Andre; Peuskens, Joseph

    2007-01-01

    Metabolic abnormalities occur frequently in patients treated with antipsychotics and are of growing concern to clinicians. This study sought to determine whether antipsychotic-associated metabolic abnormalities identified through intensive monitoring can be reversed by switching to aripiprazole. Recent evidence suggests that aripiprazole may exhibit a favorable metabolic safety profile. The study population is a subset of a large (n > 500) ongoing prospective cohort. Thirty-one consecutive patients with schizophrenia who were started on aripiprazole were included in the study. All patients underwent an extensive metabolic evaluation, including an oral glucose tolerance test, at baseline, at 6 weeks, and at 3 months post switch. Metabolic abnormalities were defined as any of the following: new onset diabetes, impaired fasting glucose, impaired glucose tolerance, metabolic syndrome (MetS) according to various definitions, and dyslipidemia. After 3 months of treatment with aripiprazole (mean daily dose 16.3 mg), there was a significant decrease in body weight, body mass index, and waist circumference. There was a significant reduction in fasting glucose, fasting insulin, insulin resistance index, and serum lipids levels (cholesterol, triglycerides, low-density lipoprotein (LDL), LDL/HDL, Chol/HDL, and non-HDL cholesterol). There was also a significant reduction in prolactin levels. All 7 cases of recent onset diabetes were reversed at 3 months follow-up. The MetS was reversed in 50% of patients at 3 months follow-up. Our results support the reversibility of recent onset diabetes on antipsychotic medication when detected early and followed by a switch to aripiprazole. PMID:16940338

  19. Evaluation of syphilis serostatus on the safety of IVF treatment.

    Science.gov (United States)

    Lin, Shengli; Li, Rong; Huang, Shuo; Zhao, Lianming; Li, Ming; Li, Junsheng; Zhu, Jinliang; Zheng, Xiaoying; Huang, Jin; Liu, Ping; Qiao, Jie

    2014-12-01

    An increasing number of infertile syphilis-infected individuals have turned to assisted reproductive technology; however, the safety of syphilis carrier serostatus on IVF and embryo transfer outcomes has not been evaluated. Data from 482 patients who delivered singletons were analysed. In the retrospective study, the rate of IVF and intracytoplasmic sperm injection fertilization was 79.50% ± 17.57%/78.72% ± 16.66% in the Treponema pallidum particle agglutination assay negative (TPPA-negative) and rapid plasma reagin negative (RPR-negative) group, 76.12% ± 22.99%/74.05% ± 20.31% in the TPPA-positive and RPR-negative group, and 75.66% ± 21.72%/70.90% ± 16.11% in the TPPA-positive and RPR-positive group. The clinical pregnancy rate was 39.79% in the TPPA-negative and RPR-negative group, 46.30% in the TPPA-positive and RPR-negative group, and 36.59% in the TPPA-positive and RPR-positive group. No significant differences were found between the groups. The neonatal gestational age and mean birth weight were not significantly different between the TPPA-negative and TPPA-positive groups. Multiple linear regression analysis also showed no association between TPPA serostatus and newborn birth weight and gestational age. The present retrospective study showed that TPPA and RPR serostatus did not affect the outcomes of IVF and embryo transfer. Syphilis-infected individuals can undergo IVF and embryo transfer cycles after penicillin treatment. Copyright © 2014. Published by Elsevier Ltd.

  20. Efficacy and safety of valsartan plus hydroclorothiazide for high blood pressure

    Science.gov (United States)

    Ruvolo, Antonio; Mercurio, Valentina; Fazio, Valeria; Carlomagno, Guido; Russo, Teresa; Affuso, Flora; Fazio, Serafino

    2010-01-01

    AIM: To evaluate efficacy and tolerability of the combination valsartan plus hydrochlorothiazide (160 mg and 25 mg daily, respectively) in young-middle aged males with high-normal blood pressure (BP) or first-degree arterial hypertension with evidence of target organ damage. METHODS: Twenty males with high-normal BP or first-degree hypertension associated with left ventricular concentric remodeling and/or increased aortic stiffness were enrolled. BP at rest and during exercise, and echocardiographic parameters of the left ventricle (LV), were evaluated at baseline and after 3 mo of treatment. The effects of treatment on aortic stiffness, metabolic parameters, renal and erectile function were also assessed. RESULTS: BP was significantly reduced by treatment both at rest (P < 0.001) and during exercise (P < 0.001), and 85% of patients achieved BP normalization (< 130/85 mmHg). Doppler echocardiography showed a significant reduction of LV mass (P < 0.005). LV hypertrophy was identified in 70% of subjects at baseline and in 5% after 3 mo of treatment. The ratio of early (E) to late (A) trans-mitral diastolic flow velocity increased, (P < 0.05), the relative wall thickness decreased (P < 0.05) and the left ventricular relaxation time shortened (P < 0.005). The left atrial diameter (P < 0.05) and the aortic diameter (P < 0.05) and stiffness (P < 0.005) also decreased. CONCLUSION: The full-dose combination of valsartan plus hydrochlorothiazide produced optimal BP control with regression of target organ damage, already after 3 mo, without relevant side effects. PMID:21160714

  1. Evaluation of the implementation of a four-year national hospital patient safety program in the Netherlands.

    OpenAIRE

    Schilp, J.; de Blok, C.; Wagner, C.

    2013-01-01

    Objectives: To evaluate the implementation of five safety themes within a four-year national hospital patient safety program in the Netherlands. Methods: In 2008, a national hospital patient safety program was started to improve patient safety in Dutch hospitals. The safety program focussed on 10 safety themes, chosen through consultation with experts in the relevant professional groups and medical specialism. For each safety theme a module was developed to support hospitals with the implemen...

  2. Evaluating software for safety systems in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Lawrence, J.D.; Persons, W.L.; Preckshot, G.G. [Lawrence Livermore National Lab., CA (United States); Gallagher, J. [Nuclear Regulatory Commission, Washington, DC (United States). Office of Nuclear Reactor Regulation

    1994-01-11

    In 1991, LLNL was asked by the NRC to provide technical assistance in various aspects of computer technology that apply to computer-based reactor protection systems. This has involved the review of safety aspects of new reactor designs and the provision of technical advice on the use of computer technology in systems important to reactor safety. The latter includes determining and documenting state-of-the-art subjects that require regulatory involvement by the NRC because of their importance in the development and implementation of digital computer safety systems. These subjects include data communications, formal methods, testing, software hazards analysis, verification and validation, computer security, performance, software complexity and others. One topic software reliability and safety is the subject of this paper.

  3. Evaluating the effectiveness of a multimedia program on home safety.

    Science.gov (United States)

    Sweeney, Mary Anne; Chiriboga, David A

    2003-06-01

    This study was designed to test the effectiveness and acceptance of multimedia home safety programming by community-dwelling seniors. A prototype CD-ROM was produced that required no reading or computer skills because the program included an audio narration of content and directions for operating the program on a touchscreen computer monitor. Volunteers (N = 126) from a senior center aged 55 and older were randomly assigned to (1) a multimedia group that used the interactive program to learn about home safety, (2) a traditional learning group that read well-established booklets on home safety, and (3) a control group that received no instruction on safety between the pre- and posttests. Repeated-measures multivariate analysis of variance showed that the multimedia group was the only group to improve in knowledge. The group was also very satisfied with the approach. Multimedia formats can effectively and economically provide information to older clients.

  4. Safety evaluation report related to operation of Fast Flux Test Facility. Supplement No. 1

    Energy Technology Data Exchange (ETDEWEB)

    1979-05-01

    This supplement provides (1) the staff's evaluation of additional information received since issuance of the Safety Evaluation Report regarding previously identified uncompleted review items, (2) a discussion of comments made by the ACRS in its report of November 8, 1978, and (3) the staff's evaluation of additional or revised information related to new or old issues that have arisen since the issuance of the Safety Evaluation Report.

  5. Evaluation of the agreement among three handheld blood glucose meters and a laboratory blood analyzer for measurement of blood glucose concentration in Hispaniolan Amazon parrots (Amazona ventralis).

    Science.gov (United States)

    Acierno, Mark J; Mitchell, Mark A; Schuster, Patricia J; Freeman, Diana; Sanchez-Migallon Guzman, David; Tully, Thomas N

    2009-02-01

    To determine the degree of agreement between 3 commercially available point-of-care blood glucose meters and a laboratory analyzer for measurement of blood glucose concentrations in Hispaniolan Amazon parrots (Amazona ventralis). 20 healthy adult Hispaniolan Amazon parrots. A 26-gauge needle and 3-mL syringe were used to obtain a blood sample (approx 0.5 mL) from a jugular vein of each parrot. Small volumes of blood (0.6 to 1.5 microL) were used to operate each of the blood glucose meters, and the remainder was placed into lithium heparin microtubes and centrifuged. Plasma was harvested and frozen at -30 degrees C. Within 5 days after collection, plasma samples were thawed and plasma glucose concentrations were measured by means of the laboratory analyzer. Agreement between pairs of blood glucose meters and between each blood glucose meter and the laboratory analyzer was evaluated by means of the Bland-Altman method, and limits of agreement (LOA) were calculated. None of the results of the 3 blood glucose meters agreed with results of the laboratory analyzer. Each point-of-care blood glucose meter underestimated the blood glucose concentration, and the degree of negative bias was not consistent (meter A bias, -94.9 mg/dL [LOA, -148.0 to -41.7 mg/dL]; meter B bias, -52 mg/dL [LOA, -107.5 to 3.5 mg/dL]; and meter C bias, -78.9 mg/dL [LOA, -137.2 to -20.6 mg/dL]). On the basis of these results, use of handheld blood glucose meters in the diagnosis or treatment of Hispaniolan Amazon parrots and other psittacines cannot be recommended.

  6. Evaluation of radiation safety in 29 central Ohio veterinary practices

    Energy Technology Data Exchange (ETDEWEB)

    Moritz, S.A.; Wilkins, J.R. III; Hueston, W.D.

    1989-07-01

    A sample of 29 veterinary practices in Central Ohio were visited to assess radiation safety practices and observance of state regulations. Lead aprons and gloves were usually available, but gloves were not always worn. Protective thyroid collars and lead glasses were not available in any practice, lead shields in only five practices, and lead-lined walls and doors in only two practices. Eighteen practices had none of the required safety notices posted.

  7. Haemolysis following rapid experimental red blood cell transfusion--an evaluation of two infusion pumps

    DEFF Research Database (Denmark)

    Hansen, Tom Giedsing; Sprogøe-Jakobsen, U; Pedersen, C M

    1998-01-01

    The vast majority of infusion pumps used for rapid transfusion of large amounts of blood have never been properly examined regarding their influence on the quality of the red blood cells (RBCs) infused. In this study, we evaluated the effect of two different infusion pumps on the degree of RBC...... destruction following rapid experimental blood transfusion....

  8. A Public-Private Consortium Advances Cardiac Safety Evaluation: Achievements of the HESI Cardiac Safety Technical Committee

    Science.gov (United States)

    The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues have been and continue to be a major cause of attrition and withdrawal due to Adverse Drug Reactions (ADRs) in pharmaceutical drug developm...

  9. Evaluation of the implementation of a four-year national hospital patient safety program in the Netherlands.

    NARCIS (Netherlands)

    Schilp, J.; Blok, C. de; Wagner, C.

    2013-01-01

    Objectives: To evaluate the implementation of five safety themes within a four-year national hospital patient safety program in the Netherlands. Methods: In 2008, a national hospital patient safety program was started to improve patient safety in Dutch hospitals. The safety program focussed on 10

  10. BLOOD

    African Journals Online (AJOL)

    benefit (altruism). '35 An individual who gives blood in replacement for that which has been given to his relation is referred to as family replacement donor. '2 But when a person donates blood for the purpose of transfusing a. defined patient, such a person is referred to as. AHMED S. G. AND HASSAN A. W. a directed donor.

  11. Introduction of a closed-system cell processor for red blood cell washing: postimplementation monitoring of safety and efficacy.

    Science.gov (United States)

    Acker, Jason P; Hansen, Adele L; Yi, Qi-Long; Sondi, Nayana; Cserti-Gazdewich, Christine; Pendergrast, Jacob; Hannach, Barbara

    2016-01-01

    After introduction of a closed-system cell processor, the effect of this product change on safety, efficacy, and utilization of washed red blood cells (RBCs) was assessed. This study was a pre-/postimplementation observational study. Efficacy data were collected from sequentially transfused washed RBCs received as prophylactic therapy by β-thalassemia patients during a 3-month period before and after implementation of the Haemonetics ACP 215 closed-system processor. Before implementation, an open system (TerumoBCT COBE 2991) was used to wash RBCs. The primary endpoint for efficacy was a change in hemoglobin (Hb) concentration corrected for the duration between transfusions. The primary endpoint for safety was the frequency of adverse transfusion reactions (ATRs) in all washed RBCs provided by Canadian Blood Services to the transfusion service for 12 months before and after implementation. Data were analyzed from more than 300 RBCs transfused to 31 recipients before implementation and 29 recipients after implementation. The number of units transfused per episode reduced significantly after implementation, from a mean of 3.5 units to a mean of 3.1 units (p processor. The ACP 215 allowed for an extended expiry time, improving inventory management and overall utilization of washed RBCs. Transfusion of fewer RBCs per episode reduced exposure of recipients to allogeneic blood products while maintaining efficacy. © 2015 AABB.

  12. Evaluation of the return rate of volunteer blood donors

    Directory of Open Access Journals (Sweden)

    Adriana de Fátima Lourençon

    2011-06-01

    Full Text Available BACKGROUND: To convert first-time blood donors into regular volunteer donors is a challenge to transfusion services. OBJECTIVES: This study aims to estimate the return rate of first time donors of the Ribeirão Preto Blood Center and of other blood centers in its coverage region. METHODS: The histories of 115,553 volunteer donors between 1996 and 2005 were analyzed. Statistical analysis was based on a parametric long-term survival model that allows an estimation of the proportion of donors who never return for further donations. RESULTS: Only 40% of individuals return within one year after the first donation and 53% return within two years. It is estimated that 30% never return to donate. Higher return rates were observed among Black donors. No significant difference was found in non-return rates regarding gender, blood type, Rh blood group and blood collection unit. CONCLUSIONS: The low percentage of first-time donors who return for further blood donation reinforces the need for marketing actions and strategies aimed at increasing the return rates.

  13. Safety evaluation of Lactobacillus pentosus strain b240.

    Science.gov (United States)

    Szabo, Nancy J; Dolan, Laurie C; Burdock, George A; Shibano, Takashi; Sato, Shin-ichi; Suzuki, Hiroshi; Uesugi, Tohru; Yamahira, Satoko; Toba, Masamichi; Ueno, Hirofumi

    2011-01-01

    Lactobacillus pentosus has a long history of use in cooked and uncooked fermented foods. Viable and heat-killed nonviable preparations of L. pentosus strain b240 were evaluated for short term and subchronic toxicity and genotoxic potential. Dose levels were determined through acute oral toxicity tests with viable (LD(50)>2500 mg/kg) and nonviable (LD(50)>2000 mg/kg) b240. In the short term study, rats received 2500 mg/kg/day (∼1.7×10(11)cfu/kg/day) viable b240 for 28 days. In the subchronic study, rats received 500, 1000 or 2000 mg/kg/day (up to ∼3.0×10(12) cfu equivalents/kg/day) nonviable b240 for 91 days followed by a 28-day recovery. No mortalities occurred. No treatment-related effects were identified for general condition, body weight, food-water consumption, ophthalmology, urinalysis, hematology, blood chemistry, organ weights, histopathology and gross pathology. Although statistically significant effects were noted for several endpoints in the short term and subchronic studies, none were related to the test materials. The NOAEL for nonviable b240 was 2000 mg/kg/day, the highest dose tested. Additionally, nonviable b240 (≤ 5000 μg/plate) was not mutagenic in Salmonella typhimurium or Escherichia coli tester strains nor did nonviable b240 orally administered to rats at levels ≤ 2000 mg/kg/day for two days, induce a clastogenic response. Copyright © 2010 Elsevier Ltd. All rights reserved.

  14. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey.

    Science.gov (United States)

    Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

    2016-01-01

    Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of "staff training and skills" were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety.

  15. Safety evaluation of lotilaner in dogs after oral administration as flavoured chewable tablets (Credelio™

    Directory of Open Access Journals (Sweden)

    Emmanuelle A. Kuntz

    2017-11-01

    Full Text Available Abstract Background Lotilaner (Credelio™, Elanco is a novel isoxazoline that provides rapid speed of flea and tick knockdown which is sustained for at least 1 month following oral administration to dogs. The safety of lotilaner flavoured chewable tablets was investigated in a randomized, blinded, parallel-group design study in healthy Beagle puppies starting at 8 weeks of age. Lotilaner was administered orally once a month over 8 months at one, three and five times the upper level of the recommended dose range (of 20 to 43 mg/kg. Methods The objective of this study was to determine the safety of lotilaner flavoured chewable tablets in healthy dogs when administered monthly over an extended time period at the highest recommended dose rate, i.e. 1× and at elevated dose rates, i.e. 3× and 5×. Sixteen male and 16 female healthy 8-week-old puppies, weighing ~1.5 to 3.0 kg, were randomized among four groups to be untreated controls or to receive lotilaner at dose rates of 43 mg/kg (1×, 129 mg/kg (3×, or 215 mg/kg (5× on eight occasions - every 4 weeks over 8 months. The control group was sham-dosed. Study dogs were fed within 30 min prior to treatment. Assessment of safety was based on general health observations, detailed clinical observations, complete physical/neurological examinations, including ophthalmological examinations and clinical pathology evaluations (haematology, clinical chemistry and urinalysis, food and water consumption, body weight, pharmacokinetic blood collections, macroscopic and microscopic examinations. Results Blood concentrations of lotilaner confirmed systemic exposure of all study dogs with the exception of the control group. Lotilaner did not induce any treatment-related effects on body weight, food consumption, opthalmoscopic, physical/neurological and electrocardiographic examinations. For clinical pathology, no changes related to treatment were noted. There were no treatment-related changes in gross

  16. Evaluation of blood lead level in methamphetamine users in Tehran

    OpenAIRE

    Mostafazadeh, Babak; Shadnia, Shahin; Tavakkoli, Mohammad Ali; Khoddami Vishteh, Hamid Reza

    2017-01-01

    Background Given the increasing number of lead poisoning in opioids users and since no study has been conducted so far to review lead poisoning in methamphetamine (crystal) users, this study aimed to investigate blood lead level in methamphetamine addicts. Methods This study was conducted on 20 patients with methamphetamine poisoning and their blood lead level was measured. The subjects were selected from among patients with a history of continuous use of methamphetamine, without a history of...

  17. Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

    Science.gov (United States)

    Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

    2015-05-01

    Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

  18. Safety evaluation on use and waste of medical radioisotopes

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Jang Hee; Chung, Y. Y.; Chun, J. H.; Ahn, H. Y.; Lee, G. B.; Park, J. O.; Oh, G. B.; Hong, C. S.; Kim, G. S. [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

    2001-03-15

    This study was performed a survey of many hospitals using radioisotopes in order to check the amount of use and used radioisotopes, radioactive waste, status of radiation safety and control and the exposure of radiation workers who are working at department of nuclear medicine. At the time of the survey, this study is provided as a guide to the safe handling radionuclides. It will prove helpful all users. The basic objective of radiation safety technique and national standardization of safe handling radioactive materials are to keep the radiation dose to man as low as are under any regulation within the annual dose limits recommended by Most. Further routine monitoring of I-131 high dose therapy ward was carried out the effectiveness of safety precautions taken to prevent undue release of I-131 to the environment.

  19. Study on Fuzzy Comprehensive Evaluation Model for the Safety of Mine Belt Conveyor

    Directory of Open Access Journals (Sweden)

    Gong Xiaoyan

    2017-01-01

    Full Text Available To improve the situation of the frequent failures of mine belt conveyor during operation, a model was used to evaluate the safety of mine belt conveyor. Based on the foundation of collecting and analyzing a large quantity of fault information of belt conveyor in the nationwide coal mine, the fault tree model of belt conveyor has been built, then the safety evaluation index system was established by analyzing and removing some secondary indicators. Furthermore, the weighted value of safety evaluation indexs was determined by analytic hierarchy process(AHP, and the single factor fuzzy evaluation matrix was constructed by experts grading method. Additionally, the model was applied in evaluating the security of belt conveyor in Nanliang coal mine. The results shows the security level is recognized to the “general”, which means that this model can be adopted widely in evaluating the safety of mine belt conveyor.

  20. Scale development of safety management system evaluation for the airline industry.

    Science.gov (United States)

    Chen, Ching-Fu; Chen, Shu-Chuan

    2012-07-01

    The airline industry relies on the implementation of Safety Management System (SMS) to integrate safety policies and augment safety performance at both organizational and individual levels. Although there are various degrees of SMS implementation in practice, a comprehensive scale measuring the essential dimensions of SMS is still lacking. This paper thus aims to develop an SMS measurement scale from the perspective of aviation experts and airline managers to evaluate the performance of company's safety management system, by adopting Schwab's (1980) three-stage scale development procedure. The results reveal a five-factor structure consisting of 23 items. The five factors include documentation and commands, safety promotion and training, executive management commitment, emergency preparedness and response plan and safety management policy. The implications of this SMS evaluation scale for practitioners and future research are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Prehospital blood transfusions in pediatric trauma and nontrauma patients: a single-center review of safety and outcomes.

    Science.gov (United States)

    Fahy, Aodhnait S; Thiels, Cornelius A; Polites, Stephanie F; Parker, Maile; Ishitani, Michael B; Moir, Christopher R; Berns, Kathleen; Stubbs, James R; Jenkins, Donald H; Zietlow, Scott P; Zielinski, Martin D

    2017-07-01

    Prehospital transfusions are a novel yet increasingly accepted intervention in the adult population as part of remote damage control resuscitation, but prehospital transfusions remain controversial in children. Our purpose was to review our pediatric prehospital transfusion experience over 12 years to describe the safety of prehospital transfusion in appropriately triaged trauma and nontrauma patients. Children (prehospital transfusions of blood products were safe in this small group of appropriately triaged pediatric patients. Further studies are needed to determine if outcomes are improved and to devise a rigorous protocol for this prehospital intervention for critically ill pediatric patients.

  2. Evaluation of food safety management systems in Serbian dairy industry

    Directory of Open Access Journals (Sweden)

    Igor Tomašević

    2016-01-01

    Full Text Available This paper reports incentives, costs, difficulties and benefits of food safety management systems implementation in the Serbian dairy industry. The survey involved 27 food business operators with the national milk and dairy market share of 65 %. Almost two thirds of the assessed dairy producers (70.4 % claimed that they had a fully operational and certified HACCP system in place, while 29.6 % implemented HACCP, but had no third party certification. ISO 22000 was implemented and certified in 29.6 % of the companies, while only 11.1 % had implemented and certified IFS standard. The most important incentive for implementing food safety management systems for Serbian dairy producers was to increase and improve safety and quality of dairy products. The cost of product investigation/analysis and hiring external consultants were related to the initial set-up of food safety management system with the greatest importance. Serbian dairy industry was not greatly concerned by the financial side of implementing food safety management systems due to the fact that majority of prerequisite programmes were in place and regularly used by almost 100 % of the producers surveyed. The presence of competency gap between the generic knowledge for manufacturing food products and the knowledge necessary to develop and implement food safety management systems was confirmed, despite the fact that 58.8 % of Serbian dairy managers had university level of education. Our study brings about the innovation emphasizing the attitudes and the motivation of the food production staff as the most important barrier for the development and implementation of HACCP. The most important identified benefit was increased safety of dairy products with the mean rank scores of 6.85. The increased customer confidence and working discipline of staff employed in food processing were also found as important benefits of implementing/operating HACCP. The study shows that the level of HACCP

  3. Insight into "Calculated Risk": An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety.

    Science.gov (United States)

    Neslo, R E J; Oei, W; Janssen, M P

    2017-09-01

    Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or transmission characteristics is lacking, which might render measures against such EIDs disputable. On the other hand, the fact that we call them "emerging" implies almost by definition that we are uncertain about at least some of their characteristics. So what is the relative importance of various disease and transmission characteristics, and how are these influenced by the degree of uncertainty associated with their actual values? We identified the likelihood of transmission by blood transfusion, the presence of an asymptomatic phase of infection, prevalence of infection, and the disease impact as the main characteristics of the perceived risk of disease transmission by blood transfusion. A group of experts in the field of infectious diseases and blood transfusion ranked sets of (hypothetical) diseases with varying degrees of uncertainty associated with their disease characteristics, and used probabilistic inversion to obtain probability distributions for the weight of each of these risk characteristics. These distribution weights can be used to rank both existing and newly emerging infectious diseases with (partially) known characteristics. Analyses show that in case there is a lack of data concerning disease characteristics, it is the uncertainty concerning the asymptomatic phase and the disease impact that are the most important drivers of the perceived risk. On the other hand, if disease characteristics are well established, it is the prevalence of infection and the transmissibility of the disease by blood transfusion that will drive the perceived risk. The risk prioritization model derived provides an easy to obtain and rational expert assessment of the relative importance of

  4. Solute Carriers in the Blood-Brain Barier: Safety in Abundance.

    Science.gov (United States)

    Nałęcz, Katarzyna A

    2017-03-01

    Blood-brain barrier formed by brain capillary endothelial cells, being in contact with astrocytes endfeet and pericytes, separates extracellular fluid from plasma. Supply of necessary nutrients and removal of certain metabolites takes place due to the activity of transporting proteins from ABC (ATP binding cassette) and SLC (solute carrier) superfamilies. This review is focused on the SLC families involved in transport though the blood-brain barrier of energetic substrates (glucose, monocarboxylates, creatine), amino acids, neurotransmitters and their precursors, as well as organic ions. Members of SLC1, SLC2, SLC3/SLC7, SLC5, SLC6, SLC16, SLC22, SLC38, SLC44, SLC47 and SLCO (SLC21), whose presence in the blood-brain barriers has been demonstrated are characterized with a special emphasis put on polarity of transporters localization in a luminal (blood side) versus an abluminal (brain side) membrane.

  5. An approach using multi-factor combination to evaluate high rocky slope safety

    Science.gov (United States)

    Su, Huaizhi; Yang, Meng; Wen, Zhiping

    2016-06-01

    A high rocky slope is an open complex giant system for which there is contradiction among different influencing factors and coexistence of qualitative and quantitative information. This study presents a comprehensive intelligent evaluation method of high rocky slope safety through an integrated analytic hierarchy process, extension matter element model and entropy weight to assess the safety behavior of the high rocky slope. The proposed intelligent evaluation integrates subjective judgments derived from the analytic hierarchy process with the extension matter model and entropy weight into a multiple indexes dynamic safety evaluation approach. A combined subjective and objective comprehensive evaluation process, a more objective study, through avoiding subjective effects on the weights, and a qualitative safety assessment and quantitative safety amount are presented in the proposed method. The detailed computational procedures were also provided to illustrate the integration process of the above methods. Safety analysis of one high rocky slope is conducted to illustrate that this approach can adequately handle the inherent imprecision and contradiction of the human decision-making process and provide the flexibility and robustness needed for the decision maker to better monitor the safety status of a high rocky slope. This study was the first application of the proposed integrated evaluation method in the safety assessment of a high rocky slope. The study also indicated that it can also be applied to other similar problems.

  6. Evaluation of the quality of blood components prepared using the Reveos automated blood processing system.

    Science.gov (United States)

    Johnson, L; Winter, K M; Kwok, M; Reid, S; Marks, D C

    2013-10-01

    The Reveos automated blood processing system has been developed to combine primary and secondary processing of whole-blood units, resulting in a plasma unit, a red-blood-cell concentrate and an interim platelet unit per input. The aim of this study was to determine product specifications and in vitro quality of components produced by the Reveos system. Whole blood was processed using the Reveos system and compared with historical Reference units produced using semi-automated methods. Reveos red cells were leucoreduced and stored in SAGM at 4°C. Reveos plasma was frozen at -30°C and factor activity was assessed after thawing. Reference red cell, plasma and buffy coats were produced by top and bottom processing. Leucoreduced Reveos and Reference platelet concentrates were prepared by pooling four interim platelet units or four buffy coats, respectively, with SSP+. Processing with the Reveos system was faster (76 min) than semi-automated separation (92 min). The red cell and platelet yields were higher in the units prepared by the Reveos system. The Reference and Reveos red cell and plasma units had very similar in vitro quality parameters. The platelet concentrates were also similar in many in vitro parameters, including pH, glucose and lactate metabolism, hypotonic shock response and phosphatidylserine expression, although platelet activation markers (CD62P and cytokine levels) were higher in the Reveos units. The Reveos system can improve blood component efficiencies through reductions in processing time, whilst maintaining similar component quality. Vox Sanguinis © 2013 International Society of Blood Transfusion.

  7. Safety evaluation of p-synephrine following 15 days of oral administration to healthy subjects: A clinical study.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Smadi, Mahmoud M

    2018-01-01

    Extracts of bitter orange (BOE, Citrus aurantium L.) and its primary protoalkaloid p-synephrine are extensively consumed as dietary supplements. p-Synephrine is also present in foods and juices prepared from various Citrus species. The safety of p-synephrine has been questioned as a result of structural similarities with ephedrine. This study assessed the cardiovascular (stimulant) and hemodynamic effects of BOE (49 mg p-synephrine) daily given to 16 healthy subjects for 15 days in a placebo-controlled, cross-over, double-blinded study. A physical evaluation by a cardiologist, as well as heart rates, blood pressures, and electrocardiograms were determined, and blood samples were drawn at baseline, and Days 5, 10, and 15. Serum levels for caffeine and p-synephrine were measured at 1 and 2 weeks. Subjects completed a 10-item health and metabolic questionnaire at baseline and on Day 15. No significant changes occurred in heart rate, electrocardiograms, systolic blood or diastolic pressures, blood cell counts, or blood chemistries in either the control or p-synephrine treated groups at any time point. No adverse effects were reported in response to the bitter orange (p-synephrine). Caffeine consumed by the participants varied markedly. Under these experimental conditions, BOE and p-synephrine were without stimulant (cardiovascular) and adverse effects. Copyright © 2017 John Wiley & Sons, Ltd.

  8. Evaluation procedure of software safety plan for digital I and C of KNGR

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jang Soo; Park, Jong Kyun; Lee, Ki Young; Kwon, Ki Choon; Kim, Jang Yeol; Cheon, Se Woo

    2000-05-01

    The development, use, and regulation of computer systems in nuclear reactor instrumentation and control (I and C) systems to enhance reliability and safety is a complex issue. This report is one of a series of reports from the Korean next generation reactor (KNGR) software safety verification and validation (SSVV) task, Korea Atomic Energy Research Institute, which investigates different aspects of computer software in reactor I and C systems, and describes the engineering procedures for developing such a software. The purpose of this guideline is to give the software safety evaluator the trail map between the code and standards layer and the design methodology and documents layer for the software important to safety in nuclear power plants. Recently, the safety planning for safety-critical software systems is being recognized as the most important phase in the software life cycle, and being developed new regulatory positions and standards by the regulatory and the standardization organizations. The requirements for software important to safety of nuclear reactor are described in such positions and standards, for example, the new standard review plan (SRP), IEC 880 supplements, IEEE standard 1228-1994, IEEE standard 7-4.3.2-1993, and IAEA safety series No. 50-SG-D3 and D8. We presented the guidance for evaluating the safety plan of the software in the KNGR protection systems. The guideline consists of the regulatory requirements for software safety in chapter 2, the evaluation checklist of software safety plan in chapter3, and the evaluation results of KNGR software safety plan in chapter 4.

  9. Semi-natural test methods to evaluate fire safety of wall claddings: Update

    Directory of Open Access Journals (Sweden)

    Smolka Miroslav

    2016-01-01

    Full Text Available There are a number of test methods worldwide to evaluate fire safety of facades. An overview of available test methods implemented in fire safety codes was presented at the 1st Conference of Fire Safety of Facades in 2013. [1] Since then, a number of changes and developments occurred. The purpose of this paper is to present the updated global overview of facade fire spread test methods made for building regulations.

  10. Comprehensive Evaluation of Entropy-hierarchical Grey Correlation Analysis for Highway Safety Life Protection Engineering

    OpenAIRE

    Jin Shuxins; Cao Xudong

    2016-01-01

    Different highway safety life protection engineering decision-making have important meaning. The achieving goals and optimal highway safety life protection engineering scheme can not only improve the function of the highway facilities and service level, still can reduce the traffic accident, which caused by the imperfect highway facilities. Different highway safety life protection engineering decision-making is a multiple targets, multi-layers and multi-schemes system evaluation problem. With...

  11. [Evaluation of efficacy and safety of drugs absorbed through skin using their physicochemical parameters].

    Science.gov (United States)

    Oshizaka, Takeshi; Todo, Hiroaki; Sugibayashi, Kenji

    2012-01-01

    Skin has been paid attention as a site of application of prescription drugs, over-the-counter drugs (non-prescription drugs) and cosmetics. Skin permeation and skin concentration of the compounds should be considered after topical administration, as well as their blood concentration to evaluate efficacy and safety. Since the evaluation of the amount of drugs permeated through skin is important for topically applied drugs, studies on the skin permeation has been greatly advanced. In addition, many reports proved that skin permeabilities of drugs could be predicted from physicochemical parameters of drugs. On the other hand, few reports have been found on the prediction of skin concentration of drugs. Furthermore, many experimented problems are left to determine the skin concentration of drugs: severe consume of human or animal skins, difficult removal of applied drugs from the skin surface, low drug extraction ratio from skin and low sensitivity to determine skin concentration of drugs, and requirement of long time measurement. Thus, fast and accurate measurement of skin concentration of applied drugs are urgently required. This report describes the relationship between skin permeation and skin concentration, and the prediction of skin concentration of drugs using skin permeation parameters of drugs.

  12. Safety evaluation of an α-cyclodextrin glycosyltranferase preparation

    NARCIS (Netherlands)

    Bär, A.; Krul, C.A.M.; Jonker, D.; Vogel, N. de

    2004-01-01

    Alpha-cyclodextrin glucosyltransferase (α-CGTase, EC 2.4.1.19) is an amylolytic enzyme used for the production of α-cyclodextrin (α-CD), a novel, soluble dietary fiber, from food-grade starch. The safety of an α-CGTase preparation obtained by batch fermentation from a recombinant strain of

  13. Quality and safety evaluation of a Ghanaian polyherbal product EAF ...

    African Journals Online (AJOL)

    Background: The widespread use of herbal medicines in recent years means that issues concerning their quality, safety and efficacy need to be answered. In the current study, the polyherbal formulation EAF-2011 used in the Centre for Scientific Research into Plant Medicine, Mampong- Akwapemfor the management of ...

  14. Use of GRA to evaluate road traffic safety strategies

    NARCIS (Netherlands)

    Lu, M.; Wevers, K.; Heijden, R.E.C.M. van der; Lin, C.T.

    2005-01-01

    Large-scale implementation of advanced driver assistance systems (ADAS) applications and extensive redesign of the physical road infrastructure are two of the main approaches to improve road traffic safety. These strategies may be to a large extent substitutes, but also partly complementary. The

  15. Economic evaluation of safety measures for transport companies

    NARCIS (Netherlands)

    Rietveld, Piet; Rienstra, Sytze A.

    1998-01-01

    Measures to reduce material damage within companies may both increase the business economic performance of the company and traffic safety in general. In this paper the notion of whether such measures are economically feasible is investigated. Results are presented of a series of interviews

  16. Physicochemical, nutritive and safety evaluation of local cereal ...

    African Journals Online (AJOL)

    Objective: The aim of this work was to contribute to the food safety of Ivorian consumers by investigating the nutritive value and the microbial quality of local cereal flours offered for retail sale on different markets located on selected areas of the District of Abidjan. Methodology and results: Local cereal flours samples were ...

  17. 21 CFR 315.6 - Evaluation of safety.

    Science.gov (United States)

    2010-04-01

    ...) Allergic or hypersensitivity responses, (2) Immunologic responses, (3) Changes in the physiologic or... information, the following types of data: (i) Pharmacology data, (ii) Toxicology data, (iii) Clinical adverse... relevant to risk and will specify the amount and type of safety data that are appropriate for each category...

  18. 21 CFR 601.35 - Evaluation of safety.

    Science.gov (United States)

    2010-04-01

    ...) Allergic or hypersensitivity responses, (2) Immunologic responses, (3) Changes in the physiologic or... information, the following types of data: (A) Pharmacology data, (B) Toxicology data, (C) Clinical adverse... relevant to risk and will specify the amount and type of safety data that are appropriate for each category...

  19. Evaluation of blood lead level in methamphetamine users in Tehran.

    Science.gov (United States)

    Mostafazadeh, Babak; Shadnia, Shahin; Tavakkoli, Mohammad Ali; Khoddami Vishteh, Hamid Reza

    2017-02-22

    Given the increasing number of lead poisoning in opioids users and since no study has been conducted so far to review lead poisoning in methamphetamine (crystal) users, this study aimed to investigate blood lead level in methamphetamine addicts. This study was conducted on 20 patients with methamphetamine poisoning and their blood lead level was measured. The subjects were selected from among patients with a history of continuous use of methamphetamine, without a history of using opiates in the past 6 months confirmed by a negative urine tests, and without a history of heavy metal poisoning. Of all, 18 patients were male and the mean age was 32 ± 10 years; 17 patients were abusing the drug via inhalation and three persons via oral administration. The mean blood lead level was 2.3 ± 1.1 μg/dL and poisoning was not observed in any of the cases. Blood lead level was not associated with age, sex, dosage, and route of administration. Although blood lead level was not at poisoning level in people who only used methamphetamine in Iran, due to the simultaneous use of other substances and because of non-specific symptoms, lead poisoning must be suspected in all cases of substances poisoning.

  20. Evaluation of blood microcirculation parameters by combined use of laser Doppler flowmetry and videocapillaroscopy methods

    Science.gov (United States)

    Volkov, M. V.; Kostrova, D. A.; Margaryants, N. B.; Gurov, I. P.; Erofeev, N. P.; Dremin, V. V.; Zharkikh, E. V.; Zherebtsov, E. A.; Kozlov, I. O.; Dunaev, A. V.

    2017-03-01

    Laser Doppler flowmetry (LDF) is widely used for diagnosing blood microcirculation diseases. It is well known that the Doppler shift of laser radiation scattered by moving red blood cells (RBC) can be assessed through analyzing photocurrent produced by a photodetector. LDF signal contains information about regulating blood flow rhythms: myogenic, cardiac, nervous and endothelial. The method of videocapillaroscopy (VCS) allows local capillary blood flow velocity evaluation and, using video data processing algorithms, is able to assess RBC velocity changes into capillary. We present the results of simultaneous investigations of changes in tissue perfusion of the distal phalanx of human finger by the LDF as well as changes in capillary blood flow velocity in the nail bed evaluated by the VCS method during arterial occlusion test. The experimental results confirmed the correspondence between blood perfusion and blood flow velocity.

  1. The granulocytes in neutropenia 1 (GIN 1) study: a safety study of granulocytes collected from whole blood and stored in additive solution and plasma.

    Science.gov (United States)

    Massey, Edwin; Harding, Kay; Kahan, Brennan C; Llewelyn, Charlotte; Wynn, Robert; Moppett, John; Robinson, Stephen P; Green, Ann; Lucas, Geoff; Sadani, Deepak; Liakopoulou, Effie; Bolton-Maggs, Paula; Marks, David I; Stanworth, Simon

    2012-08-01

    To evaluate the safety of transfusing pooled, whole blood-derived granulocytes in additive solution and plasma (GASP) in 30 recipients. Demand for granulocytes in England has increased five-fold. With the advantages of reduced red cell, plasma and overall volume, GASP maintains function in vitro. Observations were recorded prior to and post transfusion. Increments were recorded at 1 h and the following morning. Leucocyte antibody screening was undertaken prior to and at 1-6 months following transfusion. Thirty patients aged between 8 months and 68 years received 221 GASP in 148 transfusion episodes. GASP contained an average of 1.0 × 10(10) granulocytes in 207 mL. Adults usually received two packs and children 10-20 mL kg(-1). Children and adults received a median [interquartile range (IQR)] dose of 12.5 (9.1-25.3) and 19.7 (12.0-25.8) × 10(9) granulocytes per transfusion, respectively. There was one episode of transfusion-associated circulatory overload (TACO) in a patient with chronic cardiac failure following 600 mL of unpooled granulocytes, other fluids and one GASP. New leucocyte alloimmunisation occurred in 3/30 recipients 10%. No other significant reactions were reported. Median peripheral blood neutrophil increments at 1 h post transfusion were 0.06 (IQR, 0.01-0.17) in children and (0.03) (IQR, 0-0.16) in adults. GASP has a similar safety profile to other sources of granulocytes for patients with refractory infection or in need of secondary prophylactic transfusion. Further studies are required to clarify the role of GASP in the treatment of neutropenic patients. © 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.

  2. Blood coagulation evaluation of N-alkylated chitosan.

    Science.gov (United States)

    Chen, Zihao; Yao, Xinpei; Liu, Lu; Guan, Jing; Liu, Mengyuan; Li, Zhihong; Yang, Jian; Huang, Shujie; Wu, Jimin; Tian, Feng; Jing, Miaolei

    2017-10-01

    N-Alkylated chitosan (NACS) may improve the haemostatic efficiency of chitosan (CS). To study its coagulation capability and function, a series of NACS with various carbon chain lengths and substitution degrees (SD) of alkyl groups were synthesized and characterized by FTIR, NMR, and elemental analysis. Haemolysis and toxicity assays revealed that NACS showed good biocompatibility. In vitro blood clotting tests indicated that NACS had better haemostatic activity than CS, of which N-octadecyl CS with 3.85% SD showed the best results. Blood plasma coagulation tests showed that NACS was not favourable for activating coagulation factors. Platelet adhesion, intracellular Ca2+, and CD62p measurements demonstrated that the coagulation properties of NACS were not related to platelet activation. Erythrocyte adhesion examination indicated that blood coagulation of NACS may be attributable to its effects on erythrocytes. This study suggests that NACS is an ideal candidate for clotting. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Prediction methods for blood glucose concentration design, use and evaluation

    CERN Document Server

    Jørgensen, John; Renard, Eric; Re, Luigi

    2016-01-01

    This book tackles the problem of overshoot and undershoot in blood glucose levels caused by delay in the effects of carbohydrate consumption and insulin administration. The ideas presented here will be very important in maintaining the welfare of insulin-dependent diabetics and avoiding the damaging effects of unpredicted swings in blood glucose – accurate prediction enables the implementation of counter-measures. The glucose prediction algorithms described are also a key and critical ingredient of automated insulin delivery systems, the so-called “artificial pancreas”. The authors address the topic of blood-glucose prediction from medical, scientific and technological points of view. Simulation studies are utilized for complementary analysis but the primary focus of this book is on real applications, using clinical data from diabetic subjects. The text details the current state of the art by surveying prediction algorithms, and then moves beyond it with the most recent advances in data-based modeling o...

  4. In vivo evaluation of femoral blood flow measured with magnetic resonance

    DEFF Research Database (Denmark)

    Henriksen, O; Ståhlberg, F; Thomsen, C

    1989-01-01

    Quantitative measurements of blood flow based on magnetic resonance imaging (MRI) using conventional multiple spin echo sequences were evaluated in vivo in healthy young volunteers. Blood flow was measured using MRI in the femoral vein. The initial slope of the multiple spin echo decay curve...... that in vivo blood flow measurements made with MRI based on wash-out effects, commonly used in multiple spin echo imaging, do not give reliable absolute values for blood flow in the femoral artery or vein......., corrected for the T2 decay of non-flowing blood was used to calculate the blood flow. As a reference, the blood flow in the femoral artery was measured simultaneously with an invasive indicator dilution technique. T2 of non-flowing blood was measured in vivo in popliteal veins during regional circulatory...

  5. In vivo evaluation of femoral blood flow measured with magnetic resonance

    DEFF Research Database (Denmark)

    Henriksen, O; Ståhlberg, F; Thomsen, C

    1989-01-01

    Quantitative measurements of blood flow based on magnetic resonance imaging (MRI) using conventional multiple spin echo sequences were evaluated in vivo in healthy young volunteers. Blood flow was measured using MRI in the femoral vein. The initial slope of the multiple spin echo decay curve......, corrected for the T2 decay of non-flowing blood was used to calculate the blood flow. As a reference, the blood flow in the femoral artery was measured simultaneously with an invasive indicator dilution technique. T2 of non-flowing blood was measured in vivo in popliteal veins during regional circulatory...... arrest. The mean T2 of non-flowing blood was found to be 105 +/- 31 ms. The femoral blood flow ranged between 0 and 643 ml/min measured with MRI and between 280 and 531 ml/min measured by the indicator dilution technique. There was thus poor agreement between the two methods. The results indicate...

  6. Development of an Evaluation Tool for Online Food Safety Training Programs

    Science.gov (United States)

    Neal, Jack A., Jr.; Murphy, Cheryl A.; Crandall, Philip G.; O'Bryan, Corliss A.; Keifer, Elizabeth; Ricke, Steven C.

    2011-01-01

    The objective of this study was to provide the person in charge and food safety instructors an assessment tool to help characterize, identify strengths and weaknesses, determine the completeness of the knowledge gained by the employee, and evaluate the level of content presentation and usability of current retail food safety training platforms. An…

  7. Safety evaluation of aqueous extract of leaves of a plant phyllanthus ...

    African Journals Online (AJOL)

    Safety evaluation of aqueous extract of leaves of a plant phyllanthus amarus, in rat liver. ... But, so far, no safety studies have been carried out on this plant with clear documentation, especially with those plants growing in Malaysia. So the aim of this study was to determine the toxic side effects of aqueous extract of leaves of ...

  8. Health economics and outcomes methods in risk-based decision-making for blood safety

    NARCIS (Netherlands)

    Custer, Brian; Janssen, Mart P.

    2015-01-01

    Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing

  9. 78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Science.gov (United States)

    2013-11-04

    ..., and (3) the implications for safety and availability of various economic factors affecting product... session should to contact the designated Federal official to register prior to close of business on... the close of business on December 2, 2013. It is also requested that any member of the public who...

  10. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-05-06

    ... transplantation will be considered as it relates to safety. Concerns for a globally consistent coding system for... time (limited to 5 minutes) and registration must be prior to close of business on June 3, 2011. If it... the Executive Secretary prior to the close of business on June 6, 2011. Electronic comments must...

  11. Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India

    Directory of Open Access Journals (Sweden)

    Shivaram Chandrashekar

    2014-01-01

    Full Text Available Background and Objectives: It is well established that Nucleic acid testing (NAT reduces window phase of transfusion transmissible infections (TTI and helps improve blood safety. NAT testing can be done individually or in pools. The objectives of this study were to determine the utility, feasibility and cost effectiveness of an in-house minipool-NAT(MP-NAT. Materials and Methods: Blood donors were screened by history, tested by ELISA and sero-negative samples were subjected to an in-house NAT by using reverse transcriptase-polymerase chain reaction (RT-PCR. Testing was done in mini-pools of size eight (8. Positive pools were repeated with individual samples. Results: During the study period of Oct 2005-Sept 2010 (5 years all blood donors (n=53729 were screened by ELISA. Of which 469 (0.87% were positive for HIV-1, HBV or HCV. Sero-negative samples (n=53260 were screened by in-house MP-NAT. HIV-NAT yield was 1/53260 (n=1 and HBV NAT yield (n=2 was 1/26630. Conclusion: NAT yield was lower than other India studies possibly due to the lower sero-reactivity amongst our donors. Nevertheless it intercepted 9 lives including the components prepared. The in-house assay met our objective of improving blood safety at nominal cost and showed that it is feasible to set up small molecular biology units in medium-large sized blood banks and deliver blood within 24-48 hours. The utility of NAT (NAT yield will vary based on the donor population, the type of serological test used, the nature of kit employed and the sensitivity of NAT test used. The limitations of our in-house MP-NAT consisted of stringent sample preparation requirements, with labor and time involved. The benefits of our MP-NAT were that it acted as a second level of check for ELISA tests, was relatively inexpensive compared to ID-NAT and did not need sophisticated equipment.

  12. Evaluation of cellular and biochemical parameters of blood and peritoneal fluid following enterectomy in the goat.

    Science.gov (United States)

    Nazifi; Dehghani; Barzegar

    2000-07-01

    To evaluate the effects of enterectomy on cellular and biochemical parameters of blood and peritoneal fluid, an experiment was conducted using 10 Iranian crossbred male goats. Ten milliliter of blood and 1-1.5ml of peritoneal fluid were sampled from all animals prior to operation for the estimation of control values. Enterectomy was performed under local anesthesia. Blood and peritoneal fluid samples were collected at 24, 48, 72 and 96h after enterectomy. The results revealed that after enterectomy, the number of WBCs, neutrophils, monocytes and band neutrophils in the blood significantly increased (penterectomy can have profound effects on blood and peritoneal fluid parameters.

  13. Safety evaluation of neem (Azadirachta indica) derived pesticides

    NARCIS (Netherlands)

    Boeke, S.J.; Boersma, M.G.; Alink, G.M.; Loon, van J.J.A.; Huis, van A.; Dicke, M.; Rietjens, I.M.C.M.

    2004-01-01

    The neem tree, Azadirachta indica, provides many useful compounds that are used as pesticides and could be applied to protect stored seeds against insects. However in addition to possible beneficial health effects, such as blood sugar lowering properties, anti-parasitic, anti-inflammatory,

  14. A modified isometric test to evaluate blood pressure control with ...

    African Journals Online (AJOL)

    35 mmHg sysrolic and 97 ± 21 mmHg diastolic. Twenty-nine patients were unresponsive to various drug combinations as judged by diastolic blood pressures which remained above 100 mmHg at rest, while 16 had not received any prior medical therapy. Four patients had coronary artery disease, treated with nitrates and.

  15. Evaluation of the Blood-Glucose Reducing Effects of Aqueous ...

    African Journals Online (AJOL)

    Conclusion: The study indicates that since the umbelliferous fruits are used in the preparation of foods, they may be useful in the control of postprandial rise of blood glucose particularly in diabetic condition. Additionally, their daily use may help in reducing complications associated with chronic diabetes. Keywords: Diabetes ...

  16. Evaluation Of Blood Collected From Clinically Diagnosed Typhoid ...

    African Journals Online (AJOL)

    Out of the 635 patients, 505 (79.5%) were positive for Widal agglutination test using 1:160 as the cut-off antibody titre as determined in the screened sera of the healthy volunteers. Blood culture revealed that 216 (42.8%) bacterial pathogens were isolated from the Widal positive patients yielded out of which 101 (46.8%) ...

  17. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    Science.gov (United States)

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  18. Modification of JRR-4 based on safety evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Izumo, Hironobu; Nakajima, Teruo; Funayama, Yoshiro [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-10-01

    Since the first criticality was achieved on January 28, 1965, JRR-4 has been operated safely until on January 12, 1996. The modification of JRR-4 was planned according to the framework of reduced enrichment on research reactor program. The modification was designed based on the several national safety guides. JRR-4 has some modifications of facilities to satisfy the guides and guides criteria. (author)

  19. Passive Safety Features Evaluation of KIPT Neutron Source Facility

    Energy Technology Data Exchange (ETDEWEB)

    Zhong, Zhaopeng [Argonne National Lab. (ANL), Argonne, IL (United States); Gohar, Yousry [Argonne National Lab. (ANL), Argonne, IL (United States)

    2016-06-01

    Argonne National Laboratory (ANL) of the United States and Kharkov Institute of Physics and Technology (KIPT) of Ukraine have cooperated on the development, design, and construction of a neutron source facility. The facility was constructed at Kharkov, Ukraine and its commissioning process is underway. It will be used to conduct basic and applied nuclear research, produce medical isotopes, and train young nuclear specialists. The facility has an electron accelerator-driven subcritical assembly. The electron beam power is 100 kW using 100 MeV electrons. Tungsten or natural uranium is the target material for generating neutrons driving the subcritical assembly. The subcritical assembly is composed of WWR-M2 - Russian fuel assemblies with U-235 enrichment of 19.7 wt%, surrounded by beryllium reflector assembles and graphite blocks. The subcritical assembly is seated in a water tank, which is a part of the primary cooling loop. During normal operation, the water coolant operates at room temperature and the total facility power is ~300 KW. The passive safety features of the facility are discussed in in this study. Monte Carlo computer code MCNPX was utilized in the analyses with ENDF/B-VII.0 nuclear data libraries. Negative reactivity temperature feedback was consistently observed, which is important for the facility safety performance. Due to the design of WWR-M2 fuel assemblies, slight water temperature increase and the corresponding water density decrease produce large reactivity drop, which offset the reactivity gain by mistakenly loading an additional fuel assembly. The increase of fuel temperature also causes sufficiently large reactivity decrease. This enhances the facility safety performance because fuel temperature increase provides prompt negative reactivity feedback. The reactivity variation due to an empty fuel position filled by water during the fuel loading process is examined. Also, the loading mistakes of removing beryllium reflector assemblies and

  20. Evaluation of patients' engagement in radiation therapy safety.

    Science.gov (United States)

    Pernet, A; Mollo, V; Bibault, J-E; Giraud, P

    2016-12-01

    Treatment safety has become a priority in health policies after several incidents occurred around the world in radiation oncology departments. The aim of this study was to analyse the patients' contribution in that field and to understand which actions empower the patient in that regard. Several methods were used in a general hospital and in a comprehensive cancer centre to analyse the activities of the radiation therapists and the patients and the interactions between them: treatment session observations, semidirective interviews with radiation therapists and patients, self and alloconfrontation with radiation therapists and explanatory interviews with patients. Cooperation of the patients in treatment safety acts as an additional step that contributes to safer treatments. Radiation therapy sessions are a creative opportunity for the patient to observe, learn and analyse what is happening. Changes between treatment sessions are a source of anxiety for the patients. This study highlights the factors that favour the patients' participation. A trusting relationship and support from the health professionals can be leveraged in that manner. There is a common will shared between the patients and the health professionals towards better treatment safety. The cooperation is still not well-known and underused. This empowerment of the patient cannot be mandatory but should be promoted and developed. Copyright © 2016. Published by Elsevier SAS.

  1. Metals in cosmetics: an a posteriori safety evaluation.

    Science.gov (United States)

    Marinovich, Marina; Boraso, Maria Serena; Testai, Emanuela; Galli, Corrado L

    2014-08-01

    According to EU Regulation No. 1223/2009/CE cosmetic products for daily use can contain 'technically unavoidable traces' of metals. This definition is too vague. Authorities should set well-defined limits, considering the risks associated with metal contamination of personal care products (PCPs). This paper characterizes the risk arising from a number of metals (antimony, arsenic, cadmium, cobalt, chromium, mercury, nickel, lead) that may occur in 'unavoidable traces" in raw materials and, consequently, in PCPs. A 'worst case scenario' was adopted, based on the following assumptions: (i) the individual ingredients contained the maximum amount in traces allowed for each metal; (ii) the hypothetical PCP was produced exclusively with that single ingredient; (iii) when absorption through the skin was not known, data related to oral absorption were used. Risk characterization was performed calculating the Systemic Exposure Dosage (SED) and the Margin of Safety (MoS=NOAEL or BMDL10/SED). Exposure to the allegedly 'technically unavoidable' maximum amounts of metals in cosmetic ingredients resulted in MoSs exceeding 100 (safety threshold) with one exception. This suggests that the availability of experimental dermal absorption rates could enable significant improvement in MoS, thus increasing safety levels. Although results are reassuring, the authors recommend minimization of contamination, according to the state of the art of manufacturing methods. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Evaluation of the food safety training for food handlers in restaurant operations.

    Science.gov (United States)

    Park, Sung-Hee; Kwak, Tong-Kyung; Chang, Hye-Ja

    2010-02-01

    This study examined the extent of improvement of food safety knowledge and practices of employee through food safety training. Employee knowledge and practice for food safety were evaluated before and after the food safety training program. The training program and questionnaires for evaluating employee knowledge and practices concerning food safety, and a checklist for determining food safety performance of restaurants were developed. Data were analyzed using the SPSS program. Twelve restaurants participated in this study. We split them into two groups: the intervention group with training, and the control group without food safety training. Employee knowledge of the intervention group also showed a significant improvement in their score, increasing from 49.3 before the training to 66.6 after training. But in terms of employee practices and the sanitation performance, there were no significant increases after the training. From these results, we recommended that the more job-specific and hand-on training materials for restaurant employees should be developed and more continuous implementation of the food safety training and integration of employee appraisal program with the outcome of safety training were needed.

  3. Evaluation of the Patient Safety Leadership Walkabout programme of a hospital in Singapore

    Science.gov (United States)

    Lim, Raymond Boon Tar; Benjamin Boon Lui, Ng; Kok Mun, Ng

    2014-01-01

    INTRODUCTION The Patient Safety Leadership Walkabout (PSLWA) programme is a commonly employed tool in the West, in which senior leaders visit sites within the hospital that are involved in patient care to talk to healthcare staff about patient safety issues. As there is a lack of perspective regarding PSLWA in Asia, we carried out an evaluation of its effectiveness in improving the patient safety culture in Tan Tock Seng Hospital, Singapore. METHODS A mixed methods analysis approach was used to review and evaluate all documents, protocols, meeting minutes, post-walkabout surveys, action plans and verbal feedback pertaining to the walkabouts conducted from January 2005 to October 2012. RESULTS A total of 321 patient safety issues were identified during the study period. Of these, 308 (96.0%) issues were resolved as of November 2012. Among the various categories of issues raised, issues related to work environment were the most common (45.2%). Of all the issues raised during the walkabouts, 72.9% were not identified through other conventional methods of error detection. With respect to the hospital's patient safety culture, 94.8% of the participants reported an increased awareness in patient safety and 90.2% expressed comfort in openly and honestly discussing patient safety issues. CONCLUSION PSLWA serves as a good tool to uncover latent errors before actual harm reaches the patient. If properly implemented, it is an effective method for engaging leadership, identifying patient safety issues, and supporting a culture of patient safety in the hospital setting. PMID:24570316

  4. Safety and toxicological evaluation of a novel, fermented, peptide-enriched, hydrolyzed swine placenta extract powder.

    Science.gov (United States)

    Mitsui, Yukio; Bagchi, Manashi; Marone, Palma Ann; Moriyama, Hiroyoshi; Bagchi, Debasis

    2015-01-01

    Placenta is an important organ that connects the developing fetus to allow nutrient uptake, antibody provisions and gas exchange via the blood supply of the mother. We developed a novel, standardized, stable, water-soluble, peptide-enriched hydrolyzed, Horus fermented placenta powder (HFPEP) from healthy, pathogen-free, swine placenta. Earlier studies demonstrated that HFPEP significantly improves physical fatigue, hepatic functions and repair of muscle fibers. We examined the broad safety of HFPEP in various toxicology models in Good Laboratory Practices-approved laboratories. The acute oral toxicity study was conducted in female Sprague-Dawley rats, and the acute oral LD50 was found to be greater than 5000 mg/kg body weight. Ames' bacterial reverse mutation assay was conducted to determine the ability of HFPEP to induce reverse mutation at selected histidine loci in five tester strains of Salmonella typhimurium viz. TA1535, TA1537, TA98, TA100 and TA102 in the presence and absence of a metabolic activation system (S9) at the doses of 50, 15, 4.5, 1.35 and 0.41 mg/ml. No mutagenic potential was observed. Mutagenic potential was also evaluated using in vivo micronucleus test, and no mutagenic potential of HFPEP was observed. Repeated dose 28-d oral toxicity study was performed in male and female rats with 14-d recovery period at the dose levels of 250, 500 or 1000 mg/kg. No abnormal clinical signs or toxicity were detected. No observed adverse effect level of HFPEP was found to be greater than 1000 mg/kg body weight. These studies affirm that HFPEP has broad spectrum safety for human consumption.

  5. Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture.

    Science.gov (United States)

    Bump, Gregory M; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G; Jasti, Harish; McCausland, Julie B; Itri, Jason N; Patel, Rita M; Buchert, Andrew

    2015-03-01

    The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time.

  6. Evaluation of bypass lane safety, operations, and design in Kansas : [technical summary].

    Science.gov (United States)

    2015-08-01

    The construction of bypass lanes at rural intersections has typically been considered : a low-cost highway safety improvement by the transportation community. : However, this needs to be quantitatively evaluated so that decisions can be made : on whe...

  7. Leachables and extractables handbook: safety evaluation, qualification, and best practices applied to inhalation drug products

    National Research Council Canada - National Science Library

    Ball, Douglas J

    2012-01-01

    ...). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed...

  8. Safety Validation of Repeated Blood-Brain Barrier Disruption Using Focused Ultrasound

    NARCIS (Netherlands)

    Kobus, T.; Vykhodtseva, N.; Pilatou, M.; Zhang, Y.; McDannold, N.

    2016-01-01

    The purpose of this study was to investigate the effects on the brain of multiple sessions of blood-brain barrier (BBB) disruption using focused ultrasound (FUS) in combination with micro-bubbles over a range of acoustic exposure levels. Six weekly sessions of FUS, using acoustical pressures between

  9. 18F-FDG-labeled red blood cell PET for blood-pool imaging: preclinical evaluation in rats.

    Science.gov (United States)

    Matsusaka, Yohji; Nakahara, Tadaki; Takahashi, Kazuhiro; Iwabuchi, Yu; Nishime, Chiyoko; Kajimura, Mayumi; Jinzaki, Masahiro

    2017-12-01

    Red blood cells (RBCs) labeled with single-photon emitters have been clinically used for blood-pool imaging. Although some PET tracers have been introduced for blood-pool imaging, they have not yet been widely used. The present study investigated the feasibility of labeling RBCs with 18F-2-deoxy-2-fluoro-D-glucose (18F-FDG) for blood-pool imaging with PET. RBCs isolated from venous blood of rats were washed with glucose-free phosphate-buffered saline and labeled with 18F-FDG. To optimize labeling efficiency, the effects of glucose deprivation time and incubation (labeling) time with 18F-FDG were investigated. Post-labeling stability was assessed by calculating the release fraction of radioactivity and identifying the chemical forms of 18F in the released and intracellular components of 18F-FDG-labeled RBCs incubated in plasma. Just after intravenous injection of the optimized autologous 18F-FDG-labeled RBCs, dynamic PET scans were performed to evaluate in vivo imaging in normal rats and intraabdominal bleeding models (temporary and persistent bleeding). The optimal durations of glucose deprivation and incubation (labeling) with 18F-FDG were 60 and 30 min, respectively. As low as 10% of 18F was released as the form of 18F-FDG from 18F-FDG-labeled RBCs after a 60-min incubation. Dynamic PET images of normal rats showed strong persistence in the cardiovascular system for at least 120 min. In the intraabdominal bleeding models, 18F-FDG-labeled RBC PET visualized the extravascular blood clearly and revealed the dynamic changes of the extravascular radioactivity in the temporary and persistent bleeding. RBCs can be effectively labeled with 18F-FDG and used for blood-pool imaging with PET in rats.

  10. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation.

    Science.gov (United States)

    Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; van Gurp, Petra J; Wollersheim, Hub

    2013-06-22

    Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient

  11. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

    Science.gov (United States)

    2013-01-01

    Background Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Methods and design Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. Discussion We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to

  12. Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety

    Directory of Open Access Journals (Sweden)

    Davis Anne M

    2010-05-01

    Full Text Available Abstract Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein. Two hundred thirty-two (232 infants ≤ 14 days postnatal age were randomized and 220 (94.8% completed the study. Weight (g, head circumference (cm, and length (cm were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day from baseline to Week 16. Safety was assessed through monitoring of study events (SEs throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.

  13. Safety evaluations on ethanolic extract of red cabbage (Brassica oleracea L.) in mice.

    Science.gov (United States)

    Thounaojam, Menaka C; Jadeja, Ravirajsinh N; Sankhari, Jayanta M; Devkar, Ranjitsinh V; Ramachandran, A V

    2011-01-01

    The present study has carried out safety evaluations on an ethanolic extract of red cabbage (RC) leaves in terms of acute and subchronic oral toxicity tests as per Organisation for Economic Cooperation and Development (OECD) guidelines in Swiss albino mice. Single-dose administration of RC extract (1000, 2000, 3000, 4000, or 5000 mg/kg body weight) to Swiss albino mice did not manifest toxicity or any significant adverse behavioral alterations. Chronic administration of RC extract (1000, 2000, and 3000 mg/kg body weight) for 28 d also did not register any significant alterations in fluid intake, organ weights, plasma lipid profile, plasma creatine kinase-MB, lactate dehydrogenase, aspartate transaminase, alanine transaminase, creatinine, electrolytes, and calcium levels, and the total blood count showed a nonsignificant change. However, significant reduction in body-weight gain, food intake, red blood cell count, and hemoglobin content along with higher alkaline phosphatase, bilirubin, and urea levels was observed in mice treated with 3000 mg/kg body weight for 28 d. Since there was no mortality up to a dose of 5000 mg/kg body weight, 50% lethal dose (LD(50)) could not be determined, and hence, it can be assumed that, LD(50) of RC extract is >5000 mg/kg. No observable adverse effect level dose of the RC extract was found to be 2000 mg/kg body weight. Hence, consumption of RC extract for various medicinal purposes is safe. Practical Application: RC is a popularly consumed foodstuff that has been ubiquitously reported to exert medicinal properties. It is mandatory to understand the highest permissible consumption limit of any food supplement to avoid toxicity. This study establishes the safe dose of RC. These results can be of relevance for the scientific fraternity as well as laymen who consume this vegetable or its phytochemical preparation.

  14. Organic Cultivation of Tomato in India with Recycled Slaughterhouse Wastes: Evaluation of Fertilizer and Fruit Safety

    Directory of Open Access Journals (Sweden)

    Malancha Roy

    2015-09-01

    Full Text Available Environmental and health safety of recycled slaughterhouse wastes-derived fertilizer and the produce obtained through its application is not well understood. Waste bovine blood and rumen digesta were mixed, cooked and sun-dried to obtain bovine-blood-and-rumen-digesta-mixture (BBRDM, NPK 30.36:1:5.75. 1.26 ± 0.18 log CFU mL−1 fecal coliforms were recovered in BBRDM. E. coli O157:H7, Mycobacteria, Clostridium sp., Salmonella sp., Bacillus sp. and Brucella sp. were absent. No re-growth of pathogens was observed after 60 days storage in sealed bags and in the open. However, prions and viruses were not evaluated. Heavy metals (Pb, Cr, Cd, Cu, Zn, As, Ni, Mn concentrations in BBRDM were within internationally permissible limits. BBRDM was applied for field cultivation of tomato during 2012–2013 and 2013–2014. Lycopene and nitrate contents of BBRDM-grown tomatoes were higher than Diammonium phosphate (DAP + potash-grown tomatoes because BBRDM supplied 2.5 times more the amount of nitrogen than DAP (NPK 18:46:0 + potash (NPK 0:0:44. Heavy metals and nitrate/nitrite concentrations in tomatoes were within internationally acceptable limits. BBRDM-grown tomatoes showed no mutagenic activity in the Ames test. Sub-acute toxicity tests on Wistar rats fed with BBRDM-grown tomatoes did not show adverse clinical picture. Thus, no immediate environmental or health risks associated with BBRDM and the tomatoes produced were identified.

  15. Criticality Safety Evaluation of Hanford Site High Level Waste Storage Tanks

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    2000-02-17

    This criticality safety evaluation covers operations for waste in underground storage tanks at the high-level waste tank farms on the Hanford site. This evaluation provides the bases for criticality safety limits and controls to govern receipt, transfer, and long-term storage of tank waste. Justification is provided that a nuclear criticality accident cannot occur for tank farms operations, based on current fissile material and operating conditions.

  16. Evaluation of an MR-compatible blood sampler for PET

    Science.gov (United States)

    Breuer, J.; Grazioso, R.; Zhang, N.; Schmand, M.; Wienhard, K.

    2010-10-01

    The integration of magnetic resonance imaging (MRI) and positron emission tomography (PET) is an upcoming hybrid imaging technique. Prototype scanners for pre-clinical and clinical research have been built and tested. However, the potential of the PET part can be better exploited if the arterial input function (AIF) of the administered tracer is known. This work presents a dedicated MR-compatible blood sampling system for precise measurement of the AIF in an MR-PET study. The device basically consists of an LSO/APD-detector assembly which performs a coincidence measurement of the annihilation photons resulting from positron decays. During the measurement, arterial blood is drawn continuously from an artery and lead through the detector unit. Besides successful tests of the MR compatibility and the detector performance, measurements of the AIF of rats have been carried out. The results show that the developed blood sampling system is a practical and reliable tool for measuring the AIF in MR-PET studies.

  17. A New Method for the Evaluation of Vaccine Safety Based on Comprehensive Gene Expression Analysis

    Directory of Open Access Journals (Sweden)

    Haruka Momose

    2010-01-01

    Full Text Available For the past 50 years, quality control and safety tests have been used to evaluate vaccine safety. However, conventional animal safety tests need to be improved in several aspects. For example, the number of test animals used needs to be reduced and the test period shortened. It is, therefore, necessary to develop a new vaccine evaluation system. In this review, we show that gene expression patterns are well correlated to biological responses in vaccinated rats. Our findings and methods using experimental biology and genome science provide an important means of assessment for vaccine toxicity.

  18. A systems-based food safety evaluation: an experimental approach.

    Science.gov (United States)

    Higgins, Charles L; Hartfield, Barry S

    2004-11-01

    Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

  19. Evaluation of efficacy and safety of glycopyrrolate - xylazine - propofol anesthesia in buffalo calves

    Directory of Open Access Journals (Sweden)

    Sandeep Potliya

    2015-03-01

    Full Text Available Aim: To evaluate the efficacy and safety of glycopyrrolate - xylazine - propofol anesthesia in buffalo calves. Materials and Methods: The study was conducted on six clinically healthy male buffalo calves, 6-12 months of age, and weighing between 130 and 170 kg. In all the animals; glycopyrrolate (0.01 mg/kg, IM, xylazine (0.1 mg/kg, IM and 1% propofol as single bolus (1.5 mg/kg, intravenous, were administered. The parameters observed included behavioral changes, physiological; hematological and blood biochemical parameters. Results: Muzzle and nostrils became dry in all the animals after glycopyrrolate administration. A decrease in spontaneous activity and mild cutaneous analgesia was noticed after xylazine administration. After administration of propofol, loss of swallowing reflex, palpebral reflex, corneal reflexes, periosteal reflex and complete analgesia was observed. There was no significant change in rectal temperature and heart rate. However, heart rate remained elevated during anesthesia. Respiratory rate decreased significantly after propofol administration. There was a significant increase in plasma glucose after the xylazine and propofol administration which remained elevated till recovery. A significant decrease in chloride level was seen after propofol administration. Conclusions: Glycopyrrolate - xylazine - propofol anesthetic combination may safely be used for short duration anesthesia in buffalo calves.

  20. Application of drag-reducing polymer solutions as test fluids for in vitro evaluation of potential blood damage in blood pumps.

    Science.gov (United States)

    Daly, Amanda R; Sobajima, Hideo; Olia, Salim E; Takatani, Setsuo; Kameneva, Marina V

    2010-01-01

    In vitro evaluation of the potential of a circulatory-assist device to damage blood cells has generally been performed using blood from various species. Problems with this approach include the variability of blood sensitivity to mechanical stress in different species, preparation of blood including the adjustment of hematocrit to a standard value, changes in the mechanical properties of blood that occur during storage, and necessity to pool blood samples to obtain an adequate amount of blood for in vitro circulating systems. We investigated whether the mechanical degradation of a drag-reducing polymer (DRP) solution resulting in the loss of drag-reducing ability can indicate the degree of shear-induced blood damage within blood pumps. DRP solution (polyethylene oxide, 4,500 kDa, 1,000 ppm) or porcine blood were driven through a turbulent flow system by a centrifugal pump, either the Bio-Pump BPX-80 (Medtronic, Inc.) or CentriMag (Levitronix LLC) at a constant pressure gradient of 300 mm Hg for 120 minutes. DRP mechanical degradation was evaluated by reduction of flow rate and solution viscosity. A proposed index of DRP mechanical degradation (PDI) is similar to the normalized index of hemolysis (NIH) typically used to quantify the results of in vitro testing of blood pumps. Results indicate that the mechanical degradation of DRP solutions may provide a sensitive standard method for the evaluation of potential blood trauma produced by blood pumps without the use of blood.

  1. Evaluation of low dose ionizing radiation effect on some blood components in animal model

    OpenAIRE

    H. El-Shanshoury; G. El-Shanshoury; A. Abaza

    2016-01-01

    Exposure to ionizing radiation is known to have lethal effects in blood cells. It is predicted that an individual may spend days, weeks or even months in a radiation field without becoming alarmed. The study aimed to discuss the evaluation of low dose ionizing radiation (IR) effect on some blood components in animal model. Hematological parameters were determined for 110 animal rats (divided into 8 groups) pre- and post-irradiation. An attempt to explain the blood changes resulting from both ...

  2. Rapid evaluation of fibrinogen levels using the CG02N whole blood coagulation analyzer.

    Science.gov (United States)

    Hayakawa, Mineji; Gando, Satoshi; Ono, Yuichi; Mizugaki, Asumi; Katabami, Kenichi; Maekawa, Kunihiko; Miyamoto, Daisuke; Wada, Takeshi; Yanagida, Yuichiro; Sawamura, Atsushi

    2015-04-01

    Rapid evaluation of fibrinogen (Fbg) levels is essential for maintaining homeostasis in patients with massive bleeding during severe trauma and major surgery. This study evaluated the accuracy of fibrinogen levels measured by the CG02N whole blood coagulation analyzer (A&T Corporation, Kanagawa, Japan) using heparinized blood drawn for blood gas analysis (whole blood-Fbg). A total of 100 matched pairs of heparinized blood samples and citrated blood samples were simultaneously collected from patients in the intensive care unit. Whole blood-Fbg results were compared with those of citrated plasma (standard-Fbg). The whole blood coagulation analyzer measured fibrinogen levels within 2 minutes. Strong correlations between standard-Fbg and whole blood-Fbg were observed (ρ = 0.91, p coagulation analyzer can rapidly measure fibrinogen levels in heparinized blood and could be useful in critical care settings where excessive bleeding is a concern. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  3. High Speed Railway Environment Safety Evaluation Based on Measurement Attribute Recognition Model

    Directory of Open Access Journals (Sweden)

    Qizhou Hu

    2014-01-01

    Full Text Available In order to rationally evaluate the high speed railway operation safety level, the environmental safety evaluation index system of high speed railway should be well established by means of analyzing the impact mechanism of severe weather such as raining, thundering, lightning, earthquake, winding, and snowing. In addition to that, the attribute recognition will be identified to determine the similarity between samples and their corresponding attribute classes on the multidimensional space, which is on the basis of the Mahalanobis distance measurement function in terms of Mahalanobis distance with the characteristics of noncorrelation and nondimensionless influence. On top of the assumption, the high speed railway of China environment safety situation will be well elaborated by the suggested methods. The results from the detailed analysis show that the evaluation is basically matched up with the actual situation and could lay a scientific foundation for the high speed railway operation safety.

  4. Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

    Science.gov (United States)

    Fu, Xiaping; Ying, Yibin

    2016-08-17

    In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

  5. Study on development of education model and its evaluation system for radiation safety

    CERN Document Server

    Seo, K W; Nam, Y M

    2002-01-01

    As one of the detailed action strategy of multi object preparedness for strengthening of radiation safety management by MOST, this project was performed, in order to promote the safety culture for user and radiation worker through effective education program. For the prevention of radiological accident and effective implementation of radiation safety education and training, this project has been carried out the development of education model and its evaluation system on radiation safety. In the development of new education model, education course was classified; new and old radiation worker, temporary worker, lecturer and manager. The education model includes the contents of expanding the education opportunity and workplace training. In the development of evaluation system, the recognition criteria for commission-education institute and inside-education institute which should establish by law were suggested for evaluation program. The recognition criteria contains classification, student, method, facilities, ...

  6. The safety evaluation of earthquake emergency shelter based on the finite element analysis

    Science.gov (United States)

    Sun, Baitao; Yu, Jingjing; Yan, Peilei

    2017-08-01

    The earthquake emergency shelter is the powerful safeguard to resist the natural hazard, human accident and other accidents, so evaluate the buildings whether can be the earthquake emergency shelter appear to be particularly important. So far the adoptive evaluation system inland has not the united criterion and subjectivity, hence it is necessary to realize the quantitative evaluation. The paper set the example of Nenjiang county to make the safety evaluation, the method is combining the measured project profile and the calculative anti-earthquake performance index, comprehensive assessment the buildings' anti-earthquake redundancy, finally providing the identification results. Initially summary, the safety identification method to earthquake emergency shelter has definite guiding significance.

  7. Blood components and OCT reflectivity evaluated in animal model.

    Science.gov (United States)

    Sonoda, Shozo; Sakamoto, Taiji; Shirasawa, Makoto; Yamashita, Takehiro; Uchino, Eisuke; Terasaki, Hiroto

    2014-12-01

    To see the relationship between blood components and optical coherence tomography (OCT) reflectivity using an animal model in which the aqueous humor was substituted by different experimental solutions without changing the integrity of the retina. The aqueous humor of an enucleated swine eye was replaced with plasma obtained from healthy volunteers. The OCT reflectivity of the anterior chamber filled with each plasma was calculated from individual OCT images, and was expressed by an arbitrary unit (AU). The concentration of blood components such as cholesterol, hemoglobin (Hb) and bilirubin of each individual was measured, and the correlation between each of them and the OCT reflectivity of aqueous humor in an enucleated swine eye was analyzed. Using the same model, the effects of the single plasma component on OCT reflectivity were examined. Blood samples were obtained from 24 individuals. OCT reflectivity was 30.68 ± 14.8 AU (average ± SD), ranging from 11.11 to 60.31 AU. OCT reflectivity correlated significantly with the concentration of triglycerides (R = 0.634, p = 0.001) and total cholesterol (R = 0.488, p = 0.015) using Spearman's rank correlation coefficient. While a partial correlation analysis showed that it correlated significantly with triglyceride (R = 0.60, p = 0.003), but not total cholesterol. OCT reflectivity was highest in a balanced salt solution (BSS) with Hb (average 42.05 AU), followed by fibrinogen (8.08 AU), bilirubin (6.12 AU) and γ-globulin (2.85 AU). Albumin did not increase the reflectivity of the BSS with a normal concentration (1.11 AU) compared to the control BSS alone (0.73 AU). OCT reflectivity was most strongly affected by the presence of triglycerides among the blood components. Some molecules such as Hb and fibrinogen significantly increase the OCT reflectivity. This information should be helpful for interpreting the OCT findings correctly.

  8. Effectiveness and safety of nicardipine and labetalol infusion for blood pressure management in patients with intracerebral and subarachnoid hemorrhage.

    Science.gov (United States)

    Ortega-Gutierrez, Santiago; Thomas, Jiz; Reccius, Andres; Agarwal, Sachin; Lantigua, Hector; Li, Min; Carpenter, Amanda M; Mayer, Stephan A; Schmidt, J Michael; Lee, Kiwon; Claassen, Jan; Badjatia, Neeraj; Lesch, Christine

    2013-02-01

    Nicardipine and labetalol are two commonly used antihypertensives for treating elevated blood pressures in the setting of intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). There are no studies comparing these two agents as continuous infusions. A retrospective chart review was conducted of patients admitted between November 2009 and January 2011 with ICH and SAH to compare effectiveness and safety between both agents. Percent time spent at goal was set as the primary outcome. The secondary outcomes included blood pressure variability, time to goal, incidence of bradycardia, tachycardia, and hypotension. A total of 81 patients were available for analysis, 10 initiated on labetalol (LAB), 57 on nicardipine (NIC), and 14 required the combination of these agents (COMB) to reach goal. We found no difference between NIC, LAB, and the COMB groups in the median percent time at goal [88 % (61-98); 93 % (51-99); 66 % (25-95), (p = NS)]. Median percentage of blood pressure variability, hypotension, and bradycardia were also comparable between groups, however, more tachycardia was observed in the COMB group versus both LAB and NIC groups (45 vs. 0 vs. 3 %; p < 0.001). Mean time to goal SBP in 24 patients who had BP readings available at 1st h of initiation was 32 ± 34 min in the NIC group and 53 ± 42 min in the LAB group (p = 0.03). Both agents appear equally effective and safe for blood pressure control in SAH and ICH during the initial admission hours. A prospective study is needed to validate these findings.

  9. [An evaluation of Visidex test strips in the blood sugar control of diabetics].

    Science.gov (United States)

    Khristov, V; Manov, A; Nestorov, I

    1991-01-01

    The test stripes Visidex for visual evaluation of glycemia were tested clinically. The results were compared with a reference laboratory method for blood sugar measurement. A correlation coefficient of r = 0.971 with 74% coincidence in the same glycemic interval was found. The test stripes are suitable for blood sugar self-control in domestic conditions.

  10. Clinical evaluation of Statstrip(R) Lactate for use in fetal scalp blood sampling

    NARCIS (Netherlands)

    Heinis, A.M.F.; Dillen, J. van; Oosting, J.D.; Rhose, S.; Vandenbussche, F.P.; Drongelen, J. van

    2017-01-01

    INTRODUCTION: Point-of-care testing of fetal scalp blood lactate is used as an alternative to pH analysis in fetal scalp blood sampling (FBS) during labor. Lactate measurements are not standardized and values vary with each device used. The aim of this study was to evaluate StatStrip(R) Lactate

  11. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey

    Directory of Open Access Journals (Sweden)

    Sivanandy P

    2016-07-01

    Full Text Available Palanisamy Sivanandy,1 Mari Kannan Maharajan,1 Kingston Rajiah,1 Tan Tyng Wei,2 Tan Wee Loon,2 Lim Chong Yee2 1Department of Pharmacy Practice, School of Pharmacy, 2School of Pharmacy, International Medical University, Wilayah Persekutuan Kuala Lumpur, Malaysia Background: Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use.Objective: To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia.Methods: A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted.Results: The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of “staff training and skills” were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup.Conclusion: The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety. Keywords

  12. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey

    Science.gov (United States)

    Sivanandy, Palanisamy; Maharajan, Mari Kannan; Rajiah, Kingston; Wei, Tan Tyng; Loon, Tan Wee; Yee, Lim Chong

    2016-01-01

    Background Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use. Objective To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia. Methods A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted. Results The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of “staff training and skills” were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup. Conclusion The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety. PMID:27524887

  13. Organic Cultivation of Tomato in India with Recycled Slaughterhouse Wastes: Evaluation of Fertilizer and Fruit Safety

    OpenAIRE

    Malancha Roy; Rimi Das; Amit Kundu; Sanmoy Karmakar; Satadal Das; Pradip Kumar Sen; Anupam Debsarcar; Joydeep Mukherjee

    2015-01-01

    Environmental and health safety of recycled slaughterhouse wastes-derived fertilizer and the produce obtained through its application is not well understood. Waste bovine blood and rumen digesta were mixed, cooked and sun-dried to obtain bovine-blood-and-rumen-digesta-mixture (BBRDM, NPK 30.36:1:5.75). 1.26 ± 0.18 log CFU mL−1 fecal coliforms were recovered in BBRDM. E. coli O157:H7, Mycobacteria, Clostridium sp., Salmonella sp., Bacillus sp. and Brucella sp. were absent. No re-growth of p...

  14. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  15. SAFETY

    CERN Document Server

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  16. Evaluation of blood culture media for the detection of fungi.

    Science.gov (United States)

    Nawrot, U; Kowalska-Krochmal, B; Sulik-Tyszka, B; Kozak, M; Świętek, K; Pajączkowska, M; Piątkowska, E; Rosiak, D; Swoboda-Kopeć, E

    2015-01-01

    The aim of this study was to compare the utility of BACTEC™ Mycosis-IC/F (Mycosis), BACTEC™ Plus Aerobic/F (Aerobic), and BACTEC™ Plus Anaerobic/F (Anaerobic) media in the detection of fungi from simulated (obtained by the inoculation of tested media first with sterile sheep's blood and subsequently with one of 60 clinical yeast isolates) and clinical blood samples, taken during routine diagnostic examination in two hospitals. All tested strains grew on Mycosis as well as Aerobic bottles, and the time to detection obtained for Mycosis was significantly shorter (p media. In clinical samples, the detection of C. glabrata was also significantly faster in Mycosis than in Aerobic (29.22 ± 11.48 h compared to 86 ± 40 h). The media complement each other and, in 45% of clinical examination sets, a single positive medium was noted (25% in Mycosis and 19% in Aerobic). The study proved that both Aerobic and Mycosis media serve as the correct condition for the culture of fungi and that they varied significantly in the detection time of clinically important species. This result could suggest that the simultaneous use of Aerobic as well as Mycosis media may improve the time of diagnosis in many patients, especially those infected with C. glabrata or C. neoformans.

  17. Safety Evaluation of Osun River Water Containing Heavy Metals and ...

    African Journals Online (AJOL)

    olayemitoyin

    1Environmental, Analytical and Nutritional Chemistry Research Laboratory, Department of Chemical Sciences,. Osun State University ... Summary: This study evaluated the pH, heavy metals and volatile organic compounds (VOCs) in Osun river water. It also evaluated its ..... toxicity of pollutants. ALT and AST are markers of.

  18. Evaluated Conjunctival Blood Flow Velocity in Daily Contact Lens Wearers.

    Science.gov (United States)

    Shi, Yingying; Hu, Liang; Chen, Wan; Qu, Dongyi; Jiang, Hong; Wang, Jianhua

    2017-04-13

    This study examined conjunctival microvasculature development in long-term habitual contact lens (HCL) wearers after a night of sleep. Twenty HCL wearers (15 women and 5 men, aged 28.6±6.9 years, mean age±standard deviation) who had worn contact lenses on a daily basis for at least 3 years and 40 noncontact lens (NCL) wearers (23 women and 17 men, aged 36.5±6.6 years, mean age±standard deviation) participated in the study. A functional slitlamp biomicroscopy imaging system was used to image the temporal bulbar conjunctiva. Imaging was performed in the morning while the contact lens wearers were not wearing their lenses after a night of sleep. The conjunctival vessel diameters, blood flow velocities, and flow rates were measured. In addition, fractal analyses were performed to obtain the vessel network density (Dbox) and complexity (D0). The average blood flow velocity in HCL wearers after a night of sleep was 0.59±0.19 mm/s, which was significantly higher than that in NCL wearers (0.48±0.17 mm/s, P<0.05). The microvessel network density and complexity levels (Dbox=1.64±0.05 and D0=1.71±0.05, respectively) in the HCL wearers were significantly higher than those in NCL wearers (Dbox=1.61±0.05 and D0=1.69±0.04, both P<0.05). The blood flow velocity was positively correlated with the duration of contact lens wear (r=0.46, P<0.05) and with the daily number of lens-wearing hours (r=0.49, P<0.05) in HCL wearers. This study identified microvascular alterations in the conjunctiva in response to daily contact lens wear after a night of sleep in long-term daily contact lens wearers. The unrecovered changes may indicate that para-inflammation occurs on ocular surfaces because of contact lens wear and that overnight sleeping with no lenses may not sufficiently restore the ocular surface to an intact state.

  19. Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial.

    Science.gov (United States)

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, Shehani; Wathurapatha, Wasundara Sevwandi; Weeratunga, Hasitha Dhananjaya; Premakumara, G A Sirimal; Katulanda, Prasad; Constantine, Godwin Roger; Galappaththy, Priyadarshani

    2017-12-28

    Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial. This phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated. Twenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period. This is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side

  20. Evaluation of safety profile of homoeopathic mother tinctures

    Directory of Open Access Journals (Sweden)

    Surender Singh

    2014-01-01

    Methods: Toxicity studies were conducted to assess the level to which substances are toxic for humans and animals. In acute oral toxicity study, different homoeopathic mother tinctures were administered orally (a single dose of 4 ml/kgand animals were observed for toxic symptoms till 14 days as per OECD (Organisation for Economic Co-operation and Development - 423 guidelines. For sub-acute toxicity study, 28 day oral toxicity of mother tinctures (4 ml/kg daily was carried out according to the OECD guidelines for testing of chemicals - 407. At the end of 28 days, the animals were sacrificed and toxicity was assessed on parameters such as blood, biochemistry and histopathology. Results: Results indicate that there were no toxic symptoms observed in tested animals. Results of sub-acute toxicity study did not show any change in body weight, haematological and biochemical parameters as compared to control. The histopathological examination of kidney and liver also did not reveal any organ toxicities.

  1. The effectiveness and safety of aminocaproic acid for reducing blood loss in total knee and hip arthroplasty: A meta-analysis.

    Science.gov (United States)

    Dong, Qiang; Zhang, Yinguang; Sun, Xiang; Hu, Fangke

    2018-02-19

    This meta-analysis aimed to evaluate the safety and efficacy of aminocaproic acid in total knee arthroplasty (TKA) and total hip arthroplasty (THA). The electronic databases include PubMed, Medline, Embase, Web of Science and the Cochrane Library from inception to January 2018. Two reviewers abstracted total blood loss, hemoglobin drop, transfusion requirements, and postoperative complications. Data were using fixed-effects or random-effects models with weighted mean differences and risk difference for continuous and dichotomous variables, respectively. STATA 14.0 was used to perform the meta-analysis. Six studies encompassing 756 participants were retrieved for this meta-analysis. Our study indicated that intravenous aminocaproic acid was associated with a significantly reduction in total blood loss, hemoglobin drop and need for transfusion. Additionally, no increased risk of thromboembolic events were identified. Based on the present meta-analysis, intravenous aminocaproic acid is effective and safe in total knee and hip arthroplasty without increasing the incidence of thromboembolic events. Further studies should focus on the comparison of aminocaproic acid and TXA in arthroplasties. Copyright © 2018. Published by Elsevier Ltd.

  2. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Science.gov (United States)

    2011-09-22

    ... COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...-ISG-019 on ``Review of Evaluation to Address Gas Accumulation Issues in Safety Related Systems... is to clarify the NRC staff guidance to address issues of gas accumulation in safety related systems...

  3. Blood gas analyzer utility in evaluating oxygen kinetics of the aqueous humor

    Directory of Open Access Journals (Sweden)

    Ismail Ersan

    2015-04-01

    Full Text Available Purpose: To measure the partial pressure of oxygen (PO2 and carbon dioxide (PCO2 and the pH of aqueous humor (AH and arterial blood samples from rabbits using a blood gas analyzer. Methods: Twenty New Zealand rabbits were anesthetized intramuscularly with ketamine and xylazine and were then allowed to breathe room air. Using a gas blood analyzer, arterial blood and AH samples were analyzed for PO2, PCO2, and pH. Results: The mean arterial blood pressure was 87.14 ± 15.0 mmHg. The mean blood and AH PO2 were 95.18 ± 11.76 mmHg and 88.83 ± 9.92 mmHg, the mean blood and AH PCO2 were 25.86 ± 5.46 mmHg and 29.50 ± 5.36 mmHg, and the mean blood and AH pH were 7.38 ± 0.06 and 7.33 ± 0.09, respectively. Conclusion: Conclusions: The blood gas analyzer was easily employed to evaluate the aqueous humor in rabbits. When comparing the results of studies evaluating aqueous PO2, care should be taken to determine the methods used in these studies.

  4. Evaluation of the TEG® platelet mapping™ assay in blood donors

    Directory of Open Access Journals (Sweden)

    Steinbrüchel Daniel A

    2007-02-01

    Full Text Available Abstract Background Monitoring of antiplatelet therapy in patients at cardiovascular risk is difficult because existing platelet function tests are too sophisticated for clinical routine. The whole blood TEG® Platelet Mapping™ assay measures clot strength as maximal amplitude (MA and enables for quantification of platelet function, including the contribution of the adenosine diphosphate (ADP and thromboxane A2 (TxA2 receptors to clot formation. Methods In 43 healthy blood donors, the analytical (CVa and inter-individual variability (CVg of the TEG® Platelet Mapping™ assay were determined together with platelet receptor inhibition in response to arachidonic acid (AA and ADP. Results The CVa of the assay for maximal platelet contribution to clot strength (MAThrombin was 3.5%, for the fibrin contribution to clot strength (MAFibrin 5.2%, for MAAA 4.5% and for MAADP it was 6.6%. The MAThrombin CVg was 2.8%, MAFibrin 4.7%, MAAA 6.6% and for MAADP it was 26.2%. Females had a higher MAThrombin compared to males (62.8 vs. 58.4 mm, p = 0.005. The platelet TxA2 receptor inhibition was 1.2% (range 0–10% and lower than for the ADP receptor (18.6% (0–58%; p Conclusion The high variability in ADP receptor inhibition may explain both the differences in response to ADP receptor inhibitor therapy and why major bleeding sometimes develops during surgery in patients not treated with ADP receptor inhibitors. An analytical variation of ~5 % for the TEG® enables, however, for routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy.

  5. Safety evaluation of a potential ablation agent-hydrochloric acid in the rabbits' model.

    Science.gov (United States)

    Yao, Wang; Gu, Yang-Kui; Wang, Jian; Gao, Fei; Liu, Wan-Li; Huang, Jin-Hua

    2014-10-01

    To evaluate the safety of a potential ablation agent-hydrochloric acid (HCl), which may apply to treat hepatocellular carcinoma (HCC). Eighty adult New Zealand rabbits were divided into five groups of equal size (n=16), i.e., untreated group, normal saline (NS) control group, 10% HCl group, 20% HCl group and 30% HCl group. Each group was divided into two subgroups: ten rabbits for two-week toxicology study at the time points of hours 0, 0.25, 0.5, 1, 3, 6 and days 2, 7, 14 and six rabbits for imaging and histopathology study at the time points of days 2, 7 and 14. In toxicology study we evaluated the safety of HCl from arterial blood gas status, hematology and hepatic and renal functions. In imaging and histopathology study, we observed the relationship between the sizes of lesion and the concentration of HCl, as well as extension of necrosis and concentration of HCl. In this study we also observed the microcosmic and macroscopic lesion that caused by HCl. In general condition, food, water consumption and body weight decreased notablely during the beginning of the experiment. In toxicology study, alanine aminotransferase, aspartate aminotransferase and lactic acid contents were higher in the 30% hydrochloric acid group than in other groups (P<0.005), all test items returned to normal on day 14. Imaging and histopathology study showed that 30% HCl caused larger lesion area than other HCl concentration and the necrosis that caused by HCl was complete. There was also a close relationship between the size of minor damaged area and HCl concentration. The 30% HCl caused larger minor damaged area than other HCl concentration. Because the damaged area was surrounded by a layer of fiber tissue, the lesion area became larger at days 7 and 14 time points. This study also demonstrated that the adjacent organs had no obvious damage, and all the damaged areas were limited in the liver. HCl is a safe ablation agent for local injection in the liver. HCl at a lower concentration is

  6. Can auscultatory blood pressure normative values be used for evaluation of oscillometric blood pressure in children?

    Science.gov (United States)

    Šuláková, Terezie; Šuláková, Astrida; Strnadel, Jiří; Pavlíček, Jan; Obermannová, Barbora; Feber, Janusz

    2017-04-01

    The aim of the study was to analyze whether auscultatory normative values (Fourth Task Force [4TF]) can be applied to blood pressure (BP) obtained by oscillometric devices. The authors performed a retrospective analysis of oscillometric office BP and ambulatory BP monitoring in 229 children (116 boys), median age 15.31 years. Office systolic BP (SBP) and diastolic BP (DBP) values were converted into Z scores using 4TF and oscillometric (German Health Interview and Examination Survey for Children and Adolescent [KiGGS]) reference values. There was good correlation between the two normative methods (r=0.9773 for SBP, r=0.9627 for DBP). Results from Bland-Altman test revealed only minimal differences in Z scores between 4TF and KiGGS for SBP, but a significant proportional error for DBP. 4TF and KiGGS Z scores were equally predictive of ambulatory hypertension. In conclusion, auscultatory and oscillometric normative data are interchangeable for SBP but not for DBP. ©2016 Wiley Periodicals, Inc.

  7. Safety and feasibility for pediatric cardiac regeneration using epicardial delivery of autologous umbilical cord blood-derived mononuclear cells established in a porcine model system.

    Science.gov (United States)

    Cantero Peral, Susana; Burkhart, Harold M; Oommen, Saji; Yamada, Satsuki; Nyberg, Scott L; Li, Xing; O'Leary, Patrick W; Terzic, Andre; Cannon, Bryan C; Nelson, Timothy J

    2015-02-01

    Congenital heart diseases (CHDs) requiring surgical palliation mandate new treatment strategies to optimize long-term outcomes. Despite the mounting evidence of cardiac regeneration, there are no long-term safety studies of autologous cell-based transplantation in the pediatric setting. We aimed to establish a porcine pipeline to evaluate the feasibility and long-term safety of autologous umbilical cord blood mononuclear cells (UCB-MNCs) transplanted into the right ventricle (RV) of juvenile porcine hearts. Piglets were born by caesarean section to enable UCB collection. Upon meeting release criteria, 12 animals were randomized in a double-blinded fashion prior to surgical delivery of test article (n=6) or placebo (n=6). The UCB-MNC (3×10(6) cells per kilogram) or control (dimethyl sulfoxide, 10%) products were injected intramyocardially into the RV under direct visualization. The cohorts were monitored for 3 months after product delivery with assessments of cardiac performance, rhythm, and serial cardiac biochemical markers, followed by terminal necropsy. No mortalities were associated with intramyocardial delivery of UCB-MNCs or placebo. Two animals from the placebo group developed local skin infection after surgery that responded to antibiotic treatment. Electrophysiological assessments revealed no arrhythmias in either group throughout the 3-month study. Two animals in the cell-therapy group had transient, subclinical dysrhythmia in the perioperative period, likely because of an exaggerated response to anesthesia. Overall, this study demonstrated that autologous UCB-MNCs can be safely collected and surgically delivered in a pediatric setting. The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD. ©AlphaMed Press.

  8. Understanding safety culture by visualization of scenarios--development and evaluation of an interactive prototype.

    Science.gov (United States)

    Blomé, Mikael; Ek, Asa

    2012-01-01

    To be able to disseminate knowledge about maritime safety culture and safety management to different actors in the Swedish maritime sector, a preliminary pedagogical concept was developed and evaluated. As a first user group, students at upper secondary maritime schools were chosen and the pedagogical concept was adapted for this group. The concept includes an interactive prototype and a teacher's guide and is based on a model for experience-based learning which connects theory and practice by a cyclic approach. The concept was tested in a classroom setting including interaction with the students and a follow-up one week later. A preliminary evaluation of the results shows a very positive response among the students as well as the lecturers. The educational material was successful in immediately creating a relevant discussion about safety culture, and one week later, students could remember many of the safety scenarios included in the pedagogical concept.

  9. Triangulation and the importance of establishing valid methods for food safety culture evaluation.

    Science.gov (United States)

    Jespersen, Lone; Wallace, Carol A

    2017-10-01

    The research evaluates maturity of food safety culture in five multi-national food companies using method triangulation, specifically self-assessment scale, performance documents, and semi-structured interviews. Weaknesses associated with each individual method are known but there are few studies in food safety where a method triangulation approach is used for both data collection and data analysis. Significantly, this research shows that individual results taken in isolation can lead to wrong conclusions, resulting in potentially failing tactics and wasted investments. However, by applying method triangulation and reviewing results from a range of culture measurement tools it is possible to better direct investments and interventions. The findings add to the food safety culture paradigm beyond a single evaluation of food safety culture using generic culture surveys. Copyright © 2017. Published by Elsevier Ltd.

  10. Safety evaluation for packaging 222-S laboratory cargo tank for onetime type B material shipment

    Energy Technology Data Exchange (ETDEWEB)

    Nguyen, P.M.

    1994-08-19

    The purpose of this Safety Evaluation for Packaging (SEP) is to evaluate and document the safety of the onetime shipment of bulk radioactive liquids in the 222-S Laboratory cargo tank (222-S cargo tank). The 222-S cargo tank is a US Department of Transportation (DOT) MC-312 specification (DOT 1989) cargo tank, vehicle registration number HO-64-04275, approved for low specific activity (LSA) shipments in accordance with the DOT Title 49, Code of Federal Regulations (CFR). In accordance with the US Department of Energy, Richland Operations Office (RL) Order 5480.1A, Chapter III (RL 1988), an equivalent degree of safety shall be provided for onsite shipments as would be afforded by the DOT shipping regulations for a radioactive material package. This document demonstrates that this packaging system meets the onsite transportation safety criteria for a onetime shipment of Type B contents.

  11. An evaluation of an airline cabin safety education program for elementary school children.

    Science.gov (United States)

    Liao, Meng-Yuan

    2014-04-01

    The knowledge, attitude, and behavior intentions of elementary school students about airline cabin safety before and after they took a specially designed safety education course were examined. A safety education program was designed for school-age children based on the cabin safety briefings airlines given to their passengers, as well as on lessons learned from emergency evacuations. The course is presented in three modes: a lecture, a demonstration, and then a film. A two-step survey was used for this empirical study: an illustrated multiple-choice questionnaire before the program, and, upon completion, the same questionnaire to assess its effectiveness. Before the program, there were significant differences in knowledge and attitude based on school locations and the frequency that students had traveled by air. After the course, students showed significant improvement in safety knowledge, attitude, and their behavior intention toward safety. Demographic factors, such as gender and grade, also affected the effectiveness of safety education. The study also showed that having the instructor directly interact with students by lecturing is far more effective than presenting the information using only video media. A long-term evaluation, the effectiveness of the program, using TV or video accessible on the Internet to deliver a cabin safety program, and a control group to eliminate potential extraneous factors are suggested for future studies. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Tensile and burst tests in support of the cadmium safety rod failure evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, J.K.

    1992-02-01

    The reactor safety rods may be subjected to high temperatures due to gamma heating after the core coolant level has dropped during the ECS phase of hypothetical LOCA event. Accordingly, an experimental safety rod testing subtask was established as part of a task to address the response of reactor core components to this accident. This report discusses confirmatory separate effects tests conducted to support the evaluation of failures observed in the safety rod thermal tests. As part of the failure evaluation, the potential for liquid metal embrittlement (LME) of the safety rod cladding by cadmium (Cd) -- aluminum (Al) solutions was examined. Based on the test conditions, literature data, and U-Bend tests, its was concluded that the SS304 safety rod cladding would not be subject to LME by liquid Cd-Al solutions under conditions relevant to the safety rod thermal tests or gamma heating accident. To confirm this conclusion, tensile tests on SS304 specimens were performed in both air and liquid Cd-Al solutions with the range of strain rates, temperatures, and loading conditions spanning the range relevant to the safety rod thermal tests and gamma heating accident.

  13. Test and Evaluation Report of the Physio Control Blood Pressure Monitor Model LIFESTAT (Trademark) 100

    Science.gov (United States)

    1991-12-01

    oscillometric technique. Arterial pulsations acting against the inflated cuff are used to determine blood pressure and pulse rate. These pulsations are...USAARL Report No. 92-44 AD-A248 352 IIII~~~l1I7 1 111 li-l Test and Evaluation Report of the Physlo Control Blood Pres-sure Monitor Model LIFESTAT5...1. TITLE (Include Securrry Ciaspfication) Test and Evaluation Report of the Phy.’io Control Blood Pressure Monitor Model LIFESTATO 100 12 PERSONAL

  14. Safety evaluation of an enzymatically-synthesized glycogen (ESG).

    Science.gov (United States)

    Tafazoli, Shahrzad; Wong, Andrea W; Kajiura, Hideki; Kakutani, Ryo; Furuyashiki, Takashi; Takata, Hiroki; Kuriki, Takashi

    2010-01-01

    An enzymatically-synthesized glycogen (ESG), intended for use as a food ingredient, was investigated for potential toxicity. ESG is synthesized in vitro from short-chain amylose by the co-operative action of branching enzyme and amylomaltase. In an acute toxicity study, oral administration of ESG to Sprague-Dawley rats at a dose of 2000 mg/kg body weight did not result in any signs of toxicity. ESG did not exhibit mutagenic activity in an in vitro bacterial reverse mutation assay. In a subchronic toxicity study, increased cecal weights noted in the mid- (10%) and high-dose (30%) animals are common findings in rodents fed excess amounts of carbohydrates that increase osmotic value of the cecal contents, and thus were considered a physiological rather than toxicological response. The hematological and histopathological effects observed in the high-dose groups were of no toxicological concern as they were secondary to the physiological responses resulting from the high carbohydrate levels in the test diets. The no-observed-adverse-effect level for ESG in rats was therefore established to be 30% in the diet (equivalent to approximately 18 and 21 g/kg body weight/day for male and female rats, respectively). These results support the safety of ESG as a food ingredient for human consumption. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Prospective evaluation of the safety and efficacy of laparoscopic jejunostomy.

    Science.gov (United States)

    Duh, Q Y; Senokozlieff-Englehart, A L; Siperstein, A E; Pearl, J; Grant, J P; Twomey, P L; Gadacz, T R; Prinz, R A; Wolfe, B M; Soper, N J

    1995-01-01

    We prospectively assessed the safety and efficacy of laparoscopic jejunostomy done by 11 surgeons in 8 medical centers using the T-fastener technique. In all, 23 men and 13 women aged 19 to 84 (mean, 59) years required enteral feeding, but could not undergo gastrostomy and had no contraindication to laparoscopy. Of these patients, 12 had head and neck cancer and 11 had neurologic swallowing dysfunction. The procedure took 25 to 180 minutes (mean, 75). Three (8%) early cases were converted to open jejunostomy because of accidental enterotomies caused by inappropriate techniques that were avoided in later cases. Minor technical problems, such as passing a needle through the back wall of the jejunum, occurred in 7 patients, but they were easily corrected and produced no complications. Feedings were routinely begun within 24 hours of the surgical procedure. All jejunostomy catheters functioned well. This is a safe and effective technique when done by experienced laparoscopic surgeons, and serious complications are rare. Images PMID:7725683

  16. Safety effects of fixed speed cameras - An empirical Bayes evaluation.

    Science.gov (United States)

    Høye, Alena

    2015-09-01

    The safety effects of 223 fixed speed cameras that were installed between 2000 and 2010 in Norway were investigated in a before-after empirical Bayes study with control for regression to the mean (RTM). Effects of trend, volumes, and speed limit changes are controlled for as well. On road sections between 100m upstream and 1km downstream of the speed cameras a statistically significant reduction of the number of injury crashes by 22% was found. For killed and severely injured (KSI) and on longer road sections none of the results are statistically significant. However, speed cameras that were installed in 2004 or later were found to reduce injury crashes and the number of KSI on road sections from 100m upstream to both 1km and 3km downstream of the speed cameras. Larger effects were found for KSI than for injury crashes and the effects decrease with increasing distance from the speed cameras. At the camera sites (100m up- and down-stream) crash reductions are smaller and non-significant, but highly uncertain and possibly underestimated. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Safety evaluation of a Medical Device Data System.

    Science.gov (United States)

    Liddle, Stephanie; Grover, Lata; Zhang, Rachel; Khitrov, Maxim; Brown, Joan C; Cobb, J Perren; Goldman, Julian; Chou, Joseph; Yagoda, Daniel; Westover, Brandon; Reisner, Andrew T

    2012-01-01

    Our hospital became interested in the extraction of electronic data from our bedside monitor network to enrich clinical care, and enable various quality improvement projects, research projects, and future applications involving advanced decision-support. We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly to provide electronic data extraction and storage from networked General Electric Healthcare bedside patient monitors. We conducted a series of tests examining the changes in network performance when the BedMaster system was on our isolated patient monitor network. We found that use of BedMaster led to measurable, but trivial increases in network traffic and latency. We did not identify any failure scenarios in our analysis and testing. The major value of this report is to highlight potential challenges inherent in data and electronic device integration within the healthcare setting. In describing our strategy for testing the BedMaster system, it is our intention to present one testing protocol and to generate thought and discussion in the broader community about what types of problems can arise with inter-operability, and what types of testing are necessary to mitigate against these risks. Standards for inter-operability would surely reduce the inherent risks.

  18. Evaluation of Aircraft Ejection Seat Safety When Using Advanced Helmet Sensors

    Science.gov (United States)

    2015-03-09

    No. DODIG‑2015‑090 M A R C H 9 , 2 0 1 5 Evaluation of Aircraft Ejection Seat Safety When Using Advanced Helmet Sensors Report Documentation Page...DATES COVERED 00-00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Evaluation of Aircraft Ejection Seat Safety When Using Advanced Helmet Sensors...Defense F r a u d , W a s t e & A b u s e DODIG-2015-090 (Project No. D2014-DT0TAD-0002.000) │ i Results in Brief Evaluation of Aircraft Ejection Seat

  19. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    Gad, Shayne C

    2008-01-01

    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

  20. Evaluation of the quality of blood components obtained after automated separation of whole blood by a new multiunit processor.

    Science.gov (United States)

    Lagerberg, Johan W; Salado-Jimena, Jose A; Löf, Helena; Bontekoe, Ido J; Nielsen, Connie; Verheggen, Caroline; van Waeg, Geert; van der Meer, Pieter F; de Korte, Dirk; Hansen, Morten B; Knutson, Folke

    2013-08-01

    The Reveos system (Terumo BCT) is a fully automated device able to process four whole blood (WB) units simultaneously into a plasma unit, a red blood cell (RBC) unit, and an interim platelet (PLT) unit (IPU). Multiple IPUs can be pooled to form a transfusable PLT product. The aim of our study was to evaluate the quality of components made with the Reveos system from either fresh (2-8 hr) or overnight-held WB. A prototype of the Reveos system was used to process WB. RBCs were resuspended in SAGM, leukoreduced, and assayed for in vitro quality variables during a 42-day storage period at 2 to 6 °C. Twenty-four-hour in vivo recovery was determined on Day 42. Plasma was assayed for cellular contamination and activation variables. IPUs were pooled with SSP+ additive solution for in vitro quality assessments during a 7-day storage period at room temperature. Reveos-produced RBCs and plasma units met the predefined requirements. RBC recovery was superior to control units. On Day 42, hemolysis was below 0.8% and in vivo recovery was above 75% for all RBCs. Cellular contamination was lower for Reveos-produced plasma. PLT yield was higher with overnight-stored WB. PLT quality was well maintained during storage with no significant differences between the two groups. Blood components prepared with the Reveos from fresh or overnight-held WB meet quality criteria without any relevant difference between the two groups. The Reveos system has the potential to increase efficacy and standardization of blood component preparation. © 2012 American Association of Blood Banks.

  1. Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network.

    Science.gov (United States)

    Cumming, Melissa; Osinski, Anthony; O'Hearn, Lynne; Waksmonski, Pamela; Herman, Michele; Gordon, Deborah; Griffiths, Elzbieta; Knox, Kim; McHale, Eileen; Quillen, Karen; Rios, Jorge; Pisciotto, Patricia; Uhl, Lynne; DeMaria, Alfred; Andrzejewski, Chester

    2017-02-01

    A collaboration that grew over time between local hemovigilance stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for regulatory compliance purposes to statewide adoption of electronic reporting via the National Healthcare Safety Network (NHSN). The NHSN is a web-based surveillance system that offers the capacity to capture transfusion-related adverse events, incidents, and monthly transfusion statistics from participating facilities. Massachusetts' hospital blood banks share the data they enter into NHSN with the MDPH to satisfy reporting requirements. Users of the NHSN Hemovigilance Module adhere to specified data entry guidelines, resulting in data that are comparable and standardized. Keys to successful statewide adoption of this reporting method include the fostering of strong partnerships with local hemovigilance champions and experts, engagement of regulatory and epidemiology divisions at the state health department, the leveraging of existing relationships with hospital NHSN administrators, and the existence of a regulatory deadline for implementation. Although limitations exist, successful implementation of statewide use of the NHSN Hemovigilance Module for hospital blood bank reporting is possible. The result is standardized, actionable data at both the hospital and state level that can facilitate interfacility comparisons, benchmarking, and opportunities for practice improvement. © 2016 AABB.

  2. [Evaluation of blood pressure control by ambulatory blood pressure monitoring and study of factors associated with poor blood pressure control in 300 treated hypertensive type 2 diabetic patients].

    Science.gov (United States)

    Ben-Hamouda-Chihaoui, M; Kanoun, F; Ftouhi, B; Lamine-Chtioui, F; Kamoun, M; Slimane, H

    2011-04-01

    Hypertension is frequently associated with type 2 diabetes and is often difficult to control. Evaluate the frequency of controlled hypertension in our type 2 diabetic patients with known and treated hypertension and determine the factors associated with poor blood pressure control. Prospective study concerning 300 type 2 diabetic patients with a known and treated hypertension, sex-ratio: 0.64, mean age: 61.2±9.1 years (37-86). All subjects underwent physical examination, biological investigations and a 24 hours ambulatory blood pressure monitoring (ABPM). Hypertension was well controlled in 70 patients (23.3%). The concordance rate between clinical measure of blood pressure and ABPM was 70.3%. Subjects with uncontrolled hypertension were older (61.8±8.9 vs 59.1±9.3 years, Pblood pressure rhythm was noted in 239 patients (79.6%) and it was more frequently observed in patients with uncontrolled hypertension (84 vs 66%, PClose monitoring of blood pressure with adjustment of antihypertensive treatment are necessary to improve cardiovascular prognosis of our patients. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  3. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

    OpenAIRE

    Hanskamp-Sebregts, M.E.; Zegers, M.; Boeijen, W.M.J.; Westert, G.P.; Gurp, P.J.M. van; Wollersheim, H.C.

    2013-01-01

    BACKGROUND: Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little i...

  4. Safety Evaluation for Packaging 101-SY Hydrogen Mitigation Mixer Pump package

    Energy Technology Data Exchange (ETDEWEB)

    Carlstrom, R.F.

    1994-10-05

    This Safety Evaluation for Packaging (SEP) provides analysis and considered necessary to approve a one-time transfer of the 101-SY Hydrogen Mitigation Mixer Pump (HMMP). This SEP will demonstrate that the transfer of the HMMP in a new shipping container will provide an equivalent degree of safety as would be provided by packages meeting US Department of Transportation (DOT)/US Nuclear Regulatory Commission (NRC) requirements. This fulfills onsite, transportation requirements implemented by WHC-CM-2-14.

  5. Evaluating the intervening factors in patient safety: focusing on hospital nursing staff

    OpenAIRE

    Roberta Meneses Oliveira; Ilse Maria Tigre de Arruda Leitao; Leticia Lima Aguiar; Adriana Catarina de Souza Oliveira; Dionisia Mateus Gazos; Lucilane Maria Sales da Silva; Ariane Alves Barros; Renata Lopes Sampaio

    2015-01-01

    OBJECTIVE To evaluate intervening factors in patient safety, focusing on hospital nursing staff. METHOD The study is descriptive, with qualitative approach, excerpt from a larger study with analytical nature. It was undertaken in a public hospital in Fortaleza, CE, Brazil, between January and June 2013, with semi-structured interviews to 70 nurses, using Thematic Content Analysis. RESULTS The principal intervening factors in patient safety related to hospital nursing staff were staff dimensio...

  6. A psychometric evaluation of the Chinese version of the nursing home survey on patient safety culture.

    Science.gov (United States)

    Lin, Shu-Yuan; Tseng, Wei Ting; Hsu, Miao-Ju; Chiang, Hui-Ying; Tseng, Hui-Chen

    2017-12-01

    further testing of the reliability of the scale in a large Chinese sample and in different long-term care facilities was recommended. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale was developed to increase the users' intention towards safety culture assessment. It can identify areas for improvement, understand safety culture changes over time and evaluate the effectiveness of interventions. © 2017 John Wiley & Sons Ltd.

  7. Neuropharmacological safety evaluation of jigrine: A polyherbal hepatoprotective formulation

    Directory of Open Access Journals (Sweden)

    A K Najmi

    2010-01-01

    Full Text Available Objective : Jigrine is a herbal hepatoprotective formulation containing aqueous extracts of 14 medicinal plants. Present study was designed to evaluate per se neuropharmacological effects of jigrine in mice. Materials and Methods : Jigrine was evaluated in a number of pharmacological test paradigms, viz. open field arena, actophotometer, hole board, rotarod, traction test, grip strength test, spontaneous alternation behavior, passive avoidance task, and phenobarbital sleeping time. Results and Conclusions : Jigrine pretreatment (1 and 2 ml/kg, p.o. did not produce any significant effect as compared to normal saline treated animals and was found to be free from any acute undesirable central effects at these two dose levels.

  8. Idaho Chemical Processing Plant safety document ICPP hazardous chemical evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Harwood, B.J.

    1993-01-01

    This report presents the results of a hazardous chemical evaluation performed for the Idaho Chemical Processing Plant (ICPP). ICPP tracks chemicals on a computerized database, Haz Track, that contains roughly 2000 individual chemicals. The database contains information about each chemical, such as its form (solid, liquid, or gas); quantity, either in weight or volume; and its location. The Haz Track database was used as the primary starting point for the chemical evaluation presented in this report. The chemical data and results presented here are not intended to provide limits, but to provide a starting point for nonradiological hazards analysis.

  9. Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial.

    Science.gov (United States)

    Jones, Mitchell L; Martoni, Christopher J; Di Pietro, E; Simon, Ryan R; Prakash, Satya

    2012-07-01

    A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri (L. reuteri). In the present study, the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated. A randomized group of 131 subjects received a dose of 2.9×10⁹ CFU L. reuteri NCIMB 30242 capsules (n=67) or placebo capsules (n=64) twice daily for 9 weeks. Clinical chemistry and hematological parameters of safety were analyzed. The frequency, duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results. The frequency and intensity of AEs was similar in the two groups. These results demonstrate that administration of a twice daily dose of 2.9×10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

  10. Blood Pressure Lowering and Safety Improvements With Liver Angiotensinogen Inhibition in Models of Hypertension and Kidney Injury.

    Science.gov (United States)

    Mullick, Adam E; Yeh, Steve T; Graham, Mark J; Engelhardt, Jeffery A; Prakash, Thazha P; Crooke, Rosanne M

    2017-09-01

    Uncontrolled hypertension is an important contributor to cardiovascular disease. Despite the armamentarium of antihypertensive treatments, there remains a need for novel agents effective in individuals who cannot reach acceptable blood pressure levels. Inhibitors targeting the renin-angiotensin-aldosterone system (RAAS) are widely used but may not optimally inhibit RAAS and demonstrate an acceptable safety profile. Experiments were conducted to characterize a series of AGT (angiotensinogen) antisense oligonucleotides (ASOs) and compare their efficacy and tolerability to traditional RAAS blockade. AGT ASOs which target multiple systemic sites of AGT versus an N-acetylgalactosamine-conjugated AGT ASO that targets the liver were compared with captopril and losartan. Spontaneously hypertensive rats fed an 8% NaCl diet, a model of malignant hypertension resistant to standard RAAS inhibitors, demonstrated robust and durable blood pressure reductions with AGT ASO treatments, which was not observed with standard RAAS blockade. Studies in rat models of acute kidney injury produced by salt deprivation revealed kidney injury with ASO treatment that reduced kidney-expressed AGT, but not in animals treated with the N-acetylgalactosamine AGT ASO despite comparable plasma AGT reductions. Administration of either captopril or losartan also produced acute kidney injury during salt deprivation. Thus, intrarenal RAAS derived from kidney AGT, and inhibited by the standard of care, contributes to the maintenance of renal function during severe RAAS challenge. Such improvements in efficacy and tolerability by a liver-selective AGT inhibitor could be desirable in individuals not at their blood pressure goal with existing RAAS blockade. © 2017 American Heart Association, Inc.

  11. Quality and safety evaluation of a Ghanaian polyherbal product EAF ...

    African Journals Online (AJOL)

    McRoy

    Dickson et al.: Polyherbal product EAF-2011 and superficial mycoses. Int J Med Biomed Res 2013;2(2):91-102. 92. The evaluation of the quality of medicinal products is very essential as they are affected by factors that include seasonal changes, harvesting time, cultivation sites, post-harvesting processing, adulterants or.

  12. Evaluation of a bicycle helmet safety program for children.

    Science.gov (United States)

    Cusimano, Michael D; Faress, Ahmed; Luong, Wilson P; Lockhart, Sally; Amin, Khizer; Garland, Rhonda J; Russell, Kelly

    2013-09-01

    Helmets have been shown to decrease the risk of brain injury; however, helmets must be worn correctly and fit well in order to be effective. The objective of this study is to determine whether kindergarten-aged children could learn and retain appropriate helmet wearing technique through an educational bicycle safety program. Retrospective analysis of scores in questionnaires administered before and after an educational intervention to kindergarten students four to six years of age. The study took place in Prince Edward Island, Canada. A Wilcoxon Sign-Rank Test was used to determine if there was a significant overall increase in knowledge; McNemar chi-square tests were used to determine if there was an increase in knowledge for individual questions. There was significant improvement in pre-test to immediate post-tests scores and pre-test to delay post-test scores when the results were stratified by age, sex, bike riding status, and helmet wearing status (p<0.001 for all comparisons). In particular, correct responses for the questions regarding appropriate helmet distances from the eyes increased from 38.9% in the pre-test to above 90% in the post-tests (p<0.001). Correct responses for the question pertaining to appropriate fitting of helmet straps increased from 71.7% pre-test to above 90% in the post-tests (p<0.001). There was improved knowledge of appropriate helmet-wearing technique among kindergarten-aged children as a result of the educational intervention, and knowledge gains were retained for at least one month.

  13. Comparative evaluation of ankaferd blood stopper, ferric sulfate, and ...

    African Journals Online (AJOL)

    Teeth were randomly divided into three groups according to the pulpotomy agents (ABS, FC, FS). Following treatment, for 24 months, teeth were clinically and radiographically evaluated once every 3 and 6 months respectively. Statistical Analysis Used: SPSS version 15 software was used in data analysis. Kaplan– Meier ...

  14. Key techniques for evaluation of safety monitoring sensors in water conservancy and hydropower engineering

    Directory of Open Access Journals (Sweden)

    Yan XIANG

    2012-12-01

    Full Text Available For the evaluation of construction quality and the verification of the design of water conservancy and hydropower engineering projects, and especially for the control of dam safety operation behavior, safety monitoring sensors are employed in a majority of engineering projects. These sensors are used to monitor the project during the dam construction and operation periods, and play an important role in reservoir safety operation and producing benefits. With the changing of operating environments and run-time of projects, there are some factors affecting the operation and management of projects, such as a certain amount of damaged sensors and instability of the measured data. Therefore, it is urgent to evaluate existing safety monitoring sensors in water conservancy and hydropower engineering projects. However, there are neither standards nor evaluation guidelines at present. Based on engineering practice, this study examined some key techniques for the evaluation of safety monitoring sensors, including the evaluation process of the safety monitoring system, on-site detection methods of two typical pieces of equipment, the differential resistor sensor and vibrating wire sensor, the on-site detection methods of communication cable faults, and a validity test of the sensor measured data. These key techniques were applied in the Xiaolangdi Water Control Project and Xiaoxi Hydropower Project. The results show that the measured data of a majority of sensors are reliable and reasonable, and can reasonably reflect the structural change behavior in the project operating process, indicating that the availabilities of the safety monitoring sensors of the two projects are high.

  15. Evaluation of Policy Implementation at Norm Strategy Criteria Procedure Safety Management System that Influence the Safety Culture in Building Construction, Housing, Waterworks, Road and Bridge Project in Indonesia

    OpenAIRE

    Yusuf Latief; Rossy Armyn Machfudiyanto; Brain Harryanto; Cahyadi Santoso

    2017-01-01

    Unideal Safety culture in Indonesia requires an evaluation of policy implementation refers to the construction safety regulation, Ministry Regulation 05/PRT/2014. Out of Norms, Standards, Procedures and Criteria (NSPK), we only have Norms and Procedure. As for Standard and Criteria are still being planned. This research on building, housing, water resource, roads and bridges construction at the Ministry of General Works and Housing resulted in having significant relation between safety policy...

  16. Quantitative evaluation of myocardial function by a volume-normalized map generated from relative blood flow

    Energy Technology Data Exchange (ETDEWEB)

    Fukami, Tadanori [Department of Bio-system Engineering, Faculty of Engineering, Yamagata University, Yonezawa, Yamagata 992-8510 (Japan); Sato, Hidenori [Department of Bio-system Engineering, Faculty of Engineering, Yamagata University, Yonezawa, Yamagata 992-8510 (Japan); Wu, Jin [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Lwin, Thet-Thet- [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Yuasa, Tetsuya [Department of Bio-system Engineering, Faculty of Engineering, Yamagata University, Yonezawa, Yamagata 992-8510 (Japan); Kawano, Satoru [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Iida, Keiji [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Akatsuka, Takao [Department of Bio-system Engineering, Faculty of Engineering, Yamagata University, Yonezawa, Yamagata 992-8510 (Japan); Hontani, Hidekata [Department of Computer Science and Engineering, Nagoya Institute of Technology, Aichi 466-8555 (Japan); Takeda, Tohoru [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Tamura, Masao [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan); Yokota, Hiroshi [Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki 305-8575 (Japan)

    2007-07-21

    Our study aimed to quantitatively evaluate blood flow in the left ventricle (LV) of apical hypertrophic cardiomyopathy (APH) by combining wall thickness obtained from cardiac magnetic resonance imaging (MRI) and myocardial perfusion from single-photon emission computed tomography (SPECT). In this study, we considered paired MRI and myocardial perfusion SPECT from ten patients with APH and ten normals. Myocardial walls were detected using a level set method, and blood flow per unit myocardial volume was calculated using 3D surface-based registration between the MRI and SPECT images. We defined relative blood flow based on the maximum in the whole myocardial region. Accuracies of wall detection and registration were around 2.50 mm and 2.95 mm, respectively. We finally created a bull's-eye map to evaluate wall thickness, blood flow (cardiac perfusion) and blood flow per unit myocardial volume. In patients with APH, their wall thicknesses were over 10 mm. Decreased blood flow per unit myocardial volume was detected in the cardiac apex by calculation using wall thickness from MRI and blood flow from SPECT. The relative unit blood flow of the APH group was 1/7 times that of the normals in the apex. This normalization by myocardial volume distinguishes cases of APH whose SPECT images resemble the distributions of normal cases.

  17. Safety Comprehensive Evaluation of Spacecraft Assembly Process Based on Grey-Fuzzy Method

    Directory of Open Access Journals (Sweden)

    Jin Tian

    2014-04-01

    Full Text Available Multilevel evaluation indicator system for spacecraft assembly safety was built, considering six aspects: operators, process equipment, operating environment, operation types, objects to be operated, and emergency measures. Based on that, a grey-fuzzy comprehensive evaluation approach was proposed to support the spacecraft assembly safety evaluation. In the approach, analytic hierarchy process and grey degree were applied to construct weight matrix, and the principle with which the appropriate memberships could be determined was taken as a basis for creation of grey-fuzzy comprehensive evaluation matrix. The docking assembly, a typical stage in spacecraft assembly process, was taken as the case study to evaluate its safety level by the proposed grey-fuzzy comprehensive evaluation method, and it was confirmed that the result is coherent with the reality of the accident statistics. The evaluation results can be utilized as a technical basis for developing safety and protective measures, perfecting risk management, and furthermore lowering the risk to minimize economic loss and behind-schedule of project.

  18. Hypertension on Target with TENORMIN (HOTT Study-Evaluation of the Effectiveness and Safety of Atenolol in Indian Population

    Directory of Open Access Journals (Sweden)

    Qayum Mukaddam

    2014-01-01

    Full Text Available Background: Atenolol is a widely used anti-hypertensive drug worldwide. Despite well-studied from other population, due to the paucity of data from Indians, this study was conducted. Materials and Methods: This was a prospective cohort study conducted in 566 tertiary care hospitals in India. Adult male or female naïve patients with Stage I 1 or Stage II 2 (Seventh Report of the Joint National Committee essential hypertension or patients uncontrolled on current monotherapy or other combination therapy. Demographic details, blood pressure and heart rate readings (weeks 2, 8, and 12 and drug-related details of the study participants were collected and analyzed. Results: A total of 2657 participants were evaluated. The mean (standard deviation [SD] baseline systolic and diastolic blood pressure of the study participants were 161.73 (15.13 and 99.21 (11.37, respectively. Mean (SD of the baseline heart rate was 84.39 (10.17 beats/min. Statistically significant reductions (P < 0.05 were noted in both the blood pressures and heart rate at all the follow-up visits in comparison to baseline. Of the total 632 patients with Stage I hypertension, 153 (24.21% achieved a reduction in blood pressure <120/80 mmHg, while 245 (38.77% had their blood pressure between 121 and 140 mmHg systolic and/or 81-90 mmHg diastolic at 12 weeks of therapy. Global assessment of the efficacy and tolerability were found to be at least satisfactory in the majority of the study participants. Conclusion: To conclude, atenolol as an anti-hypertensive agent seems to be promising both in terms of effectiveness and safety profile in the Indian population.

  19. Comparative assessment of nanomaterial definitions and safety evaluation considerations.

    Science.gov (United States)

    Boverhof, Darrell R; Bramante, Christina M; Butala, John H; Clancy, Shaun F; Lafranconi, Mark; West, Jay; Gordon, Steve C

    2015-10-01

    Nanomaterials continue to bring promising advances to science and technology. In concert have come calls for increased regulatory oversight to ensure their appropriate identification and evaluation, which has led to extensive discussions about nanomaterial definitions. Numerous nanomaterial definitions have been proposed by government, industry, and standards organizations. We conducted a comprehensive comparative assessment of existing nanomaterial definitions put forward by governments to highlight their similarities and differences. We found that the size limits used in different definitions were inconsistent, as were considerations of other elements, including agglomerates and aggregates, distributional thresholds, novel properties, and solubility. Other important differences included consideration of number size distributions versus weight distributions and natural versus intentionally-manufactured materials. Overall, the definitions we compared were not in alignment, which may lead to inconsistent identification and evaluation of nanomaterials and could have adverse impacts on commerce and public perceptions of nanotechnology. We recommend a set of considerations that future discussions of nanomaterial definitions should consider for describing materials and assessing their potential for health and environmental impacts using risk-based approaches within existing assessment frameworks. Our intent is to initiate a dialogue aimed at achieving greater clarity in identifying those nanomaterials that may require additional evaluation, not to propose a formal definition. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  20. The Decision Making Trial and Evaluation Laboratory (Dematel and Analytic Network Process (ANP for Safety Management System Evaluation Performance

    Directory of Open Access Journals (Sweden)

    Rolita Lisa

    2018-01-01

    Full Text Available In order to improve airport safety management system (SMS performance, an evaluation system is required to improve on current shortcomings and maximize safety. This study suggests the integration of the DEMATEL and ANP methods in decision making processes by analyzing causal relations between the relevant criteria and taking effective analysis-based decision. The DEMATEL method builds on the ANP method in identifying the interdependencies between criteria. The input data consists of questionnaire data obtained online and then stored in an online database. Furthermore, the questionnaire data is processed using DEMATEL and ANP methods to obtain the results of determining the relationship between criteria and criteria that need to be evaluated. The study cases on this evaluation system were Adi Sutjipto International Airport, Yogyakarta (JOG; Ahmad Yani International Airport, Semarang (SRG; and Adi Sumarmo International Airport, Surakarta (SOC. The integration grades SMS performance criterion weights in a descending order as follow: safety and destination policy, safety risk management, healthcare, and safety awareness. Sturges' formula classified the results into nine grades. JOG and SMG airports were in grade 8, while SOG airport was in grade 7.

  1. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  2. A critical evaluation of automated blood gas measurements in comparative respiratory physiology.

    Science.gov (United States)

    Malte, Christian Lind; Jakobsen, Sashia Lindhøj; Wang, Tobias

    2014-12-01

    Precise measurements of blood gases and pH are of pivotal importance to respiratory physiology. However, the traditional electrodes that could be calibrated and maintained at the same temperature as the experimental animal are increasingly being replaced by new automated blood gas analyzers. These are typically designed for clinical use and automatically heat the blood sample to 37°C for measurements. While most blood gas analyzers allow for temperature corrections of the measurements, the underlying algorithms are based on temperature-effects for human blood, and any discrepancies in the temperature dependency between the blood sample from a given species and human samples will bias measurements. In this study we review the effects of temperature on blood gases and pH and evaluate the performance of an automated blood gas analyzer (GEM Premier 3500). Whole blood obtained from pythons and freshwater turtles was equilibrated in rotating Eschweiler tonometers to a variety of known P(O2)'s and P(CO2)'s in gas mixtures prepared by Wösthoff gas mixing pumps and blood samples were measured immediately on the GEM Premier 3500. The pH measurements were compared to measurements using a Radiometer BMS glass capillary pH electrode kept and calibrated at the experimental temperature. We show that while the blood gas analyzer provides reliable temperature-corrections for P(CO2) and pH, P(O2) measurements were substantially biased. This was in agreement with the theoretical considerations and emphasizes the need for critical calibrations/corrections when using automated blood gas analyzers. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Evaluating SafeClub: can risk management training improve the safety activities of community soccer clubs?

    Science.gov (United States)

    Abbott, K; Klarenaar, P; Donaldson, A; Sherker, S

    2008-06-01

    To evaluate a sports safety-focused risk-management training programme. Controlled before and after test. Four community soccer associations in Sydney, Australia. 76 clubs (32 intervention, 44 control) at baseline, and 67 clubs (27 intervention, 40 control) at post-season and 12-month follow-ups. SafeClub, a sports safety-focused risk-management training programme (3x2 hour sessions) based on adult-learning principles and injury-prevention concepts and models. Changes in mean policy, infrastructure and overall safety scores as measured using a modified version of the Sports Safety Audit Tool. There was no significant difference in the mean policy, infrastructure and overall safety scores of intervention and control clubs at baseline. Intervention clubs achieved higher post-season mean policy (11.9 intervention vs 7.5 controls), infrastructure (15.2 vs 10.3) and overall safety (27.0 vs 17.8) scores than did controls. These differences were greater at the 12-month follow-up: policy (16.4 vs 7.6); infrastructure (24.7 vs 10.7); and overall safety (41.1 vs 18.3). General linear modelling indicated that intervention clubs achieved statistically significantly higher policy (pfoundations and processes for good risk-management practice, in a sustainable way.

  4. Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment.

    Science.gov (United States)

    Rothe, H; Fautz, R; Gerber, E; Neumann, L; Rettinger, K; Schuh, W; Gronewold, C

    2011-08-28

    The consumer exposure to the vast majority of cosmetic products is limited to dermal contact. Even spray applications tend to be topically exposed to skin or hair. Besides this skin contact, spray products require additional considerations in regard to potential inhalation for building a robust and reliable safety assessment. Over the years, cosmetic industry developed prediction models for the best estimate of inhalation exposure combining data from computer simulation programs available in the market, individual real measured data and last but not least the experience from the market. Such attempt is driven by the toxicological profile of individual used ingredients. The focus of this review is on the determination of inhalation exposure, and the derivation of safe exposure levels for cosmetic spray products. Many of the methods employed to ensure product safety of cosmetic sprays in accordance with the general requirements of the EC Cosmetics Directive are based on industry experience which are not necessarily consistent across companies. This paper presents an approach to compile common principles for risk assessment and thus contribute to standardisation of safety assessment methodologies utilized for spray product evaluation without interfering with the flexibility of the individual safety assessor. It is based on the experience within the author's companies and may be useful as a support document as well for SME (Small and Medium Enterprises) companies safety assessors. In this respect it can be seen as one fundamental step in a tiered approach of cosmetic spray safety evaluation. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  5. Assessing Patients' Perceptions of Safety Culture in the Hospital Setting: Development and Initial Evaluation of the Patients' Perceptions of Safety Culture Scale.

    Science.gov (United States)

    Monaca, Clara; Bestmann, Beate; Kattein, Martina; Langner, Daria; Müller, Hardy; Manser, Tanja

    2017-11-21

    Both, patient satisfaction and hospital safety culture have been recognized as key characteristics of healthcare quality and patient safety. Thus, both characteristics are measured widely to support quality and safety improvement efforts. However, because safety culture surveys focus exclusively on the perspective of hospital staff, the complimentary information to be gained from patients' perceptions of safety culture has received little research attention so far. We aimed to develop a measure explicitly focusing on patients' perceptions of safety culture in the hospital setting and perform an initial evaluation of its measurement properties. We employed a multistep development approach including (a) literature review of survey instruments for patient experience and safety culture and (b) item categorization and selection. We evaluated the measurement properties of the final item set focusing on factor structure, internal consistency, item difficulty, and discrimination. Data were collected from June to December 2015 via an online patient survey conducted routinely by a health insurer. Overall, 112,814 insured persons participated in the online survey (response rate = 19.7%). The final 11-item set formed a single scale that was named Patients' Perceptions of Safety Culture scale. Its measurement properties were deemed satisfactory based on this initial evaluation. The Patients' Perceptions of Safety Culture scale contributes to both a more comprehensive view of patients' experience of healthcare and a more balanced approach to safety culture measurement in healthcare. It contributes to an increased recognition of patients' views on safety-relevant aspects of their care that provide important inputs to patient safety improvement.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The

  6. Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a Phase III clinical trial in cardiac surgery patients.

    Science.gov (United States)

    Benjamin, Richard J; McCullough, Jeffrey; Mintz, Paul D; Snyder, Edward; Spotnitz, William D; Rizzo, Robert J; Wages, David; Lin, Jin-Sying; Wood, Lindsey; Corash, Laurence; Conlan, Maureen G

    2005-11-01

    A randomized, double-blind trial is reported of the clinical efficacy of red blood cells (RBCs) treated for pathogen inactivation with S-303, a synthetic labile alkylating agent. Patients undergoing complex cardiac surgeries were randomly assigned to receive either S-303-treated (test) or conventional (control) RBC transfusion during surgery and for 6 days thereafter. Efficacy was evaluated by comparing the occurrence of a composite primary endpoint of treatment-related morbidity (myocardial infarction and renal failure) and mortality. Two-hundred twenty-three patients were randomly assigned and 148 patients who received transfusions (74 with S-303-treated RBCs and 74 with control RBCs) were evaluable. The incidence of the primary endpoint was equivalent between the two groups (22 and 21% in the S-303-treated and control RBC groups, respectively). Secondary endpoints, including hemoglobin increment (mean, 1.4 vs. 1.5 g/dL), number of RBC transfusions (mean, 4.4 vs. 3.8 units), and other blood product support, were also comparable. The adverse event profile was similar between groups; however, patients who received S-303 RBCs were significantly more likely to develop constipation and less likely to suffer supraventricular extrasystoles. Four patients (2 test and 2 control) demonstrated positive indirect antiglobulin tests with reactivity for S-303 RBCs at one or more time points before or after transfusion, without evidence of hemolysis. S-303-treated and conventional RBCs were equivalent with respect to clinical efficacy and safety in supporting the transfusion needs of cardiac surgery patients. Investigations are under way to ascertain the significance of S-303 RBC antibodies and to prevent their occurrence.

  7. An Evaluation Methodology Development and Application Process for Severe Accident Safety Issue Resolution

    Directory of Open Access Journals (Sweden)

    Robert P. Martin

    2012-01-01

    Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.

  8. Evaluation of a Radiation Worker Safety Training Program at a nuclear facility

    Energy Technology Data Exchange (ETDEWEB)

    Lindsey, J.E.

    1993-05-01

    A radiation safety course was evaluated using the Kirkpatrick criteria of training evaluation as a guide. Thirty-nine employees were given the two-day training course and were compared with 15 employees in a control group who did not receive the training. Cognitive results show an immediate gain in knowledge, and substantial retention at 6 months. Implications of the results are discussed in terms of applications to current radiation safety training was well as follow-on training research and development requirements.

  9. Evaluating the intervening factors in patient safety: focusing on hospital nursing staff

    Directory of Open Access Journals (Sweden)

    Roberta Meneses Oliveira

    2015-02-01

    Full Text Available OBJECTIVE To evaluate intervening factors in patient safety, focusing on hospital nursing staff. METHOD The study is descriptive, with qualitative approach, excerpt from a larger study with analytical nature. It was undertaken in a public hospital in Fortaleza, CE, Brazil, between January and June 2013, with semi-structured interviews to 70 nurses, using Thematic Content Analysis. RESULTS The principal intervening factors in patient safety related to hospital nursing staff were staff dimensioning and workload, professional qualification and training, team work, being contracted to the institution, turnover and lack of job security, and bad practice/disruptive behaviors. These aspects severely interfere with the establishment of a safety culture in the hospital analyzed. CONCLUSION It is necessary for managers to invest in nursing staff, so that these workers may be valued as fundamental in the promotion of patient safety, making it possible to develop competences for taking decisions with focus on the improvement of quality care.

  10. Evaluating the intervening factors in patient safety: focusing on hospital nursing staff.

    Science.gov (United States)

    Oliveira, Roberta Meneses; Leitao, Ilse Maria Tigre de Arruda; Aguiar, Leticia Lima; Oliveira, Adriana Catarina de Souza; Gazos, Dionisia Mateus; Silva, Lucilane Maria Sales da; Barros, Ariane Alves; Sampaio, Renata Lopes

    2015-02-01

    To evaluate intervening factors in patient safety, focusing on hospital nursing staff. The study is descriptive, with qualitative approach, excerpt from a larger study with analytical nature. It was undertaken in a public hospital in Fortaleza, CE, Brazil, between January and June 2013, with semi-structured interviews to 70 nurses, using Thematic Content Analysis. The principal intervening factors in patient safety related to hospital nursing staff were staff dimensioning and workload, professional qualification and training, team work, being contracted to the institution, turnover and lack of job security, and bad practice/disruptive behaviors. These aspects severely interfere with the establishment of a safety culture in the hospital analyzed. It is necessary for managers to invest in nursing staff, so that these workers may be valued as fundamental in the promotion of patient safety, making it possible to develop competences for taking decisions with focus on the improvement of quality care.

  11. Longitudinal safety evaluation of electric vehicles with the partial wireless charging lane on freeways.

    Science.gov (United States)

    Li, Ye; Wang, Wei; Xing, Lu; Fan, Qi; Wang, Hao

    2018-02-01

    As an environment friendly transportation mode, the electric vehicle (EV) has drawn an increasing amount of attention from governments, vehicle manufactories and researchers recently. One of the biggest issue impeding EV's popularization associates with the charging process. The wireless charging lane (WCL) has been proposed as a convenient charging facility for EVs. Due to the high costs, the application of WCL on the entire freeways is impractical in the near future, while the partial WCL (PWCL) may be a feasible solution. This study aims to evaluate longitudinal safety of EVs with PWCL on freeways based on simulations. The simulation experiments are firstly designed, including deployment of PWCL on freeways and distribution of state of charge (SOC) of EVs. Then, a vehicle behavior model for EVs is proposed based on the intelligent driver model (IDM). Two surrogate safety measures, derived from time-to-collision (TTC), are utilized as indicators for safety evaluations. Sensitivity analysis is also conducted for related factors. Results show that the distribution of EVs' SOC significantly affect longitudinal safety when the PWCL is utilized. The low SOC in traffic consisting of EVs has the negative effect on longitudinal safety. The randomness and incompliance of EV drivers worsens the safety performance. The sensitivity analysis indicates that the larger maximum deceleration rate results in the higher longitudinal crash risks of EVs, while the length of PWCL has no monotonous effect. Different TTC thresholds also show no impact on results. A case study shows the consistent results. Based on the findings, several suggestions are discussed for EVs' safety improvement. Results of this study provide useful information for freeway safety when EVs are applied in the future. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Safety evaluation of joint and conventional lane merge configurations for freeway work zones.

    Science.gov (United States)

    Ishak, Sherif; Qi, Yan; Rayaprolu, Pradeep

    2012-01-01

    Inefficient operation of traffic in work zone areas not only leads to an increase in travel time delays, queue length, and fuel consumption but also increases the number of forced merges and roadway accidents. This study evaluated the safety performance of work zones with a conventional lane merge (CLM) configuration in Louisiana. Analysis of variance (ANOVA) was used to compare the crash rates for accidents involving fatalities, injuries, and property damage only (PDO) in each of the following 4 areas: (1) advance warning area, (2) transition area, (3) work area, and (4) termination area. The analysis showed that the advance warning area had higher fatality, injury, and PDO crash rates when compared to the transition area, work area, and termination area. This finding confirmed the need to make improvements in the advance warning area where merging maneuvers take place. Therefore, a new lane merge configuration, called joint lane merge (JLM), was proposed and its safety performance was examined and compared to the conventional lane merge configuration using a microscopic simulation model (VISSIM), which was calibrated with real-world data from an existing work zone on I-55 and used to simulate a total of 25 different scenarios with different levels of demand and traffic composition. Safety performance was evaluated using 2 surrogate measures: uncomfortable decelerations and speed variance. Statistical analysis was conducted to determine whether the differences in safety performance between both configurations were significant. The safety analysis indicated that JLM outperformed CLM in most cases with low to moderate flow rates and that the percentage of trucks did not have a significant impact on the safety performance of either configuration. Though the safety analysis did not clearly indicate which lane merge configuration is safer for the overall work zone area, it was able to identify the possibly associated safety changes within the work zone area under

  13. Examination of cadmium safety rod thermal test specimens and failure mechanism evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, J.K.; Peacock, H.B.; Iyer, N.C.

    1992-01-01

    The reactor safety rods may be subjected to high temperatures due to gamma heating after the core coolant level has dropped during the ECS phase of a hypothetical LOCA event. Accordingly, an experimental cadmium safety rod testing subtask was established as part of a task to address the response of reactor core components to this accident. Companion reports describe the experiments and a structural evaluation (finite element analysis) of the safety rod. This report deals primarily with the examination of the test specimens, evaluation of possible failure mechanisms, and confirmatory separate effects experiments. It is concluded that the failures observed in the cadmium safety rod thermal tests which occurred at low temperature (T < 600{degrees}C) with slow thermal ramp rates (slow cladding strain rates) resulted from localized dissolution of the stainless steel cladding by the cadmium/aluminum solution and subsequent ductility exhaustion and rupture. The slow thermal ramp rate is believed to be the root cause for the failures; specifically, the slow ramp rate led to localized cladding shear deformation which ruptured the protective oxide film on the cladding inner surface and allowed dissolution to initiate. The test results and proposed failure mechanism support the conclusion that the rods would not fail below 500{degrees}C even at slow ramp rates. The safety rod thermal test specimen failures which occurred at high temperature (T > 800{degrees}C) with fast thermal ramp rates are concluded to be mechanical in nature without significant environmental degradation. Based on these tests, tasks were initiated to design and manufacture B{sub 4}C safety rods to replace the cadmium safety rods. The B{sub 4}C safety rods have been manufactured at this time and it is currently planned to charge them to the reactor in the near future. 60 refs.

  14. Evaluation of four portable blood glucose meters in diabetic and non-diabetic dogs and cats.

    Science.gov (United States)

    Kang, Min-Hee; Kim, Do-Hyung; Jeong, In-Seong; Choi, Gab-Chol; Park, Hee-Myung

    2016-01-01

    Monitoring of an animal's blood glucose concentration is critical for diagnostic and therapeutic decisions. Over the past few decades, portable blood glucose meters (PBGMs) have been used to monitor blood glucose concentrations in animals. Recently, new and improved PBGMs have been made available on the market. The purpose of this study was to evaluate four PBGMs for use in dogs and cats. A total of 155 venous blood samples of dogs and 85 venous blood samples of cats were tested using four PBGMs. Control solutions from manufacturers were used to determine the precision of each meter. The coefficient of variation was calculated to determine precision during a set of replicates. Pearson's correlation analysis, Passing-Bablok regression, and Bland-Altman analysis were used to determine the accuracy of four PBGMs against the hexokinase reference method. Error grid analysis was used to evaluate clinical relevance. All PBGMs, except CERA-PET®, were clinically acceptable for monitoring blood glucose concentrations; AlphaTrak® and VetMate® appeared to be the most accurate ones, demonstrating that to use PBGMs for glucose monitoring, it is important to understand the strengths or limitations of each meter. The difference in results between the PBGMs and the reference method increased at high glucose concentration ranges, which were also affected by the hematocrit. Although readings of the PBGMs and the reference method varied across glycemic ranges (low, normal, and high glucose concentrations), most PBGMs were clinically acceptable for monitoring blood glucose concentrations in dogs and cats.

  15. Implementation of the new VIRTUO blood culture system: evaluation and comparison to the 3D system using simulated blood cultures.

    Science.gov (United States)

    Miller, Nathalie; Brassinne, Laetitia; Allemeersch, Daniel

    2017-06-05

    To evaluate the performances of the newly approved BacT/ALERT VIRTUO blood culture system for the recovery of bloodstream pathogens and compare it to the BacT/ALERT 3D system. Simulated blood cultures of eight clinically relevant microorganisms were used: Bacteroides fragilis (ATCC 25285), Escherichia coli (ATCC 25922), Haemophilus influenzae (ATCC 49247), Pseudomonas aeruginosa (ATCC 27853), Enterococcus faecalis (ATCC 29212), Staphylococcus aureus (ATCC 29213), Streptococcus pneumoniae (ATCC 49619) and Candida krusei (ATCC 6258). Criteria for comparison were culture positivity and time to detection (TTD). The effects of delayed entry on recovery and TTD were also evaluated. The VIRTUO exhibited around 3 h faster detection time compared to the 3D system. (p < 0.01) for aerobic and facultative microorganisms. The difference in TTD was greatest for the B. fragilis, with a median difference of 46.67 h. The anaerobic bottle of the VIRTUO (FN Plus) did not support the growth of obligate aerobes, whereas the 3D did so. Delayed entry (studied with an E. Coli isolate) had no effect on the recovery rate but proportionally reduced TTD. The VIRTUO performed better than the 3D in terms of TTD and hands-on-time. FN Plus vial appears to be more efficient than the SN bottle in the recovery of anaerobes.

  16. Stage Right operational safety analysis and evaluation of Pantex personnel operations

    Energy Technology Data Exchange (ETDEWEB)

    Rountree, S.L.K.; Whitehurst, H.O.; Tomlin, E.H.; Restrepo, L.F. [Sandia National Labs., Albuquerque, NM (United States); White, J. [Sandia National Labs., Albuquerque, NM (United States)]|[Intera, Albuquerque, NM (United States)

    1995-01-01

    This report documents a study (Stage Right Operational Safety Analysis) that was performed to evaluate the effects of new Stage Right operations on the safety of Pantex personnel who perform the operations and maintain the equipment. The primary concern of the evaluation was for personnel safety during Stage Right operations, but operations equipment damage and degradation also were taken into account. This analysis evaluates safety of the work process in the staging of dismantled nuclear weapon pits within the modified Richmond magazines only. This Stage Right Process and Operational Safety Analysis includes the following processes: moving the pelletized drums from the pallet trailer to the pallet turner, staging of pallets and removal of pallets from the magazine, recovery from an incident in a magazine, setting up, opening, and closing a Zone 4 magazine, inventory of pelletized drums in the magazines, transporting pelletized drums from Zone 12 to Zone 4, and maintenance on the shielded lift truck that involves removal of the cab shielding. The analysis includes the following undesirable consequences: injury to personnel, breach of an AL-R8 container, drop of a loaded pallet, damage to equipment, and equipment unreliability.

  17. An Evaluation Method of Underwater Ocean Environment Safety Situation Based on D-S Evidence Theory

    Directory of Open Access Journals (Sweden)

    Yuxin Zhao

    2015-01-01

    Full Text Available Because of complex ocean environment, underwater vehicles are facing many challenges in navigation safety and precise navigation. Aiming at the requirements of underwater navigation safety, this paper presents an evaluation method of underwater ocean environment safety situation based on Dempster-Shafer (D-S evidence theory. Firstly, the vital ocean environment factors which affect the underwater navigation safety are taken into account, and a novel basic probability assignment (BPA construction method of ocean environment factors is proposed according to their characteristics. Then, a new transformation method of BPA to decision-making probability is put forward to deal with the uncertainty degree. Furthermore, the super-standard weight is applied to preprocess the BPA, and D-S combination rule is used to acquire the evaluation result by fusing the preprocessed BPA. Ocean environment safety situation index is obtained by quantizing the evaluation grades. Finally, experimental results show that the method proposed has the superior practicability and reliability in actual applications.

  18. Evaluation of the human blood entropy production: a new thermodynamic approach.

    Science.gov (United States)

    Farsaci, F; Tellone, E; Galtieri, A; Russo, A; Ficarra, S

    2016-12-01

    In this paper, we follow the thermodynamic theory with internal variables of Kluitenberg evaluating the entropy production of red blood cell in saline solution and whole blood, respectively, when they are subjected to an ultrasound wave. From a thermodynamic point of view, blood is an open system; so to fully represent the entropy variation as function of frequency perturbation we employ phenomenological coefficients which allow us to qualitatively discriminate among classes of phenomena which cannot be observed in any other way. Therefore, a correlation between these coefficients and quantities experimentally measurable allows to a deeper knowledge of biological phenomena.

  19. The safety of early fresh, whole blood transfusion among severely battle injured at US Marine Corps forward surgical care facilities in Afghanistan.

    Science.gov (United States)

    Auten, Jonathan D; Lunceford, Nicole L; Horton, Jaime L; Galarneau, Mike R; Galindo, Roger M; Shepps, Craig D; Zieber, Tara J; Dewing, Chris B

    2015-11-01

    In Afghanistan, care of the acutely injured trauma patient commonly occurred in facilities with limited blood banking capabilities. Apheresis platelets were often not available. Component therapy consisted of 1:1 packed red blood cells and fresh frozen plasma. Fresh, whole blood transfusion often augmented therapy in the severely injured patient. This study analyzed the safety of fresh, whole blood use in a resource-limited setting. A retrospective analysis was performed on a prospectively collected data set of US battle injuries presenting to three US Marine Corps (USMC) expeditionary surgical care facilities in Helmand Province, Afghanistan, between January 2010 and July 2012. Included in the review were patients with Injury Severity Scores (ISSs) of 15 or higher receiving blood transfusions. Univariate analyses were performed, followed by multivariable logistic regression to describe the relationship between the treatment group and posttreatment complications such as trauma-induced coagulopathy, infection, mortality, venous thromboembolism, and transfusion reaction. Propensity scores were calculated and included in multivariable models to adjust for potential bias in treatment selection. A total of 61 patients were identified; all were male marines with a mean (SD) age of 23.5 (3.6) years. The group receiving fresh, whole blood was noted to have higher ISSs and lower blood pressure, pH, and base deficits on arrival. Traumatic coagulopathy was significantly less common in the group receiving fresh, whole blood (odds ratio, 0.01; 95% confidence interval, 0.00-0.18). Multivariable models found no other significant differences between the treatment groups. The early use of fresh, whole blood in a resource-limited setting seems to confer a benefit in reducing traumatic coagulopathy. This study's small sample size precludes further statement on the overall safety of fresh, whole blood use. Therapy study, level IV.

  20. Clinical evaluation of the Surgivet V60046, a non invasive blood pressure monitor in anaesthetized dogs.

    Science.gov (United States)

    Deflandre, Catherine J A; Hellebrekers, Ludo J

    2008-01-01

    To compare the performance of the Surgivet Non-Invasive Blood Pressure (NIBP) monitor V60046 with an invasive blood pressure (IBP) technique in anaesthetized dogs. A prospective study. Thirty-four dogs, anaesthetized for a variety of procedures. Various anaesthetic protocols were used. Invasive blood pressure measurement was made using a catheter in the femoral or the pedal artery. A cuff was placed on the contralateral limb to allow non invasive measurements. Recordings of arterial blood pressures (ABPs) were taken at simultaneous times for a range of pressures. For analysis, three pressure levels were determined: high [systolic blood pressure (SAP) > 121 mmHg], normal (91 mmHg invasive and non invasive measurements were made using Bland-Altmann analysis. The NIBP monitor consistently underestimated blood pressure at all levels. The lowest biases and greatest precision were obtained at low and normal pressure levels for SAP and mean arterial pressure (MAP). At low blood pressure levels, the biases +/- 95% confidence interval (CI) were 1.9 +/- 2.96 mmHg (SAP), 8.3 +/- 2.41 mmHg diastolic arterial pressure (DAP) and 3.5 +/- 2.09 mmHg (MAP). At normal blood pressure levels, biases and CI were: 1.2 +/- 2.13 mmHg (SAP), 5.2 +/- 2.32 mmHg (DAP) and 2.1 +/- 1.54 mmHg (MAP). At high blood pressure levels, the biases and CI were 22.7 +/- 5.85 mmHg (SAP), 5.5 +/- 3.13 mmHg (DAP) and 9.4 +/- 3.52 mmHg (MAP). In 90.6% of cases of hypotension (MAP blood pressure was correctly diagnosed by the Surgivet. Measurement of blood pressure with the indirect monitor allowed detection of hypotension using either SAP or MAP. The most accurate readings were determined for MAP at hypotensive and normal levels. The monitor lacked accuracy at high pressures. When severe challenges to the cardiovascular system are anticipated, an invasive method of recording ABP is preferable. For routine usage, the Surgivet monitor provided a reliable and safe method of NIBP monitoring in dogs, thereby

  1. Review of Overall Safety Manual for space nuclear systems. An evaluation of a nuclear safety analysis methodology for plutonium-fueled space nuclear systems

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, J.; Inhaber, H.

    1984-02-01

    As part of its duties in connection with space missions involving nuclear power sources, the Office of Nuclear Safety (ONS) of the Office of Assistant Secretary for Environmental Protection, Safety, and Emergency Preparedness has been assigned the task of reviewing the Overall Safety Manual (OSM) (memo from B.J. Rock to J.R. Maher, December 1, 1982). The OSM, dated July 1981 and in four volumes, was prepared by NUS Corporation, Rockville, Maryland, for the US Department of Energy. The OSM provides many of the technical models and much of the data which are used by (1) space launch contractors in safety analysis reports and (2) the broader Interagency Nuclear Safety Review Panel (INSRP) safety evaluation reports. If fhs interaction between the OSM, contractors, and INSRP is to work effectively, the OSM must be accurate, comprehensive, understandable, and usable.

  2. Evaluation procedures in health: Perspective of nursing care in patient safety.

    Science.gov (United States)

    da Costa, Theo Duarte; Santos, Viviane Euzébia Pereira; Junior, Marcos Antônio Ferreira; Vitor, Alynne Fortes; de Oliveira Salvador, Pétala Tuani Candido; Alves, Kisna Yasmin Andrade

    2017-06-01

    The objective research is analyzing the nursing care in intensive care units from the perspective of patient safety based on health evaluation. This is an evaluation research, for the purpose of issuance of judgment or judgment on a given system, carried out in six intensive care units. Data collection occurred from April to July 2014, in locu, with a validated instrument containing 97 questions related to patient safety. These, 73 items targeted to analyze the element "process" in safety patient nursing care. The 73 items were grouped into three elements meaning of the patient safety: "Communication and Identification", "Health and Comfort" and "Drug and Nutritional Therapy". Data analyses were used from Kappa measurement, observations conducted by the evaluators and literature on the theme. The result of three elements significant showed the following: 23 items (31.5%) were considered adequate and 50 (68.4%), non-compliant with the required standards for reliable care. Of these, 29 (39.7%) were classified as partially adequate and 21 (28.7%) as inadequate, setting a worrying care in regards care of security with large probability precipitation of undesirable events. It is emphasized that the classification unsuitability of items prevailed. Patient safety is impaired due to unsafe actions in nursing care processes. Unsafe actions in care processes increase the risk to patient safety, as precipitation falls, errors in medication administration, communication difficulties and continuity of care. Thus, immediate interventions are imperative to implement a safety culture and to avoid negligence in relation to care. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Evaluation of blood glucose fluctuation in Japanese patients with type 1 diabetes mellitus by self-monitoring of blood glucose and continuous glucose monitoring.

    Science.gov (United States)

    Kusunoki, Yoshiki; Katsuno, Tomoyuki; Nakae, Rie; Watanabe, Kahori; Akagami, Takafumi; Ochi, Fumihiro; Tokuda, Masaru; Murai, Kazuki; Miuchi, Masayuki; Miyagawa, Jun-ichiro; Namba, Mitsuyoshi

    2015-05-01

    Accurate assessment of blood glucose fluctuation is essential for managing blood glucose control while avoiding hypoglycemia in patients with diabetes mellitus. In this study, blood glucose was measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes mellitus (T1DM) whom self-monitoring of blood glucose (SMBG) was carried out three or more times per day, and evaluation was performed using blood glucose fluctuation parameters obtained by CGM and SMBG. Twenty-nine insulin-depleted patients with T1DM were enrolled. Their blood glucose fluctuations were measured at the same time by SMBG and CGM, and the correlations were evaluated. Correlations were found between the following values obtained by SMBG and CGM: mean and standard deviation of blood glucose levels, average daily risk range, Morbus value and high-blood-glucose index. The hypoglycemia duration and the nocturnal hypoglycemia duration showed no correlation with any of the blood glucose fluctuation parameters obtained by SMBG. The findings suggest that routine SMBG and glycated hemoglobin (HbA1c) measurement are sufficient for evaluation of hyperglycemia in T1DM. On the other hand, blood glucose fluctuation parameters obtained by SMBG and HbA1c have been shown to have no correlations with either hypoglycemia duration or nocturnal hypoglycemia duration. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  4. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  5. Evaluation of teicoplanin concentrations and safety analysis in neonates.

    Science.gov (United States)

    Yamada, Takaaki; Kubota, Toshio; Nakamura, Masako; Ochiai, Masayuki; Yonezawa, Mahoro; Yano, Takahisa; Kawashiri, Takehiro; Egashira, Nobuaki; Hara, Toshiro; Masuda, Satohiro

    2014-11-01

    The aims of this study were (i) to evaluate the relationship between teicoplanin (TEIC) dosage and subsequent trough concentration, (ii) to investigate factors that affect TEIC serum concentration fluctuations and (iii) to examine the association between serum concentration of TEIC and adverse reactions in neonates. A total of 37 eligible neonates (12-16 mg/kg on Day 1, followed by >6-8 mg/kg every 24 h (q24 h) was 19.6 μg/mL on Day 3 or 4, and the median trough concentration in the maintenance dose regimen of >6-8 mg/kg q24 h was 18.5 μg/mL at steady-state. There were significant correlations between serum creatinine and concentration/dose (C/D) ratio (r=0.475, P=0.019), body weight and C/D ratio (r=-0.425, P=0.038) and corrected gestational age and C/D ratio (r=-0.482, P=0.017) after administering the loading dose. The incidence of hepatic dysfunction, renal impairment and thrombocytopenia was 14.8%, 20.0% and 14.8%, respectively. There was no significant difference in the incidence of adverse reactions between the trough concentration <20 μg/mL and ≥20 μg/mL groups. These data suggest that the recommended TEIC dosage for neonates is appropriate to achieve and maintain a trough concentration range of 15-30 μg/mL, and it is possible to set the target trough concentration at ≥20 μg/mL for deep-seated infections such as endocarditis, bone and joint infections, and osteomyelitis. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  6. HACCP and water safety plans in Icelandic water supply: preliminary evaluation of experience.

    Science.gov (United States)

    Gunnarsdóttir, María J; Gissurarson, Loftur R

    2008-09-01

    Icelandic waterworks first began implementing hazard analysis and critical control points (HACCP) as a preventive approach for water safety management in 1997. Since then implementation has been ongoing and currently about 68% of the Icelandic population enjoy drinking water from waterworks with a water safety plan based on HACCP. Preliminary evaluation of the success of HACCP implementation was undertaken in association with some of the waterworks that had implemented HACCP. The evaluation revealed that compliance with drinking water quality standards improved considerably following the implementation of HACCP. In response to their findings, waterworks implemented a large number of corrective actions to improve water safety. The study revealed some limitations for some, but not all, waterworks in relation to inadequate external and internal auditing and a lack of oversight by health authorities. Future studies should entail a more comprehensive study of the experience with the use of HACCP with the purpose of developing tools to promote continuing success.

  7. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...... of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... of these changes in risk factors on accident occurrence cannot be predicted. On the whole, the research that has been reported so far regarding road safety effects of porous asphalt is inconclusive. The studies are not of high quality and the findings are inconsistent....

  8. The environmental, health, and safety issues of acoustical materials: A strategy for finding, using, and evaluating information effectively

    Science.gov (United States)

    Bischel, Marsha S.

    2005-09-01

    Concern over the safety of our indoor environments has increased in recent years. The definition of safety has also evolved to include not just life safety issues such as fire, but issues such as mold growth, toxins, the emission of volatile organic compounds, seismic concerns, and ergonomic issues. Consequently, the understanding of product safety has become increasingly more complex. Simultaneously, there has been an explosion in the number of products available to specifiers, due largely to access to the World Wide Web by international manufacturers of all sizes. Some of these manufacturers may be unable to test all aspects of product safety, or simply may be unaware of safety regulations. Specifiers can no longer assume a product is inherently safe and must do their own evaluations of product safety attributes. This paper will lay out a basic methodology for finding, using, and evaluating environmental, health, and safety information on acoustical products in an effective manner.

  9. Visualized Evaluation of Blood Flow to the Gastric Conduit and Complications in Esophageal Reconstruction.

    Science.gov (United States)

    Noma, Kazuhiro; Shirakawa, Yasuhiro; Kanaya, Nobuhiko; Okada, Tsuyoshi; Maeda, Naoaki; Ninomiya, Takayuki; Tanabe, Shunsuke; Sakurama, Kazufumi; Fujiwara, Toshiyoshi

    2018-03-01

    Evaluation of the blood supply to gastric conduits is critically important to avoid complications after esophagectomy. We began visual evaluation of blood flow using indocyanine green (ICG) fluorescent imaging in July 2015, to reduce reconstructive complications. In this study, we aimed to statistically verify the efficacy of blood flow evaluation using our simplified ICG method. A total of 285 consecutive patients who underwent esophagectomy and gastric conduit reconstruction were reviewed and divided into 2 groups: before and after introduction of ICG evaluation. The entire cohort and 68 patient pairs after propensity score matching (PS-M) were evaluated for clinical outcomes and the effect of visualized evaluation on reducing the risk of complication. The leakage rate in the ICG group was significantly lower than in the non-ICG group for each severity grade, both in the entire cohort (285 subjects) and after PS-M; the rates of other major complications, including recurrent laryngeal nerve palsy and pneumonia, were not different. The duration of postoperative ICU stay was approximately 1 day shorter in the ICG group than in the non-ICG group in the entire cohort, and approximately 2 days shorter after PS-M. Visualized evaluation of blood flow with ICG methods significantly reduced the rate of anastomotic complications of all Clavien-Dindo (CD) grades. Odds ratios for ICG evaluation decreased with CD grade (0.3419 for CD ≥ 1; 0.241 for CD ≥ 2; and 0.2153 for CD ≥ 3). Objective evaluation of blood supply to the reconstructed conduit using ICG fluorescent imaging reduces the risk and degree of anastomotic complication. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  10. The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS).

    Science.gov (United States)

    Vinardell, M P

    2015-03-01

    In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Evaluation of the effectiveness of packed red blood cell irradiation by a linear accelerator

    Directory of Open Access Journals (Sweden)

    Ricardo Aparecido Olivo

    2015-06-01

    Full Text Available Irradiation of blood components with ionizing radiation generated by a specific device is recommended to prevent transfusion-associated graft-versus-host disease. However, a lin- ear accelerator can also be used in the absence of such a device, which is the case of the blood bank facility studied herein. In order to evaluate the quality of the irradiated packed red blood cells, this study aimed to determine whether the procedure currently employed in the facility is effective in inhibiting the proliferation of T lymphocytes without damaging blood components. The proliferation of T lymphocytes, plasma potassium levels, and the degree of hemolysis were evaluated and compared to blood bags that received no irradiation. Packed red blood cell bags were irradiated at a dose of 25 Gy in a linear accelerator. For this purpose, a container was designed to hold the bags and to ensure even distribution of irradiation as evaluated by computed tomography and dose-volume histogram. Irradiation was observed to inhibit the proliferation of lymphocytes. The percentage of hemolysis in irradiated bags was slightly higher than in non-irradiated bags (p-value >0.05, but it was always less than 0.4% of the red cell mass. Although potassium increased in both groups, it was more pronounced in irradiated red blood cells, especially after seven days of storage, with a linear increase over storage time. The findings showed that, at an appropriate dosage and under validated conditions, the irradiation of packed red blood cells in a linear accelerator is effective, inhibiting lymphocyte proliferation but without compromising the viability of the red cells.

  12. Implementation and evaluation of a prototype consumer reporting system for patient safety events.

    Science.gov (United States)

    Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C; Quigley, Denise D; Hunter, Lauren E; Ridgely, M Susan; Schneider, Eric C

    2017-08-01

    No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline. Mixed methods evaluation. The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015. Patients, family members and caregivers associated with two US healthcare systems. A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries. Key informant interviews, measurement of website traffic and analysis of completed reports. Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups. While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems.

  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. Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies

    NARCIS (Netherlands)

    P.M. Coloma (Preciosa); B. Becker (Benedikt); M.C.J.M. Sturkenboom (Miriam); E.M. Van Mulligen (Erik M.); J.A. Kors (Jan)

    2015-01-01

    textabstractIntroduction: There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. Objective: The aim of this study was to evaluate the potential contribution of mining social

  15. Safety evaluation for packaging transport of LSA-II liquids in MC-312 cargo tanks

    Energy Technology Data Exchange (ETDEWEB)

    Carlstrom, R.F.

    1996-09-11

    This safety evaluation for packaging authorizes the onsite transfer of bulk LSA-II radioactive liquids in the 222-S Laboratory Cargo Tank and Liquid Effluent Treatment Facility Cargo Tanks (which are U.S. Department of Transportation MC-312 specification cargo tanks) from their operating facilities to tank farm facilities.

  16. 75 FR 62895 - Notice of Availability of Safety Evaluation Report; AREVA Enrichment Services LLC, Eagle Rock...

    Science.gov (United States)

    2010-10-13

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Availability of Safety Evaluation Report; AREVA Enrichment Services LLC, Eagle Rock... special nuclear material. This proposed facility is known as the Eagle Rock Enrichment Facility (EREF) and...

  17. Evaluation of On-Farm Food Safety Programming in Pennsylvania: Implications for Extension

    Science.gov (United States)

    Nayak, Roshan; Tobin, Daniel; Thomson, Joan; Radhakrishna, Rama; LaBorde, Luke

    2015-01-01

    Penn State Extension conducted on-farm food safety workshops statewide to train fruit and vegetable growers on Good Agricultural Practices (GAPs). These workshops were evaluated using pre- and post-tests to assess the impact of the training on participating growers. Results indicate overall increases in produce growers' knowledge, attitudes,…

  18. Quantification and evaluation of safety risks related to the use of ammonia and hydrocarbons as refrigerants

    Energy Technology Data Exchange (ETDEWEB)

    Van Gerwen, R.J.M.; Verwoerd, M. [Department of Refrigeration and Heat Pump Technology, Netherlands Organization for Applied Scientific Research TNO, Apeldoorn (Netherlands)

    1997-10-01

    Models and techniques for the quantification and evaluation of safety aspects related to the use of ammonia and hydrocarbons as working fluids are discussed. TNO has been working with Quantitative Risk Analysis (QRA) for a number of years, and have applied the advanced models in many case studies. 9 refs.

  19. A risk assessment approach to evaluating food safety based on product surveillance

    NARCIS (Netherlands)

    Notermans, S.; Nauta, M.J.; Jansen, J.; Jouve, J.L.; Mead, G.C.

    1998-01-01

    This paper outlines a risk assessment approach to food safety evaluation, which is based on testing a particular type of food, or group of similar foods, for relevant microbial pathogens. The results obtained are related to possible adverse effects on the health of consumers. The paper also gives an

  20. Evaluation of safety, performance and emissions of synthetic fuel blends in a Cessna Citation II

    NARCIS (Netherlands)

    Snijders, T.A.; Melkert, J.A.

    2011-01-01

    Prior to being used in aviation, alternative fuels have to be tested thoroughly to ensure safe operation. At Delft University of Technology, a test programme was performed to evaluate the safety, performance and emissions of synthetic fuel blends. During test preparations, compatibility of the

  1. Evaluation of Dairy Sector Safety and Security in Three Hypermarkets (A, B, C from Transylvania County

    Directory of Open Access Journals (Sweden)

    Romina Alina Vlaic

    2013-11-01

    Full Text Available The safety and  security of milk and dairy products were monitored in three hypermarkets from Transylvania County by evaluation of  several essential key parameters. Results showed variations of quality indicators and this leaded to nomination of each source of interference in order to determine the responsibility of each supermarket

  2. Advancing the Science of Developmental Neurotoxicity (DNT) Testing for Better Safety Evaluation

    DEFF Research Database (Denmark)

    Bal-Price, Anna; Coecke, Sandra; Costa, Lucio

    2012-01-01

    Bal-Price AK, Coecke S, Costa L, Crofton KM, Fritsche E, Goldberg A, Grandjean P, Lein PJ, Li A, Lucchini R, Mundy WR, Padilla S, Persico A, Seiler AEM, Kreysa J. Conference Report: Advancing the Science of Developmental Neurotoxicity (DNT) Testing for Better Safety Evaluation. Altex 2012: 29: 202-15....

  3. Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.

    Science.gov (United States)

    Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney

    2017-08-09

    Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining

  4. Evaluating the safety impact of adaptive cruise control in traffic oscillations on freeways.

    Science.gov (United States)

    Li, Ye; Li, Zhibin; Wang, Hao; Wang, Wei; Xing, Lu

    2017-07-01

    Adaptive cruise control (ACC) has been considered one of the critical components of automated driving. ACC adjusts vehicle speeds automatically by measuring the status of the ego-vehicle and leading vehicle. Current commercial ACCs are designed to be comfortable and convenient driving systems. Little attention is paid to the safety impacts of ACC, especially in traffic oscillations when crash risks are the highest. The primary objective of this study was to evaluate the impacts of ACC parameter settings on rear-end collisions on freeways. First, the occurrence of a rear-end collision in a stop-and-go wave was analyzed. A car-following model in an integrated ACC was developed for a simulation analysis. The time-to-collision based factors were calculated as surrogate safety measures of the collision risk. We also evaluated different market penetration rates considering that the application of ACC will be a gradual process. The results showed that the safety impacts of ACC were largely affected by the parameters. Smaller time delays and larger time gaps improved safety performance, but inappropriate parameter settings increased the collision risks and caused traffic disturbances. A higher reduction of the collision risk was achieved as the ACC vehicle penetration rate increased, especially in the initial stage with penetration rates of less than 30%. This study also showed that in the initial stage, the combination of ACC and a variable speed limit achieved better safety improvements on congested freeways than each single technique. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Safety evaluation for packaging (onsite) for the Pacific Northwest National Laboratory HEPA filter box

    Energy Technology Data Exchange (ETDEWEB)

    McCoy, J.C.

    1998-07-15

    This safety evaluation for packaging (SEP) evaluates and documents the safe onsite transport of eight high-efficiency particulate air (HEPA) filters in the Pacific Northwest National Laboratory HEPA Filter Box from the 300 Area of the Hanford Site to the Central Waste Complex and on to burial in the 200 West Area. Use of this SEP is authorized for 1 year from the date of release.

  6. Evaluation of droplet digital PCR for quantification of residual leucocytes in red blood cell concentrates.

    Science.gov (United States)

    Doescher, A; Loges, U; Petershofen, E K; Müller, T H

    2017-11-01

    Enumeration of residual white blood cells in leucoreduced blood components is essential part of quality control. Digital PCR has substantially facilitated quantitative PCR and was thus evaluated for measurements of leucocytes. Target for quantification of leucocytes by digital droplet PCR was the blood group gene RHCE. The SPEF1 gene was added as internal control for the entire assay starting with automated DNA extraction. The sensitivity of the method was determined by serial dilutions of standard samples. Quality control samples were analysed within 24 h, 7 days and 6 months after collection. Routine samples from leucodepleted red blood cell concentrates (n = 150) were evaluated in parallel by flow-cytometry (LeucoCount) and by digital PCR. Digital PCR reliably detected at least 0·4 leucocytes per assay. The mean difference between PCR and flow-cytometric results from 150 units was -0·01 (±1·0). DNA samples were stable for up to at least six months. PCR measurement of leucocytes in samples from plasma and platelet concentrates also provided valid results in a pilot study. Droplet digital PCR to enumerate leucocytes offers an alternative for quality control of leucoreduced blood products. Sensitivity, specificity and reproducibility are comparable to flow-cytometry. The option to collect samples over an extended period of time and the automatization introduce attractive features for routine quality control. © 2017 International Society of Blood Transfusion.

  7. In vitro combinations of red blood cell, plasma and platelet components evaluated by thromboelastography.

    Science.gov (United States)

    Agren, Anna; Edgren, Gustaf; Kardell, Malin; Ostlund, Anders; Wikman, Agneta Taune

    2014-10-01

    Thromboelastography is increasingly used to evaluate coagulation in massively bleeding patients. The aim of this study was to investigate how different combinations of blood components affect in vitro whole blood clotting measured by thromboelastography. Packed red blood cells, plasma and platelets from fresh and old blood components were mixed in vitro, in proportions of 4:4:1, 5:5:2, 8:4:1 and 2:1:0, and analysed with thromboelastography. For the ratio 4:4:1 the experiment was done at both 37 °C and 32 °C. Thromboelastography curves were within normal reference values for the blood component proportions of 4:4:1 and 5:5:2. For 8:4:1, the angle and maximal amplitude were reduced below normal values, indicating low levels of fibrinogen and/or platelets. For the 2:1:0 proportion, all parameters were affected resulting in severely impaired in vitro clot formation. The reaction-time, reflecting the coagulation factor-dependent, initial clot formation, was slightly increased at a low temperature. Prolonged storage of the components did not affect the curve. With the introduction of guidelines on the management of massive bleeding it is important to have tools for the assessment of the new protocols. In vitro evaluation of mixtures of packed red blood cells, plasma and platelets by thromboelastography may be relevant in the prediction of in vivo clot formation and haemostasis.

  8. Doppler sonographic evaluation of the digital blood flow in horses with laminitis or septic pododermatitis.

    Science.gov (United States)

    Wongaumnuaykul, Santi; Siedler, Claudia; Schobesberger, Hermann; Stanek, Christian

    2006-01-01

    The aim of this study was to evaluate the use of Doppler ultrasonography to monitor vascular blood flow dynamics in defined diseases of the equine digit in a noninvasive way. Doppler sonography was used to evaluate medial digital artery blood flow in eight horses with septic pododermatitis and four horses with laminitis in comparison with 10 horses of a control group. Doppler sonographic measurement and lameness examinations were performed in lame horses before treatment (day 0) and at 3, 6, and 9 days following treatment. Before treatment, blood flow velocities, arterial diameter, and flow volume were significantly higher in the lame horses, while pulsatility indices (PIs) were significantly lower (P pododermatitis group, but these indices were significantly lower in the laminitis group. No significant difference between the two lame groups was recorded. After treatment, blood flow velocities and flow volume decreased significantly and PIs increased significantly in both lame groups, while RI and arterial diameter did not change. No correlation between Doppler parameters and the degree of lameness was found. Doppler sonography can be used to monitor vascular blood flow dynamics in horses suffering from septic pododermatitis and laminitis, while blood flow velocities and PI can serve as parameters for monitoring the course of the disease.

  9. Evaluation of Saphenous Venipuncture and Modified Tail-clip Blood Collection in Mice

    Science.gov (United States)

    Abatan, Omorodola I; Welch, Kathleen B; Nemzek, Jean A

    2008-01-01

    The purpose of this study was to evaluate the effects of 2 methods of blood collection in unanesthetized mice. The saphenous venipuncture method was compared with a modified tail-clip technique that requires minimal restraint. Mice were evaluated through behavioral observation and plasma corticosterone levels. The results showed that the 2 methods produced similar corticosterone responses and that the tail-clip method produced fewer behavioral reactions. In addition, the effects of saphenous venipuncture method appeared to be dependent on the handler's technical expertise. When a series of 4 blood collections were performed over 1 wk, the 2 methods yielded similar corticosterone levels that did not increase over time. Some of the behavioral signs appeared to increase over the series of blood collections obtained by the saphenous venipuncture method. Serial complete blood counts showed that the tail vessels yielded higher total white blood cell, neutrophil, and lymphocyte counts than did the saphenous vein. Neither method appeared to cause stress-associated changes in the leukogram after serial blood collection. Overall, the effects of modified tail-clip method were similar to those of the saphenous venipuncture method in unanesthetized mice. PMID:18459706

  10. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  11. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

    Science.gov (United States)

    Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

    2012-01-01

    Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

  12. Evaluation of the contribution of smoking to total blood polonium-210 in Saudi population

    Energy Technology Data Exchange (ETDEWEB)

    Shabana, E.I. E-mail: eshabana@kacst.edu.sa; Elaziz, M.A. Abd; Al-Arifi, M.N.; Al-Dhawailie, A.A.; Al-Bokari, M.M-A

    2000-01-01

    A preliminary study of {sup 210}Po concentrations in the blood of some smokers and nonsmokers is presented in order to evaluate the contribution of smoking to total blood {sup 210}Po in Saudi population. Blood samples were collected from 30 volunteers and analyzed by high resolution {alpha}-spectrometry using a radiochemical technique. The technique is based on the separation of polonium from other components of the sample by wet ashing with an HNO{sub 3}/H{sub 2}O{sub 2} oxidizing mixture and spontaneous deposition on a silver disc under the relevant conditions for {alpha}-particle counting. The results indicated that a significant fraction (about 30%) of blood {sup 210}Po is related to smoking.

  13. [A quality program in haemovigilance: evaluation of the blood transfusion chain].

    Science.gov (United States)

    Le Drezen, L; Lepiouf, L; Léostic, C; Barra, J A; Le Niger, C

    2004-07-01

    Blood transfusion, like any effective therapy, involves an element of risk. In order to reduce such risks to a maximum, a legislative and statutory framework has been set up. A reliable evaluation of this system is necessary together with an efficient evaluation method whose aim is to guarantee quality service. Favouring the development of the evaluation of professional practices is one of the priorities of the National Agency of Accreditation and Evaluation in Health (ANAES) created in April 1996. Following the recommendations from ANAES, the University Hospital of Brest decided to set up an evaluation of blood transfusion chain from the prescription of blood products to the transfusion act and follow-up of receivers in two health care services. The method used for this evaluation was a clinical audit. It is a method of evaluation, which allows with the help of certain criteria, care practices to be compared to accepted references, in order to measure the quality of these practices and the results of hospital care, so that improvements may be added. We present here the method and results of this evaluation, as well as the improvements we have put in place.

  14. Technology Development, Evaluation, and Application (TDEA) FY 2001 Progress Report Environment, Safety, and Health (ESH) Division

    Energy Technology Data Exchange (ETDEWEB)

    L.G. Hoffman; K. Alvar; T. Buhl; E. Foltyn; W. Hansen; B. Erdal; P. Fresquez; D. Lee; B. Reinert

    2002-05-01

    This progress report presents the results of 11 projects funded ($500K) in FY01 by the Technology Development, Evaluation, and Application (TDEA) Committee of the Environment, Safety, and Health Division (ESH). Five projects fit into the Health Physics discipline, 5 projects are environmental science and one is industrial hygiene/safety. As a result of their TDEA-funded projects, investigators have published sixteen papers in professional journals, proceedings, or Los Alamos reports and presented their work at professional meetings. Supplement funds and in-kind contributions, such as staff time, instrument use, and workspace, were also provided to TDEA-funded projects by organizations external to ESH Divisions.

  15. [Evaluation of fructosamine as a parameter of blood glucose control in diabetic pregnant women].

    Science.gov (United States)

    Feitosa, Alina Coutinho Rodrigues; Andrade, Flávio Silva

    2014-10-01

    To evaluate the alternative parameters to monitor glycemia in pregnant women with diabetes studying the relationship between fructosamine testing and self monitoring of blood glucose in pregnant women with diabetes. Serum fructosamine levels and the self monitoring of blood glucose over 14 days before the collection of fructosamine were evaluated in 47 diabetic pregnant women. Seventy-one fructosamine levels and 2,238 glucose measurements (CGs) were analysed. Levels of fructosamine correlated with high blood glucose index (HBGI) and the standard deviation of glycemias (r = 0.28; p = 0.021 and r = 0.26; p = 0.03, respectively). The comparison between the mothers of the newborns with appropriated or large birthweight and those who gave birth to small newborns for their gestational age (SGA) showed that the latter had a lower glycemic mean (105 vs. 114 and 119 mg/dL), a higher low blood glucose index (5.8 vs. 1.3 and 0.7) and a higher percentage of hyperglycemias (11 vs. 0 and 0%) even when the fructosamine falls within the reference values (242 vs. 218 and 213 μmol/l). The levels of fructosamine can be used as further parameter to aid self monitoring of blood glucose to evaluate hyperglycemias and glycemic variability, however, this can underestimate hypoglycemias in pregnant women carrying small-for-gestational age fetuses.

  16. 75 FR 22817 - Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation...

    Science.gov (United States)

    2010-04-30

    ... of risk from, and prioritization of response to, emerging infectious diseases relevant to blood... HUMAN SERVICES Food and Drug Administration Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety and Quantitative Risk Assessment: Blood Safety and...

  17. Reevaluation of the utilization of arterial blood gas analysis in the Intensive Care Unit: effects on patient safety and patient outcome.

    Science.gov (United States)

    Blum, Franziska E; Lund, Elisa Takalo; Hall, Heather A; Tachauer, Allan D; Chedrawy, Edgar G; Zilberstein, Jeffrey

    2015-04-01

    Arterial blood gas (ABG) analysis is a useful tool to evaluate hypercapnia in the context of conditions and diseases affecting the lungs. Oftentimes, indications for ABG analysis are broad and nonspecific and lead to frequent testing without test results influencing patient management. Electronic charts of 300 intensive care unit (ICU) patients at a single institution were reviewed retrospectively. Reassessment of indications for ABGs led to a decrease of the number of ABGs in the ICU between March and November 2012. Data relating to ventilator days, length of stay, number of reintubations, mortality, complications after arterial puncture, demographics, and medications in 159 ICU patients between December 2011 and February 2012 (group 1) were compared with 141 ICU patients between December 2012 and February 2013 (group 2). Subgroup analysis in ventilated patients was performed. A decrease of number of ABGs per patient (6.12 ± 5.9, group 1 vs 2.03 ± 1.66, group 2 in ventilated patients; P = .007) was found along with a decrease in the number of ventilator days per patient (P = .004) and a shorter length of stay for ventilated patients in group 2 compared with group 1 (P = .04). A significant decrease of ABGs obtained in the ICU does not negatively impact patient outcome and safety. A decrease in the number of ABGs per patient allows cost-efficient patient care with a lower risk for complications. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Evaluation Standard for Safety Coefficient of Roller Compacted Concrete Dam Based on Finite Element Method

    Directory of Open Access Journals (Sweden)

    Bo Li

    2014-01-01

    Full Text Available The lack of evaluation standard for safety coefficient based on finite element method (FEM limits the wide application of FEM in roller compacted concrete dam (RCCD. In this paper, the strength reserve factor (SRF method is adopted to simulate gradual failure and possible unstable modes of RCCD system. The entropy theory and catastrophe theory are used to obtain the ultimate bearing resistance and failure criterion of the RCCD. The most dangerous sliding plane for RCCD failure is found using the Latin hypercube sampling (LHS and auxiliary analysis of partial least squares regression (PLSR. Finally a method for determining the evaluation standard of RCCD safety coefficient based on FEM is put forward using least squares support vector machines (LSSVM and particle swarm optimization (PSO. The proposed method is applied to safety coefficient analysis of the Longtan RCCD in China. The calculation shows that RCCD failure is closely related to RCCD interface strength, and the Longtan RCCD is safe in the design condition. Considering RCCD failure characteristic and combining the advantages of several excellent algorithms, the proposed method determines the evaluation standard for safety coefficient of RCCD based on FEM for the first time and can be popularized to any RCCD.

  19. Method of evaluation of process of red blood cell sedimentation based on photometry of droplet samples.

    Science.gov (United States)

    Aristov, Alexander; Nosova, Ekaterina

    2017-04-01

    The paper focuses on research aimed at creating and testing a new approach to evaluate the processes of aggregation and sedimentation of red blood cells for purpose of its use in clinical laboratory diagnostics. The proposed method is based on photometric analysis of blood sample formed as a sessile drop. The results of clinical approbation of this method are given in the paper. Analysis of the processes occurring in the sample in the form of sessile drop during the process of blood cells sedimentation is described. The results of experimental studies to evaluate the effect of the droplet sample focusing properties on light radiation transmittance are presented. It is shown that this method significantly reduces the sample volume and provides sufficiently high sensitivity to the studied processes.

  20. GROWTH OF THE INTERNATIONAL CRITICALITY SAFETY AND REACTOR PHYSICS EXPERIMENT EVALUATION PROJECTS

    Energy Technology Data Exchange (ETDEWEB)

    J. Blair Briggs; John D. Bess; Jim Gulliford

    2011-09-01

    Since the International Conference on Nuclear Criticality Safety (ICNC) 2007, the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and the International Reactor Physics Experiment Evaluation Project (IRPhEP) have continued to expand their efforts and broaden their scope. Eighteen countries participated on the ICSBEP in 2007. Now, there are 20, with recent contributions from Sweden and Argentina. The IRPhEP has also expanded from eight contributing countries in 2007 to 16 in 2011. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Criticality Safety Benchmark Experiments1' have increased from 442 evaluations (38000 pages), containing benchmark specifications for 3955 critical or subcritical configurations to 516 evaluations (nearly 55000 pages), containing benchmark specifications for 4405 critical or subcritical configurations in the 2010 Edition of the ICSBEP Handbook. The contents of the Handbook have also increased from 21 to 24 criticality-alarm-placement/shielding configurations with multiple dose points for each, and from 20 to 200 configurations categorized as fundamental physics measurements relevant to criticality safety applications. Approximately 25 new evaluations and 150 additional configurations are expected to be added to the 2011 edition of the Handbook. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Reactor Physics Benchmark Experiments2' have increased from 16 different experimental series that were performed at 12 different reactor facilities to 53 experimental series that were performed at 30 different reactor facilities in the 2011 edition of the Handbook. Considerable effort has also been made to improve the functionality of the searchable database, DICE (Database for the International Criticality Benchmark Evaluation Project) and verify the accuracy of the data contained therein. DICE will be discussed in separate papers at ICNC 2011. The status of the

  1. Assessment of the global trigger tool to measure, monitor and evaluate pateint safety in cancer patients

    DEFF Research Database (Denmark)

    Otto Mattsson, Thea; Lehmann-Knudsen, Janne; Lauritsen, Jens M

    2013-01-01

    BACKGROUND: Countries around the world are currently aiming to improve patient safety by means of the Institute for Healthcare Improvement global trigger tool (GTT), which is considered a valid tool for evaluating and measuring patient safety within organisations. So far, only few data....... RESULTS: Only 31% of adverse events (AE) were identified by both teams, and further differences in categorisation of identical events was found. Moderate interrater agreement (κ=0.45) between teams gave rise to different conclusions on the patient safety process when monitoring using SPC charts. The Bland...... on identical charts by two independent review teams in 2010 at a department of oncology in a university hospital. Standard GTT outcome measurements were obtained and compared between teams using statistical process control (SPC) charts. A Bland-Altman plot assessed measurement error and limits of agreement...

  2. Restart of K-Reactor, Savannah River Site: Safety evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1991-04-01

    This Safety Evaluation Report (SER) focuses on those issues required to support the restart of the K-Reactor at the Savannah River Plant. This SER provides the safety criteria for restart and documents the results of the staff reviews of the DOE and operating contractor activities to meet these criteria. To develop the restart criteria for the issues discussed in this SER, the Savannah River Restart Office and Savannah River Special Projects Office staffs relied, when possible, on commercial industry codes and standards and on NRC requirements and guidelines for the commercial nuclear industry. However, because of the age and uniqueness of the Savannah River reactors, criteria for the commercial plants were not always applicable. In these cases, alternate criteria were developed. The restart criteria applicable to each of the issues are identified in the safety evaluations for each issue. The restart criteria identified in this report are intended to apply only to restart of the Savannah River reactors. Following the development of the acceptance criteria, the DOE staff and their support contractors evaluated the results of the DOE and operating contractor (WSRC) activities to meet these criteria. The results of those evaluations are documented in this report. Deviations or failures to meet the requirements are either justified in the report or carried as open or confirmatory items to be completed and evaluated in supplements to this report before restart. 62 refs., 1 fig.

  3. Evaluating ambulatory practice safety: the PROMISES project administrators and practice staff surveys.

    Science.gov (United States)

    Singer, Sara J; Reyes Nieva, Harry; Brede, Namara; Ling, Judy; Leydon, Nicholas; Weissman, Joel S; Goldmann, Don; Griswold, Paula; Yoon, Catherine; Orav, E John; Bates, David W; Biondolillo, Madeleine; Schiff, Gordon D

    2015-02-01

    Ambulatory practices deliver most health care services and contribute to malpractice risk. Yet, policymakers and practitioners often lack information about safety and malpractice risk needed to guide improvement. To assess staff and administrator perceptions of safety and malpractice risk in ambulatory settings. We administered surveys in small-sized to medium-sized primary care practices in Massachusetts as part of a randomized controlled trial to reduce ambulatory malpractice risk. Twenty-five office practice managers/administrators and 482 staff, including [physicians, physician assistants, and nurse practitioners (MD/PA/NPs)], nurses, other clinicians, managers, and administrators. Surveys included structured questions about 3 high-risk clinical domains: referral, test result, and medication management, plus communication with patients and among staff. The 30-item administrator survey evaluated the presence of organizational safety structures and processes; the 63-item staff survey queried safety and communication concerns. Twenty-two administrators (88%) and 292 staff (61%) responded. Administrators frequently reported important safety systems and processes were absent. Suboptimal or incomplete implementation of referral and test result management systems related to staff perceptions of their quality (Pmanagement system safety, talking openly about safety problems, willingness to report mistakes, and feeling rushed. MD/PA/NPs viewed high-risk system reliability more negatively (P<0.0001) and teamwork more positively (P<0.03) than others. Results show opportunities for improvement in closing informational loops and establishing more reliable systems and environments where staff feels respected and safe speaking up. Initiatives to transform primary care should emphasize improving communication among facilities and practitioners.

  4. Evaluation of the efficacy and safety of the ophthalmic insert Mydriasert in patients undergoing retinal angiography.

    Science.gov (United States)

    Cagini, Carlo; Caricato, Anna; Tosi, Gianluigi; Pascale, Angelo; Cesari, Claudia; Fiore, Tito

    2014-01-01

    To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert (ophthalmic insert containing tropicamide and phenylephrine) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops (tropicamide 1% and phenylephrine 10%). This was a prospective randomized study. A total of 154 eyes of 77 patients were randomly divided into 2 groups: group 1 consisted of 78 eyes, group 2 consisted of 76 eyes, and the patients were monitored for pupillary dilation, blood pressure, heart rate, and possible adverse effects at 0, 20, 40, 60, and 90 minutes. No severe adverse effects were observed in either group. In the entire sample studied, the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes, while mydriasis was similar in the 2 groups after 60 minutes. The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes, and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes. There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points. Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients. There are no differences in efficacy or safety between the insert and the usually administered eyedrops, but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects.

  5. Preliminary safety evaluation of the Gas Turbine-Modular Helium Reactor (GT-MHR)

    Energy Technology Data Exchange (ETDEWEB)

    Dunn, T.D.; Lommers, L.J.; Tangirala, V.E.

    1994-04-01

    A qualitative comparison between the safety characteristics of the Gas Turbine-Modular Helium Reactor (GT-MHR) and those of the steam cycle shows that the two designs achieve equivalent levels of overall safety performance. This comparison is obtained by applying the scaling laws to detailed steam-cycle computations as well as the conclusions obtained from preliminary GT-MHR model simulations. The gas turbine design is predicted to be superior for some event categories, while the steam cycle design is better for others. From a safety perspective, the GT-MHR has a modest advantage for pressurized conduction cooldown events. Recent computational simulations of 102 column, 550 MW(t) GT-MHR during a depressurized conduction cooldown show that peak fuel temperatures are within the limits. The GT-MHR has a significantly lower risk due to water ingress events under operating conditions. Two additional scenarios, namely loss of load event and turbine deblading event that are specific to the GT-MHR design are discussed. Preliminary evaluation of the GT-MHR`s safety characteristics indicate that the GT-MHR can be expected to satisfy or exceed its safety requirements.

  6. Portable blood gas and electrolyte analyzer evaluated in a multiinstitutional study

    NARCIS (Netherlands)

    J. Lindemans (Jan); P. Hoefkens (Peter); A.L. van Kessel; M. Bonnay; W.R. Kulpmann; J.D.E. van Suijlen

    1999-01-01

    textabstractA recently introduced blood gas/electrolyte analyzer (SenDx 100((R)), renamed ABL70) intended for point-of-care, near-patient, or stat laboratory use was evaluated simultaneously in four different institutions and compared with three different laboratory

  7. EVALUATION OF ADHERENCE FUNCTION FOR VARIOUS SUBPOPULATIONS OF PERIPHERAL BLOOD MONONUCLEARS TO ENDOTHELIAL CELLS

    Directory of Open Access Journals (Sweden)

    D. I. Sokolov

    2007-01-01

    Full Text Available Abstract. In present article, essentially new methods are described for evaluation of adhesion of peripheral blood mononuclears to human endothelial cell line Ea.Hy926. These methods are suitable for both experimental purposes and research in clinical immunology, including laboratory diagnostics of immune deficiencies, infectious diseases, complicated pregnancy, and other kinds of clinical disorders.

  8. Evaluation of a radioimmunoassay (/sup 125/I) kit for cannabinoid metabolites in urine and whole blood

    Energy Technology Data Exchange (ETDEWEB)

    Childs, P.S.; McCurdy, H.H.

    The Abuscreen kit (Roche Diagnostics) for the analysis of 11-nor-..delta../sup 9/-tetrahydrocannabinol-9-carboxylic acid and other cannabinoids in urine was evaluated in terms of its accuracy, reproducibility, and sensitivity. A procedure is also presented for the analysis of total cannabinoids in whole blood using the RIA kit.

  9. Evaluation of Patient Safety Culture and Organizational Culture as a Step in Patient Safety Improvement in a Hospital in Jakarta, Indonesia

    Directory of Open Access Journals (Sweden)

    Afrisya Iriviranty

    2016-07-01

    Full Text Available Introduction: Establishment of patient safety culture is the first step in the improvement of patient safety. As such, assessment of patient safety culture in hospitals is of paramount importance. Patient safety culture is an inherent component of organizational culture, so that the study of organizational culture is required in developing patient safety. This study aimed to evaluate patient safety culture among the clinical staff of a hospital in Jakarta, Indonesia and identify organizational culture profile. Materials and Methods: This cross-sectional, descriptive, qualitative study was conducted in a hospital in Jakarta, Indonesia in 2014. Sample population consisted of nurses, midwives, physicians, pediatricians, obstetrics and gynecology specialists, laboratory personnel, and pharmacy staff (n=152. Data were collected using the Hospital Survey on Patient Safety Culture developed by the Agency for Healthcare Research and Quality (AHRQ and Organizational Culture Assessment Instrument (OCAI. Results: Teamwork within units” was the strongest dimension of patient safety culture (91.7%, while “staffing” and “non-punitive response to error” were the weakest dimensions (22.7%. Moreover, clan culture was the most dominant type of organizational culture in the studied hospital. This culture serves as a guide for the changes in the healthcare organization, especially in the development of patient safety culture. Conclusion: According to the results of this study, healthcare providers were positively inclined toward the patient safety culture within the organization. As such, the action plan was designed through consensus decision-making and deemed effective in articulating patient safety in the vision and mission of the organization.

  10. Evaluation of Risk Minimisation Measures for Blood Components - Based on Reporting Rates of Transfusion-Transmitted Reactions (1997-2013).

    Science.gov (United States)

    Funk, Markus B; Heiden, Margarethe; Volkers, Peter; Lohmann, Annette; Keller-Stanislawski, Brigitte

    2015-07-01

    To assess the impact of safety measures, we compared reporting rates of transfusion-related reactions before and after the implementation of six measures in 1999, 2004, 2006, 2008 and 2009. Reporting rates of transfusion-transmitted bacterial infection (TTBI), viral infection (TTVI) and immune-mediated transfusion-related acute lung injury (TRALI) were calculated on the basis of confirmed annual reports and distributed blood components. The introduction of HCV NAT testing caused a significant reduction of HCV reporting rate from 1:0.6 to 1:83.16 million administered blood components (p haemovigilance data, a significant benefit could be demonstrated for four of six implemented safety measures.

  11. Evaluation of noninvasive oscillometric blood pressure monitoring in anesthetized boid snakes.

    Science.gov (United States)

    Chinnadurai, Sathya K; Wrenn, Amy; DeVoe, Ryan S

    2009-03-01

    To determine the accuracy of a noninvasive oscillometric monitor in the measurement of arterial blood pressure in anesthetized boid snakes. Evaluation study. 4 boa constrictors (Boa constrictor), 2 carpet pythons (Morelia spilota), and 2 reticulated pythons (Python reticulatus). After induction of anesthesia with isoflurane, each snake was instrumented with an arterial catheter connected to a pressure transducer and oscilloscope to obtain invasive measurements of systolic (SAP), diastolic (DAP), and mean (MAP) arterial blood pressure as well as a pressure waveform. A cuff connected to an oscillometric device was placed on the tail immediately distal to the vent for noninvasive measurements. Heart rate, respiratory rate, and invasive and noninvasive measurements of SAP, DAP, and MAP were obtained every 5 minutes for 45 minutes. Delivered isoflurane concentration was increased in 15-minute increments to induce hypotension. Repeatability of each device and fixed and proportional biases between devices were calculated. Throughout most of the measured ranges of blood pressures, the oscillometric unit overestimated the SAP and underestimated the DAP and MAP, compared with respective direct measurements. When the invasively determined SAP was > 100 mm Hg, the oscillometric unit underestimated all 3 variables. Fixed bias was significant for SAP and DAP, and proportional bias was significant for SAP and MAP. When using an oscillometric blood pressure monitor on anesthetized boid snakes, veterinarians can potentially monitor changes in blood pressure, although the displayed readings may underestimate DAP and MAP and overestimate SAP. Indirect measurements of blood pressure made with the oscillometric device cannot substitute for direct measurements.

  12. Evaluation of blood cell attachment on Er: YAG laser applied root surface using scanning electron microscopy.

    Science.gov (United States)

    Cekici, Ali; Maden, Ilay; Yildiz, Sercan; San, Tangul; Isik, Gulden

    2013-01-01

    Periodontal regeneration is dependent on the uninterrupted adhesion, maturation and absorption of fibrin clots to a periodontally compromised root surface. The modification of the root surface with different agents has been used for better fibrin clot formation and blood cell attachment. It is known that Er:YAG laser application on dentin removes the smear layer succesfully. The aim of this study is to observe blood cell attachment and fibrin network formation following ER:YAG laser irradiation on periodontally compromised root surfaces in comparison to chemical root conditioning techniques in vitro. 40 dentin blocks prepared from freshly extracted periodontally compromised hopeless teeth. Specimens were divided in 5 groups; those applied with PBS, EDTA, Citric acid and Er:YAG. They were further divided into two groups: those which had received these applications, and the control group. The specimens were evaluated with scanning electron microscope and micrographs were taken. Smear layer and blood cell attachment scoring was performed. In the Er:YAG laser applied group, smear layer were totally removed. In the blood applied specimens, better fibrin clot formation and blood cell attachment were observed in the Er:YAG group. In the group that had been applied with citric acid, the smear layer was also removed. The smear layer could not be fully removed in the EDTA group. Er:YAG laser application on the root dentin seems to form a suitable surface for fibrin clot formation and blood cell attachment. Further clinical studies to support these results are necessitated.

  13. Blood pressure reduction, persistence and costs in the evaluation of antihypertensive drug treatment – a review

    Directory of Open Access Journals (Sweden)

    Hasford Joerg

    2009-03-01

    Full Text Available Abstract Background Blood pressure lowering drugs are usually evaluated in short term trials determining the absolute blood pressure reduction during trough and the duration of the antihypertensive effect after single or multiple dosing. A lack of persistence with treatment has however been shown to be linked to a worse cardiovascular prognosis. This review explores the blood pressure reduction and persistence with treatment of antihypertensive drugs and the cost consequences of poor persistence with pharmaceutical interventions in arterial hypertension. Methods We have searched the literature for data on blood pressure lowering effects of different antihypertensive drug classes and agents, on persistence with treatment, and on related costs. Persistence was measured as patients' medication possession rate. Results are presented in the form of a systematic review. Results Angiotensin II receptor blocker (ARBs have a competitive blood pressure lowering efficacy compared with ACE-inhibitors (ACEi and calcium channel blockers (CCBs, beta-blockers (BBs and diuretics. 8 studies describing the persistence with treatment were identified. Patients were more persistent on ARBs than on ACEi and CCBs, BBs and diuretics. Thus the product of blood pressure lowering and persistence was higher on ARBs than on any other drug class. Although the price per tablet of more recently developed drugs (ACEi, ARBs is higher than that of older ones (diuretics and BBs, the newer drugs result in a more favourable cost to effect ratio when direct drug costs and indirect costs are also considered. Conclusion To evaluate drugs for the treatment of hypertension several key variables including the blood pressure lowering effect, side effects, compliance/persistence with treatment, as well as drug costs and direct and indirect costs of medical care have to be considered. ARBs, while nominally more expensive when drug costs are considered only, provide substantial cost savings

  14. In vivo evaluation of centrifugal blood pump for cardiopulmonary bypass-Spiral Pump.

    Science.gov (United States)

    da Silva, Cibele; da Silva, Bruno Utiyama; Leme, Juliana; Uebelhart, Beatriz; Dinkhuysen, Jarbas; Biscegli, José F; Andrade, Aron; Zavaglia, Cecília

    2013-11-01

    The Spiral Pump (SP), a centrifugal blood pump for cardiopulmonary bypass (CPB), has been developed at the Dante Pazzanese Institute of Cardiology/Adib Jatene Foundation laboratories, with support from Sintegra Company (Pompeia, Brazil). The SP is a disposable pump with an internal rotor-a conically shaped fuse with double entrance threads. This rotor is supported by two ball bearings, attached to a stainless steel shaft fixed to the housing base. Worm gears provide axial motion to the blood column, and the rotational motion of the conically shaped impeller generates a centrifugal pumping effect, improving pump efficiency without increasing hemolysis. In vitro tests were performed to evaluate the SP's hydrodynamic performance, and in vivo experiments were performed to evaluate hemodynamic impact during usual CPB. A commercially available centrifugal blood pump was used as reference. In vivo experiments were conducted in six male pigs weighing between 60 and 90 kg, placed on CPB for 6 h each. Blood samples were collected just before CPB (T0) and after every hour of CPB (T1-T6) for hemolysis determination and laboratory tests (hematological and biochemical). Values of blood pressure, mean flow, pump rotational speed, and corporeal temperature were recorded. Also, ergonomic conditions were recorded: presence of noise, difficulty in removing air bubbles, trouble in installing the pump in the drive module (console), and difficulties in mounting the CPB circuit. Comparing the laboratory and hemolysis results for the SP with those of the reference pump, we can conclude that there is no significant difference between the two devices. In addition, reports made by medical staff and perfusionists described a close similarity between the two devices. During in vivo experiments, the SP maintained blood flow and pressure at physiological levels, consistent with those applied in cardiac surgery with CPB, without presenting any malfunction. Also, the SP needed lower rotational

  15. Development and Psychometric Evaluation of the Patient Safety Violation Scale in Medical Oncology Units in Iran.

    Science.gov (United States)

    Shali, Mahboobeh; Ghaffari, Fatemeh; Joolaee, Soodabeh; Ebadi, Abbas

    2016-01-01

    Patient safety is one of the key components of nursing care for cancer cases. Valid and reliable context-based instruments are necessary for accurate evaluation of patient safety in oncology units. The aim of the present study was to develop and evaluate the psychometric properties of the Patient Safety Violation Scale in medical oncology units in Iran. In this methodological study, a pool of 58 items was generated through reviewing the existing literature. The validity of the 58-item scale was assessed through calculating impact score, content validity ratio, and content validity index for its items as well as conducting exploratory factor analysis. The reliability of the scale was evaluated by assessing its internal consistency and test- retest stability. Study sample consisted of 300 oncology nurses who were recruited from thirteen teaching hospitals affiliated to Tehran University of Medical Sciences, Tehran, Iran. Sixteen items were excluded from the scale due to having low impact scores, content validity ratios, or content validity indices. In exploratory factor analysis, the remaining 42 items were loaded on five factors including patient fall, verification of patientidentity, harm during care delivery, delay in care delivery, and medication errors. These five factors explained 62% of the total variance. The Cronbach's alpha of the scale and the test-retest interclass correlation coefficient were equal to 0.933 and 0.92, respectively. The 42-item Patient Safety Violation Scale is a simple and short scale which has acceptable validity and reliability. Consequently, it can be used for assessing patient safety in clinical settings such as medical oncology units and for research projects.

  16. Human health safety evaluation of cosmetics in the EU: a legally imposed challenge to science.

    Science.gov (United States)

    Pauwels, M; Rogiers, V

    2010-03-01

    As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alone piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.

  17. Safety Evaluation Report for the Claiborne Enrichment Center, Homer, Louisiana (Docket No. 70-3070)

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    This report documents the US Nuclear Regulatory Commission (NRC) staff review and safety evaluation of the Louisiana Energy Services, L.P. (LES, the applicant) application for a license to possess and use byproduct, source, and special nuclear material and to enrich natural uranium to a maximum of 5 percent U-235 by the gas centrifuge process. The plant, to be known as the Claiborne Enrichment Center (CEC), would be constructed near the town of Homer in Claiborne Parish, Louisiana. At full production in a given year, the plant will receive approximately 4,700 tonnes of feed UF{sub 6} and produce 870 tonnes of low-enriched UF{sub 6}, and 3,830 tonnes of depleted UF{sub 6} tails. Facility construction, operation, and decommissioning are expected to last 5, 30, and 7 years, respectively. The objective of the review is to evaluate the potential adverse impacts of operation of the facility on worker and public health and safety under both normal operating and accident conditions. The review also considers the management organization, administrative programs, and financial qualifications provided to assure safe design and operation of the facility. The NRC staff concludes that the applicant`s descriptions, specifications, and analyses provide an adequate basis for safety review of facility operations and that construction and operation of the facility does not pose an undue risk to public health and safety.

  18. Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists.

    Science.gov (United States)

    Walpola, Ramesh L; Fois, Romano A; McLachlan, Andrew J; Chen, Timothy F

    2017-02-25

    Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns' patient safety attitudes. However, other factors likely influenced their attitudes in the longer term.

  19. Evaluation of canine red blood cell quality after processing with an automated cell salvage device.

    Science.gov (United States)

    Hofbauer, Nina; Windberger, Ursula; Schwendenwein, Ilse; Tichy, Alexander; Eberspächer, Eva

    2016-05-01

    To evaluate the properties of RBC concentrate harvested after processing fresh whole blood units from healthy dogs with an automated cell salvage device. Prospective, in vitro, experimental study. University teaching hospital. Sixteen healthy, privately owned dogs of various breeds. Fresh canine whole blood collected in bags with citrate phosphate dextrose adenine solution was processed with an automated cell salvage device and analyzed in vitro. Laboratory values determined before (baseline, from a catheter sample) and after processing RBCs (procRBCs) included a complete blood count, selected blood chemistry analytes, erythrocyte osmotic resistance, whole blood viscosity, RBC aggregation, and RBC deformability. Total recovery of RBCs was 80% ± 12%. Hematocrit of the procRBCs yielded by the device was 77% ± 3.7% (mean ± standard deviation). Gross morphology of the RBCs remained unchanged. The mean corpuscular volume, erythrocyte osmotic resistance, RBC deformability, RBC aggregation, and the activity of lactate dehydrogenase showed minor but statistically significant changes from baseline. No differences in the concentrations of free hemoglobin were observed. Whole blood viscosity was less in the procRBCs. Seventy-seven percent (mean) of the platelets were washed out, while a mean of 57% of the leukocytes remained in the procRBCs. Although processing canine blood with this automated cell salvage device leads to slight changes in some properties of RBCs, most of these changes are comparable to changes seen in human blood after processing. Present data indicate that the use of this cell salvage device does not induce changes in canine RBC concentrate that would preclude its use for transfusion. © Veterinary Emergency and Critical Care Society 2016.

  20. Evaluation of S-101 courses Orientation to Occupational Safety Compliance in DOE''

    Energy Technology Data Exchange (ETDEWEB)

    Wright, T S

    1992-02-01

    This section summarizes trainee evaluations for the Safety Training Section course, Supervisors' Orientation to Occupational Safety in DOE,'' (S-101) which was conducted August 5 to 8, 1991 at Hanford, in Richland, Washington. This report summarizes the quantitative course evaluations that trainees provided upon completion of the course. Appendix A provides a transcript of the trainees' written comments. Numeric course ratings were generally positive and show that the course material and instruction were very effective. Written comments supported the positive numeric ratings. The course content and knowledge gained by the trainees exceeded most of the students' expectations of the course. Results from the final examination showed that students gained significant knowledge from the course.

  1. Safety evaluation for packaging (onsite) plutonium recycle test reactor graphite cask

    Energy Technology Data Exchange (ETDEWEB)

    Romano, T.

    1997-09-29

    This safety evaluation for packaging (SEP) provides the evaluation necessary to demonstrate that the Plutonium Recycle Test Reactor (PRTR) Graphite Cask meets the requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for transfer of Type B, fissile, non-highway route controlled quantities of radioactive material within the 300 Area of the Hanford Site. The scope of this SEP includes risk, shieldling, criticality, and.tiedown analyses to demonstrate that onsite transportation safety requirements are satisfied. This SEP also establishes operational and maintenance guidelines to ensure that transport of the PRTR Graphite Cask is performed safely in accordance with WHC-CM-2-14. This SEP is valid until October 1, 1999. After this date, an update or upgrade to this document is required.

  2. ApproAches to AdvAncing Blood sAfety through hAemovigilAnce: A ...

    African Journals Online (AJOL)

    2009-12-01

    Dec 1, 2009 ... and anaphylaxis. the term “safe blood transfusion” implies an outcome that is totally beneficent and nonmaleficent to the patient. Safe blood practice is dependent on several factors including selection of volunteer blood donors with low risk for transfusion transmissible infections (tti), aseptic collection of.

  3. Evaluating North Carolina Food Pantry Food Safety-Related Operating Procedures.

    Science.gov (United States)

    Chaifetz, Ashley; Chapman, Benjamin

    2015-11-01

    Almost one in seven American households were food insecure in 2012, experiencing difficulty in providing enough food for all family members due to a lack of resources. Food pantries assist a food-insecure population through emergency food provision, but there is a paucity of information on the food safety-related operating procedures used in the pantries. Food pantries operate in a variable regulatory landscape; in some jurisdictions, they are treated equivalent to restaurants, while in others, they operate outside of inspection regimes. By using a mixed methods approach to catalog the standard operating procedures related to food in 105 food pantries from 12 North Carolina counties, we evaluated their potential impact on food safety. Data collected through interviews with pantry managers were supplemented with observed food safety practices scored against a modified version of the North Carolina Food Establishment Inspection Report. Pantries partnered with organized food bank networks were compared with those that operated independently. In this exploratory research, additional comparisons were examined for pantries in metropolitan areas versus nonmetropolitan areas and pantries with managers who had received food safety training versus managers who had not. The results provide a snapshot of how North Carolina food pantries operate and document risk mitigation strategies for foodborne illness for the vulnerable populations they serve. Data analysis reveals gaps in food safety knowledge and practice, indicating that pantries would benefit from more effective food safety training, especially focusing on formalizing risk management strategies. In addition, new tools, procedures, or policy interventions might improve information actualization by food pantry personnel.

  4. [Evaluation of the blood analyzer Beckman Coulter LH 750: analytic performance, decision rules].

    Science.gov (United States)

    Amouroux, I; Balay, M; Marfaing-Koka, A

    2003-01-01

    We evaluated the new analyzer Beckman Coulter, an instrument dedicated to the cell blood count (CBC) and to the white blood cell (WBC) differential (including nucleated red blood cells (NRBCs)) over a global one month period, with three purposes: 1) evaluation of the analytical performance (precision, reproducibility, contamination, linearity); 2) accuracy of numerical results, by comparison to the laboratory instrument (CBC and WBC diff) or to the blood smear (NRBCs, low platelets); 3) evaluation, in terms of sensitivity and specificity, a set of abnormality messages built from the suspect flags and a few quantitative abnormalities. The analytical performances were found satisfactory. The WBC and platelet ranges of linearity were wider than in the GEN.S, as stated in the system specifications. However, the lack of adequate biological material made impossible the study of the whole mentioned linearity range. The accuracy of the CBC and differential parameters, as well as of reticulocytes, was studied with the Coulter GEN.S as reference instrument. The coefficients of correlation and the regression lines showed that the LH 750 results were similar to the GEN.S results. Furthermore, samples with thrombocytopenia and circulating NRBCs were evaluated and compared to the result obtained with microscopic lecture. The results showed a good relationship between platelets results given by the GEN.S and manual count leading to appropriate decision of transfusion. The correlation between GEN.S and manual count of NRBC was estimated as satisfactory. We used the LH 750 software to create conditional rules on the basis of qualitative and quantitative criteria, in order to define and enter a message system for detection of abnormalities. Our study showed that such a system flagged 95.7% of morphological abnormalities with a rate of unnecessary slide review (absence of any morphological abnormality on the blood smear) estimated at 8.3%. Furthermore, in 86% of the abnormalities

  5. Criticality safety evaluation of disposing of K Basin sludge in double-shell tank AW-105

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    1999-06-04

    A criticality safety evaluation is made of the disposal of K Basin sludge in double-shell tank (DST) AW-105 located in the 200 east area of Hanford Site. The technical basis is provided for limits and controls to be used in the development of a criticality prevention specification (CPS). A model of K Basin sludge is developed to account for fuel burnup. The iron/uranium mass ration required to ensure an acceptable magrin of subcriticality is determined.

  6. Safety evaluation for packaging for onsite transfer of B Plant organic waste

    Energy Technology Data Exchange (ETDEWEB)

    Mercado, M.S.

    1996-10-07

    This safety evaluation for packaging authorizes the use of a 17,500-L (4,623-gal) tank manufactured by Brenner Tank, Incorporated, to transport up to 16,221 L (4,285 gal) of radioactive organic liquid waste. The waste will be transported from the organic loading pad to a storage pad. Both pads are within the B Plant complex, but approximately 4 mi apart.

  7. Safety evaluation of Bon-sant? cleanser? polyherbal in male Wistar rats

    OpenAIRE

    O.E. Kale; Awodele, O.

    2016-01-01

    Background The potential harm of medicinal herbs has been recently observed following herbal toxicity studies after ingestion of polyherbal remedies. This was the rationale for the food and drug regulatory agency decision for thorough safety evaluation of herbal medicines. Androgenic, antipyretic, analgesic and anti-inflammatory potentials as well as chemical compositions of extracts of massularia acuminata, terminalia ivorensis, anogeissus leiocarpus and macuna pruriens respectively have bee...

  8. Application safety evaluation of the radio frequency identification tag under magnetic resonance imaging

    OpenAIRE

    Fei, Xiaolu; Li,Shanshan; Gao, Shan; Wei, Lan; Wang, Lihong

    2014-01-01

    Background Radio Frequency Identification(RFID) has been widely used in healthcare facilities, but it has been paid little attention whether RFID applications are safe enough under healthcare environment. The purpose of this study is to assess the effects of RFID tags on Magnetic Resonance (MR) imaging in a typical electromagnetic environment in hospitals, and to evaluate the safety of their applications. Methods A Magphan phantom was used to simulate the imaging objects, while active RFID ta...

  9. Evaluation of HBsAg, anti-HCV, anti-HIV and VDRL test results in blood donors

    Directory of Open Access Journals (Sweden)

    Canan Ağalar

    2011-12-01

    Full Text Available Objectives: The most frequently encountered complication in the transfusion of blood and blood products are transmitted infections from these products. Infections caused by hepatitis B virus (HBV, hepatitis C virus (HCV, and human immunodeficiency virus (HIV remain the leading most important health problems in the transfusion of blood and blood products worldwide. Therefore, screening tests such as HBsAg, anti-HCV, anti-HIV, and RPR or VDRL for Treponema pallidum are mandatory tests to look at before transfusion of blood and blood products. In this study, the screening tests results of blood donors examined were evaluated and the results were compared with the results of the other blood banks stated in our country.Materials and methods: Screening tests results of a total of 784 blood donors, which have been admitted the Kırıkkale University Hospital Blood Center for blood donation between January 2003 and December 2004, evaluated retrospectively. Blood samples which taken from blood donors before blood donation were investigated for HBsAg, anti-HCV, and anti-HIV tests with chemiluminescense (ELISA method by automated analyzer. VDRL screening test was investigated by commercial test kit.Results: A total of 734 (93.7% of 784 blood donors were male and 50 (6.3% were female. HBsAg was positive in 11 (1.4% blood donors and anti-HCV in 2 (0.2% blood donors. None of the blood donors were found to anti-HIV and VDRL seropositivity.Conclusions: Seropositivity rates of HBsAg and anti-HCV were lower than that of Turkey in general. J Clin Exp Invest 2011; 2 (4: 416-419

  10. Development of Non-safety System Architecture and Evaluation of Components/Systems

    Energy Technology Data Exchange (ETDEWEB)

    Oh, I. S.; Lee, C. K.; Kim, D. H.; Lee, J. W.; Lee, D. Y.; Park, W. M.; Hwang, I. K.; Hur, S.; Kim, J. T.; Park, J. C.; Lee, J. W

    2007-10-15

    We describe in this report the works performed for a technical evaluation of the non-safety digital control system of the KNICS, the non-safety process control system of the KNICS, a communication load analysis for the MMIS (including both the non-safety and the safety systems) of the KNICS, the development of MMI and an implementation of the logic for the CVCS, and the works performed to support writing a proposal needed for bidding an I and C system based on the KNICS. The technical evaluation results were aimed to be used by the designers to detect parts needed to be corrected or to be newly inserted, and also by the developers during the development phase. The requirement specifications and the data requirement characteristics have been identified for each subsystem of the determined KNICS structure. For each communication node, the specifications related to the data transfer including the data capacity for interfaces, delay time for the data transfer, and the marginal availability of its performance capabilities have been analyzed to identify the amount of data transfer and hence to verify that both of the designed structures for the safety related communications network and for the digital communications network are appropriate. The results of the supporting work performed for writing the technical specifications related to each subsystem of the KNICS structure, are expected to be useful in writing a proposal for the expected Uljin new units 1 and 2, and in the I and C upgrade for any of the existing nuclear power plants under operation. Also included in this report are the descriptions on a design of the chemical volume control system (CVCS), on the supporting work performed to draw the logic diagrams for CVCS using the tool ISaGRAF, and on the generation of a set of system displays to be used as references.

  11. Evaluating Nurses' Perception of Patient Safety Design Features in Intensive Care Units.

    Science.gov (United States)

    Islam, Faria; Rashid, Mahbub

    A methodological study was conducted to test the validity and reliability of the patient safety (PS) scale developed by Rashid (2007) for evaluating nurses' perception of adult intensive care unit (ICU) design features related to patient safety. Data for the study were collected using a Web-based survey instrument. A link to the survey instrument was posted on the Web site of American Association of Critical-Care Nurses (AACN) for ICU nurses in different US states to participate. A sample of 587 valid responses was divided into 2 halves for cross-validation. The first half of the sample was used for exploratory factor analysis and the second half for confirmatory factor analysis. This method was applied to identify any latent factor structure in the PS scale. Based on the factor analyses, 4 relevant PS subscales-Efficient Work Process, Patient Room, Accessibility and Visibility, and Maintain Sterility-were identified. These PS subscales were used to investigate whether ICU unit characteristics, nurse characteristics, and hospital type affected nurses' perception of ICU design features in relation to patient safety. The study shows that nurses' perception of ICU design features related to patient safety can be influenced by such factors as nurse characteristics and unit characteristics. When using the scales, therefore, the designers can be aware of the influence of these external factors on nurses' perception. It is hoped that the PS subscales evaluating nurses' perception of ICU physical environmental features related to patient safety would help designers and health care personnel make better ICU design choices.

  12. Comprehensive Evaluation of Entropy-hierarchical Grey Correlation Analysis for Highway Safety Life Protection Engineering

    Directory of Open Access Journals (Sweden)

    Jin Shuxins

    2016-01-01

    Full Text Available Different highway safety life protection engineering decision-making have important meaning. The achieving goals and optimal highway safety life protection engineering scheme can not only improve the function of the highway facilities and service level, still can reduce the traffic accident, which caused by the imperfect highway facilities. Different highway safety life protection engineering decision-making is a multiple targets, multi-layers and multi-schemes system evaluation problem. With regard to lack of concrete data on multiple targets, multi-layers and multi-schemes system evaluation problem, make analytical hierarchy process combined with the entropy value analysis into the grey relational comprehensive evaluation method, and then get entropy-hierarchical grey correlation analysis method. This method is a qualitative and quantitative decision method, which combine comparison principle of analytic hierarchy process (AHP and the entropy principle of entropy value analysis method to determine the relative weight of various indexes between factors layer-by-layer. Then using grey relational analysis by low-layer to high-layer step by step in the possible scheme and referenced scheme. Finally, calculating the comprehensive correlation degree between the possible scheme and referenced scheme, the best plan which has maximum grey correlation degree can be selected.

  13. Embedding technology into inter-professional best practices in home safety evaluation.

    Science.gov (United States)

    Burns, Suzanne Perea; Pickens, Noralyn Davel

    2017-08-01

    To explore inter-professional home evaluators' perspectives and needs for building useful and acceptable decision-support tools for the field of home modifications. Twenty semi-structured interviews were conducted with a range of home modification professionals from different regions of the United States. The interview transcripts were analyzed with a qualitative, descriptive, perspective approach. Technology supports current best practice and has potential to inform decision making through features that could enhance home evaluation processes, quality, efficiency and inter-professional communication. Technological advances with app design have created numerous opportunities for the field of home modifications. Integrating technology and inter-professional best practices will improve home safety evaluation and intervention development to meet client-centred and societal needs. Implications for rehabilitation Understanding home evaluators technology needs for home safety evaluations contributes to the development of app-based assessments. Integrating inter-professional perspectives of best practice and technological needs in an app for home assessments improves processes. Novice and expert home evaluators would benefit from decision support systems embedded in app-based assessments. Adoption of app-based assessment would improve efficiency while remaining client-centred.

  14. Evaluation of blood flow and electromyographic activity in the perioral muscles.

    Science.gov (United States)

    Dei, Ayano; Miyamoto, Jun J; Takada, Jun-Ichi; Ono, Takashi; Moriyama, Keiji

    2016-10-01

    Although the electromyographic (EMG) activity of the perioral muscles, including the orbicularis oris and mentalis muscles, has been described in individuals with lip incompetence during lip sealing, blood flow through these muscles remains to be elucidated. The purpose of this study was to examine the blood flow associated with EMG activity in the perioral muscles using laser speckle imaging in individuals with lip incompetence. Blood flow and EMG activity of the superior and inferior orbicularis oris and mentalis muscles were measured with the lips in contact (C condition) and apart (O condition) in lip incompetence (experimental) and control subjects (n = 15 in each group; mean age: 29.5 years). The change ratios of blood flow and EMG activity in the C condition versus O condition (C/O ratios) were calculated and plotted in a scattergram. The Mann-Whitney U-test, Wilcoxon signed-rank test, discriminant analysis using the Mahalanobis generalized distance, and Spearman correlation were used for statistical analysis. In the experimental group, blood flow and EMG activity in all muscles were significantly greater in the C condition than in the O condition. The plots of C/O ratios in the experimental group showed a distinct and wide distribution and were significantly different than those in the control group. In both groups, a significant positive correlation was observed between blood flow and EMG activity in the mentalis muscle. The present findings suggest that observing blood flow in the mentalis muscle is an effective and easily performed method of evaluating lip incompetence. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  15. Evaluation of blood signal in cardiac MR imaging using ''black-blood'' technique

    Energy Technology Data Exchange (ETDEWEB)

    Nakanishi, Tadashi; Yamada, Takayuki; Tamura, Akihisa; Miyasaka, Kenji; Kohata, Minako; Ono, Chiaki; Kajima, Toshio; Ito, Katsuhide [Hiroshima Univ. (Japan). School of Medicine

    1999-10-01

    Degradation of image quality encountered in cardiac imaging has been attributed to flowing blood signal in the ventricular cavity. To solve this problem, a sequence in which a pair of selective and non-selective inversion pulse in used for a preparation pulse, has been proposed. However, even with this sequence we frequently observed the signal in the blood pool caused by blood itself rather than blood flow. In this article, we investigated the characteristics of those signals. Five healthy normal volunteers and 13 patients with ischemic heart disease were scanned with a 1.5-tesla MR imager. Breath-hold ECG gated fast spin echo with the pair of inversion pulses was performed to obtain cardiac images with T{sub 2} contrast. Typical blood signal appeared as inhomogeneous high intense band adjacent to inner surface of left ventricular apex. At ventricular base, no such signal was encountered even at akinetic myocardium in patients with old myocardial infarction. This signal was observed in all volunteers and 39% of patients. Decrease of TR resulting from tachycardia tended to reduce the blood signal in the left ventricular cavity. Thicker slice section and selective inversion pulse tended to increase the blood signal. Recognition of the signal is essential to differentiate true myocardial infarcts from blood signal, although bright blood imaging like gradient echo or thinner section can partly be helpful. (author)

  16. Re-evaluation of RN blood pool scintigraphy for hepatic hemangiomas

    Energy Technology Data Exchange (ETDEWEB)

    Sano, Kumiko; Mashima, Yasuoki; Nagase, Masanori; Mori, Yutaka; Kawakami, Kenji (Jikei Univ., Tokyo (Japan). School of Medicine); Tada, Katsuhiko; Ariizumi, Mitsuko

    1989-10-01

    Hemangioma of the liver is benign tumor without any complaints. But some cases of hemangioma are very difficult to diagnose because of their various findings. Blood pool scintigraphy has been applied as a useful modality for diagnosis of hepatic hemangioma. But reports about imaging time are not enough. We evaluated on this study the best imaging time of blood pool scintigraphy for hemangioma. We examined blood pool scintigraphy on 19 foci of the hepatic hemangiomas in 12 patients which were confirmed by angiography, operation, CT, Echo or clinical findings. After 20 mCi of Tc-99m-albumin or Tc-99m-RBC was injected, angiographic phase (30 sec/frame), and blood pool images were obtained in 15, 30 min, 1, 2, 4, 6 and 24 hrs. The imaging time to delineate most clearly the hemangiomas was investigated. As a result, clear images were obtained until 2 hrs after injection. Hemangiomas smaller than 2 cm were failed to detect in any imaging time. This result suggests that blood pool scintigraphy is a useful method for assessment of hepatic hemangiomas. (author).

  17. Evaluating the presence of Toxoplasma gondii in peripheral blood of patients with diverse forms of uveitis.

    Science.gov (United States)

    Belfort, Rubens N; Isenberg, Jordan; Fernandes, Bruno F; Di Cesare, Sebastian; Belfort, Rubens; Burnier, Miguel N

    2017-02-01

    The purpose of this study was to evaluate the presence of Toxoplasmosis gondii in samples of peripheral blood from patients with varying etiologies of uveitis. Whole blood from patients with different forms of uveitis was tested for the presence of T. gondii using real-time PCR targeting the well-characterized 529 bp fragment. Extracted DNA was both frozen. Thirty-one patients were included in the current study and grouped as follows: acute toxoplasmosis (n = 10); toxoplasmic retinal scars (n = 9); non-infectious etiologies of uveitis (n = 6); and IgG negative for toxoplasmosis (n = 6). In total, only two patients were shown to have circulating T. gondii in peripheral blood; both of these patients were IgG positive for toxoplasmosis, were receiving immunosuppressive therapy for autoimmune uveitis, and had no clinical features of toxoplasmosis. T. gondii was identified in peripheral blood of some immunosuppressed patients. No other patients, including those with acute toxoplasmosis, had circulating parasites in peripheral blood.

  18. Safe Eats: an evaluation of the use of social media for food safety education.

    Science.gov (United States)

    Bramlett Mayer, Ashley; Harrison, Judy A

    2012-08-01

    Many undergraduate students are cooking for the first time, and they need to learn safe food practices to reduce their risk of foodborne illness. Social media tools are being utilized to disseminate public health messages, but limited research has been conducted to examine the effectiveness of these tools for food safety education. The purpose of this study was to develop and evaluate a social media-based intervention for young adults to improve food safety attitudes, practices, and knowledge. Preliminary surveys were conducted and online focus groups were convened to guide design of this social media intervention. College students (710) were included in treatment and control groups. Results from pretests and posttests indicate that participation in the "Safe Eats" Facebook intervention leads to improvements in food safety attitudes, practices, and knowledge. Although students reported that they learned more from the intervention than from a traditional lecture, the combination of lecture and Facebook resulted in higher knowledge scores than those resulting from the intervention alone. Participants who spent more time on the Facebook page had greater improvements in food safety attitudes and practices.

  19. EVALUATION OF BRACHYTHERAPY FACILITY SHIELDING STATUS IN KOREA OBTAINED FROM RADIATION SAFETY REPORTS

    Directory of Open Access Journals (Sweden)

    MI HYUN KEUM

    2013-10-01

    Full Text Available Thirty-eight radiation safety reports for brachytherapy equipment were evaluated to determine the current status of brachytherapy units in Korea and to assess how radiation oncology departments in Korea complete radiation safety reports. The following data was collected: radiation safety report publication year, brachytherapy unit manufacturer, type and activity of the source that was used, affiliation of the drafter, exposure rate constant, the treatment time used to calculate workload and the HVL values used to calculate shielding design goal values. A significant number of the reports (47.4% included the personal information of the drafter. The treatment time estimates varied widely from 12 to 2,400 min/week. There was acceptable variation in the exposure rate constant values (ranging between 0.469 and 0.592 (R-m2/Ci·hr, as well as in the HVLs of concrete, steel and lead for Iridium-192 sources that were used to calculate shielding design goal values. There is a need for standard guidelines for completing radiation safety reports that realistically reflect the current clinical situation of radiation oncology departments in Korea. The present study may be useful for formulating these guidelines.

  20. An evaluation of safety-critical Java on a Java processor

    DEFF Research Database (Denmark)

    Rios Rivas, Juan Ricardo; Schoeberl, Martin

    2014-01-01

    The safety-critical Java (SCJ) specification provides a restricted set of the Java language intended for applications that require certification. In order to test the specification, implementations are emerging and the need to evaluate those implementations in a systematic way is becoming important....... In this paper we evaluate our SCJ implementation which is based on the Java Optimized Processor JOP and we measure different performance and timeliness criteria relevant to hard real-time systems. Our implementation targets Level 0 and Level1 of the specification and to test it we use a series of micro...

  1. [Evaluation of hearing loss parameters in workers and its relationship with fasting blood glucose levels].

    Science.gov (United States)

    Vicente-Herrero, M Teofila; Lladosa Marco, Silvia; Ramírez-Iñiguez de La Torre, M Victoria; Terradillos-García, M Jesús; López-González, Ángel Arturo

    2014-05-01

    Hearing loss due to noise is considered within the prevention plans of the most common occupational diseases. In addition to evaluation of working conditions, other personal factors increasing the risk of hypoacusis, such as diabetes, should be taken into account. To explore hearing loss in the workplace and its relationship to impaired fasting baseline blood glucose levels. An observational, cross-sectional study enrolling 1636 workers from service companies was conducted. Full audiometric evaluation was performed at different frequencies: high frequency (HF), early loss index (ELI), speech average loss (SAL), and monaural and binaural loss. Results were categorized by baseline blood glucose levels: G1 (125mg/dl). Based on both HF and ELI, 11% of workers had clear indication of deafness. Women with G3 levels showed significant differences in the results of HF and ELI indexes as compared to the G1 group (P=.038 and .046, respectively). A positive association was found between hearing loss and G3 blood glucose levels in HF (OR: .338; p=.002), ELI (OR: .407; p=.007), and the monaural test in the left ear (OR: 4.77×10-5; p=.006). Despite the methodological limitations of this study, there is evidence for an increased risk of high frequency hearing loss in workers with high baseline blood glucose levels. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

  2. The use of blood analyses to evaluate mineral status in livestock.

    Science.gov (United States)

    Herdt, T H; Rumbeiha, W; Braselton, W E

    2000-11-01

    Animal responses are useful means of evaluating and assessing nutritional status. Blood mineral concentrations can be useful nutritional responses, although there are important limitations. The nutritional value in monitoring blood mineral concentrations varies with the specific mineral, being generally most valuable for those minerals in which homeostasis is regulated primarily by renal excretion, as opposed to regulation by variable absorptive efficiency. Examples of minerals for which blood concentrations are good measures of nutritional intake are selenium and magnesium. Blood mineral concentrations are affected by multiple variability factors. The strategy for use in mineral status assessment is to minimize non-nutritional variation by grouping animals for testing based on physiologic factors that affect, or are likely to affect, the concentration of the mineral or minerals being tested. Care should be taken to use the proper sampling protocol, so as not to cause artifactual variation. Removal of the serum from the clot within 2 hours of sample collection is an important step, among others. Sampling adequate numbers of animals and evaluating the herd mean and SD can minimize the effect of random variation on interpretation.

  3. Evaluation of day-to-day variability of serial blood glucose concentration curves in diabetic dogs.

    Science.gov (United States)

    Fleeman, Linda M; Rand, Jacquie S

    2003-02-01

    To evaluate day-to-day variability of serial blood glucose concentration curves in dogs with diabetes mellitus. Prospective clinical study. 10 dogs with diabetes mellitus. Paired 12-hour serial blood glucose concentration curves performed during 2 consecutive days were obtained on 3 occasions from each dog. Dogs received the same dose of insulin and meal every 12 hours on both days. For each pair of curves, comparison was made between the results of days 1 and 2. Mean absolute difference (without regard to sign) between days 1 and 2 for each parameter was significantly > 0, disproving the hypothesis that there is minimal day-to-day variability of serial blood glucose concentration curves when insulin dose and meals are kept constant. Coefficient of variation of the absolute difference between days 1 and 2 for each parameter ranged from 68 to 103%. Evaluation of the paired curves led to an opposite recommendation for adjustment of the insulin dose on day 2, compared with day 1, on 27% of occasions. Disparity between dosage recommendations was more pronounced when glucose concentration nadir was dogs. Day-to-day variability of serial blood glucose concentration curves has important clinical implications, particularly in dogs with good glycemic control.

  4. Portal blood flow volume measurement in schistosomal patients: evaluation of Doppler ultrasonography reproducibility

    Energy Technology Data Exchange (ETDEWEB)

    Leao, Alberto Ribeiro de Souza; Santos, Jose Eduardo Mourao; Moulin, Danilo Sales; Shigueoka, David Carlos; D' Ippolito, Giuseppe [Universidade Federal de Sao Paulo (UNIFESP/EPM), SP (Brazil). Escola Paulista de Medicina. Dept. de Diagnostico por Imagem]. E-mail: ar.leao@uol.com.br; Colleoni, Ramiro [Universidade Federal de Sao Paulo (UNIFESP/EPM), SP (Brazil). Escola Paulista de Medicina. Dept. de Gastroenterologia

    2008-09-15

    Objective: To evaluate the reproducibility of Doppler ultrasonography in the measurement of portal blood flow volume in schistosomal patients. Materials and methods: Prospective, transversal, observational and self-paired study evaluating 21 patients with hepatosplenic schistosomiasis submitted to Doppler ultrasonography performed by three independent observers for measurement of portal blood flow. Pairwise interobserver agreement was calculated by means of the intraclass correlation coefficient, paired t-test and Pearson's correlation coefficient. Results: Interobserver agreement was excellent. Intraclass correlation ranged from 80.6% to 93.0% (IC at 95% [65.3% ; 95.8%]), with the Pearson's correlation coefficient ranging between 81.6% and 92.7% with no statistically significant interobserver difference regarding the mean portal blood flow volume measured by Doppler ultrasonography (p = 0.954 / 0.758 / 0.749). Conclusion: Doppler ultrasonography has demonstrated to be a reliable method for measuring the portal blood flow volume in patients with portal hypertension secondary to schistosomiasis, with a good interobserver agreement. (author)

  5. Evaluation of PCR Approaches for Detection of Bartonella bacilliformis in Blood Samples.

    Directory of Open Access Journals (Sweden)

    Cláudia Gomes

    2016-03-01

    Full Text Available The lack of an effective diagnostic tool for Carrion's disease leads to misdiagnosis, wrong treatments and perpetuation of asymptomatic carriers living in endemic areas. Conventional PCR approaches have been reported as a diagnostic technique. However, the detection limit of these techniques is not clear as well as if its usefulness in low bacteriemia cases. The aim of this study was to evaluate the detection limit of 3 PCR approaches.We determined the detection limit of 3 different PCR approaches: Bartonella-specific 16S rRNA, fla and its genes. We also evaluated the viability of dry blood spots to be used as a sample transport system. Our results show that 16S rRNA PCR is the approach with a lowest detection limit, 5 CFU/μL, and thus, the best diagnostic PCR tool studied. Dry blood spots diminish the sensitivity of the assay.From the tested PCRs, the 16S rRNA PCR-approach is the best to be used in the direct blood detection of acute cases of Carrion's disease. However its use in samples from dry blood spots results in easier management of transport samples in rural areas, a slight decrease in the sensitivity was observed. The usefulness to detect by PCR the presence of low-bacteriemic or asymptomatic carriers is doubtful, showing the need to search for new more sensible techniques.

  6. Evaluation of countermeasures for red light running by traffic simulator-based surrogate safety measures.

    Science.gov (United States)

    Lee, Changju; So, Jaehyun Jason; Ma, Jiaqi

    2018-01-02

    The conflicts among motorists entering a signalized intersection with the red light indication have become a national safety issue. Because of its sensitivity, efforts have been made to investigate the possible causes and effectiveness of countermeasures using comparison sites and/or before-and-after studies. Nevertheless, these approaches are ineffective when comparison sites cannot be found, or crash data sets are not readily available or not reliable for statistical analysis. Considering the random nature of red light running (RLR) crashes, an inventive approach regardless of data availability is necessary to evaluate the effectiveness of each countermeasure face to face. The aims of this research are to (1) review erstwhile literature related to red light running and traffic safety models; (2) propose a practical methodology for evaluation of RLR countermeasures with a microscopic traffic simulation model and surrogate safety assessment model (SSAM); (3) apply the proposed methodology to actual signalized intersection in Virginia, with the most prevalent scenarios-increasing the yellow signal interval duration, installing an advance warning sign, and an RLR camera; and (4) analyze the relative effectiveness by RLR frequency and the number of conflicts (rear-end and crossing). All scenarios show a reduction in RLR frequency (-7.8, -45.5, and -52.4%, respectively), but only increasing the yellow signal interval duration results in a reduced total number of conflicts (-11.3%; a surrogate safety measure of possible RLR-related crashes). An RLR camera makes the greatest reduction (-60.9%) in crossing conflicts (a surrogate safety measure of possible angle crashes), whereas increasing the yellow signal interval duration results in only a 12.8% reduction of rear-end conflicts (a surrogate safety measure of possible rear-end crash). Although increasing the yellow signal interval duration is advantageous because this reduces the total conflicts (a possibility of total

  7. The role of the anaesthetised guinea-pig in the preclinical cardiac safety evaluation of drug candidate compounds

    Energy Technology Data Exchange (ETDEWEB)

    Marks, Louise, E-mail: louise.marks@astrazeneca.com [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Borland, Samantha; Philp, Karen; Ewart, Lorna; Lainée, Pierre; Skinner, Matthew [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Kirk, Sarah [Innovative Medicines, Discovery Sciences, AstraZeneca, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom); Valentin, Jean-Pierre [Safety Assessment UK, AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TG (United Kingdom)

    2012-09-01

    Despite rigorous preclinical and clinical safety evaluation, adverse cardiac effects remain a leading cause of drug attrition and post-approval drug withdrawal. A number of cardiovascular screens exist within preclinical development. These screens do not, however, provide a thorough cardiac liability profile and, in many cases, are not preventing the progression of high risk compounds. We evaluated the suitability of the anaesthetised guinea-pig for the assessment of drug-induced changes in cardiovascular parameters. Sodium pentobarbitone anaesthetised male guinea-pigs received three 15 minute intravenous infusions of ascending doses of amoxicillin, atenolol, clonidine, dobutamine, dofetilide, flecainide, isoprenaline, levosimendan, milrinone, moxifloxacin, nifedipine, paracetamol, verapamil or vehicle, followed by a 30 minute washout. Dose levels were targeted to cover clinical exposure and above, with plasma samples obtained to evaluate effect/exposure relationships. Arterial blood pressure, heart rate, contractility function (left ventricular dP/dt{sub max} and QA interval) and lead II electrocardiogram were recorded throughout. In general, the expected reference compound induced effects on haemodynamic, contractility and electrocardiographic parameters were detected confirming that all three endpoints can be measured accurately and simultaneously in one small animal. Plasma exposures obtained were within, or close to the expected clinical range of therapeutic plasma levels. Concentration–effect curves were produced which allowed a more complete understanding of the margins for effects at different plasma exposures. This single in vivo screen provides a significant amount of information pertaining to the cardiovascular risk of drug candidates, ultimately strengthening strategies addressing cardiovascular-mediated compound attrition and drug withdrawal. -- Highlights: ► Evaluation of the anaesthetised guinea-pig to determine cardiac liability.

  8. Applications of hyperspectral imaging in chicken meat safety and quality detection and evaluation: a review.

    Science.gov (United States)

    Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan

    2015-01-01

    Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.

  9. Evaluation of the quality of blood components obtained after automated separation of whole blood by a new multiunit processor

    DEFF Research Database (Denmark)

    Lagerberg, Johan W; Salado-Jimena, Jose A; Löf, Helena

    2013-01-01

    The Reveos system (Terumo BCT) is a fully automated device able to process four whole blood (WB) units simultaneously into a plasma unit, a red blood cell (RBC) unit, and an interim platelet (PLT) unit (IPU). Multiple IPUs can be pooled to form a transfusable PLT product. The aim of our study...

  10. A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.

    Science.gov (United States)

    Chandnani, Sonia R; Ramakrishna, C D; Dave, Bhargav A; Kothavade, Pankaj S; Thakkar, Ashok S

    2017-05-01

    The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. To assess the performance of EXIMO™ (Meril Diagnostics Pvt. Ltd., Vapi, Gujarat, India) BGMS as per International Organization for Standardization (ISO) 15197:2013 section 8 user performance criteria. This was a non-randomized and post-marketing study conducted at a tertiary care centre of India. A total of 1005 patients with diabetes themselves performed fingertip blood glucose measurement using EXIMO™ BGMS. Immediately after capillary blood glucose measurement using the blood glucose monitoring system, venous blood sample from each patient was obtained by a trained technician which was assessed by reference laboratory method- Cobas Integra 400 plus (Roche Instrument Centre, Rotkreuz, Switzerland). All the blood glucose measurements assessed by EXIMO™ were compared with laboratory results. Performance of the system was assessed as per ISO 15197:2013 criteria using Bland-Altman plot, Parkes-Consensus Error Grid (CEG) and Surveillance Error Grid analyses (SEG). A total of 1005 patients participated in the study. Average age of the patients was 44.93±14.65 years. Evaluation of capillary fingertip blood glucose measurements demonstrated that 95.82% measurements fulfilled ISO 15197:2013 section 8 user performance criteria. All the results lie within clinically non-critical zones; Zone A (99.47%; n=1000) and Zone B (0.53%; n=05) of the CEG analysis. As per SEG analysis, majority of the results fell within "no-risk" zone (risk score 0 to 0.5; 90.42%). The result of the study confirmed that intended users are able to obtain accurate

  11. Clinical Evaluation of the FilmArray Blood Culture Identification Panel in Identification of Bacteria and Yeasts from Positive Blood Culture Bottles

    OpenAIRE

    Altun, Osman; Almuhayawi, Mohammed; Ullberg, Måns; Özenci, Volkan

    2013-01-01

    The FilmArray platform (FA; BioFire, Salt Lake City, UT) is a closed diagnostic system allowing high-order multiplex PCR analysis with automated readout of results directly from positive blood cultures in 1 h. In the present study, we evaluated the clinical performance of the FilmArray blood culture identification (BCID) panel, which includes 19 bacteria, five yeasts, and three antibiotic resistance genes. In total, 206 blood culture bottles were included in the study. The FilmArray could ide...

  12. Evaluation of venous blood gas levels, blood chemistry and haemocytometric parameters in milk fed veal calves at different periods of livestock cycle.

    Science.gov (United States)

    Giambelluca, S; Fiore, E; Sadocco, A; Gianesella, M; Vazzana, I; Orefice, T; Morgante, M

    2016-12-01

    An evaluation of blood chemistry profile in relation to specific stages of livestock cycle can help better understand variations in physiological conditions in order to adjust management systems to animal needs. In addition to basal hematological investigation, the acid-base balance and blood gases are essential tools in evaluating metabolism in calves. The relationship between blood gas parameters, diet and growth should be further investigated. The aim of this study was to evaluate changes in acid-base status, blood gases, serum chemistry and hematological parameters in veal calves at different periods of livestock cycle. One hundred twenty-eight healthy cross breeding calves were enrolled in a farm in North-East Italy. Blood samplings were carried out from the jugular vein on day 1 (t1), 60 (t2) and 150 (t3) after arrival. Blood gas analysis was performed and hematological parameters were evaluated. One-way ANOVA and Tukey-Kramer post-hoc test were performed to assess differences between blood parameter values at the different periods. The main differences in blood gas parameter levels during the livestock cycle concerned pH, Base Excess and HCO3 with higher values recorded in t3. Urea, creatinine, gamma-glutamyl transpeptidase and bilirubin mean values were significantly higher in t1 than in t2 and t3. Aspartate aminotransferase increased from t1 to t2 and t3. Alkaline Phosphatase was higher in t2. Fe levels severely dropped in t2 and in t3, and the decrease led to a restrained but significant reduction in haemoglobin values. A correspondent decrease in the other haemocytometric parameters was found.

  13. Patch test responses to rockwool of different diameters evaluated by cutaneous blood flow measurement.

    Science.gov (United States)

    Eun, H C; Lee, H G; Paik, N W

    1991-04-01

    Rockwool is a man-made mineral fiber used mainly for insulation, which can cause mechanical skin irritation. This study was performed to evaluate the irritant potential of rockwools of different diameters and to compare the change of blood flow, measured by laser Doppler flowmetry, at different patch test occlusion times with rockwools. Rockwool A (mean diameter 4.20 +/- 1.96 mu) was more irritating than rockwool B (mean diameter 3.20 +/- 1.5 mu). The difference was more clearly observed in a 48-h patch test than in an 8-h or 24-h test. We concluded that laser Doppler blood flow measurement was a useful experimental tool for the evaluation of irritant patch test responses to mechanical irritants like rockwool, and that 48 h or more of occlusion time was necessary to produce irritant patch test responses to certain types of rockwool.

  14. Evaluation of the Safety Detective Program: A Classroom-Based Intervention to Increase Kindergarten Children's Understanding of Home Safety Hazards and Injury-Risk Behaviors to Avoid.

    Science.gov (United States)

    Morrongiello, Barbara A; Bell, Melissa; Park, Katey; Pogrebtsova, Katya

    2016-01-01

    Home injuries are a leading cause of mortality and morbidity for young children. Most programs that aim to improve their knowledge of home safety have been narrowly focused on one injury type and/or required specialized personnel for delivery. The purpose of the current study was to evaluate the effectiveness of a new Safety Detective Program that was designed to teach young children (4-6 years) about several types of home safety hazards and unsafe behaviors, with the program delivered in a classroom setting by non-experts based on manualized training. The current study used a randomized group, pre-post design to evaluate the effectiveness of the program to increase children's knowledge and understanding of home safety hazards and injury-risk behaviors to avoid. Children participated in six structured sessions, covering burns, falls, drowning, and poisoning. Each session involved play-based activities (storybook, song, and game or craft) to teach main messages about hazards and injury-risk behaviors, a take home activity, and a parent information sheet about the injury type covered that day. An individually administered photo-sort task with follow-up interview was used to measure intervention and control group participants' knowledge and understanding of injury-risk behaviors before and after program delivery. Children in the intervention, but not the control, group exhibited significant gains in their knowledge and understanding of home safety hazards and injury-risk behaviors to avoid, establishing the effectiveness of the program. This evaluation indicates that the Safety Detective Program can be delivered in classrooms without requiring specialized personnel or extensive training and with positive changes obtained. The program holds much promise as a means of improving kindergarten children's understanding of a broad range of home hazards and injury-risk behaviors that are relevant to their safety.

  15. Safety evaluation of saffron stigma (Crocus sativus L.) aqueous extract and crocin in patients with schizophrenia.

    Science.gov (United States)

    Mousavi, Bentolhoda; Bathaie, Seyedeh Zahra; Fadai, Farbod; Ashtari, Zabihollah; Ali Beigi, Neda; Farhang, Sara; Hashempour, Sara; Shahhamzei, Nasim; Heidarzadeh, Hamid

    2015-01-01

    Saffron is the stigma of Crocus sativus L., which has the potentials to play a role in the treatment of many diseases. Although many researches are now going on this precious spice, there are few data on saffron safety in human, especially in patients with chronic mental illnesses. This study aimed to evaluate the short-term safety and tolerability of both saffron and crocin (its major constituent) in adult patients with schizophrenia. The capsules of saffron aqueous extract (SAE) and crocin were used to evaluate short-term safety and tolerability in patients with schizophrenia. A double-blind, placebo-controlled study was performed on patients with schizophrenia. The patients were all male and were divided into three 22-patient groups. While receiving their normal treatment, they also received a 12 week treatment with SAE (15 mg twice daily), crocin (15 mg twice daily) or placebo. A total of 61 patients completed the trial; none of them reported a serious side effect. WBC count increased significantly in patients receiving saffron aqua extract (SAE), but it was within the normal range and had no clinical significance. Other hematologic components, markers of thyroid, liver and kidney or inflammation markers had no statistically significant difference among the groups. This study showed that SAE and crocin in doses of 15 mg twice daily were safely tolerated in patients with schizophrenia.

  16. D GIS Based Evaluation of the Available Sight Distance to Assess Safety of Urban Roads

    Science.gov (United States)

    Bassani, M.; Grasso, N.; Piras, M.

    2015-08-01

    The available sight distance (ASD) in front of the driver to detect possible conflicts with unexpected obstacles is fundamental for traffic safety. In the last 20 years, road design software (RDS) has been continuously updated with dedicated modules to estimate ASD, thus assessing the quality of project from a safety point of view. Unfortunately, the evaluation of ASD still represents an issue in the case of existing road, and the object of discussion in the research community. To avoid problems related to the limitation associated with the use of digital terrain models typically employed in RDS, the Geographic Information Systems (GIS) software can use digital surface models (DSM) which are more flexible in the modelling of sight obstruction due to vegetation, street furniture, and vertical surfaces largely diffused in urbanized areas. The paper deals with the evaluation of GIS in the estimation of ASD in a typical urban road where the density of sight obstruction along the roadside is relatively high. The work explores the case study of a collector road in the city of Turin (Italy). Results confirm the potentiality of GIS software in capturing the complex morphology of the urban environment, thus confirming that GIS could become an important analysis tool for road engineers in the field of road safety. The investigation here described is part of the Pro-VISION Project (funded in 2014 by the Regione Piemonte, Italy).

  17. Cornell Alliance for Science Evaluation of Consensus on Genetically Modified Food Safety: Weaknesses in Study Design.

    Science.gov (United States)

    Antoniou, Michael N; Robinson, Claire J

    2017-01-01

    Cornell Alliance for Science has launched an initiative in which "citizen scientists" are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance's citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS's statement. We identify a number of fundamental weaknesses in the Alliance's study design, including evaluation is based only on information provided in the publication abstract; there is a lack of clarity as to what material is included in the 12,000 study abstracts to be reviewed, since the number of appropriately designed investigations addressing GM food safety are few; there is uncertainty as to whether studies of toxic effects arising from GM crop-associated pesticides will be included; there is a lack of clarity regarding whether divergent yet equally valid interpretations of the same study will be taken into account; and there is no definition of the cutoff point for consensus or non-consensus on GM food safety. In addition, vital industry proprietary biosafety data on GM crops and associated pesticides are not publicly available and is thus cannot inform this project. Based on these weaknesses in the study design, we believe it is questionable as to whether any objective or meaningful conclusion can be drawn from the Alliance's initiative.

  18. Safety evaluation of saffron stigma (Crocus sativus L. aqueous extract and crocin in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Bentolhoda Mousavi

    2015-08-01

    Full Text Available Objectives: Saffron is the stigma of Crocus sativus L., which has the potentials to play a role in the treatment of many diseases. Although many researches are now going on this precious spice, there are few data on saffron safety in human, especially in patients with chronic mental illnesses. This study aimed to evaluate the short-term safety and tolerability of both saffron and crocin (its major constituent in adult patients with schizophrenia. Materials and Methods: The capsules of saffron aqueous extract (SAE and crocin were used to evaluate short-term safety and tolerability in patients with schizophrenia. A double-blind, placebo-controlled study was performed on patients with schizophrenia. The patients were all male and were divided into three 22-patient groups. While receiving their normal treatment, they also received a 12 week treatment with SAE (15 mg twice daily, crocin (15 mg twice daily or placebo. Results: A total of 61 patients completed the trial; none of them reported a serious side effect. WBC count increased significantly in patients receiving saffron aqua extract (SAE, but it was within the normal range and had no clinical significance. Other hematologic components, markers of thyroid, liver and kidney or inflammation markers had no statistically significant difference among the groups. Conclusions: This study showed that SAE and crocin in doses of 15 mg twice daily were safely tolerated in patients with schizophrenia.

  19. 3D GIS BASED EVALUATION OF THE AVAILABLE SIGHT DISTANCE TO ASSESS SAFETY OF URBAN ROADS

    Directory of Open Access Journals (Sweden)

    M. Bassani

    2015-08-01

    Full Text Available The available sight distance (ASD in front of the driver to detect possible conflicts with unexpected obstacles is fundamental for traffic safety. In the last 20 years, road design software (RDS has been continuously updated with dedicated modules to estimate ASD, thus assessing the quality of project from a safety point of view. Unfortunately, the evaluation of ASD still represents an issue in the case of existing road, and the object of discussion in the research community. To avoid problems related to the limitation associated with the use of digital terrain models typically employed in RDS, the Geographic Information Systems (GIS software can use digital surface models (DSM which are more flexible in the modelling of sight obstruction due to vegetation, street furniture, and vertical surfaces largely diffused in urbanized areas. The paper deals with the evaluation of GIS in the estimation of ASD in a typical urban road where the density of sight obstruction along the roadside is relatively high. The work explores the case study of a collector road in the city of Turin (Italy. Results confirm the potentiality of GIS software in capturing the complex morphology of the urban environment, thus confirming that GIS could become an important analysis tool for road engineers in the field of road safety. The investigation here described is part of the Pro-VISION Project (funded in 2014 by the Regione Piemonte, Italy.

  20. Evaluation of the concomitant use of two different EIA tests for HIV screening in blood banks.

    Science.gov (United States)

    Otani, Marcia M; Salles, Nanci A; Barreto, Angela M E; Barreto, Claudia C; Chamone, Dalton F; Sabino, Ester C

    2003-01-01

    In 1998, the Brazilian Ministry of Health made it mandatory for all blood banks in the country to screen donated blood for human immunodeficiency virus (HIV) concomitantly using two different enzyme immunoassay (EIA) tests. Concerned with the best use of available resources, our objective with this study was to evaluate the usefulness of conducting two EIA screening tests instead of just one. We analyzed data from 1999 through 2001 obtained by testing 698 191 units of donated blood using two EIA HIV screening tests concomitantly at the Pro-Blood Foundation/Blood Center of São Paulo (Fundação Pró-Sangue/Hemocentro de São Paulo), which is a major blood center in the city of São Paulo, Brazil. All samples reactive in at least one of the two EIA tests were submitted for confirmation by a Western blot (WB) test, and the persons who had donated those samples were also asked to return and provide a follow-up sample. Out of the 698 191 blood units that were donated, 2 718 of them (0.4%) had to be discarded because they were reactive to at least one of the EIA tests. There were two WB-positive donation samples that were reactive in only one HIV EIA screening test. On their follow-up samples, both donors tested WB-negative. These cases were considered false positive results at screening. Of the 2 718 donors who were asked to return and provide a follow-up sample, 1 576 of them (58%) did so. From these 1 576 persons, we found that there were two individuals who had been reactive to only one of the two EIA screening tests and who had also been negative on the WB at screening but who were fully seroconverted on the follow-up sample. We thus estimated that, in comparison to the use of a single EIA screening test, the use of two EIA screening tests would detect only one extra sample out of 410 700 units of blood. Our data do not support the use of two different, concomitant EIA screening tests for HIV. The great majority of HIV-positive donors have already seroconverted and

  1. Implementation and Benefit Evaluation of Recommendations for Patient Safety in Ambulatory Surgical Care.

    Science.gov (United States)

    Monaca, C; Buchmann, M; Manser, T

    2016-09-01

    Objective: The aim of this study was to evaluate the degree of implementation of recommendations for patient safety in ambulatory surgical care and their benefit as perceived by surgeons in the ambulatory sector. Based on 2 practice recommendations issued by the Association of Statutory Health Insurance Physicians in Westphalia-Lippe, recommendations were formulated specifically for ambulatory surgery and distributed in 2013 to all physicians licensed to conduct ambulatory surgery in Westphalia-Lippe. Methods: We conducted a written survey covering all safety measures addressed by the 2 practice recommendations and assessed the degree of implementation and the perceived benefit for each of these measures as well as the strengths of the recommendations and the challenges of implementing them. The survey was distributed in late 2014 to 2 454 surgeons in the ambulatory setting. The survey period was 7 weeks. The analysis of the quantitative data was mainly descriptive and we conducted thematic summaries of free text answers to open-ended questions. Results: The participation rate was 17% (n=405). The recommendations were known to 86% of the respondents. The majority of recommended safety measures had been implemented systemically in more than 50% of the participating institutions. An increased interprofessional awareness of patient safety measurements was reported as the main impact of the recommendations. Respondents indicated further need for information and practice recommendations concerning the following topics: risk and error management, implementation of the Medical Devices Act, hygiene in medical practice and processing of instruments. Conclusion: This study highlights the valuable contribution practice recommendations can make to patient safety improvement in ambulatory surgical care. Their dissemination to other regions as well as to other ambulatory care settings such as family practice can therefore be recommended. © Georg Thieme Verlag KG Stuttgart

  2. Preclinical safety evaluation of intravenously administered SAL200 containing the recombinant phage endolysin SAL-1 as a pharmaceutical ingredient.

    Science.gov (United States)

    Jun, Soo Youn; Jung, Gi Mo; Yoon, Seong Jun; Choi, Yun-Jaie; Koh, Woo Suk; Moon, Kyoung Sik; Kang, Sang Hyeon

    2014-01-01

    Phage endolysins have received increasing attention as potent antibacterial agents. However, although safety evaluation is a prerequisite for the drug development process, a good laboratory practice (GLP)-compliant safety evaluation has not been reported for phage endolysins. A safety evaluation of intravenously administered SAL200 (containing phage endolysin SAL-1) was conducted according to GLP standards. No animals died in any of the safety evaluation studies. In general toxicity studies, intravenously administered SAL200 showed no sign of toxicity in rodent single- and repeated-dose toxicity studies. In the dog repeated-dose toxicity test, there were no abnormal findings, with the exception of transient abnormal clinical signs that were observed in some dogs when daily injection of SAL200 was continued for more than 1 week. In safety pharmacology studies, there were also no signs of toxicity in the central nervous and respiratory system function tests. In the cardiovascular function test, there were no abnormal findings in all tested dogs after the first and second administrations, but transient abnormalities were observed after the third and fourth administrations (2 or 3 weeks after the initial administration). All abnormal findings observed in these safety evaluation studies were slight to mild, were apparent only transiently after injection, and resolved quickly. The safety evaluation results for SAL200 support the implementation of an exploratory phase I clinical trial and underscore the potential of SAL200 as a new drug. We have designed an appropriate phase I clinical trial based on the results of this study.

  3. Bioprotective properties of Dragon's blood resin: In vitro evaluation of antioxidant activity and antimicrobial activity

    OpenAIRE

    Gupta Rajinder K; Gupta Deepika

    2011-01-01

    Abstract Background Food preservation is basically done to preserve the natural characteristics and appearance of the food and to increase the shelf life of food. Food preservatives in use are natural, chemical and artificial. Keeping in mind the adverse effects of synthetic food preservatives, there is a need to identify natural food preservatives. The aims of this study were to evaluate in vitro antioxidant and antimicrobial activities of Dragon's blood resin obtained from Dracaena cinnabar...

  4. Evaluation of blood glucose in type II diabetic patients submitted to local anesthesia with different vasoconstrictors

    OpenAIRE

    MELLO, Renan Pollettini de; Ramacciato, Juliana Cama; PERUZZO, Daiane Cristine; Vicentini,Carllini Barroso; Bergamaschi,Cristiane de Cássia; Motta,Rogério Heládio Lopes

    2016-01-01

    ABSTRACT Objective: In the dental clinic, the use of local anesthetics containing vasoconstrictors in diabetic patients are still controversial raising some doubts. Thus, the objective of this randomized crossover clinical trial was to evaluate blood glucose, pulse oximetry and heart rate of type 2 diabetic patients when submitted to local anesthesia using prilocaine 3% associated to felypressin 0,03UI / ml (G1) and 2% lidocaine associated to epinephrine 1: 100,000 (G2). Methods: The sample...

  5. Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

    Energy Technology Data Exchange (ETDEWEB)

    Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.; Buczek, Jeffrey A.; Lietzow, J.; McCoy, F.; Beranek, F.; Gupta, M.

    2013-11-07

    A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25 recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.

  6. Evaluation of C-reactive protein as an inflammatory biomarker in rabbits for vaccine nonclinical safety studies

    NARCIS (Netherlands)

    Destexhe, E.; Prinsen, M.K.; Schöll, I. van; Kuper, C.F.; Garçon, N.; Veenstra, S.; Segal, L.

    2013-01-01

    Introduction: Inflammatory reactions are one of the potential safety concerns that are evaluated in the framework of vaccine safety testing. In nonclinical studies, the assessment of the inflammation relies notably on the measurement of biomarkers. C-reactive protein (CRP) is an acute-phase plasma

  7. The Development of a Food Safety Brochure for Families: The Use of Formative Evaluation and Plain Language Strategies

    Science.gov (United States)

    Perry, Christina; Albrecht, Julie; Litchfield, Ruth; Meysenburg, Rebecca L.; Er, Ida NgYin; Lum, Adeline; Beattie, Sam; Larvick, Carol; Schwarz, Carol; Temple, Jan; Meimann, Elizabeth

    2012-01-01

    Printed materials have been used extensively as an educational tool to increase food safety awareness. Few educational materials have been designed to target families with young children for food safety education. This article reports the use of the formative evaluation process to develop a brochure designed to enhance awareness about food safety…

  8. Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

    Directory of Open Access Journals (Sweden)

    Jung-Nein Lai

    2013-01-01

    Full Text Available Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM. Methods. We have proactively monitored the safety profiles of Duhuo Jisheng Tang (DJT, Suan Zao Ren Tang (SZRT, and TMN-1. A list of adverse events (AEs, complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens. Results. A total of 221, 287, and 203 AEs were detected after SZRT, DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related to SZRT treatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such as Mu Tong and an increased risk of CKD, ESRD, and urinary tract cancer. Conclusion. Prospective and retrospective observational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies.

  9. Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

    Science.gov (United States)

    Tang, Jin-Ling; Wang, Jung-Der

    2013-01-01

    Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM). Methods. We have proactively monitored the safety profiles of Duhuo Jisheng Tang (DJT), Suan Zao Ren Tang (SZRT), and TMN-1. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens. Results. A total of 221, 287, and 203 AEs were detected after SZRT, DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related to SZRT treatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such as Mu Tong and an increased risk of CKD, ESRD, and urinary tract cancer. Conclusion. Prospective and retrospective observational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies. PMID:24159351

  10. Safety evaluation of molten steel carrier by using instrument indentation technique

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jeong Ki; Kim, Yi Gon; Yoo, Dae Wha; Kim, Chung Youb [School of Mechanical Design Engineering, Chonnam National University, Yeosu (Korea, Republic of); Kim, Kwang Ho [Frontics Co., Ltd., Seoul (Korea, Republic of); Lee, Kyeong Ro [Dept. of Automotive Management, Joongbu University, Geumsan (Korea, Republic of)

    2014-02-15

    Because a molten steel carrier is used in high-temperature and corrosive environments, erosion and corrosion decrease the thickness of the structure and expand the vent hole for emitting gas generated from refractory bricks. This increases the stress throughout the structure and introduces a significant stress concentration around the vent hole. In addition, the high-temperature environment degrades mechanical properties such as the yield and tensile strengths. These problems seriously affect the safety of the structure. In this study, the safety of a 10-year-old structure was evaluated by analyzing the stress distribution and measuring the mechanical properties of the structure. The mechanical properties were directly measured on the structure surface using the instrument indentation technique.

  11. Safety Performance Evaluations for the Vehicle Based Movable Barriers Using Full Scale Crash Tests

    Directory of Open Access Journals (Sweden)

    Jin Minsoo

    2017-01-01

    Full Text Available The present study aims to develop a prototype of large-size movable barriers to protect roadside workers from incoming vehicles to the road work area with the following functions: maximization of work space in the right and left directions, convenient mobility, and minimization of impact without modification of the inside of movable barriers into traffic lanes and perform safety performance assessment on passengers through full scale crash tests. The large movable barrier was divided into folder type and telescope type and the development stage was now at the prototype phase. A full scale crash test was conducted prior to certification test at a level of 90%. The full scale crash test result showed that both types of folder type movable barrier and telescope type movable barrier satisfied the standard of the passenger safety performance evaluation at a level of 90%.

  12. Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Farmer, Mitchell T. [Argonne National Lab. (ANL), Argonne, IL (United States); Bunt, R. [Southern Nuclear, Atlanta, GA (United States); Corradini, M. [Univ. of Wisconsin, Madison, WI (United States); Ellison, Paul B. [GE Power and Water, Duluth, GA (United States); Francis, M. [Argonne National Lab. (ANL), Argonne, IL (United States); Gabor, John D. [Erin Engineering, Walnut Creek, CA (United States); Gauntt, R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Henry, C. [Fauske and Associates, Burr Ridge, IL (United States); Linthicum, R. [Exelon Corp., Chicago, IL (United States); Luangdilok, W. [Fauske and Associates, Burr Ridge, IL (United States); Lutz, R. [PWR Owners Group (PWROG); Paik, C. [Fauske and Associates, Burr Ridge, IL (United States); Plys, M. [Fauske and Associates, Burr Ridge, IL (United States); Rabiti, Cristian [Idaho National Lab. (INL), Idaho Falls, ID (United States); Rempe, J. [Rempe and Associates LLC, Idaho Falls, ID (United States); Robb, K. [Argonne National Lab. (ANL), Argonne, IL (United States); Wachowiak, R. [Electric Power Research Inst. (EPRI), Knovville, TN (United States)

    2015-01-31

    The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affect reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).

  13. [Screening of HIV in blood banks. Evaluation of fourth generation kits].

    Science.gov (United States)

    Canna, Fernando; Treviño, Elena; Domínguez, Claudia; Gastaldello, Rene; Barbas, Gabriela; Cudola, Analia; Irizar, Marta; Bepre, Hector; Gallego, Sandra

    2003-01-01

    Use of detection tests for p24 HIV antigen (p24Ag) in blood banks in Argentina is recommended by the Argentinean Society of Hemotherapy and Immunohematology. In the blood bank of the National University of Cordoba (Argentina), the recent implementation of the p24Ag screening test has considerably increased the cost of the battery of screening tests and its use in all blood donations has not produced the benefits expected. A 4th generation EIA was evaluated for the screening of HIV in comparison with the currently used assays in the blood bank of National University of Cordoba (3rd generation EIA + p24Ag assay). For this comparison, 11 serum samples from subjects with early HIV infection (early seroconversion period) were tested, as well as 27 serum samples from asymptomatic HIV-infected subjects and other 39 from non-HIV infected subjects. The 3rd generation EIA and the 4th generation EIA showed the same sensitivity value (100%) but the specificity of the 3rd generation EIA was higher (97.5%) comparing with 4th generation (95.1%). Besides, the p24Ag test failed to detect 2 samples from subjects with early HIV infection. These results indicate a good performance of both 3rd and 4th generation assays for screening of HIV. However, due to the lowest cost of 4th generation EIA kit, it could replace the currently used assays for HIV screening in regional blood banks. This screening assay will lead to gain in effectiveness and reduced costs until the detection of HIV RNA can be implemented in blood banks.

  14. INTEGRAL BENCHMARKS AVAILABLE THROUGH THE INTERNATIONAL REACTOR PHYSICS EXPERIMENT EVALUATION PROJECT AND THE INTERNATIONAL CRITICALITY SAFETY BENCHMARK EVALUATION PROJECT

    Energy Technology Data Exchange (ETDEWEB)

    J. Blair Briggs; Lori Scott; Enrico Sartori; Yolanda Rugama

    2008-09-01

    Interest in high-quality integral benchmark data is increasing as efforts to quantify and reduce calculational uncertainties accelerate to meet the demands of next generation reactor and advanced fuel cycle concepts. The International Reactor Physics Experiment Evaluation Project (IRPhEP) and the International Criticality Safety Benchmark Evaluation Project (ICSBEP) continue to expand their efforts and broaden their scope to identify, evaluate, and provide integral benchmark data for method and data validation. Benchmark model specifications provided by these two projects are used heavily by the international reactor physics, nuclear data, and criticality safety communities. Thus far, 14 countries have contributed to the IRPhEP, and 20 have contributed to the ICSBEP. The status of the IRPhEP and ICSBEP is discussed in this paper, and the future of the two projects is outlined and discussed. Selected benchmarks that have been added to the IRPhEP and ICSBEP handbooks since PHYSOR’06 are highlighted, and the future of the two projects is discussed.

  15. Evaluation of Chromosomal Disorders in Tissue and Blood Samples in Patients with Oral Squamous Cell Carcinoma

    Directory of Open Access Journals (Sweden)

    A. Parvaneroo

    2004-12-01

    Full Text Available Statement of Problem: Many studies have indicated that genetic disturbances are common findings in patients with Oral Squamous Cell Carcinoma (OSCC. Identification of these changes can be helpful in diagnostic procedures of these tumors.Purpose: The aim of this study was to appraise the chromosomal disorders in blood and tissue patients with OSCC.Methods and Materials: In this descriptive study, the study group consisted of all OSCC patients who were referred to the Faculty of Dentistry, Tehran University of Medical Sciences, Maxillofacial Surgery Clinic of Shariati Hospital, and Amir Aalam Hospital fromSeptember 2000 to November 2002. In order to study chromosomal disorders in the peripheral blood lymphocytes, 5 mL of blood was obtained from each patient In patients with the large lesion, a piece of involved tissue were obtained and cultured for 24 hours.This led to 29 blood samples and 16 tissue specimens and any relation between OSCC and age, sex, smoking and alcohol use were evaluated.Results: In this study, OSCC was more common in males than in females (3 to 5. 31% of our patients were smokers, and one had a history of alcoholic consumption. There was an increase in incidence of OSCC with age. In this study, all patients had numerical(aneuploidy, polyploidy and structural chromosomal disorders (double minute, fragment,breakage and dicentric. There was significant difference between blood and tissue chromosomal disorders (aneuploidy, polyploidy,breakage in OSCC patients.Conclusion: It can be concluded that chromosomes in patients with OSCC might show some genetic aberration and evaluation of involved tissue might be better way for determining this disorders.

  16. An Economic Evaluation of Food Safety Education Interventions: Estimates and Critical Data Gaps.

    Science.gov (United States)

    Zan, Hua; Lambea, Maria; McDowell, Joyce; Scharff, Robert L

    2017-08-01

    The economic evaluation of food safety interventions is an important tool that practitioners and policy makers use to assess the efficacy of their efforts. These evaluations are built on models that are dependent on accurate estimation of numerous input variables. In many cases, however, there is no data available to determine input values and expert opinion is used to generate estimates. This study uses a benefit-cost analysis of the food safety component of the adult Expanded Food and Nutrition Education Program (EFNEP) in Ohio as a vehicle for demonstrating how results based on variable values that are not objectively determined may be sensitive to alternative assumptions. In particular, the focus here is on how reported behavioral change is translated into economic benefits. Current gaps in the literature make it impossible to know with certainty how many people are protected by the education (what are the spillover effects?), the length of time education remains effective, and the level of risk reduction from change in behavior. Based on EFNEP survey data, food safety education led 37.4% of participants to improve their food safety behaviors. Under reasonable default assumptions, benefits from this improvement significantly outweigh costs, yielding a benefit-cost ratio of between 6.2 and 10.0. Incorporation of a sensitivity analysis using alternative estimates yields a greater range of estimates (0.2 to 56.3), which highlights the importance of future research aimed at filling these research gaps. Nevertheless, most reasonable assumptions lead to estimates of benefits that justify their costs.

  17. Research on the measurement technology and evaluation method of photobiological safety

    Science.gov (United States)

    Dai, Cai-hong; Wu, Zhi-feng; Chen, Bin-hua; Wang, Yan-fei; Li, Xiang-zhao; Fu, Lei

    2013-12-01

    Lamps and lamp system are widely used in large quantities in an era. The evaluation and control of optical radiation hazards of lamps and lamp systems is far more complicated. A special measurement and traceability facility was set up at NIM (National Institute of Metrology, China) to evaluate the optical radiation safety of lamp and lamp system, which includes a double grating spectroradiometer OL750D with two different entrance systems of spectral radiance and spectral irradiance traceable to the national primary standard of spectral irradiance by a 1000W spectral irradiance standard lamp, 40W deuterium lamp and a standard diffuser plate. The technical requirements of the measurement instrumentation used for optical radiation safety evaluation including monochromator type, wavelength accuracy, input optics, spectral scan interval and calibration sources are recommended also in this paper. Spectral radiance of a series of LED electric torches and infrared sources were measured by using the new developed system, and potential radiation hazards of retinal blue light hazard and retinal thermal hazard are calculated and evaluated. The optical radiation hazards of some samples are listed in Risk Group 2 (Moderate-Risk).

  18. Safety assessment of mushrooms in dietary supplements by combining analytical data with in silico toxicology evaluation.

    Science.gov (United States)

    VanderMolen, Karen M; Little, Jason G; Sica, Vincent P; El-Elimat, Tamam; Raja, Huzefa A; Oberlies, Nicholas H; Baker, Timothy R; Mahony, Catherine

    2017-05-01

    Despite growing popularity in dietary supplements, many medicinal mushrooms have not been evaluated for their safe human consumption using modern techniques. The multifaceted approach described here relies on five key principles to evaluate the safety of non-culinary fungi for human use: (1) identification by sequencing the nuclear ribosomal internal transcribed spacer (ITS) region (commonly referred to as ITS barcoding), (2) screening an extract of each fungal raw material against a database of known fungal metabolites, (3) comparison of these extracts to those prepared from grocery store-bought culinary mushrooms using UHPLCPDA-ELS-HRMS, (4) review of the toxicological and chemical literature for each fungus, and (5) evaluation of data establishing presence in-market. This weight-of-evidence approach was used to evaluate seven fungal raw materials and determine safe human use for each. Such an approach may provide an effective alternative to conventional toxicological animal studies (or more efficiently identifies when studies are necessary) for the safety assessment of fungal dietary ingredients. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Criticality safety evaluation for the Advanced Test Reactor enhanced low enriched uranium fuel elements

    Energy Technology Data Exchange (ETDEWEB)

    Montierth, Leland M. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-07-19

    The Global Threat Reduction Initiative (GTRI) convert program is developing a high uranium density fuel based on a low enriched uranium (LEU) uranium-molybdenum alloy. Testing of prototypic GTRI fuel elements is necessary to demonstrate integrated fuel performance behavior and scale-up of fabrication techniques. GTRI Enhanced LEU Fuel (ELF) elements based on the ATR-Standard Size elements (all plates fueled) are to be fabricated for testing in the Advanced Test Reactor (ATR). While a specific ELF element design will eventually be provided for detailed analyses and in-core testing, this criticality safety evaluation (CSE) is intended to evaluate a hypothetical ELF element design for criticality safety purposes. Existing criticality analyses have analyzed Standard (HEU) ATR elements from which controls have been derived. This CSE documents analysis that determines the reactivity of the hypothetical ELF fuel elements relative to HEU ATR elements and whether the existing HEU ATR element controls bound the ELF element. The initial calculations presented in this CSE analyzed the original ELF design, now referred to as Mod 0.1. In addition, as part of a fuel meat thickness optimization effort for reactor performance, other designs have been evaluated. As of early 2014 the most current conceptual designs are Mk1A and Mk1B, that were previously referred to as conceptual designs Mod 0.10 and Mod 0.11, respectively. Revision 1 evaluates the reactivity of the ATR HEU Mark IV elements for a comparison with the Mark VII elements.

  20. [Development of human embryonic stem cell platforms for human health-safety evaluation].

    Science.gov (United States)

    Yu, Guang-yan; Cao, Tong; Zou, Xiao-hui; Zhang, Xue-hui; Fu, Xin; Peng, Shuang-qing; Deng, Xu-liang; Li, Sheng-lin; Liu, He; Xiao, Ran; Ouyang, Hong-wei; Peng, Hui; Chen, Xiao; Zhao, Zeng-ming; Wang, Xiao-ying; Fang, Hai-qin; Lu, Lu; Ren, Yu-lan; Xu, Ming-ming

    2016-02-18

    The human embryonic stem cells (hESCs) serve as a self-renewable, genetically-healthy, pluripotent and single source of all body cells, tissues and organs. Therefore, it is considered as the good standard for all human stem cells by US, Europe and international authorities. In this study, the standard and healthy human mesenchymal progenitors, ligament tissues, cardiomyocytes, keratinocytes, primary neurons, fibroblasts, and salivary serous cells were differentiated from hESCs. The human cellular health-safety of NaF, retinoic acid, 5-fluorouracil, dexamethasone, penicillin G, adriamycin, lead acetate PbAc, bisphenol A-biglycidyl methacrylate (Bis-GMA) were evaluated selectively on the standardized platforms of hESCs, hESCs-derived cardiomyocytes, keratinocytes, primary neurons, and fibroblasts. The evaluations were compared with those on the currently most adopted cellular platforms. Particularly, the sensitivity difference of PM2.5 toxicity on standardized and healthy hESCs derived fibroblasts, currently adopted immortalized human bronchial epithelial cells Beas-2B and human umbilical vein endothelial cells (HUVECs) were evaluated. The RESULTS showed that the standardized hESCs cellular platforms provided more sensitivity and accuracy for human cellular health-safety evaluation.