Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Science.gov (United States)

2005-01-01

323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices

CFD Analysis of the Safety Injection Tank and Fluidic Device

Energy Technology Data Exchange (ETDEWEB)

Cho, Jai Oan; Nietiadi, Yohanes Setiawan; Lee, Jeong Ik [KAIST, Daejeon (Korea, Republic of); Addad, Yacine [KUSTAR, Abu Dhabi (United Arab Emirates)

2016-05-15

One of the most important components in the ECCS is the safety injection tank (SIT). Inside the SIT, a fluidic device is installed, which passively controls the mass flow of the safety injection and eliminates the need for low pressure safety injection pumps. As more passive safety mechanisms are being pursued, it has become more important to understand flow structure and the loss mechanism within the fluidic device. Current computational fluid dynamics (CFD) calculations have had limited success in predicting the fluid flow accurately. This study proposes to find a more exact result using CFD and more realistic modeling to predict the performance during accident scenarios more accurately. The safety injection tank with fluidic device was analyzed thoroughly using CFD. The preliminary calculation used 60,000 meshes for the initial test calculation. The results fit the experimental results surprisingly despite its coarse grid. Nonetheless, the mesh resolution was increased to capture the vortex in the fluidic device precisely. Once a detailed CFD computation is finished, a small-scale experiment will be conducted for the given conditions. Using the experimental results and the CFD model, physical models can be improved to fit the results more accurately.

Safety and feasibility research of CIPT-Ⅱ irradiation device

International Nuclear Information System (INIS)

Zhang Zhihua; Mi Xiangmiao; Li Rundong

2014-01-01

CITP-Ⅱ irradiation device, which is specially designed for fusion tritium breeder research, works in a thermal neutron reactor. With lithium orthosilicate as the breeder, the safety analysis was done to work out the device's influence on physical parameters of the reactor and get the breeder's temperature distribution and thermo-technical features in the n-γ field. The stiffness and strength were checked, and also the safety characters of the device were assessed. The feasibility of gap gas regulating the temperature and gas refueling the breeder was demonstrated. The calculation and analysis results provide data for comprehensive performance assessment. (authors)

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.

Science.gov (United States)

Sackner-Bernstein, Jonathan

2017-03-01

The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

Science.gov (United States)

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

A safety control device for detecting undesirable conditions

Energy Technology Data Exchange (ETDEWEB)

1974-09-26

The invention relates to safety control devices. It deals with a device adapted to transmit a warning signal and to the detection of an undesirable condition in an associated apparatus, said device comprising switching means comprising transistors mounted in a reaction path, feeding means for opening the switching means whenever an undesirable condition has been detected by sensors, whereby an oscillator is caused to stop oscillating, and an outlet device controlled by the oscillator stoppage. This can be applied to the supervision of nuclear reactor.

Use of digital computing devices in systems important to safety

International Nuclear Information System (INIS)

1986-01-01

The incorporation of digital computing devices in systems important to safety now is progressing fast in several countries, including Canada, France, Federal Republic of Germany, Japan, USA. There are now reactors with microprocessors in some trip systems. The major functions of those systems are: reactor trip initiation, display, monitoring, testing, re-calibration of detectors. The benefits of moving to a fully computerized shut-down system should be improved reliability, greater flexibility, better man-machine interface, improved testing, higher reactor output and lower overall cost. With the introduction of computer devices in systems important to safety, plant availability and safety are improved because disturbances are treated before they lead to safety action, in this way helping the operator to avoid errors. The Meeting presentations were divided into sessions devoted to the following topics: Needs for the use of digital devices (DCD) in safety important systems (SIS) (5 papers); Problems raised by the integration SIS in the NPP control (7 papers); Description and presentation of DCD of SIS (6 papers); Results of experiences in engineering, manufacture, qualification operation of DCD hardware and software (5 papers). A separate abstract was prepared for each of these papers

Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…

FAST and SAFE Passive Safety Devices for Sodium-cooled Fast Reactor

Energy Technology Data Exchange (ETDEWEB)

Hartanto, Donny; Kim, Chihyung; Kim, In-Hyung; Kim, Yonghee [KAIST, Daejeon (Korea, Republic of)

2015-05-15

The major factor is the impact of the neutron spectral hardening. The second factor that affects the CVR is reduced capture by the coolant when the coolant voiding occurs. To improve the CVR, many ideas and concepts have been proposed, which include introduction of an internal blanket, spectrum softening, or increasing the neutron leakage. These ideas may reduce the CVR, but they deteriorate the neutron economy. Another potential solution is to adopt a passive safety injection device such as the ARC (autonomous reactivity control) system, which is still under development. In this paper, two new concepts of passive safety devices are proposed. The devices are called FAST (Floating Absorber for Safety at Transient) and SAFE (Static Absorber Feedback Equipment). Their purpose is to enhance the negative reactivity feedback originating from the coolant in fast reactors. SAFE is derived to balance the positive reactivity feedback due to sodium coolant temperature increases. It has been demonstrated that SAFE allows a low-leakage SFR to achieve a self-shutdown and self-controllability even though the generic coolant temperature coefficient is quite positive and the coolant void reactivity can be largely managed by the new FAST device. It is concluded that both FAST and SAFE devices will improve substantially the fast reactor safety and they deserve more detailed investigations.

Effect of electronic device use on pedestrian safety : a literature review.

Science.gov (United States)

2016-04-01

This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Science.gov (United States)

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied on for Safety AGENCY: Nuclear Regulatory Commission. ACTION... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital...

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

Science.gov (United States)

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

NASA safety standard for lifting devices and equipment

Science.gov (United States)

1990-09-01

NASA's minimum safety requirements are established for the design, testing, inspection, maintenance, certification, and use of overhead and gantry cranes (including top running monorail, underhung, and jib cranes), mobile cranes, derrick hoists, and special hoist supported personnel lifting devices (these do not include elevators, ground supported personnel lifts, or powered platforms). Minimum requirements are also addressed for the testing, inspection, and use of Hydra-sets, hooks, and slings. Safety standards are thoroughly detailed.

Autonomous booster device of a safety valve

International Nuclear Information System (INIS)

Namand, H.

1983-01-01

The invention concerns an autonomous booster device of a protection safety valve of a pressure vessel. The valve comprises a hollow structure, a seat connected with a mobile flap forming one piece with a stem and a calibration spring bearing on the stem and on the valve structure to maintain the flap bearing on the seat. The stem of the flap is prolongated in a box forming one piece with the valve structure and receives an added push of a spring. The box acts as a pressure device of which the piston can exercise on the stem a push opposite to and larger than the spring one. The feeding device of the pressure box is finally described in detail [fr

Product-based Safety Certification for Medical Devices Embedded Software.

Science.gov (United States)

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

Safety device for nuclear reactors

International Nuclear Information System (INIS)

Gruhl, H.

1974-01-01

The safety device is used to capture fragments of the lid of a pressure vessel when this vessel ruptures. It consists of a catcher structure attached to the concrete vessel, which is open at the top, and surrounding the pressure vessel. The catcher structure in this case may be designed as a ring installed very close to the concrete vessel, as a closure plate or may be made of transverse beams arranged parallel to each other. It is anchored either rigidly or elastically to the concrete vessel by means of springs or to the foundation by means of steel stretching members. (DG) [de

MRI with cardiac pacing devices – Safety in clinical practice

Energy Technology Data Exchange (ETDEWEB)

Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)

2014-08-15

Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.

An examination of safety reports involving electronic flight bags and portable electronic devices

Science.gov (United States)

2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

The Role of Patient Safety in the Device Purchasing Process

National Research Council Canada - National Science Library

Johnson, Todd R; Zhang, Jiajie; Patel, Vimla L; Keselman, Alla; Tang, Xiaozhou; Brixey, Juliana J; Paige, Danielle; Turley, James P

2005-01-01

To examine how patient safety considerations are incorporated into medical device purchase decisions, individuals involved in recent infusion pump purchasing decisions at three different health care...

Safety considerations in the design of the Fusion Engineering Device

International Nuclear Information System (INIS)

Barrett, R.J.

1983-01-01

The US Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris

Motorcycle safety device investigation: A case study on airbags

Indian Academy of Sciences (India)

analysis methods for research evaluation of rider crash protective devices fitted to ... The safety evaluation is then based on simulation of the 200 impact types. ... with recording of ISO 13232 car-front impact tests to evaluate the qualitative.

Universal Safety Distance Alert Device for Road Vehicles

Directory of Open Access Journals (Sweden)

Matic Virant

2016-04-01

Full Text Available Driving with too short of a safety distance is a common problem in road traffic, often with traffic accidents as a consequence. Research has identified a lack of vehicle-mountable devices for alerting the drivers of trailing vehicles about keeping a sufficient safe distance. The principal requirements for such a device were defined. A conceptual study was performed in order to select the components for the integration of the device. Based on the results of this study, a working prototype of a flexible, self-contained device was designed, built and tested. The device is intended to be mounted on the rear of a vehicle. It uses radar as the primary distance sensor, assisted with a GPS receiver for velocity measurement. A Raspberry Pi single-board computer is used for data acquisition and processing. The alerts are shown on an LED-matrix display mounted on the rear of the host vehicle. The device software is written in Python and provides automatic operation without requiring any user intervention. The tests have shown that the device is usable on almost any motor vehicle and performs reliably in simulated and real traffic. The open issues and possibilities for future improvements are presented in the Discussion.

Condition Monitoring and Fault Diagnosis for an Antifalling Safety Device

Directory of Open Access Journals (Sweden)

Guangxiang Yang

2015-01-01

Full Text Available There is a constant need for the safe operation and reliability of antifalling safety device (AFSD of an elevator. This paper reports an experimental study on rotation speed and catching torque monitoring and fault diagnosis of an antifalling safety device in a construction elevator. Denoising the signal using wavelet transform is presented in this paper. Based on the denoising effects for several types of wavelets, the sym8 wavelet basis, which introduces the high order approximation and an adaptive threshold, is employed for denoising the signal. The experimental result shows a maximum data error reduction of 7.5% is obtained and SNRs (signal-to-noise ratio of rotation speed and catching torque are improved for 3.9% and 6.4%, respectively.

Thermal-Responsive Polymers for Enhancing Safety of Electrochemical Storage Devices.

Science.gov (United States)

Yang, Hui; Leow, Wan Ru; Chen, Xiaodong

2018-03-01

Thermal runway constitutes the most pressing safety issue in lithium-ion batteries and supercapacitors of large-scale and high-power density due to risks of fire or explosion. However, traditional strategies for averting thermal runaway do not enable the charging-discharging rate to change according to temperature or the original performance to resume when the device is cooled to room temperature. To efficiently control thermal runaway, thermal-responsive polymers provide a feasible and reversible strategy due to their ability to sense and subsequently act according to a predetermined sequence when triggered by heat. Herein, recent research progress on the use of thermal-responsive polymers to enhance the thermal safety of electrochemical storage devices is reviewed. First, a brief discussion is provided on the methods of preventing thermal runaway in electrochemical storage devices. Subsequently, a short review is provided on the different types of thermal-responsive polymers that can efficiently avoid thermal runaway, such as phase change polymers, polymers with sol-gel transitions, and polymers with positive temperature coefficients. The results represent the important development of thermal-responsive polymers toward the prevention of thermal runaway in next-generation smart electrochemical storage devices. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Software used to size the safety devices

CERN Multimedia

CERN. Geneva

2016-01-01

To avoid mistakes during the calculation, CEA/SBT has decided to write a software that take into account all the situations it is possible to encountered (subcritical state, supercritical state, …). The goal is to permit to the engineer in charge of a cryostat manufacturing to perform this calculation; he is the only person able to do the accidental analysis which is fundamental for the sizing of the safety device. The software performed will be presented.

Factors affecting the utilization of safety devices by commercial ...

African Journals Online (AJOL)

Background: Motorcycle crashes are common causes of morbidity and mortality for both riders and passengers. To prevent and reduce the severity of injuries sustained through road traffic accidents (RTA) many countries enforce the use of safety devices while riding. Certain factors including non-enforcement of the existing ...

Design and construction of safety devices utilizing methods of measurement and control engineering

Energy Technology Data Exchange (ETDEWEB)

Greiner, B; Weidlich, S

1982-08-01

This article considers a proposed concept for the design and construction of measurement and control devices for the safety of chemical plants with the aim of preventing danger to persons and the environment and damage. Such measurement and control devices are generally employed when primary measures adopted for plant safety, such as safety valves, collection vessels, etc. are not applicable or insufficient by themselves. The concept regards the new sheet no. 3 of the VDI/VDE code draft 2180 ''Safety of chemical engineering plant'' and proposes a further subdivision of class A into safety classes A0, A1, and A2. Overall, it is possible, on the basis of the measures for raising the availability of measurement and control equipment which are presented in this article, to make selection appropriate to the potential danger involved. The proposed procedure should not, however, be regarded as a rigid scheme but rather as leading to a systematic view and supporting decisions resting on sound operating experience.

Stakeholder challenges in purchasing medical devices for patient safety.

Science.gov (United States)

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

10 CFR 32.101 - Schedule B-prototype tests for luminous safety devices for use in aircraft.

Science.gov (United States)

2010-01-01

....101 Schedule B—prototype tests for luminous safety devices for use in aircraft. An applicant for a... 10 Energy 1 2010-01-01 2010-01-01 false Schedule B-prototype tests for luminous safety devices for use in aircraft. 32.101 Section 32.101 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES...

Medical Device Safety

Science.gov (United States)

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

Regulatory Experience of the Embedded Digital Devices for Safety I and C Systems on Nuclear Power Plants

Energy Technology Data Exchange (ETDEWEB)

Kim, Y. M.; Lee, H. K.; Park, H. S. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Conventional I and C(Instrumentation and Control) systems are tend to becoming unavailable and being replaced by smart equipment. These smart equipment is usually called embedded digital devices (EDDs) or industrial digital devices of limited functionality. Usually, some of these devices are found embedded in plant equipment such as sensing instrumentation, motors, pumps, actuators and breakers. They typically have a micro-processor, RAM, communication interface, a power source, etc. The U.S. Nuclear Regulatory Commission (US NRC) is concerning that these EDDs might exist in procured equipment used in safety systems without the devices having been explicitly identified in procurement documentation. This paper addresses the regulatory experiences of KINS of the EDDs for safety I and C systems and the future works for them. In this paper, we showed regulatory experiences of EDDs which used for safety grade equipment. EDDs might exist in safety grade procured equipment without explicit identification. Undetected defects of EDDs might be the potential safety concerns. EDDs should meet certain specific requirements in order to be selected and used in safety I and C system. We have plan to develop technical positions for identification and qualifying them. The technical position will address, but may not be limited to, quality and reliability, CCFs via software errors, EMC, and CGID for EDDs.

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Research Devices Maintenance Programs and Safety Network Infrastructures in Nuclear Malaysia

International Nuclear Information System (INIS)

Zainudin Jaafar; Muhammad Zahidee Taat; Ishak Mansor

2015-01-01

Instrumentation and Automation Center (PIA) is responsible in carrying out maintenance work for building safety infrastructure and area for nuclear scientific and research work. Care cycle and nuclear scientific tools starting from the preparation of specifications until devices disposal- to get the maximum output from devices therefore PIA has introduced Effective and Comprehensive Maintenance Plan under Management/ Trust/ Development/ Science Fund budgets and also user, Asset Management, caring and handling of the devices. This paper also discussed more on case study related to using and handling so that it can be guidance and standard when its involving mishandling, improper maintenance, inadequacy of supervision and others including improvement suggestion programs. (author)

Utilization of ocular safety devices among Sawmill workers in Nigeria

African Journals Online (AJOL)

Objective: The study was carried out to assess the use of eye safety devices in sawmill workers in Nigeria. Methods: A cross-sectional study of sawmill workers was carried out using pretested questionnaires. Ocular examination was done on site with a pen torch, portable hand-held slit lamp bio-microscope and direct ...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2012-10-04

... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-06-12

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2011-06-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

Risk assessment of medical devices: evaluation of microbiological and toxicological safety

International Nuclear Information System (INIS)

Dorpema, J.W.

1995-01-01

Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)

Passive safety device and internal short tested method for energy storage cells and systems

Science.gov (United States)

Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad

2015-09-22

A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.

78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-03-21

... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

41 CFR 102-34.250 - Do Federal employees in Government motor vehicles have to use all safety devices and follow all...

Science.gov (United States)

2010-07-01

... safety devices and follow all safety guidelines? Yes, Federal employees in Government motor vehicles have... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section...

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Science.gov (United States)

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

Science.gov (United States)

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Safety catching device for pipes in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1976-01-01

The safety catching device consists of a steel wire passed in U-shape around the pipe to be caught and supported by two anchor ties embedded in the concrete of the missile shielding cylinder. This flexible catching device is to cause the energy released in case of a pipe rupture to be absorbed and no dangerous bending shesses to be transferred to the walls of the missile shielding cylinder. (UWI) [de

Safety evaluation of stamp type digital microneedle devices in hairless mice.

Science.gov (United States)

Park, Kui Young; Jang, Woo Sun; Lim, Yun Young; Ahn, Joo Hee; Lee, Sang Jin; Kim, Chan Woong; Kim, Sung Eun; Kim, Beom Joon; Kim, Myeung Nam

2013-02-01

Microneedles provide a minimally invasive means to transport molecules into the skin. A number of specific strategies have been employed to use microneedles for transdermal delivery. The purpose of this study was to investigate the safety of two new digital microneedle devices (Digital Hand® and Digital Pro®; Bomtech Electronics Co., Ltd., Seoul, Korea) for the perforation of skin in skin-hairless-1 mice. This device replaces conventional needles and is designed specifically for intradermal delivery. We used two newly developed digital microneedle devices to perforate the skin of skin-hairless-1 mice. We conducted a comparative study of the two digital microneedle devices and DTS® (Disk type-microneedle Therapy System; DTS lab., Seoul, Korea). To evaluate skin stability, we performed visual and dermatoscopic inspections, measurements of transepidermal water loss, and biopsies. The two novel digital microneedle devices did not induce significant abnormalities of the skin on visual or dermatoscopic inspection, regardless of needle size (0.25~2.0 mm). No significant histopathological changes, such as inflammatory cell infiltration, desquamation of the stratum corneum, or disruption of the basal layer, were observed. The digital microneedle devices and microneedle therapy system produced similar results on measures of skin stability. These two novel digital microneedle devices are safe transdermal drug delivery systems.

The Challenges of Balancing Safety and Security in Implantable Medical Devices.

Science.gov (United States)

Katzis, Konstantinos; Jones, Richard W; Despotou, George

2016-01-01

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

ACCIDENT WITH NEEDLESTICK: KNOWLEDGE AND USE OF SAFETY DEVICE

Directory of Open Access Journals (Sweden)

Sandra Maria Souza da Silva

2016-07-01

Full Text Available Health workers engaged in labour activities in environments surrounded the occupational hazards. Identify knowledge and use of safety devide for preventing accidents with sharp objects between nurses and nurse technicians, workers of the Intensive Care Unit, Emergency and Surgical Block, during the month of may 2015. Exploratory study, quantitative, developed in a teaching hospital in in Recife-PE. The data collection was conducted using a questionnaire prepared by the research authors. The results were submitted to descriptive statistical analysis, being evidenced that, although data indicate high rate of respondents know and use products with referencing safety devices to prevent accidents, cite gloves and masks as representatives of those materials, which requires clarification in discussion of the study. It is necessary to guide and clarify as to such mechanisms, through the permanent education, and training among workers.

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

Science.gov (United States)

Ho, Anita; Quick, Oliver

2018-03-06

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

Materials for electrochemical device safety

Science.gov (United States)

Vissers, Daniel R.; Amine, Khalil; Thackeray, Michael M.; Kahaian, Arthur J.; Johnson, Christopher S.

2015-04-07

An electrochemical device includes a thermally-triggered intumescent material or a gas-triggered intumescent material. Such devices prevent or minimize short circuits in a device that could lead to thermal run-away. Such devices may include batteries or supercapacitors.

Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.

Science.gov (United States)

Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis

2013-11-25

Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction

The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

Energy Technology Data Exchange (ETDEWEB)

Yuan, Yongguang; Zong, Yao; Zheng, Qishan [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Qian, Garrett [University of New South Wales (Australia); Qian, Xiaobin; Li, Yujie; Shao, Wanwen [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Gao, Qianying, E-mail: gaoqy@mail.sysu.edu.cn [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China)

2016-05-01

Purpose: To evaluate the efficacy and safety of posterior scleral reinforcement (PSR) device for myopia suppression in rabbits' eyes. Methods: PSR surgery was performed on the normal 12 8-week-old New Zealand white rabbits' right eyes. To determine efficacy of the device, ophthalmic examination would be taken at pre-operation and post-operation (1 week, 1 month, 3 months, 6 months, and 1 year), such as A-ultrasound, diopter and B-ultrasound. Evaluation of safety were based on the following indicators: intraocular pressure (IOP), slit lamp, fundus photography, fundus fluorescein angiography and pathological examination after surgery. The efficacy and safety of PSR device were evaluated by comparison (treated eyes and contralateral eyes) of pre and post-operation. Results: The novel PSR device could significantly shorten axial length (preoperative axial length: 16.36 ± 0.14 mm, postoperative 1 week, 1 month, 3 months, 6 months and 1 year axial lengths: 15.03 ± 0.28 mm, 15.23 ± 0.32 mm, 15.39 ± 0.31 mm, 15.45 ± 0.22 mm and 15.45 ± 0.22 mm; P = 0.00037 < 0.001) in the treated eyes (right eyes) after surgery. At different postoperative time points, the B-ultrasound images showed that the PSR located in appropriate position and supported the posterior sclera very well. At the same time, IOP of treated eyes kept a relatively stable level (preoperative IOP: 12.56 ± 2.01 mmHg, postoperative IOP: ranging from 11.33 ± 1.23 mmHg to 13.44 ± 2.19 mmHg, P > 0.05) post-operation 1 year. During observation period, there was no significant inflammatory reaction and complications such as anterior chamber flare, empyema, endophthalmitis, vitreous hemorrhage, retina detachment and retinal choroid neovascularization by slit lamp, fundus photography and fundus fluorescein angiography. In addition, there were no pathologic changes be found by comparison treated eyes group and contralateral group eyes based on pathological examinations. Conclusions: In vivo study

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

Science.gov (United States)

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States.

Science.gov (United States)

Frost, Karen L; van Roosmalen, Linda; Bertocci, Gina; Cross, Douglas J

2012-01-01

An overview of the current status of wheelchair transportation safety in fixed route and demand-responsive, non-rail, public transportation vehicles within the US is presented. A description of each mode of transportation is provided, followed by a discussion of the primary issues affecting safety, accessibility, and usability. Technologies such as lifts, ramps, securement systems, and occupant restraint systems, along with regulations and voluntary industry standards have been implemented with the intent of improving safety and accessibility for individuals who travel while seated in their wheeled mobility device (e.g., wheelchair or scooter). However, across both fixed route and demand-responsive transit systems a myriad of factors such as nonuse and misuse of safety systems, oversized wheeled mobility devices, vehicle space constraints, and inadequate vehicle operator training may place wheeled mobility device (WhMD) users at risk of injury even under non-impact driving conditions. Since WhMD-related incidents also often occur during the boarding and alighting process, the frequency of these events, along with factors associated with these events are described for each transit mode. Recommendations for improving WhMD transportation are discussed given the current state of

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

Science.gov (United States)

Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

2011-06-01

Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

The design study of the JT-60SU device. No.8. Nuclear shielding and safety design

Energy Technology Data Exchange (ETDEWEB)

Miya, Naoyuki; Kikuchi, Mitsuru; Ushigusa, Kenkichi [Japan Atomic Energy Research Inst., Naka, Ibaraki (Japan). Naka Fusion Research Establishment] [and others

1998-03-01

Results of nuclear shielding design study and safety analysis for the steady-state tokamak device JT-60SU are described. D-T operation (option) for two years is adopted in addition to ten years operation using deuterium. Design work has been done in accordance with general laws for radioisotopes handling in Japan as a guideline of safety evaluation, which is applied to the operation of present JT-60U device. Optimization of the shielding design for the device structure including vacuum vessel has been presented to meet with allowable limits of biological shielding determined in advance. It is shown that JT-60SU can be operated safely in the present JT-60 experimental building. It is planed to use 100g/year of tritium in D-T operation phase. A concept of multiple -barrier system is applied to the facility design to prevent propagation of tritium, in which the torus hall and the tritium removal room provide the tertiary confinement. From the design of atmosphere detritiation system for accidental tritium release, it is shown that tritium concentration level can be reduced to the allowable level after two weeks with reasonable compact size components. Safety assessment related to activation of coolant/air, and atmospheric tritium effluents are discussed. (author)

Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology

DEFF Research Database (Denmark)

Town, Graham; Ash, C; Dierickx, C

2012-01-01

. These guidelines provide a definition of light-based home-use technology, to inform healthcare professionals about home-use light-based technology and encourage manufacturers wishing to sell in Europe to adopt 'best practice'. The review presents the current status on standards and regulation issues and considers...... home-use safety issues, encompassing human, device and electrical safety, given risks to the eyes and skin from optical radiation both to the consumer and persons in the vicinity. Proposed technical measurement methodology is considered with focus on recognized critical parameters for the safe use...... of light-based hair removal technology including recording the technical performance and safety claims of a range of home-use hair removal devices. The literature review emphasizes potential adverse incidents and safety aspects of treating cosmetic conditions, such as unwanted hair growth. Although some...

The safety of non-incineration waste disposal devices in four hospitals of Tehran.

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

The safe management of hospital waste is a challenge in many developing countries. The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries.

76 FR 23255 - Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and Associated Equipment

Science.gov (United States)

2011-04-26

... petitions for reconsideration from Harley-Davidson Motor Company (January 18, 2008) and Ford Motor Company... [Docket No. NHTSA-2007-28322] Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and... part, the petitions for reconsideration of the December 4, 2007, final rule reorganizing Federal Motor...

Safety motion increase of trains by improvement diagnostics process devices of railway automation

Directory of Open Access Journals (Sweden)

B.M.Bondarenko

2012-12-01

Full Text Available The complex use of methods of nondestructive check for the automated diagnostics electromagnetic relays of railway automation the first class reliability is offered. The methods determination of their mechanical parameters are resulted, that allows to exclude a human factor from the control, promote reliability of devices railway automation and safety motion of railway transport.

An overview of review guidelines for HDL programmable devices in nuclear safety systems

International Nuclear Information System (INIS)

Komanduri, Raghavan; Srivani, L.; Thirugnana Murthy, D.

2013-01-01

HDL programmable devices viz. CPLDs and FPGAs are increasingly being used to implement digital designs in the I and C systems performing safety functions of nuclear power plants. Synthesizable RTL descriptions manually written in HDLs are the first step in developing industry standard large scale digital designs. The reliability of the implementation is determined by the methodologies followed by the designer during development. Very few guidelines on HPD design practices, specific to nuclear industry are available. This paper presents an overview of the existing guidelines such as IEC 62566 and U.S. NRC's 'Review guidelines for FPGAs in nuclear power plant safety systems'. (author)

The safety of non-incineration waste disposal devices in four hospitals of Tehran

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

Background: The safe management of hospital waste is a challenge in many developing countries. Objectives: The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. Methods: VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. Results: There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. Conclusions: There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries. PMID:25000113

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

A novel safety device with metal counter meshing gears discriminator directly driven by axial flux permanent magnet micromotors based on MEMS technology

Science.gov (United States)

Zhang, Weiping; Chen, Wenyuan; Zhao, Xiaolin; Li, Shengyong; Jiang, Yong

2005-08-01

In a novel safety device based on MEMS technology for high consequence systems, the discriminator consists of two groups of metal counter meshing gears and two pawl/ratchet wheel mechanisms. Each group of counter meshing gears is onepiece and driven directly by an axial flux permanent magnet micromotor respectively. The energy-coupling element is an optical shutter with two collimators and a coupler wheel. The safety device's probability is less than 1/106. It is fabricated by combination of an LiGA-like process and precision mechanical engineering. The device has simple structure, few dynamic problems, high strength and strong reliability.

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

Directory of Open Access Journals (Sweden)

Anna R Gagliardi

Full Text Available Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI is a concern and how it is managed.A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.Twenty-two physicians (10 cardiovascular, 12 orthopedic were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how

Device for removing hydrogen gas from the safety containment vessel of a nuclear reactor

International Nuclear Information System (INIS)

Stiefel, M.

1983-01-01

The safe processing of all concentrations of gas mixtures should be possible with such a device using a thermal recombiner of compact construction. A recombiner consisting of a metal case and diverter sheets situated in it is heated by induction. The incoming pipe for the gas mixture enriched with hydrogen and the outgoing pipe for the gas mixture with low hydrogen content are connected together by a three way valve. The third connection to the safety valve takes the larger port of the gas mixture with low hydrogen content back to the safety containment vessel. Sufficient amount of the gas mixture with low hydrogen content is taken via the three way valve to the safety containment vessel to ensure that the hydrogen content of the gas mixture taken to the recombiner remains below the 4% by volume limit. (orig./PW)

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study

NARCIS (Netherlands)

Eekeren, R. van; Boersma, D.; Elias, S.; Holewijn, S.; Werson, D.A.; Vries, J.P. de; Reijnen, M.M.P.J.

2011-01-01

PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the

Reactor safety device

International Nuclear Information System (INIS)

Okada, Yasumasa.

1987-01-01

Purpose: To scram control rods by processing signals from a plurality of temperature detectors and generating abnormal temperature warning upon occurrence of abnormal temperature in a nuclear reactor. Constitution: A temperature sensor comprising a plurality of reactors each having a magnetic body as the magnetic core having a curie point different from each other and corresponding to the abnormal temperature against which reactor core fuels have to be protected is disposed in an identical instrumentation well near the reactor core fuel outlet/inlet of a reactor. A temperature detection device actuated upon detection of an abnormal temperature by the abrupt reduction of the reactance of each of the reactors is disposed. An OR circuit and an AND circuit for conducting OR and AND operations for each of the abnormal temperature detection signals from the temperature detection device are disposed. The output from the OR circuit is used as the abnormal temperature warning signal, while the output from the AND circuit is utilized as a signal for actuating the scram operation of control rod drive mechanisms. Accordingly, it is possible to improve the reliability of the reactor scram system, particularly, improve the reliability under a high temperature atmosphere. (Kamimura, M.)

Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy.

Science.gov (United States)

Hieb, Robert A; Neisen, Melissa J; Hohenwalter, Eric J; Molnar, Jim A; Rilling, William S

2008-12-01

To retrospectively evaluate the safety and effectiveness of the use of the AngioSeal device for repeat arterial closure in patients with hepatic malignancy. A retrospective analysis of patients with hepatic malignancy who had undergone repeated arterial closure with the AngioSeal device was performed. All charts for patients undergoing transarterial chemoembolization or TheraSphere radioembolization were reviewed for the method of hemostasis and the number of arterial closures. A total of 53 patients (58.5% men, 41.5% women; mean age, 58.7 years) had repeat AngioSeal arterial puncture closure after chemoembolization or TheraSphere treatment. Percutaneous closure of the common femoral artery with the AngioSeal device was performed in accordance with the manufacturer's recommendations. The patients were examined for complications on follow-up. Effectiveness was defined by the ability to obtain satisfactory hemostasis. Safety was assessed by the absence of groin complications and by vessel patency on follow-up angiograms of the puncture site obtained at subsequent liver-directed therapy sessions. Fifty-three patients in this study group had a total of 203 common femoral artery punctures. There were a total of 161 closures with the AngioSeal device (79.3%): 58 (36%) single closures and 103 (64.0%) repeat closures. Of the 161 attempts at AngioSeal closure, there was one closure failure in the single-puncture group, yielding a success rate of 98.3%; and one closure failure in the repeat-puncture group, yielding a success rate of 99%. In these two patients, hemostasis was achieved with traditional manual compression without the need for any other device, and no complications were noted. The overall success rate of AngioSeal device closure was 98.7%. The repeat use of the AngioSeal closure device is safe and effective in patients with hepatic malignancy undergoing regional oncologic interventional procedures.

Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices.

Science.gov (United States)

Elder, Alexander; Paterson, Caron

2006-12-01

To review the literature on sharps injuries and occupational bloodborne virus transmission in health care in the UK and the worldwide evidence for injury prevention of sharps safety devices. Literature review by online database and Internet resource search. Twenty-four relevant publications were identified regarding UK reported sharps injury rates. UK studies showed as much as a 10-fold difference between injuries reported through standard reporting systems (0.78-5.15 per 100 person-years) and rates estimated from retrospective questionnaires of clinical populations (30-284 per 100 person-years). National surveillance data from England, Wales and Northern Ireland gives a rate of 1.43 known hepatitis C virus or human immunodeficiency virus (HIV) transmissions to health care workers per annum. When extrapolated, this suggests an approximate rate of 0.009 such viral transmissions per 1000 hospital beds per annum. Risk of infection from sources with no risk factors is extremely small (less than one in one million for HIV transmission based on Scottish data). Thirty-one studies on the efficacy of sharps safety devices showed evidence of a reduction in injuries, with the greatest reductions achieved by blunt suture needles and safety cannulae. Although injuries remain common, confirmed viral transmission in the UK has been relatively rare. The degree of under-reporting of sharps injuries may be as much as 10-fold. Safety-engineered devices are likely to be effective at injury reduction.

Recommended safety procedures for the selection and use of demonstration-type gas discharge devices in schools

International Nuclear Information System (INIS)

1979-01-01

A 1972 survey of 30 Ottawa secondary schools revealed a total of 347 actual or potential X-ray sources available in these schools. More than half of these sources were gas discharge tubes. Some gas discharge tubes, in particular the cold cathode type, can emit X-rays at significantly high levels. Unless such tubes are used carefully, and with regard for good radiation safety practices, they can result in exposures to students that are in excess of the maximum levels recommended by the International Commission on Radiological Protection. Several cases of the recommended dose being exceeded were found in the classes surveyed. This document has been prepared to assist science teachers and others using demonstration-type gas discharge devices to select and use such devices so as to present negligible risk to themselves and students. Useful information on safety procedures to be followed when performing demonstrations or experiments is included. (J.T.A.)

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

30 CFR 77.808 - Disconnecting devices.

Science.gov (United States)

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Surface High-Voltage Distribution § 77.808 Disconnecting devices. Disconnecting devices shall be installed at the...

Nuclear reactor safety protection device

International Nuclear Information System (INIS)

Okido, Fumiyasu; Noguchi, Atomi; Matsumiya, Shoichi; Furusato, Ken-ichiro; Arita, Setsuo.

1994-01-01

The device of the present invention extremely reduces a probability of causing unnecessary scram of a nuclear reactor. That is, four control devices receive signals from each of four sensors and output four trip signals respectively in a quardruplicated control device. Each of the trip signals and each of trip signals via a delay circuit are inputted to a logical sum element. The output of the logical sum circuit is inputted to a decision of majority circuit. The decision of majority circuit controls a scram pilot valve which conducts scram of the reactor by way of a solenoid coils. With such procedures, even if surge noises of a short pulse width are mixed to the sensor signals and short trip signals are outputted, there is no worry that the scram pilot valve is actuated. Accordingly, factors of lowering nuclear plant operation efficiency due to erroneous reactor scram can be reduced. (I.S.)

Estimating Safety Effects of Green-Man Countdown Devices at Signalized Pedestrian Crosswalk Based on Cellular Automata

Directory of Open Access Journals (Sweden)

Chen Chai

2017-01-01

Full Text Available Safety effects of Green-Man Countdown Device (GMCD at signalized pedestrian crosswalks are evaluated. Pedestrian behavior at GMCD and non-GMCD crosswalks is observed and analyzed. A microsimulation model is developed based on field observations to estimate safety performance. Simulation outputs allow analysts to assess the impacts of GMCD at various conditions with different geometric layout, traffic and pedestrian volumes, and the green time. According to simulation results, it is found that the safety impact of GMCD is affected by traffic condition as well as different time duration within green-man signal phase. In general, GMCD increases average walking velocity, especially during the last few seconds. The installation of GMCD improves safety performance generally, especially at more crowded crossings. Conflict severity is increased during last 10 s after GMCD installation. Findings from this study suggest that the current practice, which is to install GMCD at more crowded crosswalks or near the school zone, is effective. Moreover, at crosswalks with GMCD, longer all red signal phase is suggested to improve pedestrian safety during intergreen period.

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

International Nuclear Information System (INIS)

Bang, Young Seok; Yoo, Seung Hun

2016-01-01

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level

Hydrodynamics of Safety Injection Tank with Fluidic Device in Recent Regulation

Energy Technology Data Exchange (ETDEWEB)

Bang, Young Seok; Yoo, Seung Hun [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Safety Injection Tank (SIT) with Fluidic Device (FD) has been used in several APR1400 nuclear power plants. It was designed to provide a longer passive safety injection than the existing accumulator to improve the safety for Large Break Loss-of-Coolant Accident (LBLOCA) by changing the injected flow through the FD and the standpipe of the SIT. As a result, high flow injection phase and the subsequent low flow one can be achieved as longer than the existing accumulator. The present paper discusses the major concerns related to SIT hydrodynamics and the directions to resolution recently concerned. Modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing are included. Based on the discussion, a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The present paper discussed the SIT hydrodynamics including the modeling of SIT/FD by total hydraulic resistances, potential of nitrogen intrusion, and effect of initial pressure of SIT testing. Also a table of the important phenomena of the SIT/FD was proposed with the relevancy of the calculation models applied. The following conclusions are obtained uncertainty due to the assumption of the total Kfactor as constant for high flow, transition phase, and low flow phase should be considered and nitrogen intrusion phenomena during the transition phase should be considered with a conservatism, especially considering the current situation of nonmeasuring the standpipe level.

A systematic review of light-based home-use devices for hair removal and considerations on human safety

DEFF Research Database (Denmark)

Thaysen-Petersen, D; Bjerring, P; Dierickx, C

2012-01-01

To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. Methods A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled......, uncontrolled or randomized and with a sample size of at least 10 individuals. Results We identified a total of seven studies: one controlled (CT) and six uncontrolled trials (UCTs). No randomized controlled trials (RCT) were recognized. The best evidence was found for IPL (intense pulsed light) (three devices...

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

Science.gov (United States)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Extraglottic airway devices: technology update

Directory of Open Access Journals (Sweden)

Sharma B

2017-08-01

Full Text Available Bimla Sharma, Chand Sahai, Jayashree Sood Department of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India Abstract: Extraglottic airway devices (EADs have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS formed the Airway Device Evaluation Project Team (ADEPT to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues. Keywords: extraglottic airway devices, laryngeal mask airway, other extraglottic airway devices, safety, technology update

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

Directory of Open Access Journals (Sweden)

Faunce Thomas

2006-03-01

Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

Safety analysis of an irradiation device for 99Mo production in RA-3 reactor

International Nuclear Information System (INIS)

Lerner, Ana Maria; Madariaga, Marcelo; Waldman, Ricardo

2000-01-01

The Argentine RA-3 research reactor (5 MW) has been converted to LEU fuel more than nine years ago. Since then, it has been operating with LEU fuel, which has been designed and fabricated at the National Atomic Energy Commission (CNEA). The Nuclear Regulatory Authority (ARN) is the institution in charge of the installation safety control. It is under this framework that the ARN has elaborated a neutronic calculation model for the RA-3 core, paying special attention to the device presently used for the irradiation of (HEU) 235 U targets required to obtain 9 '9Mo as a fission product. A regulatory analysis of results is carried out in the framework of ARN standards for fixed experiments. For such purpose, calculated reactivity values associated with such device are compared with recently measured values at the installation. Finally, and according to guidelines established in the first part of this work, a calculation model for a new device proposed by CNEA for the irradiation of metallic (LEU) uranium targets and still at its design stage, is here analysed. (author)

An experimental study of the flow characteristics of fluidic device in a passive safety injection tank

International Nuclear Information System (INIS)

Cho, Seok; Song, Chul Hwa; Won, Suon Yeon; Min, Kyong Ho; Chung, Moon Ki

1998-01-01

It is considered to adopt passive safety injection tank (SIT) as a enhanced safety feature in KNGR. Passive SIT employs a vortex chamber as a fluidic device, which control injection flow rate passively by the variation of flow resistance produced by vortex intensity within the vortex chamber. To investigate the flow characteristics of the vortex chamber many tests have been carried out by using small-scale test facility. In this report the effects of geometric parameters of vortex chamber on discharge flow characteristics and the velocity measurement result of flow field, measured by PIV, are presented and discussed. (author). 25 refs., 11 tabs., 31 figs

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

Science.gov (United States)

Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

2017-12-01

To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Development of a safety case for the use of current limiting devices to manage short circuit currents on electrical distribution networks. Final report

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

The original objective of this study was to review the safety issues associated with the use of current limiting devices and to write a risk assessment in accordance with good practice. But, when legislative procedures became apparent, the scope was changed to include involvement with the HSE, the DTI and Ofgem. It turned out that it would have been very difficult to write a safety case that would satisfy all of the agencies, or a risk assessment that would cover all applications. The scope of the study was therefore changed to focus on how the existing barriers should be tackled and the implications of the existing legislation. The approach to the study is described; it included reviews of background information and literature, questionnaires to manufacturers, a review of the reliability and hazards of the devices, and a review of UK safety legislation. The Final Report describes all this and includes discussion on the consequences of failure of fault current limiting devices, control measures which could be used to minimise risk, and recommendations for a way forward.

Reactor safety

International Nuclear Information System (INIS)

Butz, H.P.; Heuser, F.W.; May, H.

1985-01-01

The paper comprises an introduction into nuclear physics bases, the safety concept generally speaking, safety devices of pwr type reactors, accident analysis, external influences, probabilistic safety assessment and risk studies. It further describes operational experience, licensing procedures under the Atomic Energy Law, research in reactor safety and the nuclear fuel cycle. (DG) [de

Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

Science.gov (United States)

2015-11-20

The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

International Nuclear Information System (INIS)

Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

2015-01-01

Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

Reactor protecting device

International Nuclear Information System (INIS)

Ono, Hiroshi; Kasuga, Hajime; Kasuga, Hiroshi.

1984-01-01

Purpose: To reduce the recycling flowrate thereby decrease the neutron flux level before the reactor shutdown upon generation of abnormality such as increase in the neutron flux, by setting the safety level lower than the value for generating the reaction scram signal. Constitution: A netron flux safety level setter and an instruction signal generator are disposed between a neutron flux detector and a recycling flowrate control device. A neutron flux safety level lower than the level for generating a reactor scram signal and higher that the level for the ordinary operation is set and, if the detection level for the neutron flux in the reactor core arrives at the safety level, a neutron flux decreasing instruction signal is outputted from the instruction signal generator to the recycling flowrate control device to thereby decrease the recycling flowrate and decrease the neutron flux without reaching the reactor shutdown, whereby the thermal safety of the fuel rod can be maintained and the reactor operation performance can be improved. (Moriyama, K.)

Safety analysis and evaluation of the next fusion device

International Nuclear Information System (INIS)

Kobayashi, Shigetada; Honda, Tsutomu; Ohmura, Hiroshi; Kawai, Masayoshi; Shimizu, Takeshi; Yamaoka, Mitsuaki; Nakahara, Katsuhiko; Seki, Yasushi.

1988-12-01

As a part of safety evaluation, a probabilistic risk assessment (PRA) has been attempted for the Next Fusion Device system. Among the various events related to safety, a number of representative events have been selected for assessment, from the events in normal operation state, repair and maintenance state and accidental state. In the first chapter, in order to conduct the probabilistic risk assessment of the whole Fusion Experimental Reactor (FER), the data base required for the analysis was investigated in 1.1, the results on the failure mode and effects analysis (FMEA), accident sequence, radioactive inventory leakage flow path, event tree analysis (ETA) and fault tree analysis (FTA) were summarized in 1.2 to 1.5, respectively. Based on these results, accident initiating events were evaluated in 1.6, and overall risk was assessed in 1.7 and the tasks for the future were summarized in 1.8. It is important to analyze and evaluate various events during normal operations, repair and maintenance and accidents. However, due to the large uncertainties in the modeling of phenomena or the data base, there are many events for which realistic analyses are difficult. Three such events were selected and studied in chapter two. In 2.1, the temperature rise in the reactor structure after the Loss-of-Coolant-Accident caused by the decay heat under various heat removal conditions were investigated. In 2.2, the radiation dose of personnel during repair and maintenance period caused by the release of activated dust were estimated. Lastly, in 2.3 tritium behavior in the stainless steel first wall and graphite armour were studied. (author)

Operating room fire prevention: creating an electrosurgical unit fire safety device.

Science.gov (United States)

Culp, William C; Kimbrough, Bradly A; Luna, Sarah; Maguddayao, Aris J

2014-08-01

To reduce the incidence of surgical fires. Operating room fires represent a potentially life-threatening hazard and are triggered by the electrosurgical unit (ESU) pencil. Carbon dioxide is a fire suppressant and is a routinely used medical gas. We hypothesize that a shroud of protective carbon dioxide covering the tip of the ESU pencil displaces oxygen, thereby preventing fire ignition. Using 3-dimensional modeling techniques, a polymer sleeve was created and attached to an ESU pencil. This sleeve was connected to a carbon dioxide source and directed the gas through multiple precisely angled ports, generating a cone of fire-suppressive carbon dioxide surrounding the active pencil tip. This device was evaluated in a flammability test chamber containing 21%, 50%, and 100% oxygen with sustained ESU activation. The sleeve was tested with and without carbon dioxide (control) until a fuel was ignited or 30 seconds elapsed. Time to ignition was measured by high-speed videography. Fires were ignited with each control trial (15/15 trials). The control group median ± SD ignition time in 21% oxygen was 3.0 ± 2.4 seconds, in 50% oxygen was 0.1 ± 1.8 seconds, and in 100% oxygen was 0.03 ± 0.1 seconds. No fire was observed when the fire safety device was used in all concentrations of oxygen (0/15 trials; P fire ignition was 76% to 100%. A sleeve creating a cone of protective carbon dioxide gas enshrouding the sparks from an ESU pencil effectively prevents fire in a high-flammability model. Clinical application of this device may reduce the incidence of operating room fires.

33 CFR 159.95 - Safety.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety. 159.95 Section 159.95... SANITATION DEVICES Design, Construction, and Testing § 159.95 Safety. (a) Each device must— (1) Be free of... explosion or over pressurization as a result of an accumulation of gases; and (3) Meet all other safety...

'The Closer'-percutaneous vascular suture device: evaluation of safety and performance in neuroangiography

International Nuclear Information System (INIS)

Henk, Christine B.; Grampp, Stephan; Heimberger, Karl; Czerny, Christian; Schindler, Erwin; Mostbeck, Gerhard H.

2003-01-01

Objective: To evaluate the use of the suture mediated vascular closure device concerning practicability and safety in clinical angiography practice. Material and methods: One hundred and seventeen patients (59 female, 58 male, mean age 40.9±13.4) underwent percutaneous closure of common femoral arterial puncture sites following diagnostic neuroangiography using the suture device 'the Closer' (Perclose Inc., Redwood City, CA, USA). Primary success, early problems (within 24 h) and late complications were evaluated. Complications were graded as minor and severe with or without need of surgical intervention and categorized by type. Parameters such as age, gender, sheath size and number of previous arterial punctures were evaluated with respect to complications. Results: Percutaneous closure was primary successful in 85% (100/117). The overall complication rate was 32% (28% mild n=35, 4% severe n=6, which needed surgical intervention). All but one problem occurred within the first 24 h after the suture. Additional manual compression was necessary in 32 cases (25%). There was no significant difference in age and gender between the groups with and without complications. Sheath size was significantly larger (P<0.01) and numbers of preceding angiograms were significantly higher (P<0.01) in the complications group compared with uncomplicated cases. Conclusion: The evaluated percutaneous vascular suture device is useful in clinical practice but limitations concerning patient selection seem to emerge in order to avoid complications

Nuclear criticality safety and time reactivity enhancement aspects of energy amplifier system devices

Energy Technology Data Exchange (ETDEWEB)

Siciliano, F [ENEA, Centro Ricerche Trisaia, Rotondelle, Matera (Italy). Direzione INFO

1995-12-01

As far as the Rubbia`s and colleagues proposal of innovating Energy Amplifier system (E.A.s.) device driven by a particle beam accelerator is concerned, four basic topics are comprised in the present paper: (1) A short outline of the nuclear aspects of Th-U and U-Pu fuel cycles regarding their general breeding and efficiency features. (2) The needed nuclear criticality control requirements have been studied in terms of safety regulating parameters on the basis of the ThO2 mixed oxides selected as fuel kind for the E.A.s. device technology development. Particular attention is devoted to time evolution of neutron multiplication factor since delayed development of the 233U buildup and so system reactivity are expected in the Th-U cycle. (3) Code E.A.s. device irradiation and post-irradiation modelling for determining higher actinides buildup, fission products formation and fuel consumption trends as function of time, system enrichment degree and flux level parameters. (4) The confirmation, on the basis of the same specific power irradiation, of expected actinides waste obtainment cleaner than the one deriving from the U-Pu cycle utilization. For this end, a model comparison of equivalent enriched fissile nuclides in both cycles has been devised as having, within the range of 0-700 days, ten irradiation periods of about 53 MW/ton specific power and equivalent cooling time post-irradiation periods.

Safety work with MRI devices in medicine

International Nuclear Information System (INIS)

Zivkovic, D.; Hrnjak, M.

1999-01-01

This paper gives the basis of biological effects of physical factors which could affect personnel working on MRI devices and patients, and corresponding protection measures. Medical personnel working with MRI devices and patients could be exposed to static magnetic field, time varying fields and radiofrequency radiation, danger from electric current and chemical matters, and there is a high risk from moving metal objects which could wound the persons near-by. The protection from static magnetic field could be ensured by increasing the distance from the source. If MRI device is put in Faradays cage it could be corresponding protection of radiofrequency radiation. (author)

Model-based engineering for medical-device software.

Science.gov (United States)

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

Preventing medical device recalls

CERN Document Server

Raheja, Dev

2014-01-01

Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety     Overview of FDA Quality System Regulation     Overview of Risk Management Standard ISO 14971     Overview of FDA Device Approval Process     Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and

Safety of mechanical chest compression devices AutoPulse and LUCAS in cardiac arrest: a randomized clinical trial for non-inferiority

NARCIS (Netherlands)

Koster, Rudolph W.; Beenen, Ludo F.; van der Boom, Esther B.; Spijkerboer, Anje M.; Tepaske, Robert; van der Wal, Allart C.; Beesems, Stefanie G.; Tijssen, Jan G.

2017-01-01

Aims Mechanical chest compression (CC) during cardiopulmonary resuscitation (CPR) with AutoPulse or LUCAS devices has not improved survival from cardiac arrest. Cohort studies suggest risk of excess damage. We studied safety of mechanical CC and determined possible excess damage compared with manual

Radiation emitting devices act

International Nuclear Information System (INIS)

1970-01-01

This Act, entitled the Radiation Emitting Devices Act, is concerned with the sale and importation of radiation emitting devices. Laws relating to the sale, lease or import, labelling, advertising, packaging, safety standards and inspection of these devices are listed as well as penalties for any person who is convicted of breaking these laws

Safety catching device for pipe lines in missile shielding cylinders of nuclear power plants

International Nuclear Information System (INIS)

Hering, S.; Doll, B.

1975-01-01

The safety catching device for pipes in the missile shielding cylinders consists of a flexible steel cable surrounding the pipe in a distance in U-shape. The arrester cable - which works as a spring and is freely movable in all directions - is attached to the cylinder wall. For this, the ends of the cable are primarily fastened to anchor boxes which are then inserted in a stay tube with the same axis as the cable ends. The anchor boxes are fastened to the outer wall of the missile shielding cylinder by anchor bolts and holding plates. (DG/AK) [de

The risk of a safety-critical event associated with mobile device use in specific driving contexts.

Science.gov (United States)

Fitch, Gregory M; Hanowski, Richard J; Guo, Feng

2015-01-01

We explored drivers' mobile device use and its associated risk of a safety-critical event (SCE) in specific driving contexts. Our premise was that the SCE risk associated with mobile device use increases when the driving task becomes demanding. Data from naturalistic driving studies involving commercial motor vehicle drivers and light vehicle drivers were partitioned into subsets representative of specific driving contexts. The subsets were generated using data set attributes that included level of service and relation to junction. These attributes were selected based on exogenous factors known to alter driving task demands. The subsets were analyzed using a case-cohort approach, which was selected to complement previous investigations of mobile device SCE risk using naturalistic driving data. Both commercial motor vehicle and light vehicle drivers varied as to how much they conversed on a mobile device but did not vary their engagement in visual-manual subtasks. Furthermore, commercial motor vehicle drivers conversed less frequently as the driving task demands increased, whereas light vehicle drivers did not. The risk of an SCE associated with mobile device use was dependent on the subtask performed and the driving context. Only visual-manual subtasks were associated with an increased SCE risk, whereas conversing was associated with a decreased risk in some driving contexts. Drivers' engagement in mobile device subtasks varies by driving context. The SCE risk associated with mobile device use is dependent on the types of subtasks performed and the driving context. The findings of this exploratory study can be applied to the design of driver-vehicle interfaces that mitigate distraction by preventing visual-manual subtasks while driving.

CIRSE Vascular Closure Device Registry

NARCIS (Netherlands)

Reekers, Jim A.; Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2011-01-01

Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. The CIRSE registry of closure devices

Fast reactor recharging device

International Nuclear Information System (INIS)

Artemiev, L.N.; Kurilkin, V.V.

1979-01-01

Disclosure is made of a device for recharging a fast-neutron reactor, intended for the transfer of fuel assemblies and rods of the control and safety system, having profiled heads to be gripped on the outside. The device comprises storage drums whose compartments for rods of the control and safety system are identical to compartments for fuel assemblies. In order to store and transport rods of the control and safety system from the storage drums to the recharging mechanism provision is made for sleeve-type holders. When placed in such a holder, the dimensions of a rod of the control and safety system are equal to those of a fuel assembly. To join a holder to a rod of the control and safety system, on the open end of each holder there is mounted a collet, whereas on the surface of each rod of the control and safety system, close to its head, there is provided an encircling groove to interact with the collet. The grip of the recharging mechanism is provided with a stop interacting with the collet in order to open the latter and withdraw the safety and control system rod from its holder

Traffic sounds and cycling safety : the use of electronic devices by cyclists and the quietness of hybrid and electric cars.

NARCIS (Netherlands)

Stelling-Konczak, A. Hagenzieker, M.P. & Wee, B. van

2015-01-01

The growing popularity of electric devices and the increasing number of hybrid and electric cars have recently raised concerns about the use of auditory signals by vulnerable road users. This paper consolidates current knowledge about the two trends in relation to cycling safety. Both a literature

Safety-related control air systems

International Nuclear Information System (INIS)

Anon.

1977-01-01

This Standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This Standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this Standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

Developments of radiation safety requirements for the management of radiation devices

International Nuclear Information System (INIS)

Lee, Hee Seock; Choi, Jin Ho; Cheong, Yuon Young

2002-03-01

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research

Developments of radiation safety requirements for the management of radiation devices

Energy Technology Data Exchange (ETDEWEB)

Lee, Hee Seock [Pohang Accelerator Lab, Pohang (Korea, Republic of); Choi, Jin Ho [Gachun University of Medicine and science, Incheon (Korea, Republic of); Cheong, Yuon Young [Asan Medical Center, Seoul (Korea, Republic of)] (and others)

2002-03-15

The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research.

[Industry regulation and its relationship to the rapid marketing of medical devices].

Science.gov (United States)

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Science.gov (United States)

2011-04-15

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...

A novel mechanical design of broken rope protection device for enhancing the safety performances of overhead manned equipment in coal mine

Directory of Open Access Journals (Sweden)

Xiaoguang Zhang

2015-08-01

Full Text Available A novel mechanical design of the broken rope protection device is proposed to enhance the safety performances of the overhead manned equipment. According to the operating characteristics and functional requirements of the overhead manned equipment, a three-dimensional mechanical model of the broken rope protection device was redesigned. Based on the known parameters of the mechanical model, the stress and strength of the main components are readjusted using the statics characteristics of finite element analysis. To ensure the reliability of the control system of the broken rope protection device, the process of people’s falling, the response performance of the tension sensor, and the signal extraction of the broken rope are analyzed under different loading and unloading speeds. The working principle of the broken rope protection device is expounded in detail. The experimental results showed that better effect is obtained by the new broken rope protection device, which is characterized by good durability, low investment, and high reliability.

30 CFR 75.208 - Warning devices.

Science.gov (United States)

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Roof Support § 75.208 Warning devices. Except during the..., or a physical barrier shall be installed to impede travel beyond permanent support. ...

Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

Science.gov (United States)

Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

2017-12-15

Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

Health and safety manual

International Nuclear Information System (INIS)

1980-02-01

The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices

Device for increasing the safety in the environment of nuclear facilities in case of containment failure

International Nuclear Information System (INIS)

Morlock, G.; Wiesemes, J.; Bachner, D.

1978-01-01

In order to increase the safety in the environment of nuclear facilities, e.g. in case of containment failure, with respect to released radioactive material new or existing facilities are covered with ground. The ground material has got a consistency very much reducing the permeability for liquids and gases. In addition irrigation devices for keeping the ground wet and/or intermediate layers of films pervious to water, e.g. perforated sheets, may be provided. Additionally the ground is protected against frost. Especially suited for ground material is clay. (DG) [de

Licensing of simple digital devices

International Nuclear Information System (INIS)

Jackson, T. W.

2008-01-01

The inability to guarantee error-free software gave rise to the potential for common-cause failure of digital safety systems in nuclear power plants. To address this vulnerability, the U. S. Nuclear Regulatory Commission (NRC) required a quality software development process and a defense-in-depth and diversity analysis for digital safety systems. As a result of recent interim [NRC] staff guidance in the digital instrumentation and control (I and C) area, licensing of simple digital devices decreases some regulatory burden with respect to demonstrating a quality software development process and defense-in-depth and diversity analysis. This paper defines simple digital devices and addresses the interim staff guidance that applies to such devices. The paper also highlights the technical aspects that affect the licensing of such devices and incorporates licensing experience in the U.S. to date. (authors)

Rumble devices for road traffic safety

CSIR Research Space (South Africa)

Jobson, AJ

1973-01-01

Full Text Available on the approaches to hazardous curves or intersections. City and town engineers had little to report on rumble installations but showed a keen interest in their potential usefulness. Each type of rumble device has certain merits and these are discussed...

30 CFR 57.9311 - Anchoring stationary sizing devices.

Science.gov (United States)

2010-07-01

... NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and Loading and...

Eat-by-light fiber-optic and micro-optic devices for food quality and safety assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Grimaldi, M. F.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-06-01

A selection is presented of fiber-optic and micro-optic devices that have been designed and tested for guaranteeing the quality and safety of typical foods, such as extra virgin olive oil, beer, and milk. Scattered colorimetry is used to authenticate various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids, which are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma that is capable of distinguishing different ageing levels of extra virgin olive oil is also presented. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer for the rapid monitoring of the carcinogenic M1 aflatoxin in milk, is experimented.

Eat-by-light: fiber-optic and micro-optic devices for food safety and quality assessment

Science.gov (United States)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-07-01

A selection of fiber-optic and micro-optic devices is presented designed and tested for monitoring the quality and safety of typical foods, namely the extra virgin olive oil, the beer, and the milk. Scattered colorimetry is used for the authentication of various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids that are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma is presented. It is capable of distinguishing different ageing levels of extra virgin olive oil. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer is experimented for the rapid monitoring of the carcinogenic M1 aflatoxin in milk.

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

Science.gov (United States)

2011-07-20

... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

Science.gov (United States)

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

30 CFR 57.9306 - Warning devices for restricted clearances.

Science.gov (United States)

2010-07-01

... AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and...

Safety-related control air systems - approved 1977

International Nuclear Information System (INIS)

Anon.

1978-01-01

This standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

Science.gov (United States)

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.

Science.gov (United States)

2014-07-08

The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

OpenAIRE

A. Yu. Galkin; A. G. Komar; A. A. Grigorenko

2015-01-01

In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO...

Safety Evakuation Of Triga-2000 Reactor Operation Viewed From Safety Culture

International Nuclear Information System (INIS)

Karliana, Itjeu

2001-01-01

The safety evaluation activities of TRIGA-2000 operation viewed from safety culture performed by questioners data collected from the operators and supervisor site of TRIGA-2000 P3TN, Bandung. There are 9 activity aspects surveyed, for instant to avail the policy of safety from their chairman, safety management, education and training, emergency aids planning, safety consultancy, accident information, safety analysis, safety devices, safety and occupational health. The surveying undertaken by filling the questioner that containing of 9 activity aspects and 20 samples of employees. The safety evaluation results' of the operation personnel in TRIGA-2000 P3TN are good implemented by both the operators and supervisors should be improve and attention need to provide the equipment's. The education and training especially for safety refreshment must be performing

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

Science.gov (United States)

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-15

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill.

Science.gov (United States)

Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

2016-09-01

Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty.

The Development of Computer Code for Safety Injection Tank (SIT) with Fluidic Device(FD) Blowdown Test

International Nuclear Information System (INIS)

Lee, Joo Hee; Kim, Tae Han; Choi, Hae Yun; Lee, Kwang Won; Chung, Chang Kyu

2007-01-01

Safety Injection Tanks (SITs) with the Fluidic Device (FD) of APR1400 provides a means of rapid reflooding of the core following a large break Loss Of Coolant Accident (LOCA), and keeping it covered until flow from the Safety Injection Pump (SIP) becomes available. A passive FD can provide two operation stages of a safety water injection into the RCS and allow more effective use of borated water in case of LOCA. Once a large break LOCA occurs, the system will deliver a high flow rate of cooling water for a certain period of time, and thereafter, the flow rate is reduced to a lower flow rate. The conventional computer code 'TURTLE' used to simulate the blowdown of OPR1000 SIT can not be directly applied to simulate a blowdown process of the SIT with FD. A new computer code is needed to be developed for the blowdown test evaluation of the APR1400 SIT with FD. Korea Power Engineering Company (KOPEC) has developed a new computer code to analyze the characteristics of the SIT with FD and validated the code through the comparison of the calculation results with the test results obtained by Ulchin 5 and 6 units pre-operational test and VAlve Performance Evaluation Rig (VAPER) tests performed by The Korea Atomic Energy Research Institute (KAERI)

The inverted cup device for blood transfer on malaria RDTs: ease of use, acceptability and safety in routine use by health workers in Nigeria.

Science.gov (United States)

Incardona, Sandra; Mwancha-Kwasa, Magoma; Rees-Channer, Roxanne R; Albertini, Audrey; Havumaki, Joshua; Chiodini, Peter; Oyibo, Wellington; Gonzalez, Iveth J

2018-01-15

Malaria rapid diagnostic tests (RDTs) are becoming widely adopted for case management at community level. However, reports and anecdotal observations indicate that the blood transfer step poses a significant challenge to many users. This study sought to evaluate the inverted cup device in the hands of health workers in everyday clinical practice, in comparison with the plastic pipette, and to determine the volume accuracy of the device made of a lower-cost plastic. The volume accuracy of inverted cup devices made of two plastics, PMMA and SBC, was compared by transferring blood 150 times onto filter paper and comparing the blood spot areas with those produced by 20 reference transfers with a calibrated micropipette. The ease of use, safety and acceptability of the inverted cup device and the pipette were evaluated by 50 health workers in Nigeria. Observations were recorded on pre-designed questionnaires, by the health workers themselves and by trained observers. Focus group discussions were also conducted. The volume accuracy assessment showed that the device made from the low-cost material (SBC) delivered a more accurate volume (mean 5.4 μL, SD 0.48 μL, range 4.5-7.0 μL) than the PMMA device (mean 5.9 μL, SD 0.48 μL, range 4.9-7.2 μL). The observational evaluation demonstrated that the inverted cup device performed better than the pipette in all aspects, e.g. higher proportions of health workers achieved successful blood collection (96%, vs. 66%), transfer of the required blood volume (90%, vs. 58%), and blood deposit without any loss (95%, vs. 50%). Majority of health workers also considered it' very easy' to use (81%),'very appropriate' for everyday use (78%), and 50% of them reported that it was their preferred BTD. The good volume accuracy and high acceptability of the inverted cup device shown in this study, along with observed ease of use and safety in hands of health workers, further strengthens prior findings which demonstrated its higher

Components for containment enclosures. Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices

International Nuclear Information System (INIS)

2001-01-01

ISO 11933 consists of the following parts, under the general title Components for containment enclosures: Part 1: Glove/bag ports, bungs for glove/bag ports, enclosure rings and interchangeable units; Part 2: Gloves, welded bags, gaiters for remote-handling tongs and for manipulators; Part 3: Transfer systems such as plain doors, airlock chambers, double door transfer systems, leaktight connections for waste drums; Part 4: Ventilation and gas-cleaning systems such as filters, traps, safety and regulation valves, control and protection devices; Part 5: Penetrations for electrical and fluid circuits. This part of ISO 11933 specifies the design criteria and the characteristics of various components used for ventilation and gas-cleaning in containment enclosures. These components are either directly fixed to the containment enclosure wall, or used in the environment of a shielded or unshielded containment enclosure or line of such enclosures. They can be used alone or in conjunction with other mechanical components, including those specified in ISO 11933-1 and ISO 11933-3. This part of ISO 11933 is applicable to: filtering devices, including high-efficiency particulate air (HEPA) filters and iodine traps; safety valves and pressure regulators; systems ensuring the mechanical protection of containment enclosures; control and pressure-measurement devices

Expediting Clinician Adoption of Safety Practices: The UCSF Venous Access Patient Safety Interdisciplinary Education Project

National Research Council Canada - National Science Library

Donaldson, Nancy E; Plank, Rosemary K; Williamson, Ann; Pearl, Jeffrey; Kellogg, Jerry; Ryder, Marcia

2005-01-01

...) Venous Access Device (VAD) Patient Safety Interdisciplinary Education Project was to develop a 30-hour/one clinical academic unit VAD patient safety course with the aim of expediting clinician adoption of critical concepts...

Neutronic, thermal-hydraulics and safety calculations of a Miniplate Irradiation Device (MID) of dispersion type fuel elements

International Nuclear Information System (INIS)

Domingos, Douglas Borges

2010-01-01

Neutronic, thermal-hydraulics and accident analysis calculations were developed to estimate the safety of a Miniplate Irradiation Device (MID) to be placed in the IEA-R1 reactor core. The irradiation device is used to receive miniplates of U 3 O 8 -Al and U 3 Si 2 - Al dispersion fuels, LEU type (19.75 % 235 U) with uranium densities of, respectively, 3.2 gU/cm 3 and 4.8 gU/cm 3 . The fuel miniplates will be irradiated to nominal 235 U burnup levels of 50% and 80%, in order to qualify the above high-density dispersion fuels to be used in the Brazilian Multipurpose Reactor (RMB), now in the conception phase. For the neutronic calculation, the computer codes CITATION and 2DB were utilized. The computer code FLOW was used to calculate the coolant flow rate in the irradiation device, allowing the determination of the fuel miniplate temperatures with the computer model MTRCR-IEA-R1. A postulated Loss of Coolant Accident (LOCA) was analyzed with the computer codes LOSS and TEMPLOCA, allowing the calculation of the fuel miniplate temperatures after the reactor pool draining. The calculations showed that the irradiation should occur without adverse consequences in the IEA-R1 reactor. (author)

Radiation Safety in Industrial Radiography. Specific Safety Guide

International Nuclear Information System (INIS)

2011-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

Development of Network Protocol for the Integrated Safety System

Energy Technology Data Exchange (ETDEWEB)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M. [Hannam Univ., Daejeon (Korea, Republic of)

2007-06-15

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants.

Development of Network Protocol for the Integrated Safety System

International Nuclear Information System (INIS)

Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M.

2007-06-01

Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants

30 CFR 75.320 - Air quality detectors and measurement devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Air quality detectors and measurement devices... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.320 Air quality detectors and measurement devices. (a) Tests for methane shall be made by a qualified person with...

Evolution of atherectomy devices.

Science.gov (United States)

Al Khoury, G; Chaer, R

2011-08-01

Percutaneous atherectomy provides an alternative approach to the endovascular treatment of peripheral atherosclerotic occlusive disease beyond angioplasty and stenting, and has the theoretical advantage of lesion debulking and minimizing barotrauma to the vessel wall. Atherectomy has evolved greatly during the last decade, with currently four FDA approved devices for the treatment of peripheral arterial disease. Several reports have focused on the initial technical success rates, and demonstrated the safety and short as well as mid-term efficacy of atherectomy devices. This article will review the evolution of current atherectomy devices and the associated literature.

Innovative safety ideas for fusion experimental machines

International Nuclear Information System (INIS)

Brereton, S.J.; Gouge, M.; Piet, S.J.; Merrill, B.J.; Holland, D.F.; Sze, D.K.

1990-01-01

Throughout the early stages of design of fusion experimental devices, such as ITER, safety experts have worked with designers to incorporate safety features into the design. Recent efforts have focused on passive safety features. Although designs of near-term fusion machines may appear consistent with expected regulatory requirements, the safety characteristics can potentially be more attractive. Here, a variety of suggestions that appear promising in terms of improving safety are given. These include new concepts, innovative technologies, further support of past concepts, and possible modification to operating scenarios. Some technical discussion on the feasibility of the proposals is provided. The ideas are generally conceptual at this stage and require further assessment and development work. However, each has the potential for enhancing the safety of experimental devices. 33 refs., 6 figs., 9 tabs

Feasibility and Safety of Endovascular Stripping of Totally Implantable Venous Access Devices

International Nuclear Information System (INIS)

Heye, Sam; Maleux, Geert; Goossens, G. A.; Vaninbroukx, Johan; Jerôme, M.; Stas, M.

2012-01-01

Purpose: To evaluate the safety and feasibility of percutaneous stripping of totally implantable venous access devices (TIVAD) in case of catheter-related sleeve and to report a technique to free the catheter tip from vessel wall adherence. Materials and Methods: A total of 37 stripping procedures in 35 patients (14 men, 40%, and 21 women, 60%, mean age 53 ± 14 years) were reviewed. Totally implantable venous access devices were implanted because of malignancy in most cases (85.7%). Catheter-related sleeve was confirmed as cause of persistent catheter dysfunction despite instillation of thrombolytics. A technique to mobilize the catheter tip from the vessel wall was used when stripping with the snare catheter was impossible. Technical success, complication rate, and outcome were noted. Results: A total of 55.9% (n = 19) of the 34 technically successful procedures (91.9%) could be done with the snare catheter. In 15 cases (44.1%), additional maneuvers to free the TIVAD’s tip from the vessel wall were needed. Success rate was not significantly lower before (72.4%) than after (96.7%) implementation of the new technique (P = 0.09). No complications were observed. Follow-up was available in 67.6% of cases. Recurrent catheter dysfunction was found in 17 TIVADs (78.3%) at a mean of 137.7 days and a median of 105 days. Conclusions: Stripping of TIVADs is technically feasible and safe, with an overall success rate of 91.9%. Additional endovascular techniques to mobilize the distal catheter tip from the wall of the superior vena cava or right atrium to allow encircling the TIVAD tip with the snare catheter may be needed in 44.1% of cases.

Healthcare Provider Attitudes of Safety of Intrauterine Devices in the Postpartum Period.

Science.gov (United States)

Rauh-Benoit, Lisa A; Tepper, Naomi K; Zapata, Lauren B; Whiteman, Maura K; Curtis, Kathryn M; Mandel, Michele G; Marchbanks, Polly A; Jamieson, Denise J

2017-07-01

Immediate postpartum intrauterine devices (IUDs) have been underutilized in the United States despite their known safety. Understanding how providers' attitudes contribute to underutilization is important in improving access. Our objective was to examine healthcare providers' perceptions of the safety of immediate postpartum IUDs before publication of United States contraceptive guidelines. We analyzed survey data collected from December 2009 to March 2010 from 635 office-based physicians and 1368 Title X clinic providers (overall response rate of 64.8%). Providers were asked how safe they thought copper and levonorgestrel (LNG) IUDs were in postpartum women (very safe, safe, unsafe, very unsafe, and unsure). Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for characteristics associated with considering immediate and delayed postpartum IUDs to be safe. Less than 40% of respondents considered immediate or delayed IUD insertion to be safe. Providers with postpartum IUD insertion to be safe compared with unsafe/unsure (aOR 0.18, 95% CI 0.04-0.84 for copper IUD and aOR 0.17, 95% CI 0.04-0.81 for LNG-IUD). Providers without training in postpartum or interval copper IUD insertion had decreased odds of considering immediate postpartum copper IUD insertion (aOR 0.40, 95% CI 0.16-0.79) and delayed postpartum insertion for both IUD types to be safe (aOR 0.34, 95% CI 0.18-0.66 for copper IUD and aOR 0.41, 95% CI 0.21-0.77 for LNG-IUD). Before United States contraceptive guidelines, a majority of providers perceived immediate postpartum IUDs to be unsafe.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

Science.gov (United States)

2017-12-19

The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

47 CFR 95.1125 - RF safety.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...

ACED devices and SECAF supports for the control of structure, pipe network and equipment behaviour at seismic movements in order to enhance the safety margin

International Nuclear Information System (INIS)

Serban, Viorel; Prisecaru, I.; Cretu, D.; Moldoveanu, T.

2002-01-01

In order to enhance the safety margin of structure, pipe networks and equipment associated to the existing NPPs, the classic consolidation solutions are very expensive and many times, impossible to be implemented. Structures, pipe networks, systems and equipment have geometries imposed by the basic construction requirements, operating and safety requirements and their modifications is not always possible. In order to enhance the strength capacity of (new or old) structures, systems and equipment mechanical devices with controlled elasticity and damping (ACED) have been designed, constructed and experimented. These devices are capable to support very large static loads over which dynamic loads (shock, vibration and seismic movements) overlap (which are damped). To increase the strength capacity of (new or existing) pipe networks and equipment connecting with pipes, SECAF supports that allow displacements from thermal expansions with low reaction force have been designed, constructed and experimented. SECAF supports are capable elastically to take permanent loads over which shocks, vibrations and seismic movements (which are damp) overlap. ACED devices and SECAF supports can be used to rehabilitate the existing NPPs with law financial costs and an increase of their strength capacity up to 100% under seismic movements, shocks and vibrations. ACED devices and SECAF supports do not require maintenance, are not affected by presence of a radiation field and their estimated service-life is similar to the NPPs

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

Science.gov (United States)

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Safety implications of a graphite oxidation accident in the compact ignition tokamak device

International Nuclear Information System (INIS)

Merrill, B.J.; O'Brien, M.H.

1989-01-01

This paper addresses the possible safety consequences of an air ingress accident for the Compact Ignition Tokamak (CIT) device. An experimental program was undertaken to determine oxidation rates of four nuclear grade graphites in air at temperatures ranging from 800 to 1800 C and flow velocities from 3 to 7 m/s. On the basis of these test results, an analytic model was developed to assess the extent of first wall/divertor protective tile oxidation and the amount of energy released from this oxidation. For CIT, a significant restriction to vacuum vessel air inflow will be provided by the air seals and walls of the surrounding test cells. Under these conditions, the graphite oxidation reaction inside the vacuum vessel will become oxygen starved within minutes of the onset of this event. Since significant oxidation rates were not achieved, the heat release did not elevate structural temperatures to levels of concern with regard to activated material release. 7 refs., 9 figs

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

Science.gov (United States)

Bohnet-Joschko, Sabine; Zippel, Claus; Siebert, Hartmut

2015-01-01

The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment. Copyright © 2015. Published by Elsevier GmbH.

Safety in the Internet

Directory of Open Access Journals (Sweden)

Semenko T.V.

2016-11-01

Full Text Available the modern world is the world of computer technology, and the children living in this world feel comfortable in it, they master the computer, mobile devices, new-fangled gadgets easily and use them skillfully. However, their knowledge of the safety in the Internet lags behind their ability to develop new devices. The number of the Internet users is increased every year, so the problem of children safety in the Internet is very urgent. It is necessary for parents, educators and teachers to conduct explanatory conversations and activities for explanation and consolidation the rules of “The Safe Internet”.

Assisting the older driver : intersection design and in-car devices to improve the safety of the older driver. Proefschrift Rijksuniversiteit Groningen RUG, Groningen.

NARCIS (Netherlands)

Davidse, R.J.

2007-01-01

In this thesis, the main focus was on assistive devices that may improve and prolong the safe mobility of older drivers. Older drivers form a group of road users that is getting more and more attention in road safety research and policy. An important reason for this growing interest is the increase

A Wii-controlled safety device for electric chainsaws

Directory of Open Access Journals (Sweden)

R. Gubiani

2013-09-01

Full Text Available Forestry continues to represent one of the most hazardous economic sectors of human activity, and historically, the operation of chainsaws has mainly been restricted to professional lumberjacks. In recent years, because of low cost, chainsaws have become popular among unprofessionals, e.g. for cutting firewood and trimming trees. Serious or lethal lesions due to the use of chainsaws or electric chainsaws are often observed by traumatologists or forensic pathologists. Such serious accidents often occur during occupational activities and are essentially due to kickback or uncorrected use of the tool, or when the operator falls down losing the control of the implement. A new device in order to stop a cutting chain was developed and adapted to an electric chainsaw. The device is based on a Wiimote controller (Nintendo™, including two accelerometers and two gyroscopes for detecting rotation and inclination. A Bluetooth wireless technology is used to transfer data to a portable computer. The data collected about linear and angular acceleration are filtered by an algorithm, based on the Euclid norm, capable to distinguishing between normal movements and dangerous chainsaw movements. The result show a good answer to device and when happen a dangerous situation an alarm signal is sent back to the implement in order to stop the cutting chain. The device show a correct behavior in tested dangerous situations and is envisaged to extend to combustion engine chainsaws, as well as to other portable equipment used in agriculture and forestry operations and for this objectives were patented.

Texas curve margin of safety.

Science.gov (United States)

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

30 CFR 57.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 57.19006 Section 57.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 57.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

30 CFR 56.19006 - Automatic hoist braking devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 56.19006 Section 56.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 56.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

Overview of Robotic Devices for Nursing Care Project.

Science.gov (United States)

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

Cybersecurity for Connected Diabetes Devices.

Science.gov (United States)

Klonoff, David C

2015-04-16

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. © 2015 Diabetes Technology Society.

Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

Science.gov (United States)

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Science.gov (United States)

2013-05-10

... DEPARTMENT OF LABOR Mine Safety and Health Administration Coal Mine Dust Sampling Devices; Correction AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: On April 30, 2013, Mine Safety and Health Administration (MSHA) published a notice in the Federal Register...

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

Directory of Open Access Journals (Sweden)

Paul J Feldblum

Full Text Available To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC in routine service delivery in Kenya.We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs and time to complete healing, and interviewed men about acceptability and pain.Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%, all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%. Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58, and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.ClinicalTrials.gov NCT01711411.

TH-C-18C-01: MRI Safety

Energy Technology Data Exchange (ETDEWEB)

Pooley, R [Mayo Clinic, Jacksonville, FL (United States); Bernstein, M; Shu, Y; Gorny, K; Felmlee, J [Mayo Clinic, Rochester, MN (United States); Panda, A [Mayo Clinic, Arizona, Scottsdale, AZ (United States)

2014-06-15

Clinical diagnostic medical physicists may be responsible for implementing and maintaining a comprehensive MR safety program. Accrediting bodies including the ACR, IAC, Radsite and The Joint Commission each include aspects of MR Safety into their imaging accreditation programs; MIPPA regulations further raise the significance of non-compliance. In addition, The Joint Commission recently announced New and Revised Diagnostic Imaging Standards for accredited health care organizations which include aspects of MR Safety. Hospitals and clinics look to the physicist to understand guidelines, regulations and accreditation requirements related to MR safety. The clinical medical physicist plays a significant role in a clinical practice by understanding the physical basis for the risks and acting as a facilitator to successfully implement a safety program that provides well-planned siting, allows for the safe scanning of certain implanted devices, and helps radiologists manage specific patient exams. The MRI scanning of specific devices will be discussed including cardiac pacemakers and neurostimulators such as deep brain stimulators. Furthermore for sites involved in MR guided interventional procedures, the MR physicist plays an essential role to establish safe practices. Creating a framework for a safe MRI practice includes the review of actual safety incidents or close calls to determine methods for prevention in the future. Learning Objectives: Understand the requirements and recommendations related to MR safety from accrediting bodies and federal regulations. Understand the Medical Physicist's roles to ensure MR Safety. Identify best practices for dealing with implanted devices, including pacemakers and deep brain stimulators. Review aspects of MR safety involved in an MR guided interventional environment. Understand the important MR safety aspects in actual safety incidents or near misses.

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

Science.gov (United States)

Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J

2015-05-01

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

Science.gov (United States)

Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore

2015-10-01

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal). © The Author(s) 2015.

Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

Science.gov (United States)

2014-07-03

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Safeguards of basic protection devices, high-protection devices, full-protection devices and school X-ray devices. Guideline for manufacturer and evaluating experts, rev. 1.0; Sicherheitsvorrichtungen von Basisschutzgeraeten, Hochschutzgeraeten, Vollschutzgeraeten und Schulroentgeneinrichtungen. Anforderungen fuer die Bauartpruefung nach der Roentgenverordnung. Leitfaden fuer Hersteller und Gutachter Rev. 1.0

Energy Technology Data Exchange (ETDEWEB)

Dombrowski, Harald; Grottker, Ulrich; Pullner, Bjoern; Roettger, Annette; Zwiener, Roland

2017-07-15

This report describes the PTB requirements for engineered safeguards of basic-protection devices, high-protection devices, full-protection devices and school X-ray devices within the framework of type tests according to the German X-ray Ordinance. It contains detailed requirements for the hard- and software to ensure the required safety level. Especially manufacturers and evaluators of such X-ray tube assemblies are addressed.

Practice of Regulatory Science (Development of Medical Devices).

Science.gov (United States)

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

Fast-acting nuclear reactor control device

International Nuclear Information System (INIS)

Kotlyar, O.M.; West, P.B.

1993-01-01

A fast-acting nuclear reactor control device is described for controlling a safety control rod within the core of a nuclear reactor, the reactor controlled by a reactor control system, the device comprising: a safety control rod drive shaft and an electromagnetic clutch co-axial with the drive shaft operatively connected to the safety control rod for driving and positioning the safety control rod within or without the reactor core during reactor operation, the safety rod being oriented in a substantially vertical position to allow the rod to fall into the reactor core under the influence of gravity during shutdown of the reactor; the safety control rod drive shaft further operatively connected to a hydraulic pump such that operation of the drive shaft simultaneously drives and positions the safety control rod and operates the hydraulic pump such that a hydraulic fluid is forced into an accumulator, filling the accumulator with oil for the storage and supply of primary potential energy for safety control rod insertion such that the release of potential energy in the accumulator causes hydraulic fluid to flow through the hydraulic pump, converting the hydraulic pump to a hydraulic motor having speed and power capable of full length insertion and high speed driving of the safety control rod into the reactor core; a solenoid valve interposed between the hydraulic pump and the accumulator, said solenoid valve being a normally open valve, actuated to close when the safety control rod is out of the reactor during reactor operation; and further wherein said solenoid opens in response to a signal from the reactor control system calling for shutdown of the reactor and rapid insertion of the safety control rod into the reactor core, such that the opening of the solenoid releases the potential energy in the accumulator to place the safety control rod in a safe shutdown position

Radiation Safety in Industrial Radiography. Specific Safety Guide (Spanish Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (French Edition)

International Nuclear Information System (INIS)

2013-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in … shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography

Radiation Safety in Industrial Radiography. Specific Safety Guide (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

NARCIS (Netherlands)

Dorr, H.G.; Zabransky, S.; Keller, E.; Otten, B.J.; Partsch, C.J.; Nyman, L.; Gillespie, B.K.; Lester, N.R.; Wilson, A.M.; Hyren, C.; Kuijck, M.A. van; Schuld, P.; Schoenfeld, S.L.

2003-01-01

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of

Radiation safety in X-ray facilities

International Nuclear Information System (INIS)

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2

Radiation safety in X-ray facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-09-01

The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2.

Instructions included? Make safety training part of medical device procurement process.

Science.gov (United States)

Keller, James P

2010-04-01

Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

Science.gov (United States)

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

Science.gov (United States)

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical device risk management and its economic impact

Directory of Open Access Journals (Sweden)

Katerina Krsteva Jakimovska

2013-10-01

Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

Activity of safety review for the facilities using nuclear material (2). Safety review results and maintenance experiences for hot laboratories

International Nuclear Information System (INIS)

Amagai, Tomio; Fujishima, Tadatsune; Mizukoshi, Yasutaka; Sakamoto, Naoki; Ohmori, Tsuyoshi

2009-01-01

In the site of O-arai Research and Development Center of Japan Atomic Energy Agency (JAEA), five hot laboratories for post-irradiation examination and development of plutonium fuels are operated more than 30 years. A safety review method for preventive maintenance on these hot laboratories includes test facilities and devices are established in 2003. After that, the safety review of these facilities and devices are done and taken the necessary maintenance based on the results in each year. In 2008, 372 test facilities and devices in these hot laboratories were checked and reviewed by this method. As a results of the safety review, repair issues of 38 facilities of above 372 facilities were resolved. This report shows the review results and maintenance experiences based on the results. (author)

ALARA issues arising for safety and security of radiation sources and security screening devices - Summary and recommendations of the 12. European ALARA network workshop

International Nuclear Information System (INIS)

Shaw, P.; Crouail, P.; Drouet, F.

2010-01-01

The 12. European ALARA Network (EAN) workshop on 'ALARA issues arising for safety and security of radiation sources and security screening devices' took place in Vienna (Austria) in October 2009. The aim of that workshop was to consider how the implementation of ALARA3, in terms of planned and emergency situations, involving worker and public doses, is affected by the introduction of security-related measures. In the case of new equipment and procedures, there was also the question of whether exposures arising from security screening devices can be justified and optimised. This workshop consisted of invited oral presentations, which highlighted the main issues, and half of the programme was devoted to discussions within working groups on specific topics. During their discussions, the working groups identified recommendations dealing with the following topics: the implementation of the Code of Conduct and HASS4 - ensuring ALARA; balancing security and safety - how to achieve an optimum solution; the management of an emergency exposure situation from an ALARA perspective; the justification and optimisation of the use of security devices. The objective of this paper is to present the main conclusions and recommendations produced during the workshop. Individual presentations (papers and slides) as well as the reports from the working groups are available to download on the EAN web site (http://www.eu-alara.net). (authors)

Review of Wearable Device Technology and Its Applications to the Mining Industry

Directory of Open Access Journals (Sweden)

Mokhinabonu Mardonova

2018-03-01

Full Text Available This paper reviews current trends in wearable device technology, and provides an overview of its prevalent and potential deployments in the mining industry. This review includes the classification of wearable devices with some examples of their utilization in various industrial fields as well as the features of sensors used in wearable devices. Existing applications of wearable device technology to the mining industry are reviewed. In addition, a wearable safety management system for miners and other possible applications are proposed. The findings of this review show that by introducing wearable device technology to mining sites, the safety of mining operations can be enhanced. Therefore, wearable devices should be further used in the mining industry.

Current challenges for clinical trials of cardiovascular medical devices.

Science.gov (United States)

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Safety and efficiency of emergency department interrogation of cardiac devices.

Science.gov (United States)

Neuenschwander, James F; Peacock, W Frank; Migeed, Madgy; Hunter, Sara A; Daughtery, John C; McCleese, Ian C; Hiestand, Brian C

2016-12-01

Patients with implanted cardiac devices may wait extended periods for interrogation in emergency departments (EDs). Our purpose was to determine if device interrogation could be done safely and faster by ED staff. Prospective randomized, standard therapy controlled, trial of ED staff device interrogation vs. standard process (SP), with 30-day follow-up. Eligibility criteria: ED presentation with a self-report of a potential device related complaint, with signed informed consent. SP interrogation was by company representative or hospital employee. Of 60 patients, 42 (70%) were male, all were white, with a median (interquartile range) age of 71 (64 to 82) years. No patient was lost to follow up. Of all patients, 32 (53%) were enrolled during business hours. The overall median (interquartile range) ED vs. SP time to interrogation was 98.5 (40 to 260) vs. 166.5 (64 to 412) minutes (P=0.013). While ED and SP interrogation times were similar during business hours, 102 (59 to 138) vs. 105 (64 to 172) minutes (P=0.62), ED interrogation times were shorter vs. SP during non-business hours; 97 (60 to 126) vs. 225 (144 to 412) minutes, P=0.002, respectively. There was no difference in ED length of stay between the ED and SP interrogation, 249 (153 to 390) vs. 246 (143 to 333) minutes (P=0.71), regardless of time of presentation. No patient in any cohort suffered an unplanned medical contact or post-discharge adverse device related event. ED staff cardiac device interrogations are faster, and with similar 30-day outcomes, as compared to SP.

Design and construction of engineering test device of a multi-purpose radwaste incineration system

International Nuclear Information System (INIS)

Wang Peiyi; Zhou Lianquan; Ma Mingxie; Qiu Mingcai; Yang Liguo; Li Xiaohai; Zhang Xiaobin; Lu Xiaowu; Dong Jingling; Wang Xujin; Li Chuanlian; Yang Baomin

2002-01-01

The author describes designs of main un-standard devices, monitoring system and safety system, as well as construction of the engineering system devices for a multi-purpose radwaste incineration system. Un-standard devices include waste crusher, pyrolysis furnace, incinerator furnace, cool stream dilution device and bag filter, etc. The monitoring system mainly includes industrial controlled computer, supported by conventional electrical equipment and instruments. Designs of system safety takes account of containment of radioactive materials fire-prevention, explosion prevention, anti-corrosion, redundance and reservation, emergency system, controlling and electric safety system, etc. Results show that main technological system remains good airtight with leakage ratio at 0.67%

Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.

Science.gov (United States)

Fistonić, Ivan; Sorta Bilajac Turina, Iva; Fistonić, Nikola; Marton, Ingrid

2016-03-01

To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity. This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS). An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction. © 2016 Wiley Periodicals, Inc.

Guide On Safety Tests

Energy Technology Data Exchange (ETDEWEB)

NONE

1987-05-15

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Guide On Safety Tests

International Nuclear Information System (INIS)

1987-05-01

This book tells US important things to do safety tests, which includes basic caution for experiment treatment of used materials such as ignition substance inflammables, explosive substance and toxic substance, handling of used equipment like inflammable device, machine, high pressure device, high pressure gas, and high energy device, first aid such as addiction by drug, flame, radiation exposure, and heart massage treatment of waste in laboratory like cautions on general treatment, handling of inorganic waste, organic waste and waste treatment with disposal facilities.

Consumers' Use of Personal Electronic Devices in the Kitchen.

Science.gov (United States)

Lando, Amy M; Bazaco, Michael C; Chen, Yi

2018-02-23

Smartphones, tablets, and other personal electronic devices have become ubiquitous in Americans' daily lives. These devices are used by people throughout the day, including while preparing food. For example, a device may be used to look at recipes and therefore be touched multiple times during food preparation. Previous research has indicated that cell phones can harbor bacteria, including opportunistic human pathogens such as Staphylococcus and Klebsiella spp. This investigation was conducted with data from the 2016 Food Safety Survey (FSS) and from subsequent focus groups to determine the frequency with which consumers use personal electronic devices in the kitchen while preparing food, the types of devices used, and hand washing behaviors after handling these devices. The 2016 FSS is the seventh wave of a repeated cross-sectional survey conducted by the U.S. Food and Drug Administration in collaboration with the U.S. Department of Agriculture. The goal of the FSS is to evaluate U.S. adult consumer attitudes, behaviors, and knowledge about food safety. The FSS included 4,169 adults that were contacted using a dual-frame (land line and cell phone interviews) random-digit-dial sampling process. The personal electronics module was the first of three food safety topics discussed by each of eight consumer focus groups, which were convened in four U.S. cities in fall 2016. Results from the 2016 FSS revealed that of those individuals who use personal electronic devices while cooking, only about one third reported washing hands after touching the device and before continuing cooking. This proportion is significantly lower than that for self-reported hand washing behaviors after touching risky food products such as raw eggs, meat, chicken, or fish. Results from the focus groups highlight the varied usage of these devices during food preparation and the related strategies consumers are using to incorporate personal electric devices into their cooking routines.

Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.

Science.gov (United States)

Gold, Michael H; Biron, Julie; Levi, Liora; Sensing, Whitney

2017-03-01

The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation. This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance. Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end. Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles. © 2016 Wiley Periodicals, Inc.

Safety Assessment of Wearing the AN/PVS-14 Monocular Night Vision Device (MNVD) and AN/AVS-6 Aviators' Night Vision Imaging System (ANVIS) During 5-Ton and HMMWV Night Driving

National Research Council Canada - National Science Library

Redden, Elizabeth

2002-01-01

.... The Communications-Electronics Command Directorate for Safety Risk Management, Fort Monmouth, New Jersey, will use the results of the assessment to determine the suitability of both devices for driving...

Safety valve opening and closing operation monitor

International Nuclear Information System (INIS)

Kodama, Kunio; Takeshima, Ikuo; Takahashi, Kiyokazu.

1981-01-01

Purpose: To enable the detection of the closing of a safety valve when the internal pressure in a BWR type reactor is a value which will close the safety valve, by inputting signals from a pressure detecting device mounted directly at a reactor vessel and a safety valve discharge pressure detecting device to an AND logic circuit. Constitution: A safety valve monitor is formed of a pressure switch mounted at a reactor pressure vessel, a pressure switch mounted at the exhaust pipe of the escape safety valve and a logic circuit and the lide. When the input pressure of the safety valve is raised so that the valve and the pressure switch mounted at the exhaust pipe are operated, an alarm is indicated, and the operation of the pressure switch mounted at a pressure vessel is eliminated. If the safety valve is not reclosed when the vessel pressure is decreased lower than the pressure at which it is to be reclosed after the safety valve is operated, an alarm is generated by the logic circuit since both the pressure switches are operated. (Sekiya, K.)

Formalising Java safety -- An overview

NARCIS (Netherlands)

Hartel, Pieter H.; Domingo-Ferrer, J; Chan, D.; Watson, A.

We review the existing literature on Java safety, emphasizing formal approaches, and the impact of Java safety on small footprint devices such as smart cards. The conclusion is that while a lot of good work has been done, a more concerted effort is needed to build a coherent set of machine readable

Volume 8 No. 4 2008 December 2008 427 THE USE OF SAFETY ...

African Journals Online (AJOL)

the knowledge and use of safety devices and methods attached to the proper application of the ... farmers aware of the high risk due to inadequate education, training and safety devices in ..... delivery in Southwestern Nigeria. Ph. D Thesis.

Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

Science.gov (United States)

2013-03-04

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Science.gov (United States)

2012-02-14

... premarket notification, prior to marketing the device, which contains information about the endovascular...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

Monitor for safety engineering facility

International Nuclear Information System (INIS)

Sato, Akira; Kaneda, Mitsunori.

1982-01-01

Purpose: To improve the reactor safety and decrease misoperation upon periodical inspection by instantly obtaining the judgement for the stand-by states in engineering safety facilities of a nuclear power plant. Constitution: Process inputs representing the states of valves, pumps, flowrates or the likes of the facility are gathered into an input device and inputted to a status monitor. The status of the facility inputted to the input device are judged for each of the inputs in a judging section and recognized as a present system stand-by pattern of the system (Valve) to be inspected. While on the other hand, a normal system stand-by pattern previously stored in a memory unit is read out by an instruction from an operator console and judged by comparison with the system stand-by pattern in a comparison section. The results are displayed on a display device. Upon periodical inspection, inspection procedures stored in the memory unit are displayed on the display device by the instruction from the operator console. (Seki, T.)

X-ray safety at the Los Alamos National Laboratory

International Nuclear Information System (INIS)

Gutierrez, J.A.

1986-11-01

An organized and structured safety program for x-ray generating devices was initiated in October, 1979. An X-ray Device Control Office was established to manage the program that currently oversees the activities of 201 x-ray generating devices and to provide SOP reviews, perform shielding calculations, and provide training for both the operators and health physics x-ray device surveyors. The new program also establishes controls for procurement of new equipment, requires the writing of Standard Operating Procedures, requires training for operators and provides routine and non-routine safety inspections of x-ray generating devices. Prior to this program going into effect, the Laboratory had recorded nine documented x-ray related exposure accidents. Since then, there have been none. Program elements and experiences of interest to other x-ray device users are discussed. 3 refs

Norms concerning the programmable automatic control devices

International Nuclear Information System (INIS)

Fourmentraux, G.

1995-01-01

This presentation is a report of the studies carried out by the Work Group on Functioning Safety of Programmable Automatic Control Devices and by the Group for Prevention Studies (GEP) from the CEA. The objective of these groups is to evaluate the methods which could be used to estimate the functioning safety of control and instrumentation systems involved in the Important Elements for Safety (EIS) of the Basic Nuclear Installations (INB) of the CEA, and also to carry out a qualification of automatic control devices. Norms, protocols and tools for the evaluation are presented. The problem comprises two aspects: the evaluation of fault avoidance techniques and the evaluation of fault control techniques used during the conceiving. For the fault avoidance techniques, the quality assurance organization, the environment tests, and the software quality plans are considered. For the fault control techniques, the different available tools and fault injection models are analysed. The results of an analysis carried out with the DEF.I tool from the National Institute for Research and Safety (INRS) are reported. (J.S.). 23 refs

Reactor power control device

International Nuclear Information System (INIS)

Ishii, Yoshihiko; Arita, Setsuo; Miyamoto, Yoshiyuki; Fukazawa, Yukihisa; Ishii, Kazuhiko

1998-01-01

The present invention provides a reactor power control device capable of enhancing an operation efficiency while keeping high reliability and safety in a BWR type nuclear power plant. Namely, the device of the present invention comprises (1) a means for inputting a set value of a generator power and a set value of a reactor power, (2) a means for controlling the reactor power to either smaller one of the reactor power corresponding to the set value of the generator power and the set value of the reactor power. With such procedures, even if the nuclear power plant is set so as to operate it to make the reactor power 100%, when the generator power reaches the upper limit, the reactor power is controlled with a preference given to the upper limit value of the generator power. Accordingly, safety and reliability are not deteriorated. The operation efficiency of the plant can be improved. (I.S.)

Tritium radioluminescent devices, Health and Safety Manual

Energy Technology Data Exchange (ETDEWEB)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information.

Tritium radioluminescent devices, Health and Safety Manual

International Nuclear Information System (INIS)

Traub, R.J.; Jensen, G.A.

1995-06-01

This document consolidates available information on the properties of tritium, including its environmental chemistry, its health physics, and safe practices in using tritium-activated RL lighting. It also summarizes relevant government regulations on RL lighting. Chapters are divided into a single-column part, which provides an overview of the topic for readers simply requiring guidance on the safety of tritium RL lighting, and a dual-column part for readers requiring more technical and detailed information

Reliability evaluation programmable logic devices

International Nuclear Information System (INIS)

Srivani, L.; Murali, N.; Thirugnana Murthy, D.; Satya Murty, S.A.V.

2014-01-01

Programmable Logic Devices (PLD) are widely used as basic building modules in high integrity systems, considering their robust features such as gate density, performance, speed etc. PLDs are used to implement digital design such as bus interface logic, control logic, sequencing logic, glue logic etc. Due to semiconductor evolution, new PLDs with state-of-the-art features are arriving to the market. Since these devices are reliable as per the manufacturer's specification, they were used in the design of safety systems. But due to their reduced market life, the availability of performance data is limited. So evaluating the PLD before deploying in a safety system is very important. This paper presents a survey on the use of PLDs in the nuclear domain and the steps involved in the evaluation of PLD using Quantitative Accelerated Life Testing. (author)

Electronic cigarette devices and oro-facial trauma (Literature review)

Science.gov (United States)

Ghazali, A. F.; Ismail, A. F.; Daud, A.

2017-08-01

Detrimental effects of cigarette smoking have been well described and recognized globally. With recent advancement of technology, electronic cigarette has been introduced and gained its popularity and became a global trend, especially among young adults. However, the safety of the electronic devices remains debatable. This paper aimed to compile and review the reported cases of oro-facial trauma related to the usage of electronic cigarette devices. A literature search was conducted using PubMed/Medline in December 2016. The search terms used were a combination of “oral trauma”, “dental trauma”, “oral injury” and “electronic cigarette”. The search included all abstract published from the inception of the database until December 2016. Abstract that was written in English, case report, letter to editors, clinical and human studies were included for analysis. All selected abstract were searched for full articles. A total of 8 articles were included for review. All of the articles were published in 2016 with mostly case reports. The sample size of the studies ranged from 1 to 15 patients. Seven of the included articles are from United States of America and one from Mexico. Our review concluded that the use of electronic cigarette devices posed not only a safety concern but also that the devices were mostly unregulated. There should be a recognized authority body to regulate the safety and standard of the electronic devices.

Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

Science.gov (United States)

Ansel, Gary M; Hopkins, L Nelson; Jaff, Michael R; Rubino, Paolo; Bacharach, J Michael; Scheinert, Dierk; Myla, Subbarao; Das, Tony; Cremonesi, Alberto

2010-07-01

The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) 2010 Wiley-Liss, Inc.

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Science.gov (United States)

2011-04-14

... looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user...). The special control for this device is the FDA guidance document entitled ``Guidance for Industry and...

30 CFR 90.206 - Approved sampling devices; equivalent concentrations.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...

Cybersecurity and the Medical Device Product Development Lifecycle.

Science.gov (United States)

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

Industrial Personal Computer based Display for Nuclear Safety System

International Nuclear Information System (INIS)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min

2014-01-01

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view

Industrial Personal Computer based Display for Nuclear Safety System

Energy Technology Data Exchange (ETDEWEB)

Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min [KEPCO, Youngin (Korea, Republic of)

2014-08-15

The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

Science.gov (United States)

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

International Nuclear Information System (INIS)

Green, Michael A.

2005-01-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

Energy Technology Data Exchange (ETDEWEB)

Green, Michael A.

2005-08-20

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Science.gov (United States)

2013-06-12

... necessary to assure the safety and effectiveness of the device. II. Regulatory History of the Device On... petitioner's own history of use, the petitioner's own preclinical testing, and the development of relevant... inclined planes (forward, backward, and lateral); [cir] Demonstration of the ability of the device to...

Home Healthcare Medical Devices: A Checklist

Science.gov (United States)

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

Surgical tools and medical devices

CERN Document Server

Jackson, Mark

2016-01-01

This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...

Microfluidic chip-capillary electrophoresis devices

CERN Document Server

Fung, Ying Sing; Du, Fuying; Guo, Wenpeng; Ma, Tongmei; Nie, Zhou; Sun, Hui; Wu, Ruige; Zhao, Wenfeng

2015-01-01

Capillary electrophoresis (CE) and microfluidic chip (MC) devices are relatively mature technologies, but this book demonstrates how they can be integrated into a single, revolutionary device that can provide on-site analysis of samples when laboratory services are unavailable. By introducing the combination of CE and MC technology, Microfluidic Chip-Capillary Electrophoresis Devices broadens the scope of chemical analysis, particularly in the biomedical, food, and environmental sciences. The book gives an overview of the development of MC and CE technology as well as technology that now allows for the fabrication of MC-CE devices. It describes the operating principles that make integration possible and illustrates some achievements already made by the application of MC-CE devices in hospitals, clinics, food safety, and environmental research. The authors envision further applications for private and public use once the proof-of-concept stage has been passed and obstacles to increased commercialization are ad...

Vehicle Battery Safety Roadmap Guidance

Energy Technology Data Exchange (ETDEWEB)

Doughty, D. H.

2012-10-01

The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

APR1400 Fluidic Device Sensitivity Test

International Nuclear Information System (INIS)

Choi, Nam Hyun; Chu, In Cheol; Min, Kyong Ho; Song, Chul Hwa

2005-12-01

In the safety injection tank at the emergency core cooling system of APR1400, a new safety design feature, passive fluidic device is equipped which includes no active driving system. It is essential to evaluate the new design feature with various experiments. For this reason, three categories of sensitivity tests have been performed in the present study. As the first sensitivity experiment, the effect of the height of the stand pipe was investigated. The second sensitivity test was conducted with removing the insert plate gasket to examine its effect. The effect of the expansion of the control nozzle width was ascertained from the third sensitivity test. The results of each test showed that the passive fluidic device which will be equipped in the SIT tank of APR1400 has great integrity and repeatability

Safety strategy and safety analysis of nuclear power plants

International Nuclear Information System (INIS)

Franzen, L.F.

1976-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the finding derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant, it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essentail for accident analyses, and the determination of the loads occurring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig.) [de

Medical devices, electronic health records and assuring patient safety : Future challenges?

NARCIS (Netherlands)

Kalkman, Cor J.

2015-01-01

The patient safety movement was triggered by publications showing that modern health care is more unsafe than road travel and that more patients are killed annually by avoidable adverse events than by breast cancer [1]. As a result, an urgent need to improve patient safety has dominated

Efficiency and safety of percuSurge distal protection device in acute ...

African Journals Online (AJOL)

user

2011-04-25

Apr 25, 2011 ... myocardial infarction. The long-term effects of the distal protection device are still in controversy. The enhanced myocardial efficacy and recovery by aspiration of liberated debris (EMERALD) trial failed to show the effectiveness of the distal protection device in patients with AMI (Yamada and Topol, 2000).

Reactor control device

International Nuclear Information System (INIS)

Fukami, Haruo; Morimoto, Yoshinori.

1981-01-01

Purpose: To operate a reactor always with safety operation while eliminating the danger of tripping. Constitution: In a reactor control device adapted to detect the process variants of a reactor, control a control rod drive controlling system based on the detected signal to thereby control the driving the control rods, control the reactor power and control the electric power generated from an electric generator by the output from the reactor, detection means is provided for the detection of the electric power from said electric generator, and a compensation device is provided for outputting control rod driving compensation signals to the control rod driving controlling system in accordance with the amount of variation in the detected value. (Seki, T.)

Safety Education in Driving. 2nd Revision.

Science.gov (United States)

Ohio State Univ., Columbus. Vocational Instructional Materials Lab.

Intended for driving instruction students, this publication contains instructional materials for safety education. It contains six sections on facts and figures; defensive driving; safety devices; restraints; emergency situations; and other highway users. Each section consists of reading material followed by an activity or activities. A total of…

Plasma position and shape control device for thermonuclear device

International Nuclear Information System (INIS)

Takeuchi, Kazuhiro; Abe, Mitsushi; Kinoshita, Shigemi.

1993-01-01

A plasma position and shape control system is constituted with a measuring device, a quenching probability calculation section and a control calculation section. A quenching probability is calculated in the quenching probability calculation section by using a measuring data on temperature, electric current and magnetic field of superconductive coils, based on a margin upto a limit value. The control calculation section selects a control method which decreases applied voltage or current instruction value as the quenching probability of the coils is higher. Since the quenching probability of the superconductive coils can be forecast and a state of low quenching danger can be selected, the safety of the device is improved. When the quenching danger is allowed to a predetermined value, a wide operation region can be provided. (N.H.)

Control device for a nuclear reactor with a multitude of control rods, extending into the reactor core from above, with linear drive mechanisms and additional gripper devices

International Nuclear Information System (INIS)

Bevilacqua, F.

1979-01-01

The components of the additional gripper devices with magnetically operated finger-shaped latches are separated from the also magnetically operated latches of the linear drive mechanisms in order to avoid common-mode failures when fast shutdown is required. Only part of the safety rods are held by the additional gripping devices in the withdrawn position. There is provided for recording elements indicating positively which one of the safety locks is gearing with the control rods. At the upper end of each control rod there is a coupling head held by electromagnetically operated locking devices in the withdrawn position, if control power is available. (DG) [de

Evaluation of Automated Flagger Assistance Devices

Science.gov (United States)

2018-02-01

Automated flagger assistance devices (AFADs) are designed to improve worker safety by replacing flaggers who are typically located near traffic approaching a work zone. In this study, a new AFAD developed by the Missouri Department of Transportation ...

Safety code 19: recommended safety procedures for the selection, installation and use of x-ray diffraction equipment

International Nuclear Information System (INIS)

1984-01-01

This document is one of a series of Safety Codes prepared by the Radiation Protection Bureau to set out requirements for the safe use of radiation emitting devices. The equipment and installation guidelines and safety procedures detailed in this Code are primarily for the instruction and guidance of persons employed in Federal Public Service Departments and Agencies, as well as those coming under the jurisdiction of the Canada Labour Code. This Safety Code is also intended to assist other users of X-ray diffraction equipment to select safe equipment and to install and use it so that the radiation hazard to the operator and other persons in its vicinity is negligible. It should be noted that facilities under provincial jurisdiction may be subject to requirements specified under provincial statutes. This Code supersedes Safety Code RPD-SC-7, entitled 'Requirements For Non-Medical X-Ray Equipment, Use and Installation', insofar as X-ray diffraction equipment is concerned, and it is intended to complement X-ray equipment design, construction and performance standards promulgated under the Radiation Emitting Devices Act

Review of safety reports involving electronic flight bags

Science.gov (United States)

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

Assurance Cases for Medical Devices

Science.gov (United States)

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Report by the work-group on 'safety of medical devices emitting ionizing radiations'. Articulation of radiation protection requirements of the 97/43/Euratom directive and IAEA recommendations with the essential requirements of the 93/42/CEE directive related to medical devices used in external radiotherapy

International Nuclear Information System (INIS)

2010-01-01

As some dysfunctions and events had been reported in 2007 and 2008 in field of radiotherapy, this report aims at clarifying the articulation between the different European regulations concerning medical devices emitting ionizing radiations and radiation protection. The authors report a survey with device manufacturers, and analyze the content of the different regulations and recommendations. Then, the authors recommend and propose a set of actions related to the IAEA requirements and recommendations, to CE marking requirements, and to new radiation protection and safety requirements present in the Euratom directive

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery. Final order.

Science.gov (United States)

2017-12-28

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Safety flywheel

Energy Technology Data Exchange (ETDEWEB)

Schneider, R.T.

1977-01-17

The patent application relates to an inertial energy storage device employing a safety flywheel which is made of flexible material such as a twisted rope ring. The rigidity required for such a device is achieved through centrifugal forces inherent in such a device when it is operating. A small number of the strands of the rope ring have a tensile strength that is lower than the vast majority of the strands of the rope ring whereby should any of these strands fail, they will begin to whiplash allowing such a failure to be detected and braked before a catastrophic failure occurs. This is accomplished by the inclusion of glass tubes located around the periphery of the flywheel. The tubes are in communication with a braking fluid reservoir. The flywheel and glass tubes are enclosed within a vacuum-tight housing.

76 FR 67020 - Railroad Safety Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-10-28

... Device Distraction, Critical Incident, Track Safety Standards, Dark Territory, Passenger Safety, and... requisite range of views and expertise necessary to discharge its responsibilities. See the RSAC Web site...

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy.

Science.gov (United States)

Steinhaus, Daniel A; Waks, Jonathan W; Collins, Robert; Kleckner, Karen; Kramer, Daniel B; Zimetbaum, Peter J

2015-07-01

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of 1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. Copyright © 2015 Elsevier Inc. All rights reserved.

Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

Science.gov (United States)

Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

2012-07-01

High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Can we use IEC 61850 for safety related functions?

Directory of Open Access Journals (Sweden)

Luca Rocca

2016-08-01

Full Text Available Safety is an essential issue for processes that present high risk for human beings and environment. An acceptable level of risk is obtained both with actions on the process itself (risk reduction and with the use of special safety systems that switch the process into safe mode when a fault or an abnormal operation mode happens. These safety systems are today based on digital devices that communicate through digital networks. The IEC 61508 series specifies the safety requirements of all the devices that are involved in a safety function, including the communication network. Also electrical generation and distribution systems are processes that may have a significant level of risk, so the criteria stated by the IEC 61508 applies. Starting from this consideration, the paper analyzes the safety requirement for the communication network and compare them with the services of the communication protocol IEC 61850 that represents the most used protocol for automation of electrical plants. The goal of this job is to demonstrate that, from the technical point of view, IEC 61850 can be used for implementing safety-related functions, even if a formal safety certification is still missing.

[Ethic review on clinical experiments of medical devices in medical institutions].

Science.gov (United States)

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Safety philosophy in Plowshare

Energy Technology Data Exchange (ETDEWEB)

Thalgott, R H [Nevada Operations Office, U.S. Atomic Energy Commission (United States)

1969-07-01

A nuclear device can be detonated safely when it can ascertained that the detonation can be accomplished without injury to people, either directly or indirectly, and without unacceptable damage to the ecological system and natural or man made structures. This philosophy has its origin in the nuclear weapons testing program dating back to the first detonation in 1945 and applies without reservation to PIowshare projects. This paper therefore will outline the mechanics employed by government in implementing this safety philosophy. The talk will describe those type of actions taken by safety oriented organizations and committees to assure that necessary and desirable safety reviews are conducted. (author)

Safety philosophy in Plowshare

International Nuclear Information System (INIS)

Thalgott, R.H.

1969-01-01

A nuclear device can be detonated safely when it can ascertained that the detonation can be accomplished without injury to people, either directly or indirectly, and without unacceptable damage to the ecological system and natural or man made structures. This philosophy has its origin in the nuclear weapons testing program dating back to the first detonation in 1945 and applies without reservation to PIowshare projects. This paper therefore will outline the mechanics employed by government in implementing this safety philosophy. The talk will describe those type of actions taken by safety oriented organizations and committees to assure that necessary and desirable safety reviews are conducted. (author)

77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

Science.gov (United States)

2012-03-23

... notification, prior to marketing the device, which contains information about the NIR Brain Hematoma Detector...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...

Clinician-Driven Design of VitalPAD–An Intelligent Monitoring and Communication Device to Improve Patient Safety in the Intensive Care Unit

Science.gov (United States)

Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter

2018-01-01

The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...

Safety as experienced by patients themselves: a Finnish survey of the most recent period of care.

Science.gov (United States)

Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele

2014-06-01

We examined patients' experiences of patient safety and participation in promoting safe care during their most recent care period. A survey of patients (N = 175) revealed that treatment, medication, and device safety were mostly experienced as very good or excellent, but responses varied by age and experience. Patients ages 66-75 were most critical of treatment and medication safety. Device safety was rated the worst aspect of safety. Twenty percent of respondents had experienced errors at some time during their care. Patients who had experienced errors and those who were treated at inpatient wards versus a day surgery unit were most critical towards patient participation. Open and transparent error management involving patients is needed to promote treatment, medication, and especially device safety. © 2014 Wiley Periodicals, Inc.

75 FR 74128 - Manual on Uniform Traffic Control Devices (MUTCD) Compliance Dates

Science.gov (United States)

2010-11-30

... existing non-compliant devices based on what it believes to be a reasonable balance of the safety benefits... public works agencies, that State and local governments must balance with highway safety and traffic... service life of sign sheeting materials. \\7\\ D. Ripley. Quantifying the Safety Benefits of Traffic Control...

A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

Science.gov (United States)

Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

2015-03-01

To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Science.gov (United States)

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... relating to EMC and wireless technology and human exposure to non-ionizing radiation. Therefore, on March... electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design...

Organizational Culture and Safety

Science.gov (United States)

Adams, Catherine A.

2003-01-01

'..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

Highway Safety, Economic Behavior, and Driving Environment

OpenAIRE

Keeler, Theodore E.

1991-01-01

Economic analysis has enhanced our understanding of the efficacy of highway safety regulations. Specifically, a consumer-theoretic literature has developed on drivers' responses to regulations, based on ideas first set forth by Lester lave and W. E. Weber (1970) and more fully thought out by Sam Peltzman (1975). Meanwhile, an empirical literature has also developed, testing hypotheses relating to the effects on safety of speed limits, safety-device regulations, and alcohol policies, among oth...

30 CFR 90.205 - Approved sampling devices; operation; air flowrate.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...

Act to keep patients safe: device-related adverse event reporting.

Science.gov (United States)

Schoem, Scott R; Shah, Udayan K

2010-05-01

Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

Efficacy and Safety of REVIVE SE Thrombectomy Device for Acute Ischemic Stroke: River JAPAN (Reperfuse Ischemic Vessels with Endovascular Recanalization Device in Japan).

Science.gov (United States)

Sakai, Nobuyuki; Ota, Shinzo; Matsumoto, Yasushi; Kondo, Rei; Satow, Tetsu; Kubo, Michiya; Tsumoto, Tomoyuki; Enomoto, Yukiko; Kataoka, Taketo; Imamura, Hirotoshi; Todo, Kenichi; Hayakawa, Mikito; Yamagami, Hiroshi; Toyoda, Kazunori; Ito, Yasushi; Sugiu, Kenji; Matsumaru, Yuji; Yoshimura, Shinichi

2018-04-15

REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≥2a. Secondary endpoints were clot migration/embolization; recanalization without symptomatic intracranial hemorrhage (ICH) at 24 h; symptomatic ICH; good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≥10) at day 90; device- or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years; males 46.9%; middle cerebral artery (MCA) occlusion 83.7%; median NIHSS score 17). A post-procedure TICI score ≥2a was observed in 73.5% (36/49, 95% confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5% (30/48, 95% CI 47.4-76.0). The good neurological outcome was achieved in 66.7% (32/48) patients. Symptomatic ICH and device- or procedure-related SAEs were reported in 6.3% and 12.2% of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.

Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making.

Science.gov (United States)

Hatfield, Laura A; Baugh, Christine M; Azzone, Vanessa; Normand, Sharon-Lise T

2017-07-01

Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals. The 2 rules produced different actions for nearly half of hospitals (45%). In the simulation, decisions that minimize Bayes risk outperform Z score-based decisions, even when the loss functions or hierarchical models are misspecified. Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging. A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

Science.gov (United States)

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Radiation Safety in Industrial Radiography. Specific Safety Guide (French Edition); Surete radiologique en radiographie industrielle

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-05-15

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in Horizontal-Ellipsis shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

The Angio-Seal™ femoral closure device allows immediate ambulation after coronary angiography and percutaneous coronary intervention

DEFF Research Database (Denmark)

Hvelplund, Anders; Jeger, Raban; Osterwalder, Remo

2011-01-01

To test the safety of immediate mobilisation of patients undergoing coronary angiography and percutaneous coronary intervention (PCI) closed with Angio-Seal™ -a femoral vascular closure device.......To test the safety of immediate mobilisation of patients undergoing coronary angiography and percutaneous coronary intervention (PCI) closed with Angio-Seal™ -a femoral vascular closure device....

Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices.

Science.gov (United States)

Sezdi, Mana

2016-01-01

A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices.

Radiation safety

International Nuclear Information System (INIS)

Jain, Priyanka

2014-01-01

The use of radiation sources is a privilege; in order to retain the privilege, all persons who use sources of radiation must follow policies and procedures for their safe and legal use. The purpose of this poster is to describe the policies and procedures of the Radiation Protection Program. Specific conditions of radiation safety require the establishment of peer committees to evaluate proposals for the use of radionuclides, the appointment of a radiation safety officer, and the implementation of a radiation safety program. In addition, the University and Medical Centre administrations have determined that the use of radiation producing machines and non-ionizing radiation sources shall be included in the radiation safety program. These Radiation Safety policies are intended to ensure that such use is in accordance with applicable State and Federal regulations and accepted standards as directed towards the protection of health and the minimization of hazard to life or property. It is the policy that all activities involving ionizing radiation or radiation emitting devices be conducted so as to keep hazards from radiation to a minimum. Persons involved in these activities are expected to comply fully with the Canadian Nuclear Safety Act and all it. The risk of prosecution by the Department of Health and Community Services exists if compliance with all applicable legislation is not fulfilled. (author)

Electromedical devices test laboratories accreditation

International Nuclear Information System (INIS)

Murad, C; Rubio, D; Ponce, S; Alvarez Abri, A; Terron, A; Vicencio, D; Fascioli, E

2007-01-01

In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University

Effects on LOCA mass and energy release of the SIT Fluidic device for SKN 3 and 4

International Nuclear Information System (INIS)

Song, Jeung Hyo; Kim, Tae Yoon; Choi, Han Rim; Choi, Chul Jin; Seo, Jong Tae

2003-01-01

A fluidic device is employed for the control of safety injection tank flow during a large break loss of coolant accident in Shin Kori Nuclear power plant Unit 3 and 4. It is installed in the safety injection tank and provides two stages of safety injection tank flow injection, initially high flow injection and then low flow injection after the reactor vessel downcomer annulus full. This allows a more effective use of safety injection tank water inventory during a loss of coolant accident. However, the fluidic device may have an adverse impact on the mass and energy release during the accident. That is, the steam mass and energy release will be increased by a considerable amount because the safety injection tank low flow injection via fluidic device is not credited to condense the steam flows through intact cold legs. The increased mass and energy releases have an impact on the peak pressure and temperature of the containment. This effect of the fluidic device is analyzed on the mass and energy release and the peak pressure and temperature of the containment. The calculation has been done using the CEFLASH-4A, the FLOOD3 with some modifications for the fluidic device and the CONTEMPT-LT code. The results show that the mass and energy release and the peak pressure and temperature were considerably increased when compared with the case without the fluidic device. However, the results satisfy the required design margin

Effects on LOCA mass and energy release of the SIT Fluidic device for SKN 3 and 4

Energy Technology Data Exchange (ETDEWEB)

Song, Jeung Hyo; Kim, Tae Yoon; Choi, Han Rim; Choi, Chul Jin; Seo, Jong Tae [Korea Power Engineering Company, Daejon (Korea, Republic of)

2003-07-01

A fluidic device is employed for the control of safety injection tank flow during a large break loss of coolant accident in Shin Kori Nuclear power plant Unit 3 and 4. It is installed in the safety injection tank and provides two stages of safety injection tank flow injection, initially high flow injection and then low flow injection after the reactor vessel downcomer annulus full. This allows a more effective use of safety injection tank water inventory during a loss of coolant accident. However, the fluidic device may have an adverse impact on the mass and energy release during the accident. That is, the steam mass and energy release will be increased by a considerable amount because the safety injection tank low flow injection via fluidic device is not credited to condense the steam flows through intact cold legs. The increased mass and energy releases have an impact on the peak pressure and temperature of the containment. This effect of the fluidic device is analyzed on the mass and energy release and the peak pressure and temperature of the containment. The calculation has been done using the CEFLASH-4A, the FLOOD3 with some modifications for the fluidic device and the CONTEMPT-LT code. The results show that the mass and energy release and the peak pressure and temperature were considerably increased when compared with the case without the fluidic device. However, the results satisfy the required design margin.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

Science.gov (United States)

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

RF radiation safety handbook

International Nuclear Information System (INIS)

Kitchen, Ronald.

1993-01-01

Radio frequency radiation can be dangerous in a number of ways. Hazards include electromagnetic compatibility and interference, electro-explosive vapours and devices, and direct effects on the human body. This book is a general introduction to the sources and nature of RF radiation. It describes the ways in which our current knowledge, based on relevant safety standards, can be used to safeguard people from any harmful effects of RF radiation. The book is designed for people responsible for, or concerned with, safety. This target audience will primarily be radio engineers, but includes those skilled in other disciplines including medicine, chemistry or mechanical engineering. The book covers the problems of RF safety management, including the use of measuring instruments and methods, and a review of current safety standards. The implications for RF design engineers are also examined. (Author)

OPG waterways public safety program

Energy Technology Data Exchange (ETDEWEB)

Bennett, T [Ontario Power Generation Inc., Niagara Falls, ON (Canada)

2009-07-01

Ontario Power Generation (OPG) has 64 hydroelectric generating stations, 241 dams, and 109 dams in Ontario's registry with the International Commission on Large Dams (ICOLD). In 1986, it launched a formal dam safety program. This presentation addressed the importance of public safety around dams. The safety measures are timely because of increasing public interaction around dams; the public's unawareness of hazards; public interest in extreme sports; easier access by recreational vehicles; the perceived right of public to access sites; and the remote operation of hydroelectric stations. The presentation outlined the OPG managed system approach, with particular reference to governance; principles; standards and procedures; and aspects of implementation. Specific guidelines and governing documents for public safety around dams were identified, including guidelines for public safety of waterways; booms and buoys; audible warning devices and lights; public safety signage; fencing and barricades; and risk assessment for public safety around waterways. The presentation concluded with a discussion of audits and management reviews to determine if safety objectives and targets have been met. figs.

Proximal Occlusion of Medium-Sized Vessels with the Penumbra Occlusion Device: A Study of Safety and Efficacy

Energy Technology Data Exchange (ETDEWEB)

Jambon, E.; Petitpierre, F. [Pellegrin Hospital, Department of Radiology (France); Brizzi, V.; Dubuisson, V. [Pellegrin Hospital, Department of Surgery (France); Bras, Y. Le; Grenier, N.; Cornelis, F., E-mail: cornelisfrancois@gmail.com [Pellegrin Hospital, Department of Radiology (France)

2017-02-15

PurposeTo retrospectively investigate the safety and efficacy of hybrid proximal coiling of various medium-sized vessels (4 to 8 mm) using the Penumbra Occlusion Device (POD).Materials and MethodsFrom October 2014 to February 2016, 37 proximal embolizations were performed with PODs in 36 patients (mean age: 50.8, range: 10–86; 29 male, 7 female). Vessel occlusions were achieved under fluoroscopic guidance using a 2.7 French microcatheter. Among the 36 vessels targeted, 16 were splenic arteries, 11 renal arteries, 4 mesenteric arteries, 3 arteriovenous fistulae, 1 iliac artery, and 1 gonadal vein. Intermittent follow-up angiography was performed to assess the flow for final occlusion. Outcomes and complications were assessed by clinical and/or imaging follow-up.ResultsTo produce proximal occlusion of the intended vessels, the POD was used alone in 19 embolizations (51.4 %). In 12 procedures (32.4 %), POD was used as a coil constrainer to secure the coil construct. In 6 procedures (16.2 %), additional embolic devices were used to achieve vessel occlusion after initial POD deployment. After a mean follow-up of 3.2 months, no POD migration was observed but two complications occurred (5.4 %): one post embolic syndrome and one extensive infarction with splenic abscess.ConclusionThe POD system allows safe and effective proximal embolization of medium-sized vessels in a variety of clinical settings.

Fuel cladding tube leak detection device

International Nuclear Information System (INIS)

Naito, Makoto.

1992-01-01

The device of the present invention can detect even a minute leakage or a continuous leakage during reactor operation. That is, the device of the present invention comprises a detector for analyzing nuclides of gases incorporated in a gas waste processing system, and a calculation device connected to the detector and detecting leakage from a fuel cladding tube by calculation for variation coefficient of long-life nuclides. By using theses devices, radioactivity contained in gases incorporated in the gas waste processing system is analyzed for the nuclides. Among the analized nuclides, if the amount of the long-life nuclides exceeds a predetermined value, it is judged as leakage of the fuel cladding tube. For example, the long-life nuclides include Xe-133. The device of the present invention can certainly detect occurrence of leakage even when it is minute or continues leakage. Accordingly, countermeasures can be taken in an early stage, thereby enabling to contribute improvement for the safety of a nuclear power plant. (I.S.)

CERN safety system monitoring - SSM

International Nuclear Information System (INIS)

Hakulinen, T.; Ninin, P.; Valentini, F.; Gonzalez, J.; Salatko-Petryszcze, C.

2012-01-01

CERN SSM (Safety System Monitoring) is a system for monitoring state-of-health of the various access and safety systems of the CERN site and accelerator infrastructure. The emphasis of SSM is on the needs of maintenance and system operation with the aim of providing an independent and reliable verification path of the basic operational parameters of each system. Included are all network-connected devices, such as PLCs (local purpose control unit), servers, panel displays, operator posts, etc. The basic monitoring engine of SSM is a freely available system-monitoring framework Zabbix, on top of which a simplified traffic-light-type web-interface has been built. The web-interface of SSM is designed to be ultra-light to facilitate access from hand-held devices over slow connections. The underlying Zabbix system offers history and notification mechanisms typical of advanced monitoring systems. (authors)

Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.

Science.gov (United States)

Ross, Sue; Robert, Magali; Harvey, Marie-Andrée; Farrell, Scott; Schulz, Jane; Wilkie, David; Lovatsis, Danny; Epp, Annette; Easton, Bill; McMillan, Barry; Schachter, Joyce; Gupta, Chander; Weijer, Charles

2008-06-01

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health

TU-AB-204-01: Device Approval Process

International Nuclear Information System (INIS)

Delfino, J.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-01: Device Approval Process

Energy Technology Data Exchange (ETDEWEB)

Delfino, J. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Science.gov (United States)

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

Analysis of solutions for passively activated safety shutdown devices for SFR

International Nuclear Information System (INIS)

Burgazzi, Luciano

2013-01-01

Highlights: • Innovative systems for emergency shut down of fast reactors are proposed. • The concepts of inherent and passive safety are put forward. • The relative analysis in terms of safety and reliability is presented. • A comparative assessment among the concepts is performed. • Path forward is tracked. -- Abstract: In order to enhance the inherent safety of fast reactors, innovative reactivity control systems have been proposed for intrinsic ultimate shut-down instead of conventional scram rods, to cope with the potential consequences of severe unprotected transient accidents, such as an energetic core disruptive accident, as in case of sodium fast reactors. The passive shut-down systems are designed to shut-down system only by inherent passive reactivity feedback mechanism, under unprotected accident conditions, implying failure of reactor protection system. They are conceived to be self-actuated without any signal elaboration, since the actuation of the system is triggered by the effects induced by the transient like material dilatation, in case of overheating of the coolant for instance, according to fast reactor design to meet the safety requirements. This article looks at different special shutdown systems specifically engineered for prevention of severe accidents, to be implemented on fast reactors, with main focus on the investigation of the performance of the self-actuated shutdown systems in sodium fast reactors

Development of Pneumatic Aerodynamic Devices to Improve the Performance, Economics, and Safety of Heavy Vehicles

International Nuclear Information System (INIS)

Robert J. Englar

2000-01-01

Under contract to the DOE Office of Heavy Vehicle Technologies, the Georgia Tech Research Institute (GTRI) is developing and evaluating pneumatic (blown) aerodynamic devices to improve the performance, economics, stability and safety of operation of Heavy Vehicles. The objective of this program is to apply the pneumatic aerodynamic aircraft technology previously developed and flight-tested by GTRI personnel to the design of an efficient blown tractor-trailer configuration. Recent experimental results obtained by GTRI using blowing have shown drag reductions of 35% on a streamlined automobile wind-tunnel model. Also measured were lift or down-load increases of 100-150% and the ability to control aerodynamic moments about all 3 axes without any moving control surfaces. Similar drag reductions yielded by blowing on bluff afterbody trailers in current US trucking fleet operations are anticipated to reduce yearly fuel consumption by more than 1.2 billion gallons, while even further reduction is possible using pneumatic lift to reduce tire rolling resistance. Conversely, increased drag and down force generated instantaneously by blowing can greatly increase braking characteristics and control in wet/icy weather due to effective ''weight'' increases on the tires. Safety is also enhanced by controlling side loads and moments caused on these Heavy Vehicles by winds, gusts and other vehicles passing. This may also help to eliminate the jack-knifing problem if caused by extreme wind side loads on the trailer. Lastly, reduction of the turbulent wake behind the trailer can reduce splash and spray patterns and rough air being experienced by following vehicles. To be presented by GTRI in this paper will be results developed during the early portion of this effort, including a preliminary systems study, CFD prediction of the blown flowfields, and design of the baseline conventional tractor-trailer model and the pneumatic wind-tunnel model

Development of Pneumatic Aerodynamic Devices to Improve the Performance, Economics, and Safety of Heavy Vehicles

Energy Technology Data Exchange (ETDEWEB)

Robert J. Englar

2000-06-19

Under contract to the DOE Office of Heavy Vehicle Technologies, the Georgia Tech Research Institute (GTRI) is developing and evaluating pneumatic (blown) aerodynamic devices to improve the performance, economics, stability and safety of operation of Heavy Vehicles. The objective of this program is to apply the pneumatic aerodynamic aircraft technology previously developed and flight-tested by GTRI personnel to the design of an efficient blown tractor-trailer configuration. Recent experimental results obtained by GTRI using blowing have shown drag reductions of 35% on a streamlined automobile wind-tunnel model. Also measured were lift or down-load increases of 100-150% and the ability to control aerodynamic moments about all 3 axes without any moving control surfaces. Similar drag reductions yielded by blowing on bluff afterbody trailers in current US trucking fleet operations are anticipated to reduce yearly fuel consumption by more than 1.2 billion gallons, while even further reduction is possible using pneumatic lift to reduce tire rolling resistance. Conversely, increased drag and down force generated instantaneously by blowing can greatly increase braking characteristics and control in wet/icy weather due to effective ''weight'' increases on the tires. Safety is also enhanced by controlling side loads and moments caused on these Heavy Vehicles by winds, gusts and other vehicles passing. This may also help to eliminate the jack-knifing problem if caused by extreme wind side loads on the trailer. Lastly, reduction of the turbulent wake behind the trailer can reduce splash and spray patterns and rough air being experienced by following vehicles. To be presented by GTRI in this paper will be results developed during the early portion of this effort, including a preliminary systems study, CFD prediction of the blown flowfields, and design of the baseline conventional tractor-trailer model and the pneumatic wind-tunnel model.

A Method and Support Tool for the Analysis of Human Error Hazards in Digital Devices

International Nuclear Information System (INIS)

Lee, Yong Hee; Kim, Seon Soo; Lee, Yong Hee

2012-01-01

In recent years, many nuclear power plants have adopted modern digital I and C technologies since they are expected to significantly improve their performance and safety. Modern digital technologies were expected to significantly improve both the economical efficiency and safety of nuclear power plants. However, the introduction of an advanced main control room (MCR) is accompanied with lots of changes in forms and features and differences through virtue of new digital devices. Many user-friendly displays and new features in digital devices are not enough to prevent human errors in nuclear power plants (NPPs). It may be an urgent to matter find the human errors potentials due to digital devices, and their detailed mechanisms. We can then consider them during the design of digital devices and their interfaces. The characteristics of digital technologies and devices may give many opportunities to the interface management, and can be integrated into a compact single workstation in an advanced MCR, such that workers can operate the plant with minimum burden under any operating condition. However, these devices may introduce new types of human errors, and thus we need a means to evaluate and prevent such errors, especially within digital devices for NPPs. This research suggests a new method named HEA-BIS (Human Error Analysis based on Interaction Segment) to confirm and detect human errors associated with digital devices. This method can be facilitated by support tools when used to ensure the safety when applying digital devices in NPPs

Radiation Safety in Industrial Radiography. Specific Safety Guide (Spanish Edition); Seguridad radiologica en la radiografia industrial

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-12-15

This Safety Guide provides recommendations for ensuring radiation safety in industrial radiography used in non-destructive testing. This includes industrial radiography work that utilizes X ray and gamma sources, both in shielded facilities that have effective engineering controls and in outside shielded facilities using mobile sources. Contents: 1. Introduction; 2. Duties and responsibilities; 3. Safety assessment; 4. Radiation protection programme; 5. Training and qualification; 6. Individual monitoring of workers; 7. Workplace monitoring; 8. Control of radioactive sources; 9. Safety of industrial radiography sources and exposure devices; 10. Radiography in shielded enclosures; 11. Site radiography; 12. Transport of radioactive sources; 13. Emergency preparedness and response; Appendix: IAEA categorization of radioactive sources; Annex I: Example safety assessment; Annex II: Overview of industrial radiography sources and equipment; Annex III: Examples of accidents in industrial radiography.

Digital Device Architecture and the Safe Use of Flash Devices in Munitions

Science.gov (United States)

Katz, Richard B.; Flowers, David; Bergevin, Keith

2017-01-01

Flash technology is being utilized in fuzed munition applications and, based on the development of digital logic devices in the commercial world, usage of flash technology will increase. Digital devices of interest to designers include flash-based microcontrollers and field programmable gate arrays (FPGAs). Almost a decade ago, a study was undertaken to determine if flash-based microcontrollers could be safely used in fuzes and, if so, how should such devices be applied. The results were documented in the Technical Manual for the Use of Logic Devices in Safety Features. This paper will first review the Technical Manual and discuss the rationale behind the suggested architectures for microcontrollers and a brief review of the concern about data retention in flash cells. An architectural feature in the microcontroller under study will be discussed and its use will show how to screen for weak or failed cells during manufacture, storage, or immediately prior to use. As was done for microcontrollers a decade ago, architectures for a flash-based FPGA will be discussed, showing how it can be safely used in fuzes. Additionally, architectures for using non-volatile (including flash-based) storage will be discussed for SRAM-based FPGAs.

Augmented reality for improved safety

CERN Multimedia

Stefania Pandolfi

2016-01-01

Sometimes, CERN experts have to operate in low visibility conditions or in the presence of possible hazards. Minimising the duration of the operation and reducing the risk of errors is therefore crucial to ensuring the safety of personnel. The EDUSAFE project integrates different technologies to create a wearable personnel safety system based on augmented reality.    The EDUSAFE integrated safety system uses a camera mounted on the helmet to monitor the working area.  In its everyday operation of machines and facilities, CERN adopts a whole set of measures and safety equipment to ensure the safety of its personnel, including personal wearable safety devices and access control systems. However, sometimes, scheduled and emergency maintenance work needs to be done in zones with potential cryogenic hazards, in the presence of radioactive equipment or simply in demanding conditions where visibility is low and moving around is difficult. The EDUSAFE Marie Curie Innovative&...

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

Bill C-5, an act to amend the radiation emitting devices act

International Nuclear Information System (INIS)

1984-01-01

This Act, entitled Bill C-5, allows for a series of amendments to the Radiation Emitting Devices Act. The amendments relate to regulations concerned with the sale, lease or import, labelling, advertising, packaging, safety standards and inspection of radiation emitting devices

A guide for approval of x-ray fluorescence analysis devices

International Nuclear Information System (INIS)

1990-01-01

This guide has been written to assist manufacturers, distributors and users of x-ray fluorescence analysis devices in the preparation of a submission to the Atomic Energy Control Board (AECB) in support of a request for approval of an x-ray fluorescence analysis device. Prior to the issuance of a Radioisotope licence authorizing the use or possession of an x-ray fluorescence analysis device in Canada, the design and construction of the device must be approved by the AECB. The AECB assessment is limited to the radiation safety aspects of use and packaging for transportation

Control device for start-up of reactor depressurization system

International Nuclear Information System (INIS)

Suzuki, Hiroshi; Saito, Minoru; Oda, Shingo; Miura, Satoshi; Hashimoto, Koji; Tate, Hitoshi; Fujii, Kazunobu

1998-01-01

The present invention concerns are emergency reactor core cooling system (ECCS) of a BWR type reactor and provides a control device for start-up of an automatic depressurization system. Namely, the device has an object of preventing erroneous opening of a main steam escape safety value when testing a start-up signal circuit of an automatic depressurization system for testing the automatic depressurization system. A start-up signal circuit receives both signals of a reactor container pressure high signal and a reactor pressure vessel water level low signal and outputs an automatic start-up signal for compulsorily opening a main steam escape safety valve automatically. A test switch having a self-holding circuit is disposed to a central control chamber. A test signal circuit is disposed for preventing transfer of an erroneous start-up signal to the main steam escape safety valve due to a simulation signal during output test signals by the test switch. (I.S.)

An update on mobile phones interference with medical devices.

Science.gov (United States)

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-10-01

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.

An update on mobile phones interference with medical devices

International Nuclear Information System (INIS)

Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.

2013-01-01

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. (authors)

Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

Monitoring readiness of safety relevant devices in nuclear power plants by means of CRT-colour displays

International Nuclear Information System (INIS)

Haubert, R.; Stokke, R.

1980-01-01

The development of an information system for monitoring readiness of safety relevant devices is encouraged by the requirements of KTA-rule 3501 (DIN 25434), which states in section 4.9.1.1. 'A display shall be provided for giving a survey of the condition of the components of the reactor protection system and the active engineered safeguards including their energy and auxiliary media supplies'. In the first stage of the development which was reported at the Enlarged Halden Programme Group Meeting in Loen, Norway, 5th-9th June, 1978, only the components of parts of a BWR-protection system were considered and no display was provided. This paper outlines the next step in the development which comprises implementation of the active engineered safeguards into the system and development of a display system based on a colour CRT-screen. A prototype of this computer-based system for monitoring of protection systems has been established, and it is planned to demonstrate this prototype system using the computer equipment at GRS, Garching (orig./HP)

Firearm Safety Locks: Federal Agency Implementation of the Presidential Directive

National Research Council Canada - National Science Library

1998-01-01

... deaths among children ages 5 to 14. In order to have the federal government serve as an example of gun safety, the President required that a safety lock device be provided with each handgun issued to federal law enforcement officers...

Esophageal Sphincter Device for Gastroesophageal Reflux Disease

NARCIS (Netherlands)

Ganz, Robert A.; Peters, Jeffrey H.; Horgan, Santiago; Bemelman, Willem A.; Dunst, Christy M.; Edmundowicz, Steven A.; Lipham, John C.; Luketich, James D.; Melvin, W. Scott; Oelschlager, Brant K.; Schlack-Haerer, Steven C.; Smith, C. Daniel; Smith, Christopher C.; Dunn, Dan; Taiganides, Paul A.

2013-01-01

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients

Safety assessment and quality control of medical x-ray facilities in some hospitals in Ghana

International Nuclear Information System (INIS)

Darko, E.O.; Charles, D.F.

1998-01-01

Safety assessment and quality control measurements of diagnostic x-ray installations were carried out in five hospitals in Ghana. The study was focused on the siting, design and construction of the buildings housing the x-ray units, assessment of safety systems and devices and measurements of the technical performance, and film processing conditions. The location, inadequacies in the design/construction, unavailability of relevant safety systems and devices, violation of basic safety principles and poor performance of some of the x-ray facilities indicate the need to improve quality control programmes, safety culture and enforcement of regulatory standards in diagnostic x-ray examinations in Ghana. (author). 8 refs., 11 tabs., 8 figs

The enhancement of Ignalina NPP in design and operational safety

International Nuclear Information System (INIS)

Negrivoda, G.

1999-01-01

Enhancement of Ignalina NPP design include: core design improvements; fuel channel integrity (multiple pressure tube rupture); improvements of shutdown systems; improvements of instrumentation and control devices; containment strength and tightness; design basis accident analysis; improvements of safety and support systems; seismic safety enhancement; Year 2000 project; cracks in pipes. Enhancement of operational safety includes: quality assurance; configuration management; safety management and safety culture; emergency operating procedures; training and full scope simulator; in-service inspection; fire protection and ageing monitoring and management

Soft robotic devices for hand rehabilitation and assistance: a narrative review.

Science.gov (United States)

Chu, Chia-Ye; Patterson, Rita M

2018-02-17

The debilitating effects on hand function from a number of a neurologic disorders has given rise to the development of rehabilitative robotic devices aimed at restoring hand function in these patients. To combat the shortcomings of previous traditional robotics, soft robotics are rapidly emerging as an alternative due to their inherent safety, less complex designs, and increased potential for portability and efficacy. While several groups have begun designing devices, there are few devices that have progressed enough to provide clinical evidence of their design's therapeutic abilities. Therefore, a global review of devices that have been previously attempted could facilitate the development of new and improved devices in the next step towards obtaining clinical proof of the rehabilitative effects of soft robotics in hand dysfunction. A literature search was performed in SportDiscus, Pubmed, Scopus, and Web of Science for articles related to the design of soft robotic devices for hand rehabilitation. A framework of the key design elements of the devices was developed to ease the comparison of the various approaches to building them. This framework includes an analysis of the trends in portability, safety features, user intent detection methods, actuation systems, total DOF, number of independent actuators, device weight, evaluation metrics, and modes of rehabilitation. In this study, a total of 62 articles representing 44 unique devices were identified and summarized according to the framework we developed to compare different design aspects. By far, the most common type of device was that which used a pneumatic actuator to guide finger flexion/extension. However, the remainder of our framework elements yielded more heterogeneous results. Consequently, those results are summarized and the advantages and disadvantages of many design choices as well as their rationales were highlighted. The past 3 years has seen a rapid increase in the development of soft robotic

DESIGN PACKAGE 1E SYSTEM SAFETY ANALYSIS

Energy Technology Data Exchange (ETDEWEB)

M. Salem

1995-06-23

The purpose of this analysis is to systematically identify and evaluate hazards related to the Yucca Mountain Project Exploratory Studies Facility (ESF) Design Package 1E, Surface Facilities, (for a list of design items included in the package 1E system safety analysis see section 3). This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the Design Package 1E structures/systems/components(S/S/Cs) in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the structure/system/component design, (2) add safety devices and capabilities to the designs that reduce risk, (3) provide devices that detect and warn personnel of hazardous conditions, and (4) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions.

Evaluation of the Safety of the Taraklamp Male Circumcision Device ...

African Journals Online (AJOL)

SITWALA COMPUTERS

an effective additional means of preventing transmission of the HIV virus from ... country and include: cultural tradition, pain, and safety, as ... effective. Thus, the World Health Organization (WHO) has ..... systematic review and meta-analysis.

ALARP considerations in criticality safety assessments

International Nuclear Information System (INIS)

Bowden, Russell L.; Barnes, Andrew; Thorne, Peter R.; Venner, Jack

2003-01-01

Demonstrating that the risk to the public and workers is As Low As Reasonably Practicable (ALARP) is a fundamental requirement of safety cases for nuclear facilities in the United Kingdom. This is embodied in the Safety Assessment Principles (SAPs) published by the Regulator, the essence of which is incorporated within the safety assessment processes of the various nuclear site licensees. The concept of ALARP within criticality safety assessments has taken some time to establish in the United Kingdom. In principle, the licensee is obliged to search for a deterministic criticality safety solution, such as safe geometry vessels and passive control features, rather than placing reliance on active measurement devices and plant administrative controls. This paper presents a consideration of some ALARP issues in relation to the development of criticality safety cases. The paper utilises some idealised examples covering a range of issues facing the criticality safety assessor, including new plant design, operational plant and decommissioning activities. These examples are used to outline the elements of the criticality safety cases and present a discussion of ALARP in the context of criticality safety assessments. (author)

CIRSE Vascular Closure Device Registry

International Nuclear Information System (INIS)

Reekers, Jim A.; Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2011-01-01

Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only 5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.

Canadian contributions to the safety and environmental aspects of fusion

International Nuclear Information System (INIS)

Stasko, R.; Wong, K.

1987-05-01

Since next-step fusion devices will be fuelled with mixtures of tritium and deuterium, the knowledge base and tritium handling experience associated with the operation of CANDU reactors is viewed as relevant to the development of safe fusion technology. Fusion safety issues will be compared with fission safety experience, after which specific Canadian activities in support of fusion safety will be overviewed. In addition, recommendations for appropriate fusion safety criteria will be summarized. 18 refs

Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

International Nuclear Information System (INIS)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-01-01

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design

Agility in Development of Safety-Critical Software: A Conceptual Model

DEFF Research Database (Denmark)

Tordrup Heeager, Lise; Nielsen, Peter Axel

2018-01-01

Safety-critical information systems are being used increasingly as we see applications in new areas such as personal medical devices, traffic control and detection of pathogens. A current research debate is whether safety-critical systems must be developed with traditional waterfall processes...

Bioartificial liver assist devices in support of patients with liver failure.

Science.gov (United States)

Patzer II, John F; Lopez, Roberto C; Zhu, Yue; Wang, Zi-Fa; Mazariegos, George V; Fung, John J

2002-02-01

Bioartificial liver assist devices (BALs) offer an opportunity for critical care physicians and transplant surgeons to stabilize patients prior to orthotopic liver transplantation. Such devices may also act as a bridge to transplant, providing liver support to patients awaiting transplant, or as support for patients post living-related donor transplant. Four BAL devices that rely on hepatocytes cultured in hollow fiber membrane cartridges (Circe Biomedical HepatAssist(r), Vitagen ELADTM, Gerlach BELS, and Excorp Medical BLSS) are currently in various stages of clinical evaluation. Comparison of the four devices shows that several unique approaches based upon the same overall system architecture are possible. Preliminary results of the Excorp Medical BLSS Phase I safety evaluation at the University of Pittsburgh, after treating four patients (F, 41, acetominophen-induced, two support periods; M, 50, Wilson's disease, one support period; F, 53, acute alcoholic hepatitis, two support periods; F, 24, chemotherapy-induced, one support period, are presented. All patients presented with hypoglycemia and transient hypotension at the start of extracorporeal perfusion. Hypoglycemia was treated by IV dextrose and the transient hypotension responded positively to IV fluid bolus. Heparin anticoagulation was used only in the second patient. No serious or adverse events were noted in the four patients. Moderate Biochemical response to support was noted in all patients. More complete characterization of the safety of the BLSS requires completion of the Phase I safety evaluation.

Safety, efficacy, and intraoperative characteristics of DisCoVisc and Healon ophthalmic viscosurgical devices for cataract surgery

Directory of Open Access Journals (Sweden)

Modi SS

2011-09-01

Full Text Available Satish S Modi1, James A Davison2, Tom Walters3 1Seeta Eye Centers, Poughkeepsie, NY, USA; 2Wolfe Clinic, Marshalltown, IA, USA; 3Texas Eye Care, Austin, TX, USA Purpose: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc. Patients and methods: In this prospective study, patients with cataracts were randomized to an OVD, and then received phacoemulsification and injection of an intraocular lens. After each surgery, unmasked investigators completed subjective questionnaires about OVD characteristics during each stage of the procedure. Masked technicians evaluated objective safety parameters of intraocular pressure (IOP and endothelial cell density, with 90 days of follow-up. Results: The DisCoVisc OVD group (128 eyes and the Healon OVD group (121 eyes had statistically similar outcomes for IOP and for endothelial cell loss. Subjectively assessed viscosity was statistically different (P < 0.0001, with Healon OVD most often rated “cohesive” and DisCoVisc OVD most often rated “both dispersive and cohesive”. Workspace maintenance differed between groups (P < 0.0001, with workspace most frequently rated “full chamber maintained” when using DisCoVisc OVD and most frequently rated “workspace maintained” when using Healon OVD. “Flat” or “shallow” workspace ratings occurred only in the Healon OVD group. Conclusion: DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery. Keywords: cataract, endothelial cell density, viscoelastic, phacoemulsification

The "Skull Flap" a new conceived device for decompressive craniectomy experimental study on dogs to evaluate the safety and efficacy in reducing intracranial pressure and subsequent impact on brain perfusion.

Science.gov (United States)

Salvatore, Chibbaro; Fabrice, Vallee; Marco, Marsella; Leonardo, Tigan; Thomas, Lilin; Benoit, Lecuelle; Bernard, George; Pierre, Kehrli; Eric, Vicaut; Paolo, Diemidio

2013-10-01

Decompressive craniectomy (DC) is a procedure performed increasingly often in current neurosurgical practice. Significant perioperative morbidity may be associated to this procedure because of the large skull defect; also, later closure of the skull defect (cranioplasty) may be associated to post-operative morbidity as much as any other reconstructive operation. The authors present a newly conceived/developed device: The "Skull Flap" (SF). This system, placed at the time of the craniectomy, offers the possibility to provide cranial reconstruction sparing patients a second operation. In other words, DC and cranioplasty essentially take place at the same time and in addition, patients retain their own bone flap. The current study conducted on animal models, represents the logical continuation of a prior recent study, realized on cadaver specimens, to assess the efficacy and safety of this recently developed device. This is an experimental pilot study on dogs to assess both safety and efficacy of the SF device. Two groups of experimental raised intracranial pressure animal models underwent DC; in the first group of dogs, the bone flap was left in raised position above the skull defect using the SF device; on the second group the flap was discarded. All dogs underwent transcranial Doppler (TCD) to assess brain perfusion. Head computed tomography (CT) scan to determine flap position was also obtained in the group in which the SF device was placed. SF has proved to be a strong fixation device that allows satisfactory brain decompression by keeping the bone flap elevated from the swollen brain; later on, the SF allows cranial reconstruction in a simple way without requiring a second staged operation. In addition, it is relevant to note that brain perfusion was measured and found to be better in the group receiving the SF (while the flap being in a raised as well as in its natural position) comparing to the other group. The SF device has proved to be very easy to place

The "Skull Flap" a new conceived device for decompressive craniectomy experimental study on dogs to evaluate the safety and efficacy in reducing intracranial pressure and subsequent impact on brain perfusion

Directory of Open Access Journals (Sweden)

Chibbaro Salvatore

2013-01-01

Full Text Available Background: Decompressive craniectomy (DC is a procedure performed increasingly often in current neurosurgical practice. Significant perioperative morbidity may be associated to this procedure because of the large skull defect; also, later closure of the skull defect (cranioplasty may be associated to post-operative morbidity as much as any other reconstructive operation. The authors present a newly conceived/developed device: The "Skull Flap" (SF. This system, placed at the time of the craniectomy, offers the possibility to provide cranial reconstruction sparing patients a second operation. In other words, DC and cranioplasty essentially take place at the same time and in addition, patients retain their own bone flap. The current study conducted on animal models, represents the logical continuation of a prior recent study, realized on cadaver specimens, to assess the efficacy and safety of this recently developed device. Materials and Methods: This is an experimental pilot study on dogs to assess both safety and efficacy of the SF device. Two groups of experimental raised intracranial pressure animal models underwent DC; in the first group of dogs, the bone flap was left in raised position above the skull defect using the SF device; on the second group the flap was discarded. All dogs underwent transcranial Doppler (TCD to assess brain perfusion. Head computed tomography (CT scan to determine flap position was also obtained in the group in which the SF device was placed. Results: SF has proved to be a strong fixation device that allows satisfactory brain decompression by keeping the bone flap elevated from the swollen brain; later on, the SF allows cranial reconstruction in a simple way without requiring a second staged operation. In addition, it is relevant to note that brain perfusion was measured and found to be better in the group receiving the SF (while the flap being in a raised as well as in its natural position comparing to the other

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

Science.gov (United States)

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

Evidence for the safety assurance of the radiation associated equipments for stat-up check

International Nuclear Information System (INIS)

Takahashi, Yasuyuki; Igarashi, Hiroshi; Saito, Kyoko; Kawaharada, Yasuhiro; Hirano, Kunihiro; Murase, Kenya; Mochizuki, Teruhito

2008-01-01

Based on the new amendment of the Medical Service Law and the Pharmaceutical Affairs Law, the safety control for the medical equipments and devices was strengthened; and a radiological technologist should be stipulated as a safety control manager for the medical equipments and devices. Although it is thought that Start-up check is important for the safety assurance, the enforcement situation is not clear until now. In this report, on the occasion of the start-up of the new Law, questionnaire about the start up check (time and a check items) were investigated from 56 hospitals applying the visit interview. Modality by modality check up time was obtained from 261 institutions by the descriptive study paper type. Start-up check and arming up were applied for almost all modalities about 30 minutes before start of the clinical tests. The check up items for the medical equipments and devices depended on each hospital. Therefore, safety assurance should be established, cooperating with the medical equipment distributors, the hospital sharing the checked results for the patients' safety. (author)

78 FR 25308 - Proposed Collection; Comment Request; Coal Mine Dust Sampling Devices

Science.gov (United States)

2013-04-30

...; Coal Mine Dust Sampling Devices AGENCY: Mine Safety and Health Administration, Labor. ACTION: 60-Day... mines. CPDMs must be designed and constructed for coal miners to wear and operate without impeding their... related to Coal Mine Dust Sampling Devices. MSHA is particularly interested in comments that: Evaluate...

Evaluation of personal alarm devices for fire fighters

International Nuclear Information System (INIS)

Sharry, J.; da Roza, R.A.

1984-01-01

Although three of the models of the personal alarm devices (PAD) tested had received letters of acceptability and compliance from the State of California/Occupational Safety and Health Administration (Cal/OSHA), it was found that none of the models met all of the Cal/OSHA specifications. Additional tests showed other deficiencies in the PADs' design. This points out the need for the purchaser or user of such devices to specify acceptance criteria and perform his own tests

Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.

Directory of Open Access Journals (Sweden)

Mufuta Tshimanga

Full Text Available We aimed to determine if the adverse event (AE rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46; 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459; 337 (85% on anti-retroviral therapy. Among 385 (96% observed completely healed, median days to complete healing was 42 (IQR: 35-49. There was no association between time to healing and CD4 (p = 0.66. Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5. This was non-inferior to 2% AEs (p = 0.0003. All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.

Analytical Chemistry in the Regulatory Science of Medical Devices.

Science.gov (United States)

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke

Directory of Open Access Journals (Sweden)

Christopher M. Loftus

2018-06-01

Full Text Available The United States Food and Drug Administration (FDA Center for Devices and Radiological Health (CDRH is charged with ensuring patients in the US have timely access to high-quality, safe, and effective medical devices of public health importance. Within CDRH, the Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the central and peripheral nervous system (neurotechnologies, including neurointerventional medical devices that are used in the treatment of stroke. Endovascular treatments have demonstrated recent advances in reaching the marketplace and providing more options for patients with acute ischemic stroke and intracranial aneurysms specifically. Depending upon the pathway chosen for regulatory approval, and the evidentiary standard for different regulatory pathways, neurotechnologies can have well-established safety and effectiveness profiles, varying degrees of scientific and clinical uncertainty regarding safety and effectiveness, or when a humanitarian use exists, need only demonstrate a probable benefit and safety to the patient so potentially life-saving treatments can reach the marketplace. Reperfusion therapies have had specific advances in the treatment of stroke patients that originally had limited or no treatment options and for preventative treatments in providing care to patients with intracranial aneurysms to avoid potentially more catastrophic outcomes. Collaboration in multiple forums and environments will be important to continue to foster the neurointerventional technology sector and positively impact clinical medicine, from diagnosing and treating a neurological disorder, to potentially altering the progression of disease, and in many ways, contemporary approved devices have brought a new sense of hope and optimism that serious and otherwise disabling neurological diseases can be treated and in many cases cured with modern therapy. We present here the scope of FDA�

Medical instruments and devices principles and practices

CERN Document Server

Schreiner, Steven; Peterson, Donald R

2015-01-01

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...

Anthropometric comparison of Anthropometric Test Device (ATD ...

African Journals Online (AJOL)

Anthropometric test device (ATD) is surrogate used in automotive crash testing. Female ATDs used worldwide in the evaluation of vehicle safety performance was produced based on anthropometry of U.S. population. This work is aimed at assessing the difference between the anthropometric dimensions of Nigerian female ...

Design and qualification of HPD based designs for safety systems

International Nuclear Information System (INIS)

Sharma, Mukesh Kr.; Chavan, Madhavi A.; Sawhney, Pratibha A.; Mohanty, Ashutos; John, Ajith K.; Ganesh, G.

2014-01-01

Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) are increasingly being used in C and I system of NPPs. The function of such an integrated circuit is not defined by the supplier of the physical component or micro-electronic technology but by the C and I designer. The hardware subsystems implemented in these devices typically use Hardware Description Language (HDL) like VHDL or Verilog to describe the functionality at the design entry level. These circuits are commonly known as 'HDL-Programmed Devices', (HPD). RCnD has developed a set of hardware boards to be used in next generation C and I systems. The boards have been designed based on present day technology and components. The intelligence of these boards has been implemented in HPDs (FPGA/CPLD) using VHDL. Since these boards are used in the safety and safety related systems, they have undergone a rigorous V and V process and qualification tests. This paper discusses the design attributes and qualification of these HPD based designs for nuclear class safety systems. (author)

Dynamic training devices in CRM training

Science.gov (United States)

Lawver, J.

1984-01-01

Pilot training effectiveness and flying safety of a seasonal tour flight company are described. The change from single pilot to two pilot operated twin otters is examined. The use of the ATC 810 training device, its possibilities and training capacity is outlined. Problem areas which may arise, emergency system and pilot/passenger interaction are analyzed.

Cloud/Fog Computing System Architecture and Key Technologies for South-North Water Transfer Project Safety

Directory of Open Access Journals (Sweden)

Yaoling Fan

2018-01-01

Full Text Available In view of the real-time and distributed features of Internet of Things (IoT safety system in water conservancy engineering, this study proposed a new safety system architecture for water conservancy engineering based on cloud/fog computing and put forward a method of data reliability detection for the false alarm caused by false abnormal data from the bottom sensors. Designed for the South-North Water Transfer Project (SNWTP, the architecture integrated project safety, water quality safety, and human safety. Using IoT devices, fog computing layer was constructed between cloud server and safety detection devices in water conservancy projects. Technologies such as real-time sensing, intelligent processing, and information interconnection were developed. Therefore, accurate forecasting, accurate positioning, and efficient management were implemented as required by safety prevention of the SNWTP, and safety protection of water conservancy projects was effectively improved, and intelligential water conservancy engineering was developed.

User certification of hand-held x-ray tube based analytical fluorescent devices in a canadian context

International Nuclear Information System (INIS)

Maharaj, H.P.

2005-01-01

Safety education aims to reduce personal injury and improve well being. This health promotion principle is applied in the case of hand-held open beam x-ray tube based analytical x-ray devices. Such devices not only are light weight and portable, but also present high radiation exposure levels at the beam exit port and potentially can be used in a variety of industrial applications for determination of material composition. There is much potential for radiation risks to occur with resultant adverse effects if such devices are not used by trained individuals within controlled environments. A level of radiation safety knowledge and understanding of the device design, construction and performance characteristics appear warranted. To reduce radiation risks, user certification at a federal level was introduced in 2004 based on International Standards Organization 20807, since that standard comprises elements commensurate with risk reduction strategies. Within these contexts, a federally certified user is deemed to have acquired a level of safety knowledge and skills to facilitate safe use of the device. Certification, however, does not absolve the holder from obligations of compliance with applicable provincial, territorial or federal laws respecting device operation. The union of federal certification and applicable legislative mandated operational criteria reduces radiation risks overall. (author)

Human factors evaluation of man-machine interface for periodic safety review of nuclear power plants

International Nuclear Information System (INIS)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang; Hwang, In Koo; Lee, Hyun Cheol; Jang, Tong Il; Ku, Jin Young; Kim, Soo Jin

2004-12-01

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Nuclear Power Plants(NPPs). As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The safety and efficacy of the Angio-Seal closure device in diagnostic and interventional neuroangiography setting: a single-center experience with 1,443 closures

Energy Technology Data Exchange (ETDEWEB)

Geyik, Serdar; Yavuz, Kivilcim; Akgoz, Ayca; Koc, Osman; Peynircioglu, Bora; Cil, Barbaros; Cekirge, Saruhan; Saatci, Isil [Hacettepe University Hospitals, Radiology Department, Ankara (Turkey)

2007-09-15

We evaluated the safety and efficacy of the Angio-Seal closure device used to close arterial puncture sites in patients who had undergone diagnostic cerebral angiography and neurointerventional procedures. A total of 1,443 Angio-Seal devices were placed in 1,099 patients in the Interventional Neuroradiology Unit between May 2005 and August 2006. Of these, 670 were interventional and 745 were diagnostic cerebral angiographic procedures. In 28 patients bilateral puncture of the femoral arteries was performed for endovascular treatment. In 167 patients 286 repeat diagnostic procedures were performed and 30 interventional procedures were followed by re-closure with an Angio-Seal device at the time of repeat puncture. The procedural success rate for antegrade closures was 99.7% for all procedures. The device failed in 5 of 745 diagnostic procedures (0.7%). Major complication occurred in one patient only (0.13%) in the diagnostic group. No minor complications were observed in this group. In the interventional group, the major complication rate was 1.4% (10 of 698 closures) and the minor complication rate was 2.4% (17 of 698 closures). However, in the subgroup of patients with cerebral aneurysms who received heparin in combination with antiplatelet agents after the procedure, the major complication rate was 5.3%, but in the carotid/vertebral stenting group it was 0.8%. Our experience in a relatively large series of patients shows that the use of the Angio-Seal STS vascular closure device is safe and effective in patients undergoing cerebral diagnostic angiography and neurointerventional procedures with an acceptable rate of complications, although the complication rate was higher in the group of patients who received heparin and/or antiplatelet medication. (orig.)

Using advanced mobile devices in nursing practice--the views of nurses and nursing students.

Science.gov (United States)

Johansson, Pauline; Petersson, Göran; Saveman, Britt-Inger; Nilsson, Gunilla

2014-09-01

Advanced mobile devices allow registered nurses and nursing students to keep up-to-date with expanding health-related knowledge but are rarely used in nursing in Sweden. This study aims at describing registered nurses' and nursing students' views regarding the use of advanced mobile devices in nursing practice. A cross-sectional study was completed in 2012; a total of 398 participants replied to a questionnaire, and descriptive statistics were applied. Results showed that the majority of the participants regarded an advanced mobile device to be useful, giving access to necessary information and also being useful in making notes, planning their work and saving time. Furthermore, the advanced mobile device was regarded to improve patient safety and the quality of care and to increase confidence. In order to continuously improve the safety and quality of health care, advanced mobile devices adjusted for nursing practice should be further developed, implemented and evaluated in research. © The Author(s) 2013.

Medical device integration using mobile telecommunications infrastructure.

Science.gov (United States)

Moorman, Bridget A; Cockle, Richard A

2013-01-01

Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.

Training device for nuclear power plant operators

International Nuclear Information System (INIS)

Schoessow, G. J.

1985-01-01

A simulated nuclear energy power plant system with visible internal working components comprising a reactor adapted to contain a liquid with heating elements submerged in the liquid and capable of heating the liquid to an elevated temperature, a steam generator containing water and a heat exchanger means to receive the liquid at an elevated temperature, transform the water to steam, and return the spent liquid to the reactor; a steam turbine receiving high energy steam to drive the turbine and discharging low energy steam to a condenser where the low energy steam is condensed to water which is returned to the steam generator; an electric generator driven by the turbine; indicating means to identify the physical status of the reactor and its contents; and manual and automatic controls to selectively establish normal or abnormal operating conditions in the reactor, steam generator, pressurizer, turbine, electric generator, condenser, and pumps; and to be selectively adjusted to bring the reactor to acceptable operating condition after being placed in an abnormal operation. This device is particularly useful as an education device in demonstrating nuclear reactor operations and in training operating personnel for nuclear reactor systems and also as a device for conducting research on various safety systems to improve the safety of nuclear power plants

75 FR 45696 - Pipeline Safety: Personal Electronic Device Related Distractions

Science.gov (United States)

2010-08-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... and operators of natural gas and hazardous liquid pipeline facilities are required to have and follow.... Advisory Bulletin (ADB-10-06) To: Owners and Operators of Hazardous Liquid and Natural Gas Pipeline Systems...

Safety and efficacy of the Aperio thrombectomy device when compared to the Solitaire AB/FR and the Revive devices in a pulsatile flow system.

Science.gov (United States)

Saleh, Mahdi; Spence, John Nathan; Nayak, Sanjeev; Pearce, Gillian; Tennuci, Christopher; Roffe, Christine

2012-01-01

There are a limited number of studies comparing the Aperio mechanical thrombectomy device to other stent-based devices. In this paper, we compared the Aperio thrombectomy device to the Solitaire AB, FR and Revive devices in a model of the middle cerebral artery (MCA) within a modified pulsatile flow system. Thrombi made of lamb's blood were placed into a pulsatile flow system perfused with Hartmann's solution at 80 bpm with a mean pressure of 90 mm Hg. 30 experiments were run with each device. Recanalization rates were similar for all three devices (90% with the Solitaire AB, FR, 80% with the Revive, and 90% with the Aperio). The mean number of attempts to retrieve the thrombus was also similar for all three devices (1.7 with the Solitaire AB, FR, 2.1 with the Revive, 1.6 with the Aperio). Clot fragmentation and embolization rates revealed no statistical significance but there was a trend towards lower embolization rates with the Aperio (23% compared to 40% with the Solitaire AB, FR and 47% with the Revive). The Aperio was the fastest to recanalize the MCA (mean of 66 seconds compared to 186 seconds for the Solitaire AB, FR and 169 seconds for the Revive). In this in vitro setting, the Aperio device seems to be an efficacious and safe device when compared to other similar clinically used mechanical thrombectomy devices. Larger clinical trials are warranted.

30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

Science.gov (United States)

2010-07-01

... Analysis Checklists are included in API RP 14C you must utilize the analysis technique and documentation... device requirements for pipelines are under § 250.1004. (c) Specification for surface safety valves (SSV..., Recommended Practice for Installation, Maintenance, and Repair of Surface Safety Valves and Underwater Safety...

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

DEFF Research Database (Denmark)

Eikermaan, Michaela; Gluud, Christian; Perleth, Matthias

2013-01-01

Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety...

The working of RVNRL pilot plant of Rubber Board and it's safety devices

International Nuclear Information System (INIS)

Britto, I.J.; Thomas, E.V.

1996-01-01

A pilot plant for producing radiation vulcanized natural rubber latex (RVNRL) was established at Rubber Board, India in 1992. Irradiation is done by a batch process in the plant. The plant has a versatile safety system for safety of operators and people working in and around the plant

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2017-10-01

Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint

Segmentation Scheme for Safety Enhancement of Engineered Safety Features Component Control System

International Nuclear Information System (INIS)

Lee, Sangseok; Sohn, Kwangyoung; Lee, Junku; Park, Geunok

2013-01-01

Common Caused Failure (CCF) or undetectable failure would adversely impact safety functions of ESF-CCS in the existing nuclear power plants. We propose the segmentation scheme to solve these problems. Main function assignment to segments in the proposed segmentation scheme is based on functional dependency and critical function success path by using the dependency depth matrix. The segment has functional independence and physical isolation. The segmentation structure is that prohibit failure propagation to others from undetectable failures. Therefore, the segmentation system structure has robustness to undetectable failures. The segmentation system structure has functional diversity. The specific function in the segment defected by CCF, the specific function could be maintained by diverse control function that assigned to other segments. Device level control signals and system level control signals are separated and also control signal and status signals are separated due to signal transmission paths are allocated independently based on signal type. In this kind of design, single device failure or failures on signal path in the channel couldn't result in the loss of all segmented functions simultaneously. Thus the proposed segmentation function is the design scheme that improves availability of safety functions. In conventional ESF-CCS, the single controller generates the signal to control the multiple safety functions, and the reliability is achieved by multiplication within the channel. This design has a drawback causing the loss of multiple functions due to the CCF (Common Cause Failure) and single failure Heterogeneous controller guarantees the diversity ensuring the execution of safety functions against the CCF and single failure, but requiring a lot of resources like manpower and cost. The segmentation technology based on the compartmentalization and functional diversification decreases the CCF and single failure nonetheless the identical types of controllers

Segmentation Scheme for Safety Enhancement of Engineered Safety Features Component Control System

Energy Technology Data Exchange (ETDEWEB)

Lee, Sangseok; Sohn, Kwangyoung [Korea Reliability Technology and System, Daejeon (Korea, Republic of); Lee, Junku; Park, Geunok [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2013-05-15

Common Caused Failure (CCF) or undetectable failure would adversely impact safety functions of ESF-CCS in the existing nuclear power plants. We propose the segmentation scheme to solve these problems. Main function assignment to segments in the proposed segmentation scheme is based on functional dependency and critical function success path by using the dependency depth matrix. The segment has functional independence and physical isolation. The segmentation structure is that prohibit failure propagation to others from undetectable failures. Therefore, the segmentation system structure has robustness to undetectable failures. The segmentation system structure has functional diversity. The specific function in the segment defected by CCF, the specific function could be maintained by diverse control function that assigned to other segments. Device level control signals and system level control signals are separated and also control signal and status signals are separated due to signal transmission paths are allocated independently based on signal type. In this kind of design, single device failure or failures on signal path in the channel couldn't result in the loss of all segmented functions simultaneously. Thus the proposed segmentation function is the design scheme that improves availability of safety functions. In conventional ESF-CCS, the single controller generates the signal to control the multiple safety functions, and the reliability is achieved by multiplication within the channel. This design has a drawback causing the loss of multiple functions due to the CCF (Common Cause Failure) and single failure Heterogeneous controller guarantees the diversity ensuring the execution of safety functions against the CCF and single failure, but requiring a lot of resources like manpower and cost. The segmentation technology based on the compartmentalization and functional diversification decreases the CCF and single failure nonetheless the identical types of

CIRSE Vascular Closure Device Registry

Science.gov (United States)

Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2010-01-01

Purpose Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only 5.9 cm, and two vessel occlusions. Conclusion The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters. PMID:20981425

Devices and Endoscopic Bariatric Therapies for Obesity.

Science.gov (United States)

Saunders, Katherine H; Igel, Leon I; Saumoy, Monica; Sharaiha, Reem Z; Aronne, Louis J

2018-04-17

In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.

Sensor technology for hazardous cargo transportation safety.

Science.gov (United States)

2013-08-01

The overall goal of this research project was to develop oxidant vapor detection devices that can be : used to ensure the safety of hazardous freight transportation systems. Two nanotechnology-based : systems originally developed for improvised explo...

Evaluation of the safety of the Taraklamp male circumcision device ...

African Journals Online (AJOL)

Background: Male circumcision has been proved to be an effective additional means of preventing transmission of the HIV virus from females to males in heterosexual relationships with efficacy of up to 60%. Many methods and devices for adult male circumcision have now been developed. However, there are still concerns ...

CONSIDERATIONS FOR THE DEVELOPMENT OF A DEVICE FOR THE DECOMMISSIONING OF THE HORIZONTAL FUEL CHANNELS IN THE CANDU 6 NUCLEAR REACTOR. PART 6 - PRESENTATION OF THE DECOMMISSIONING DEVICE

Directory of Open Access Journals (Sweden)

Gabi ROSCA FARTAT

2015-05-01

Full Text Available The objective of this paper is to present a possible solution for the designing of a device for the decommissioning of the horizontal fuel channels in the CANDU 6 nuclear reactor. The decommissioning activities are dismantling, demolition, controlled removal of equipment, components, conventional or hazardous waste (radioactive, toxic in compliance with the international basic safety standards on radiation protection. One as the most important operation in the final phase of the nuclear reactor dismantling is the decommissioning of fuel channels. For the fuel channels decommissioning should be taken into account the detailed description of the fuel channel and its components, the installation documents history, adequate radiological criteria for decommissioning guidance, safety and environmental impact assessment, including radiological and non-radiological analysis of the risks that can occur for workers, public and environment, the description of the proposed program for decommissioning the fuel channel and its components, the description of the quality assurance program and of the monitoring program, the equipments and methods used to verify the compliance with the decommissioning criteria, the planning of performing the final radiological assessment at the end of the fuel channel decommissioning. These will include also, a description of the proposed radiation protection procedures to be used during decommissioning. The dismantling of the fuel channel is performed by one device which shall provide radiation protection during the stages of decommissioning, ensuring radiation protection of the workers. The device shall be designed according to the radiation protection procedures. The decommissioning device assembly of the fuel channel components is composed of the device itself and moving platform support for coupling of the selected channel to be dismantled. The fuel channel decommissioning device is an autonomous device designed for

Food quality and safety: Consumer perception and demand

DEFF Research Database (Denmark)

Grunert, Klaus G.

2005-01-01

choice and consumer demand, addressing questions of price perception and the validity of willingness-to-pay measurements. It is concluded that food quality and safety are central issues in today's food economics, though many research questions remain to be addressed. Udgivelsesdato: SEP 1......Research on consumer quality perception is reviewed using the Total Food Quality Model as a structuring device. The relationship between food safety and quality is addressed, and is discussed in the context of research on consumer risk perception. Quality and safety perception is linked to food...

Food quality and safety: Consumer perception and demand

DEFF Research Database (Denmark)

Grunert, Klaus G.

2005-01-01

Research on consumer quality perception is reviewed using the Total Food Quality Model as a structuring device. The relationship between food safety and quality is addressed, and is discussed in the context of research on consumer risk perception. Quality and safety perception is linked to food...... choice and consumer demand, addressing questions of price perception and the validity of willingness-to-pay measurements. It is concluded that food quality and safety are central issues in today's food economics, though many research questions remain to be addressed. Udgivelsesdato: SEP 1...

Construction safety and waste management an economic analysis

CERN Document Server

Li, Rita Yi Man

2015-01-01

This monograph presents an analysis of construction safety problems and on-site safety measures from an economist’s point of view. The book includes examples from both emerging countries, e.g. China and India, and developed countries, e.g. Australia and Hong Kong. Moreover, the author covers an analysis on construction safety knowledge sharing by means of updatable mobile technology such as apps in Androids and iOS platform mobile devices. The target audience comprises primarily researchers and experts in the field but the book may also be beneficial for graduate students.

A Detection Device for the Signs of Human Life in Accident

Science.gov (United States)

Ning, Li; Ruilan, Zhang; Jian, Liu; Ruirui, Cheng; Yuhong, Diao

2017-12-01

A detection device for the signs of human life in accidents is a device used in emergency situations, such as the crash site. the scene of natural disasters, the battlefield ruins. it designed to detect the life signs of the distress under the injured ambulance vital signs devices. The device can on human vital signs, including pulse, respiration physiological signals to make rapid and accurate response. After some calculations, and after contrast to normal human physiological parameters given warning signals, in order for them to make timely ambulance judgment. In this case the device is required to do gymnastics convenience, ease of movement, power and detection of small flexible easy realization. This device has the maximum protection of the wounded safety significance.

MedWatch Safety Alerts for Human Medical Products

Data.gov (United States)

U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

TU-AB-204-02: Device Adverse Events and Compliance

International Nuclear Information System (INIS)

Gonzales, S.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-02: Device Adverse Events and Compliance

Energy Technology Data Exchange (ETDEWEB)

Gonzales, S. [Food & Drug Administration (United States)

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

Tank farms criticality safety manual

International Nuclear Information System (INIS)

FORT, L.A.

2003-01-01

This document defines the Tank Farms Contractor (TFC) criticality safety program, as required by Title 10 Code of Federal Regulations (CFR-), Subpart 830.204(b)(6), ''Documented Safety Analysis'' (10 CFR- 830.204 (b)(6)), and US Department of Energy (DOE) 0 420.1A, Facility Safety, Section 4.3, ''Criticality Safety.'' In addition, this document contains certain best management practices, adopted by TFC management based on successful Hanford Site facility practices. Requirements in this manual are based on the contractor requirements document (CRD) found in Attachment 2 of DOE 0 420.1A, Section 4.3, ''Nuclear Criticality Safety,'' and the cited revisions of applicable standards published jointly by the American National Standards Institute (ANSI) and the American Nuclear Society (ANS) as listed in Appendix A. As an informational device, requirements directly imposed by the CRD or ANSI/ANS Standards are shown in boldface. Requirements developed as best management practices through experience and maintained consistent with Hanford Site practice are shown in italics. Recommendations and explanatory material are provided in plain type

Requirements of safety and reliability

International Nuclear Information System (INIS)

Franzen, L.F.

1977-01-01

The safety strategy for nuclear power plants is characterized by the fact that the high level of safety was attained not as a result of experience, but on the basis of preventive accident analyses and the findings derived from such analyses. Although, in these accident analyses, the deterministic approach is predominant it is supplemented by reliability analyses. The accidents analyzed in nuclear licensing procedures cover a wide spectrum from minor incidents to the design basis accidents which determine the design of the safety devices. The initial and boundary conditions, which are essential for accident analyses, and the determination of the loads occuring in various states during regular operation and in accidents flow into the design of the individual systems and components. The inevitable residual risk and its origins are discussed. (orig./HP) [de

On the electrical safety of dielectric elastomer actuators in proximity to the human body

Science.gov (United States)

Pourazadi, S.; Shagerdmootaab, A.; Chan, H.; Moallem, M.; Menon, C.

2017-11-01

Novel devices based on the use of dielectric elastomer actuators (DEA) have been proposed for a large variety of different applications. In many of these applications, DEAs are envisioned to be in direct or close proximity to the human body. Since DEAs usually require high voltage for their actuation, the safety of individuals operating or using these devices should be ensured. In this paper, safety standards based on safe limits for electrical discharge are investigated. Flat and cylindrical DEA configurations, which are generally considered as the building blocks for the design of DEA-based systems, are investigated in detail. Relevant elements and factors that affect the electrical discharge of DEA devices are analyzed and guidelines to design DEA-based devices that are not of harm for humans are provided. The performed analyses are experimentally validated using flat DEA samples. The safety requirements that should be considered when wrapping DEAs around the body (specifically the legs) are also briefly investigated to provide a practical example of interest for the biomedical community.

IOS SAFETY APPLICATION FOR UITM

Directory of Open Access Journals (Sweden)

MOHAMAD FAHMI HUSSIN

2016-04-01

Full Text Available This paper presents an iOS application, which is developed, to ensure that every task related to safety and health such as inspection, deviation analysis and accident reporting becomes more simple and easier. Normally, these three (3 tasks are done separately and the data are saved in different ways. These situations make the tasks become complicated and consume a lot of time. Therefore, this application is developed to overcome all the problems that occurred. The main objective of this application is to allow the user to handle inspection checklist, deviation analysis and accident reporting efficiently by using iOS devices such as iPhone and iPad. Hence, using iOS device, instead of using a lot of paper, can do all the tasks. Using Xcode SDK, which is the software that is used to develop iOS application, developed this application. Xcode use Objective-C as the programming language, which is quite similar with other programming languages such as C and C++. The final result of this project is that this application can handle all the three (3 tasks and the form or the findings can be emailed to the Safety and Health Officer (SHO. This application will reduce time consume to conduct safety inspection, deviation and reporting tasks as well as avoid delay that might happen while using the traditional method.

Thyroid radiofrequency ablation: Updates on innovative devices and techniques

Energy Technology Data Exchange (ETDEWEB)

Park, Hye Sun; Baek, Jung Hwan; Chung, Sae Rom; Choi, Young Jun; Lee, Jeong Hyun [Dept. of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of); Park, Auh Whan [Dept. of Radiology, Vascular and Interventional Radiology Section, University of Virginia Health System, Charlottesville (United States)

2017-08-01

Radiofrequency ablation (RFA) is a well-known, effective, and safe method for treating benign thyroid nodules and recurrent thyroid cancers. Thyroid-dedicated devices and basic techniques for thyroid RFA were introduced by the Korean Society of Thyroid Radiology (KSThR) in 2012. Thyroid RFA has now been adopted worldwide, with subsequent advances in devices and techniques. To optimize the treatment efficacy and patient safety, understanding the basic and advanced RFA techniques and selecting the optimal treatment strategy are critical. The goal of this review is to therefore provide updates and analysis of current devices and advanced techniques for RFA treatment of benign thyroid nodules and recurrent thyroid cancers.

Electromagnetic device of the safety screw-nut type

International Nuclear Information System (INIS)

Defaucheux, Jean; Guedj, Freddy.

1981-01-01

System providing for the vertical displacement of nuclear reactor control rods in a non-magnetic and cylindrical leak tight containment. This device is composed of a stator located around the upper part of the containment and, inside this containment, a rotor also in the upper part of this containment, which is free in axial translation along its shaft which it drives rotationally but which is fixed in translation. This shaft drives a threaded rod working in conjunction with a nut and able to slide vertically without turning inside the containment and supporting the reactor control rods. When the stator is not powered, the threaded rod and nut assembly falls to the bottom of the containment and may be easily raised by powering the stator [fr

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

Directory of Open Access Journals (Sweden)

A. Yu. Galkin

2015-04-01

Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

Science.gov (United States)

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Supraglottic devices as alternative equipment to airway management in state of sudden cardiac arrest

Directory of Open Access Journals (Sweden)

Rafał Czyż

2017-08-01

All of supraglottic devices are characterized by easiness in applying without experience in use them. Additionally time need to airway management in use of them is many times shorter than with traditional endotracheal intubation. Fundamental defect in these devices is a fact that they don’t provide total safety before aspiration for chime. Current literature shows us that supraglottic airway devices are perfect alternative to endotracheal intubation.

Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

International Nuclear Information System (INIS)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang

2006-01-01

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area

Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang (and others)

2006-01-15

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area.

Posttest analysis of the FFTF inherent safety tests

International Nuclear Information System (INIS)

Padilla, A. Jr.; Claybrook, S.W.

1987-01-01

Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactor and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code

FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

Science.gov (United States)

... Related Consumer Updates Indoor Tanning: The Risks of Ultraviolet Rays 5 Tips for a Healthy Vacation More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...

Analysis of existing work-zone devices with MASH safety performance criteria.

Science.gov (United States)

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

Development of fluidic device in SIT for Korean Next Generation Reactor I

International Nuclear Information System (INIS)

Cho, Bong Hyun; Lee, Joon; Bae, Yoon Young; Park, Jong Kyun

1999-07-01

The KNGR is to install a Fluidic Device at the bottom of the inner space of the SIT (Safety Injection Tank) to control the flow rate of safety injection coolant from SIT during LBLOCA. During the past two years, a scale model test to obtain the required flow characteristics of the device under the KNGR specific conditions has been performed using the experience and existing facility of AEA Technology (UK) with appropriate modifications. The performance verification test is to be performed this year to obtain optimum characteristics and design data of full size fluidic device. The purpose of the model test was to check the feasibility of developing the device and to produce a generic flow characteristic data. The test was performed in approximately 1/7 scale in terms of flow rate with full height and pressure. This report presents the details of system performance requirements for the device, design procedure for the fluidic device to be used, test facility and test method. The time dependent flow, pressure and Euler number are presented as characteristics curves and the most stable and the most effective flow control characteristic parameters were recommended through the evaluation. A method to predict the size of the fluidic device is presented. And a sizing algorithm, which can be used to conveniently determine the major geometric data of the device for various operating conditions, and a FORTRAN program to produce the prediction of performance curves have been developed. (author). 32 refs., 15 tabs., 47 figs

Use of consumer wireless devices by South Africans with severe communication disability.

Science.gov (United States)

Bornman, Juan; Bryen, Diane Nelson; Moolman, Enid; Morris, John

2016-01-01

Advancements in wireless technology (e.g. cell phones and tablets) have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC) technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3%) needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends), for leisure activities (e.g. listening to music, watching videos, playing games), and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance). These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population.

Radioprotective shield - an adequate radioprotective device for routine stomatological radiodiagnosis

Energy Technology Data Exchange (ETDEWEB)

Wiltschke, F [Ernst-Moritz-Arndt-Univ., Greifswald (German Democratic Republic); Taschner, P; Koenig, W; Menzel, B [Staatliches Amt fuer Atomsicherheit und Strahlenschutz, Berlin (German Democratic Republic)

1975-01-01

Starting from the shortcomings of the radioprotective devices at present used in routine stomatological radiodiagnosis, the authors describe the advantages of a radioprotective shield which has been produced in the Greifswald University Stomatological Clinic. On the basis of dosimetric studies, the National Board for Nuclear Safety and Radiological Protection of the GDR (Staatliches Amt fuer Atomsicherheit und Strahlenschutz der DDR) could demonstrate the suitability of this shield as a radioprotective device for routine stomatological radiodiagnosis.

A tricalcium phosphate/polyether ether ketone anchor bionic fixation device for anterior cruciate ligament reconstruction: Safety and efficacy in a beagle model.

Science.gov (United States)

Mao, Genwen; Qin, Zili; Li, Zheng; Li, Xiang; Qiu, Yusheng; Bian, Weiguo

2018-05-02

The goal of this study was to develop a bionic fixation device based on the use of a tricalcium phosphate/polyether ether ketone anchor and harvesting of the ulnar carpal flexor muscle tendon for application as a ligament graft in a beagle anterior cruciate ligament (ACL) reconstruction model, with the goal of accelerating the ligament graft-to-bone tunnel healing and providing a robust stability through exploration of this new kind of autologous ligament graft. The safety and efficacy of this fixation device were explored 3 and 6 months after surgery in a beagle ACL reconstruction model using biomechanical tests and comprehensive histological observation. The data were compared using a two-tailed Student's t test and a paired t test. A p value <0.05 was defined as statistically significant. All the models were successfully established. This fixation device possessed the excellent mechanical properties for ACL reconstruction. A comprehensive histological observation revealed that a cartilage layer was visible in the transition zone between the tendon and bone interface at both 3 and 6 months postoperation. The trabecular of the new bone was observed six months after surgery and was found to be similar to a direct connection. This fixation technique provided not only a robust primary mechanical fixation but also a bionic fixation for long-term knee joint stability by accelerating the healing of the tendon to the bone tunnel, showing a high potential for use in clinical practice. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2018. © 2018 Wiley Periodicals, Inc.

SRV-automatic handling device

International Nuclear Information System (INIS)

Yamada, Koji

1987-01-01

Automatic handling device for the steam relief valves (SRV's) is developed in order to achieve a decrease in exposure of workers, increase in availability factor, improvement in reliability, improvement in safety of operation, and labor saving. A survey is made during a periodical inspection to examine the actual SVR handling operation. An SRV automatic handling device consists of four components: conveyor, armed conveyor, lifting machine, and control/monitoring system. The conveyor is so designed that the existing I-rail installed in the containment vessel can be used without any modification. This is employed for conveying an SRV along the rail. The armed conveyor, designed for a box rail, is used for an SRV installed away from the rail. By using the lifting machine, an SRV installed away from the I-rail is brought to a spot just below the rail so that the SRV can be transferred by the conveyor. The control/monitoring system consists of a control computer, operation panel, TV monitor and annunciator. The SRV handling device is operated by remote control from a control room. A trial equipment is constructed and performance/function testing is carried out using actual SRV's. As a result, is it shown that the SRV handling device requires only two operators to serve satisfactorily. The required time for removal and replacement of one SRV is about 10 minutes. (Nogami, K.)

30 CFR 56.6502 - Safety fuse.

Science.gov (United States)

2010-07-01

... be cut and capped in dry locations. (e) Blasting caps shall be crimped to fuse only with implements... material are securely in place. (g) Safety fuse shall be ignited only with devices designed for that... initiation systems, igniter cord and connectors, or other nonelectric initiation systems shall be used...

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.

Transcatheter Device Closure of Patent Ductus Arteriosus

International Nuclear Information System (INIS)

Sultan, M.; Ullah, M.; Sadiq, N.; Akhtar, K.; Akbar, H.

2014-01-01

Objective: To determine the efficacy, safety and immediate complications encountered during percutaneous device closure of patent ductus arteriosus (PDA). Study Design: Case series. Place and Duration of Study: Department of Paediatric Cardiology, AFIC/NIHD, Rawalpindi, from January 2005 to December 2010. Methodology: Consecutive 500 patients who underwent attempted transcatheter PDA device closure were included in the study. Device type position, success of closure and complications were described as frequency percentage. Results: In 491 cases (98.2%), PDA was successfully occluded including 4 cases (0.8%) where devices were dislodged but retrieved and redeployed in Cath laboratory. PDA occluder devices used in 448 cases (91%) while coils (single or multiple) were used in 42 cases (8.5%) and in one case (0.2%) ASD occluder device was used to occlude the PDA. There were 09 (1.8%) unsuccessful cases, 06 (1.2%) were abandoned as ducts were considered unsuitable for device closure, 02 (0.4%) devices dislodged and needed surgical retrieval and one case (0.2%) was abandoned due to faulty equipment. The narrowest PDA diameter ranged from 0.5 - 14 mm with mean of 4.5 +- 2.4 mm. There was a single (0.2%) mortality. Conclusion: Transcatheter occlusion of PDA by coil or occluder device is an effective therapeutic option with high success rate. Complication rate is low in the hands of skilled operators yet paediatric cardiac surgical back-up cover is mandatory. (author)

30 CFR 75.1723 - Stationary grinding machines; protective devices.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Stationary grinding machines; protective....1723 Stationary grinding machines; protective devices. (a) Stationary grinding machines other than... the wheel. (3) Safety washers. (b) Grinding wheels shall be operated within the specifications of the...

Performance Tests for Bubble Blockage Device

International Nuclear Information System (INIS)

Ha, Kwang Soon; Wi, Kyung Jin; Park, Rae Joon; Wan, Han Seong

2014-01-01

Postulated severe core damage accidents have a high threat risk for the safety of human health and jeopardize the environment. Versatile measures have been suggested and applied to mitigate severe accidents in nuclear power plants. To improve the thermal margin for the severe accident measures in high-power reactors, engineered corium cooling systems involving boiling-induced two-phase natural circulation have been proposed for decay heat removal. A boiling-induced natural circulation flow is generated in a coolant path between a hot vessel wall and cold coolant reservoir. In general, it is possible for some bubbles to be entrained in the natural circulation loop. If some bubbles entrain in the liquid phase flow passage, flow instability may occur, that is, the natural circulation mass flow rate may be oscillated. A new device to block the entraining bubbles is proposed and verified using air-water test loop. To avoid bubbles entrained in the natural circulation flow loop, a new device was proposed and verified using an air-water test loop. The air injection and liquid circulation loop was prepared, and the tests for the bubble blockage devices were performed by varying the geometry and shape of the devices. The performance of the bubble blockage device was more effective as the area ratio of the inlet to the down-comer increased, and the device height decreased. If the device has a rim to generate a vortex zone, the bubbles will be most effectively blocked

SAFETY

CERN Multimedia

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...

76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

Science.gov (United States)

2011-09-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Reporting Device Adverse Events Challenge'' Authority: 15 U.S.C. 3719. AGENCY: Office of the National..., specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse...

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

Directory of Open Access Journals (Sweden)

Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

77 FR 22384 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Science.gov (United States)

2012-04-13

... vehicle with the driver. The key contains a radio signal transponder which signals the control unit to... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety...

Minimally Invasive Cochlear Implantation Assisted by Bi-planar Device: An Exploratory Feasibility Study in vitro

Directory of Open Access Journals (Sweden)

Jia Ke

2016-01-01

Conclusions: This exploratory study demonstrated the safety of the newly developed image-guided minimally invasive cochlear implantation assisted by the bi-planar device and established the operational procedures. Further, more in vitro experiments are needed to improve the system operation and its safety.

75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2010-07-02

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...

Passive components of NPP safety-related systems

International Nuclear Information System (INIS)

Ionaytis Romuald, R.; Bubnova Tatyana, A.

2005-01-01

This paper presents a new passive components with having drives: fast-response cutoff valves; modular actuators with opposite cocking pneumatic drives and actuation spring drives; voting electromagnetic valve units for control of pneumatic drives; passive initiators of actuation; visual diagnostics . All these devices have been developed and tested at mock-ups. This paper presents also the following direct-action passive safety components: modular pressure-relief safety valves; pilot safety valves with passive action; check valves with remote position indicator and after-tightening; modular inserts for limiting emergency coolant flow; vortex rectifier; critical weld fasteners; gas-liquid valves; fast-removable seal assembly; seal spring loaders; grooves for increasing hydraulic resistance. Replacement of active safety system components for passive ones improves the general reliability NPP by 1.5 or 2 orders of magnitudes. (authors)

Process and device for reducing the presence in the safety containment of a nuclear reactor

International Nuclear Information System (INIS)

Stiefel, M.

1981-01-01

If faults occur, the excess pressure in the safety containment has to be reduced. Part of the gas contents of the safety containment is drawn off for this purpose. Hydrogen up to a maximum of 3.5% by volume is added to the drawn-off gas. The gas enriched with hydrogen is taken through a recombiner, where part of the oxygen content of the gas burns with the hydrogen, producing water. The gas with reduced oxygen content is returned to the safety containment via the free end of an annular pipe. The pressure existing in the safety containment is reduced according to the reduction in oxygen content. (orig./HP) [de

Concept of the LORELEI Test Device for LOCA Experiment in the JHR Reactor

International Nuclear Information System (INIS)

Moran, N.; Ferry, L.; Azulay, A.; Mileguir, O.; Weiss, Y.; Szanto, M.

2014-01-01

Modeling of nuclear fuel cladding behavior during a Loss of Coolant accident (LOCA) is a principal requirement in reactor safety analysis. Former safety criteria were obtained from experiments during the 1970's, conducted mainly with fresh fuels. Changes in modern fuel design, introduction of new cladding materials and motivation towards higher burn-ups have generated a need to re-examine safety criteria and their continued validity. This led to the growing development of both experiments and simulations meant to address this need. The Halden IFA-650 series of experiments for example, beginning in the early 2000's have clearly shown that existing criteria and experimental data are insufficient for the growing demand for higher burn-ups. In JHR material testing reactor, which is currently under construction, one significant experimental device is the LORELEI testing device. The objective is to examine the LOCA sequence influence on: thermo-mechanical behavior of the fuel clad, possible fuel relocation, corrosion at high temperature, oxidation, hydriding and resulted clad embrittment. The device is a single rod closed loop system placed on a displacement device inside a defined channel in the reflector. Several operational constrains on the device, as required by the reactor operational philosophy resulted quite a few challenges in the design. Constrains as: pre experimental re-irradiation phase under thermo-syphonic flow, application of active insulation to simulate the surrounding fuel, application of tensile force during refolding simulation, controlling the experiment with non-direct temperature measurement, etc. requires sophisticated solutions. The main objective of the conceptual design was to remove the uncertainties of those challenging requirements. The current presentation describes the approach applied defining the concept of the device, using sophisticated design combined with computational and experimental tools

Reliability analysis of diverse safety logic systems of fast breeder reactor

International Nuclear Information System (INIS)

Ravi Kumar, Bh.; Apte, P.R.; Srivani, L.; Ilango Sambasivan, S.; Swaminathan, P.

2006-01-01

Safety Logic for Fast Breeder Reactor (FBR) is designed to initiate safety action against Design Basis Events. Based on the outputs of various processing circuits, Safety logic system drives the control rods of the shutdown system. So, Safety Logic system is classified as safety critical system. Therefore, reliability analysis has to be performed. This paper discusses the Reliability analysis of Diverse Safety logic systems of FBRs. For this literature survey on safety critical systems, system reliability approach and standards to be followed like IEC-61508 are discussed in detail. For Programmable Logic device based systems, Hardware Description Languages (HDL) are used. So this paper also discusses the Verification and Validation for HDLs. Finally a case study for the Reliability analysis of Safety logic is discussed. (author)

Using Mobile Devices in Nursing Education.

Science.gov (United States)

Day-Black, Crystal; Merrill, Earlene B

2015-01-01

The use of mobile device technology in nursing education is growing. These devices are becoming more important in the health care environment with an advantage of providing a compendium of drug, nursing procedures and treatments, and disease information to nursing students. Senior baccalaureate nursing students traditionally are prohibited from medication administration during psychiatric-mental health clinical rotations, but they are required to participate in simulated medication discussions and administration experiences. The incorporation of this mobile device technology to augment clinical learning experiences has advantages including potential reduction of medication errors, and improved patient safety during students' clinical rotation. The purpose of this project is to explain how the mobile device (iPod Touch, 4th generation wireless media player) may be used to enhance and augment comprehensive nursing care in a psychiatric-mental health clinical setting. Thirty-four (34) baccalaureate senior nursing students enrolled in a clinical psychiatric-mental nursing course at a mid-Atlantic public university school of nursing were used. Each student was provided a loaner mobile device with appropriate software and the necessary training. Data were collected on the student's ability to simulate medication administration to a psychiatric-mental health client. Surveys were administered before distribution, at mid-point and at the end of two (2) seven week semesters.

78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2013-08-19

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...

75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Science.gov (United States)

2010-06-24

... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...

Radiation Safety of Electromagnetic Waves

International Nuclear Information System (INIS)

Hussein, A.Z.

2009-01-01

The wide spread of Electromagnetic Waves (EMW) through the power lines, multimedia, communications, devices, appliances, etc., are well known. The probable health hazards associated with EMW and the radiation safety criteria are to be reviewed. However, the principles of the regulatory safety are based on radiation protection procedure, intervention to combat the relevant risk and to mitigate consequences. The oscillating electric magnetic fields (EMF) of the electromagnetic radiation (EMR) induce electrical hazards. The extremely high power EMR can cause fire hazards and explosions of pyrotechnic (Rad Haz). Biological hazards of EMF result as dielectric heat, severe burn, as well as the hazards of eyes. Shielding is among the technical protective measures against EMR hazards. Others are limitation of time of exposure and separation distance apart of the EMR source. Understanding and safe handling of the EMR sources are required to feel safety.

Design of active feedback for rehabilitation device

Directory of Open Access Journals (Sweden)

Liska Ondrej

2016-01-01

Full Text Available Sensor systems are an essential part of automated equipment. They are even more important in machines that come in contact with people, because they have a significant impact on safety. This paper describes the design of active feedback for rehabilitation device driven by pneumatic artificial muscles. Here are presented three methods for measuring the load of the robot. The first is a system composed of Force Sensitive Resistors (FSR placed in the handle of the device. Two other methods are intended to measure the load of the actuator composed of artificial muscles. The principle of one method is to measure the difference in filling pressures of the muscles, second is based on strain measurement in the drive cables. The paper describes advantages and disadvantages of using each of these methods in a rehabilitation device

Photostress Testing Device for Diagnosing Retinal Disease

Directory of Open Access Journals (Sweden)

Elizabeth Swan

2014-08-01

Full Text Available Retinal diseases such as Age-Related Macular Degeneration (ARMD affect nearly one in three elderly patients. ARMD damages the central vision photoreceptors in the fovea. The Photostress Test is a simple technique for testing for the early effects of ARMD. Here, the illumination sources in a novel self-administered Photostress Testing device were modeled for safety and distribution in illumination software. After satisfying the design constraints in the model, a prototype of the illumination system was fabricated and tested to confirm the modeling results. The resultant prototype can be used to aid in the diagnosis of retinal disease and is well within retinal safety levels.

Access safety systems - New concepts from the LHC experience

International Nuclear Information System (INIS)

Ladzinski, T.; Delamare, C.; Luca, S. di; Hakulinen, T.; Hammouti, L.; Havart, F.; Juget, J.F.; Ninin, P.; Nunes, R.; Riesco, T.; Sanchez-Corral Mena, E.; Valentini, F.

2012-01-01

The LHC Access Safety System has introduced a number of new concepts into the domain of personnel protection at CERN. These can be grouped into several categories: organisational, architectural and concerning the end-user experience. By anchoring the project on the solid foundations of the IEC 61508/61511 methodology, the CERN team and its contractors managed to design, develop, test and commission on time a SIL3 safety system. The system uses a successful combination of the latest Siemens redundant safety programmable logic controllers with a traditional relay logic hard wired loop. The external envelope barriers used in the LHC include personnel and material access devices, which are interlocked door-booths introducing increased automation of individual access control, thus removing the strain from the operators. These devices ensure the inviolability of the controlled zones by users not holding the required credentials. To this end they are equipped with personnel presence detectors and the access control includes a state of the art bio-metry check. Building on the LHC experience, new projects targeting the refurbishment of the existing access safety infrastructure in the injector chain have started. This paper summarises the new concepts introduced in the LHC access control and safety systems, discusses the return of experience and outlines the main guiding principles for the renewal stage of the personnel protection systems in the LHC injector chain in a homogeneous manner. (authors)

Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

Safety device and machine system of nuclear power plant

International Nuclear Information System (INIS)

1978-10-01

It introduces principle and kinds of heat power including heat balance and nuclear power. It explains a lot of technical terms about the nuclear power system, which are primary loop, reactor, steam generator, primary coolant pump and pressurizer in PWR, chemical and volume control system, component cooling system, safety injection system, and spent fuel cooling and storage system in auxiliary system, liquid solid and gaseous waste disposal system in radwaste disposal, gland sealing system, turbine instrumentation, turning gear, hydrogen cooling system, condenser, feedwater heater, degenerate heater, auxiliary heat exchanger, centrifugal pump, rotary reciprocating and tank and pressure vessel.

Recommended safety guides for industrial laboratories and shops

Science.gov (United States)

Allison, W. W.

1971-01-01

Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.

Easy steel tower elevation. Development of a steel tower elevating aiding device; Tetto shoko wo rakuraku to. Tetto shoko hojo sochi no kaihatsu ni tsuite

Energy Technology Data Exchange (ETDEWEB)

Tobe, Y. [Kansai Electric Power Co. Inc., Osaka (Japan)

1999-02-10

Elevation of a transmission line steel tower is performed by an operator`s own force upon fixing a safety device to prevent a fall on a safety wire (SW) previously installed on a specified tower leg. It is a considerable burden for the operator to move the tower having a height of 80 to 100 m up and down several times a day. In order to reduce the fatigue, a portable, small and light-weight steel tower elevation aiding device was developed. The existing SW is used to fix the device, requiring no additional facility to be fixed on the tower. Safety assurance depends on the safety device on the SW as currently used. The device has pulling force of 50 kgf (the device operates in a range of 4 to 50 kgf to assure workability in elevation and stopping), and elevation speed of 15 to 20 m/minute (equivalent to the present work. The braking force can be adjusted in three steps at descent according to the ability of the operator). An Ni-hydrogen battery is used, capable of two returns on a tower per charge. Considering the device to be transported in mountainous area, the shape is such that a single unit can be put into a backpack. The device can also be used in general construction sites. (NEDO)

IoT Enabled Low Cost Wearable Device for Location and Information Tracking System

Directory of Open Access Journals (Sweden)

Kamaludin Nur Atika Binti

2017-01-01

Full Text Available An internet-of-things (IoT enabled low cost wearable device for location and information tracking system is developed to monitor and ensure the safety of the children while their parents are away either to work or abroad. This system aims to ensure human safety especially the children and efficiently initiate search and rescue in the event of emergencies. The device will notify the parents on the condition of the surroundings of the children, specifically inside the house and notify the parents if the children are outside the target area by using the application developed in the smartphone. The system uses a microcomputer called Beagle-Bone Black (BBB as the processor while GPS and LTE technology for wireless communication. Future improvement mainly focuses on reducing the size and power consumption of the device, improving communication module, and optimizing microcomputer’s specification.

Safety in laboratories: Indian scenario.

Science.gov (United States)

Mustafa, Ajaz; Farooq, A Jan; Qadri, Gj; S A, Tabish

2008-07-01

Health and safety in clinical laboratories is becoming an increasingly important subject as a result of emergence of highly infectious diseases such as Hepatitis and HIV. A cross sectional study was carried out to study the safety measures being adopted in clinical laboratories of India. Heads of laboratories of teaching hospitals of India were subjected to a standardized, pretested questionnaire. Response rate was 44.8%. only 60% of laboratories had person in-charge of safety in laboratory. Seventy three percent of laboratories had safety education program regarding hazards. In 91% of laboratories staff is using protective clothing while working in laboratories. Hazardous material regulations are followed in 78% of laboratories. Regular health check ups are carried among laboratory staff in 43.4% of laboratories.Safety manual is available in 56.5% of laboratories. 73.9% of laboratories are equipped with fire extinguishers. Fume cupboards are provided in 34.7% of laboratories and they are regularly checked in 87.5% of these laboratories. In 78.26% of laboratories suitable measures are taken to minimize formation of aerosols.In 95.6% of laboratories waste is disposed off as per bio-medical waste management handling rules. Laboratory of one private medical college was accredited with NABL and safety parameters were better in that laboratory. Installing safety engineered devices apparently contributes to significant decrease in injuries in laboratories; laboratory safety has to be a part of overall quality assurance programme in hospitals. Accreditation has to be made necessary for all laboratories.

Gender and other factors associated with the use of hearing protection devices at work

Directory of Open Access Journals (Sweden)

Tatiane Costa Meira

2015-01-01

Full Text Available OBJECTIVE To analyze whether sociodemographic, occupational, and health-related data are associated with the use of hearing protection devices at work, according to gender.METHODS A cross-sectional study was conducted in 2006, using a random sample of 2,429 workers, aged between 18 and 65 years old, from residential sub-areas in Salvador, BA, Northeastern Brazil. Questionnaires were used to obtain sociodemographic, occupational, and health-related data. Workers who reported that they worked in places where they needed to shout in order to be heard were considered to be exposed to noise. Exposed workers were asked whether they used hearing protection devices, and if so, how frequently. Analyses were conducted according to gender, with estimates made about prevalence of the use of hearing protection devices, prevalence ratios, and their respective 95% confidence intervals.RESULTS Twelve percent (12.3% of study subjects reported that they were exposed to noise while working. Prevalence of the use of hearing protection devices was 59.3% for men and 21.4% for women. Men from higher socioeconomic levels (PR = 1.47; 95%CI 1.14;1.90 and who had previous audiometric tests (PR = 1.47; 95%CI 1.15;1.88 were more likely to use hearing protection devices. For women, greater perceived safety was associated with the use of protection devices (PR = 2.92; 95%CI 1.34;6.34. This perception was specifically related to the presence of supervisors committed to safety (PR = 2.09; 95%CI 1.04;4.21, the existence of clear rules to prevent workplace injuries (PR = 2.81; 95%CI 1.41;5.59, and whether they were informed about workplace safety (PR = 2.42; 95%CI 1.23;4.76.CONCLUSIONS There is a gender bias regarding the use of hearing protection devices that is less favorable to women. The use of such devices among women is positively influenced by their perception of a safe workplace, suggesting that gender should be considered as a factor in hearing conservation programs.

Access Safety Systems – New Concepts from the LHC Experience

CERN Document Server

Ladzinski, T; di Luca, S; Hakulinen, T; Hammouti, L; Riesco, T; Nunes, R; Ninin, P; Juget, J-F; Havart, F; Valentini, F; Sanchez-Corral Mena, E

2011-01-01

The LHC Access Safety System has introduced a number of new concepts into the domain of personnel protection at CERN. These can be grouped into several categories: organisational, architectural and concerning the end-user experience. By anchoring the project on the solid foundations of the IEC 61508/61511 methodology, the CERN team and its contractors managed to design, develop, test and commission on time a SIL3 safety system. The system uses a successful combination of the latest Siemens redundant safety programmable logic controllers with a traditional relay logic hardwired loop. The external envelope barriers used in the LHC include personnel and material access devices, which are interlocked door-booths introducing increased automation of individual access control, thus removing the strain from the operators. These devices ensure the inviolability of the controlled zones by users not holding the required credentials. To this end they are equipped with personnel presence detectors and th...

Aceptación de los dispositivos de bioseguridad de material corto-punzante en personal de enfermería de un hospital terciario Acceptance of safety devices in nursing staff in general hospital

Directory of Open Access Journals (Sweden)

Lourdes Jiménez Bajo

2009-06-01

Full Text Available El objetivo de este estudio es evaluar la aceptación entre el personal de enfermería de los dispositivos de bioseguridad de material corto-punzante tras 20 meses de su implantación en un hospital terciario y su comparación con los resultados obtenidos en el estudio piloto previo a la implantación. Se realiza estudio descriptivo transversal en 5 servicios del hospital, Nefrología, Medicina Interna, Infecciosas, Unidad de Críticos y Cirugía General antes y tras 20 meses de implantación de los dispositivos. El cuestionario recoge variables como seguridad de usuario, comodidad y sencillez de uso, tiempo de maniobra y seguridad del paciente de cinco dispositivos, agujas intramusculares, agujas subcutáneas, jeringas de gasometría, catéter intravenoso y aguja de diálisis; valoración global de la importancia del uso generalizado de los dispositivos y necesidad de más información/ formación. El 62% considera importantísimo el uso generalizado de dispositivos de seguridad. Tras 20 meses de implantación, la aceptación de los dispositivos entre el personal de enfermería parece mayor, aunque estas diferencias no son estadísticamente significativas. Es necesario aumentar el período de estudio y reforzar las medidas de información-formación entre otras propuestas, ya que contribuyen a su mayor aceptación la frecuencia de utilización y la información/formación recibida.The purpose of this study is asses the acceptance of the safety devices in nursing staff after 20 months of implementation in general hospital and compare the results with pilot study before implementation. A descriptive study was conducted in 5 hospital services: Nephrology, Internal Medicine, Infectous Diseases Service, Intensive Care and General Surgery. The questionnaire includes following variables: user safety, comfort and ease of use, time to maneuver and patient safety of the five devices, intramuscular needle, needle subcutaneous, syringe of gas, intravenous

Seismic qualification of multiple interconnected safety-related cabinets in a high seismic zone

International Nuclear Information System (INIS)

Khan, M.R.; Chen, W.H.W.; Wang, T.Y.

1993-01-01

Certain safety-related multiple, interconnected electrical cabinets and the devices contained therein are required to perform their intended safety functions during and after a design basis seismic event. In general, seismic testing is performed to ensure the structural integrity of the cabinets and the functionality of their associated devices. Constrained by the shake table capacity, seismic testing is usually performed only for a limited number of interconnected cabinets. Also, original shake table tests performed usually did not provide detailed response information at various locations inside the cabinets. For operational and maintenance purposes, doors and panels of some cabinets may need to be opened while the adjacent cabinets are required to remain functional. In addition, in-cabinet response spectra need to be generated for the seismic qualification of new devices and the replacement parts. Consequently, seismic analysis of safety-related multiple, interconnected cabinets is frequently required for configurations which are different from the original tested conditions. This paper presents results of seismic tests of three interconnected safety-related cabinets and finite element analyses performed to compare the analytical results with those obtained from the cabinet seismic tests. Parametric analyses are performed to determine how many panels and doors can be opened while the adjacent cabinets still remain functional. The study indicates that for cabinets located in a high seismic zone, the critical damping of the cabinet is significantly higher than 5% to 7% typically used in qualifying electrical equipment. For devices mounted on the cabinet doors to performed their intended safety function, it requires stiffening of doors and that these doors be properly bolted to the cabinet frame. It also shows that even though doors and panels bolted to the cabinet frame are the primary seismic resistant element of the cabinet, opening of a limited number of them

Use of consumer wireless devices by South Africans with severe communication disability

Directory of Open Access Journals (Sweden)

Juan Bornman

2016-02-01

Full Text Available Background: Advancements in wireless technology (e.g. cell phones and tablets have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. Objectives: To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Method: Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. Results: All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3% needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends, for leisure activities (e.g. listening to music, watching videos, playing games, and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance. Conclusion: These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population.

Evaluation on thermal-hydraulic characteristics for passive safety device of APR1400

Energy Technology Data Exchange (ETDEWEB)

Yoo, Seong Yeon; Lee, S. H.; Son, M. K. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of); Jee, M. S.; Chung, M. H. [Chungnam National Univ., Taejon (Korea, Republic of)

2001-07-15

To establish evaluation and verification guideline for the APR1400, thermal-hydraulic characteristics for fuel rod bundle, reactor vessel and fluidic device is analyzed using FLUENT. Scope and major results of research are as follows : Thermal-hydraulic characteristics for nuclear fuel rod bundle: design data for nuclear fuel rod bundle and structure are surveyed, and 3 x 3 sub-channel model is adopted to investigate the fluid flow and heat transfer characteristics in fuel rod bundle. Computational results are compared with the heat transfer data measured by naphthalene sublimation method, and numerical analysis and evaluation are performed at various design conditions and flow conditions. Thermal-hydraulic characteristics for reactor vessel: reactor vessel design data are surveyed to develop numerical model. Porous media model is applied for fuel rod bundle, and full-scale, three dimensional simulation is performed at actual operating conditions. Distributions of velocity, pressure and temperature are discussed. Flow characteristics for fluidic device: three dimensional numerical model for fluidic device is developed, and numerical results are compared with experimental data obtained at KAERI in order to verify numerical simulation. In addition, variation of flow rate is investigated at various elapsed times after valve operating, and flow characteristics is analyzed at low and high flow rate conditions, respectively.

76 FR 12358 - Common Formats for Patient Safety Data Collection and Event Reporting

Science.gov (United States)

2011-03-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats... information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b...: Device or Supply, including Health Information Technology; Fall; Healthcare-Associated Infection...

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up.

Science.gov (United States)

Kühn, Anna Luisa; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Rex, David E; Massari, Francesco; Tamura, Takamitsu; Howk, Mary; Brooks, Christopher; L'Heureux, Jenna; Gounis, Matthew J; Wakhloo, Ajay K; Puri, Ajit S

2017-12-01

Evaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs). Retrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months' follow-up and assessed intimal hyperplasia at follow-up. Twenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months' follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months' follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs. Treatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Hydraulic screw fastening devices - design, maintenance, operational experience

International Nuclear Information System (INIS)

Lachner.

1976-01-01

With hydraulic screw fastening devices, pretension values with a maximum deviation of +-2.5% from the rated value can be achieved. This high degree of pretension accuracy is of considerable importance with regard to the safety factor required for the screw connection between reactor vessel head and reactor vessel. The operating rhythm of a nuclear power station with its refuelling art regular intervals makes further demands on the screw fastening device, in particular in connection with the transport of screws and for nuts. The necessary installations extend the screw fastening device into a combination of a high-pressure hydraulic cylinder system with an electrical or pneumoelectrical driving unit and an electrical control unit. Maintenance work is complicated by the large number of identical, highly stressed structural elements in connection with an unfavourable relation operating time/outage time. The problems have been perpetually reduced by close cooperation between the manufacturers and users of screw fastening devices. (orig./AK) [de

Reactor scram device for FBR type reactor

International Nuclear Information System (INIS)

Kumasaka, Katsuyuki; Arashida, Genji; Itooka, Satoshi.

1991-01-01

In a control rod attaching structure in a reactor scram device of an FBR type reactor, an anti-rising mechanism proposed so far against external upward force upon occurrence of earthquakes relies on the engagement of a mechanical structure but temperature condition is not taken into consideration. Then, in the present invention, a material having curie temperature characteristics and which exhibits ferromagnetism only under low temperature condition and a magnet device are disposed to one of a movable control rod and a portion secured to the reactor. Alternatively, a bimetal member or a shape memory alloy which actuates to fix to the mating member only under low temperature condition is secured. The fixing device is adapted to operate so as to secure the control rods when the low temperature state is caused depending on the temperature condition. With such a constitution, when the control rods are separated from a driving device, they are prevented from rising even if they undergo external upward force due to earthquakes and so on, which can improve the reactor safety. (N.H.)

an automatic safety control for immersion water heater

African Journals Online (AJOL)

NIJOTECH

An important source of concern with this appliance is the frequent possibility of outbreak of fire due to ... The safety condition is achieved by incorporating a device, which automatically .... The relay-driving network is indicated in the circuit of ...

Internal pump monitoring device

International Nuclear Information System (INIS)

Kurosaki, Toshikazu.

1996-01-01

In the present invention, a thermometer is disposed at the upper end of an internal pump casing of a coolant recycling system in a BWR type reactor to detect leakage of reactor water thereby ensuring the improvement of reliability of the internal pump. Namely, a thermometer is disposed, which can detect temperature elevation occurred when water in the internal pump leaked from a reactor pressure vessel passes through the gap between a stretch tube and an upper end of the pump casing. Signals from the thermometer are transmitted to a signal processing device by an instrumentation cable. The signal processing device generates an alarm when the temperature signal exceeds a predetermined value and announces that leakage of reactor water occurs in the internal pump. Since the present invention can detect the leakage of the reactor water in the pump casing in an early stage, it can contribute to the improvement of the safety and reliability of the internal pump. (I.S.)

A spent fuel assemblies monitoring device by nondestructive analysis 'PYTHON'

International Nuclear Information System (INIS)

Saad, M.; Broeskamp, M.; Hahn, H.; Bignan, G.; Boisset, M.; Silie, P.

1995-01-01

The monitoring of spent fuel assemblies (16 x 16 UOX) in KWG-reactor pool with the use of non-destructive methods (total Gamma and neutron counting) allow the control of average burn-up and the extremity burn-up. The measurements allow a safety-criticality control before loading the fuel assemblies into the transport casks. A device called PYTHON has been tested and qualified in France. This paper presents a description of the industrial PYTHON device and the results of the measurements. (orig.)

Sealed source and device design safety testing. Volume 4: Technical report on the findings of Task 4, Investigation of sealed source for paper mill digester

International Nuclear Information System (INIS)

Benac, D.J.; Iddings, F.A.

1995-10-01

This report covers the Task 4 activities for the Sealed Source and Device Safety testing program. SwRI was contracted to investigate a suspected leaking radioactive source that was installed in a gauge that was on a paper mill digester. The actual source that was leaking was not available, therefore, SwRI examined another source. SwRI concluded that the encapsulated source examined by SwRI was not leaking. However, the presence of Cs-137 on the interior and exterior of the outer encapsulation and hending tube suggests that contamination probably occurred when the source was first manufactured, then installed in the handling tube

Tests on instrumentation and control systems important to safety in nuclear power stations. Systempruefung der leittechnischen Einrichtungen des Sicherheitssystems in Kernkraftwerken

Energy Technology Data Exchange (ETDEWEB)

1985-01-01

The rule applies to the reactor protection system, to the protection and state boundaries, to control devices important to safety, and to danger alarms of the classes S and I. The system inspection of the control devices of the safety system comprises in-service testing and recurrent testing.

Electrodermal Activity Based Wearable Device for Drowsy Drivers

Science.gov (United States)

Malathi, D.; Dorathi Jayaseeli, JD; Madhuri, S.; Senthilkumar, K.

2018-04-01

Road safety and road accident mortality rate are a serious concern for the government. With rise in fatal road accidents, who’s leading cause is the driver being drowsy behind the wheel, measures to alleviate this problem becomes the prime task. To meet the purpose, methods adopted must be of minimum discomfort for the driver, easy to install, provide good detection accuracy and timely alert to circumvent a probable accident. A good candidate to meet these specifications is EDA. As it detects the level of sweat which directly corresponds to the mental state of the person, using EDA for the purposes of driver safety forms a good option. The novelty of this project lies in making use of EDA as a measure to detect if a person is drowsy or not. Much of the challenge lies in building a device equipped with the necessary sensors and processing the data on real-time. The novelty of this work lies in development of an embedded device interfaced with sensors and actuators to detect and alert a driver when found drowsy using sweat as a parameter.

[Innovative technology and blood safety].

Science.gov (United States)

Begue, S; Morel, P; Djoudi, R

2016-11-01

If technological innovations are not enough alone to improve blood safety, their contributions for several decades in blood transfusion are major. The improvement of blood donation (new apheresis devices, RFID) or blood components (additive solutions, pathogen reduction technology, automated processing of platelets concentrates) or manufacturing process of these products (by automated processing of whole blood), all these steps where technological innovations were implemented, lead us to better traceability, more efficient processes, quality improvement of blood products and therefore increased blood safety for blood donors and patients. If we are on the threshold of a great change with the progress of pathogen reduction technology (for whole blood and red blood cells), we hope to see production of ex vivo red blood cells or platelets who are real and who open new conceptual paths on blood safety. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

USA perspectives. Safety and security of radioactive sources

International Nuclear Information System (INIS)

Dicus, G.J.

1999-01-01

In contrast to the 103 licensed nuclear power plants in the United States, there are about 157,000 licenses that authorize the use of radioactive materials subject to US Atomic Energy Act. as amended. Each year the NRC receives about 200 reports of lost, stolen or abandoned radioactive sources and devices. The NRC has established a programme to review and analyze reports and other information on losses, thefts, abandonments, and discoveries of radioactive sources that helped to identify and characterize the problem with safety and security of radioactive sources in devices used under the general license programme. In summary, a large number of radioactive sources in use in the USA have a very good safety record. When used properly by trained personnel with effective regulatory oversight, the many uses of radioactive sources are safe and provide a net benefit to society. If problems occur such as overexposures or contamination of property, it is essential that hey are promptly reported to the regulatory authority. If necessary appropriate emergency response measures can be taken, and the problems analysed. In that way, effective risk-informed regulatory measures can be activated to assure the continued safety and security of radioactive sources

Prevention of gingival trauma : Oral hygiene devices and oral piercings

NARCIS (Netherlands)

Hoenderdos, N.L.

2017-01-01

Maintaining healthy teeth and soft oral tissues for life is important. Oral hygiene devices and oral piercings can damage the soft oral tissues. This thesis investigates the safety of manual toothbrushes, interdental brushes and rubber bristles interdental cleaners by analysing the gingival abrasion

A knee-mounted biomechanical energy harvester with enhanced efficiency and safety

Science.gov (United States)

Chen, Chao; Chau, Li Yin; Liao, Wei-Hsin

2017-06-01

Energy harvesting is becoming a major limiting issue for many portable devices. When undertaking any activity, the human body generates a significant amount of biomechanical energy, which can be collected by means of a portable energy harvester. This energy provides a method of powering portable devices such as prosthetic limbs. In this paper, a knee-mounted energy harvester with enhanced efficiency and safety is proposed and developed to convert mechanical energy into electricity during human motion. This device can change the bi-directional knee input into uni-directional rotation for an electromagnetic generator using a specially designed transmission system. Without the constraint of induced impact on the human body, this device can harvest biomechanical energy from both knee flexion and extension, improving the harvesting efficiency over previous single-direction energy harvesters. It can also provide protection from device malfunction, and increase the safety of current biomechanical energy harvesters. A highly compact and light prototype is developed taking into account human kinematics. The biomechanical energy harvesting system is also modeled and analyzed. The prototype is tested under different conditions including walking, running and climbing stairs, to evaluate the energy harvesting performance and effect on the human gait. The experimental results show that the prototype can harvest an average power of 3.6 W at 1.5 m s-1 walking speed, which is promising for portable electronic devices.

Safety precautions in atomic pile control (1962)

International Nuclear Information System (INIS)

Furet, J.

1962-01-01

We have been led to study the problem of safety in atomic pile control as a result of our participation on the one hand in the planning of C.E.A. atomic piles, and on the other hand in the pile safety sub omission considering atomic pile safety of operational or planned C.E.A. piles. We have thus had to consider the wishes occurring in piles during their operation and also their behaviour in the dynamic state The present work deals mainly with the importance of intrinsic safety devices, with the influence of reactivity variations on the power fluctuations during accidental operation, and with the development of robust and reliable safety appliances. The starting p accident has been especially studied both for low-flux piles where a compromise is necessary between the response time of the safety appliances and the statistical fluctuations and for high lux piles where xenon poisoning has an effect on the lower limit of the velocity of reactivity liberation. The desirability has been stressed of automation as a safety factor in atomic pile control. The details required for an understanding of the diagrams of the apparatus are given. (author) [fr

MDEP Common Position CP-DICWG-07. Common position on selection and use of industrial digital devices of limited functionality

International Nuclear Information System (INIS)

2014-01-01

The nuclear power industry is increasingly interested in using industrial digital devices of limited functionality in systems important to safety, but that have not been developed specifically for use in nuclear power applications. These devices should meet certain specific requirements in order to be selected and used in systems important to safety at nuclear power plants. Typically, some of these devices are found embedded in plant components and actuating devices, e.g. sensing instrumentation, motors, pumps, actuators, breakers. The Digital Instrumentation and Controls Working Group (DICWG) has agreed that a common position on this topic is warranted given the increase of use of Digital I and C in new reactor designs, its safety implications, and the need to develop a common understanding from the perspectives of regulatory authorities. This action follows the DICWG examination of the regulatory requirements of the participating members and of relevant industry standards and IAEA documents. The DICWG proposes a common position based on its recent experience with the new reactor application reviews and operating plant issues

Some safety considerations in laser-controlled thermonuclear reactors. Final report

International Nuclear Information System (INIS)

Botts, T.E.; Breton, D.; Chan, C.K.; Levy, S.I.; Sehnert, M.; Ullman, A.Z.

1978-07-01

A major objective of this study was to identify potential safety questions for laser controlled thermonuclear reactors. From the safety viewpoint, it does not appear that the actual laser controlled thermonuclear reactor conceptual designs present hazards very different than those of magnetically confined fusion reactors. Some aspects seem beneficial, such as small lithium inventories, and the absence of cryogenic devices, while other aspects are new, for example the explosion of pressure vessels and laser hazards themselves. Major aspects considered in this report include: (a) general safety considerations, (b) tritium inventories, (c) system behavior during loss of flow accidents, and (d) safety considerations of laser related penetrations

Study on high reliability safety valve for railway vehicle

Science.gov (United States)

Zhang, Xuan; Chen, Ruikun; Zhang, Shixi; Xu, BuDu

2017-09-01

Now, the realization of most of the functions of the railway vehicles rely on compressed air, so the demand for compressed air is growing higher and higher. This safety valve is a protection device for pressure limitation and pressure relief in an air supply system of railway vehicles. I am going to introduce the structure, operating principle, research and development process of the safety valve designed by our company in this document.

Clinical efficacy and safety evaluation of a novel fractional unipolar radiofrequency device on facial tightening: A preliminary report.

Science.gov (United States)

Suh, Dong Hye; Byun, Eun Jung; Lee, Sang Jun; Song, Kye Yong; Kim, Hei Sung

2017-06-01

Previous studies have shown that radiofrequency (RF) energy is safe and effective for improving skin laxity. Unlike monopolar and bipolar devices, little has been studied with the unipolar hand piece. We sought to evaluate the safety and efficacy of a novel fractional unipolar RF device on facial tightening. This was a retrospective, single-center study of 14 subjects with age-related facial laxity who underwent five sessions of fractional unipolar RF at an interval of 2 weeks, and then followed-up for 3 months. Standardized photos were taken at baseline and at 3-months follow-up, and were assessed by two independent dermatologists using a 4-point scale (0=no improvement, 1=mild improvement, 2=moderate improvement, 3=significant improvement). Punch biopsies (2 mm) were performed and a questionnaire was used to evaluate the patient's satisfaction and the incidence of adverse reactions. Fourteen subjects with mild to moderate age-related facial laxity were included in the study. The mean age of the subjects was 49.7 years (range 32-80). 35.7% of the subjects showed significant improvement, 50% moderate improvement, and 14.3% slight improvement of facial laxity in their follow-up photos. About 85.7% of the patients replied that they were either greatly satisfied or satisfied with the results at 3-months follow-up. Skin biopsies revealed an increase in collagen in the dermis. None of the subjects experienced any serious adverse events during or after the procedure. Our findings suggest that fractional Unipolar RF can be safely performed on the face and is effective in skin tightening. It has a great advantage over other forms of RF by being entirely painless. © 2017 Wiley Periodicals, Inc.

Formalizing the Safety of Java, the Java Virtual Machine and Java Card

NARCIS (Netherlands)

Hartel, Pieter H.; Moreau, Luc

2001-01-01

We review the existing literature on Java safety, emphasizing formal approaches, and the impact of Java safety on small footprint devices such as smart cards. The conclusion is that while a lot of good work has been done, a more concerted effort is needed to build a coherent set of machine readable

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.

Selected fault testing of electronic isolation devices used in nuclear power plant operation

International Nuclear Information System (INIS)

Villaran, M.; Hillman, K.; Taylor, J.; Lara, J.; Wilhelm, W.

1994-05-01

Electronic isolation devices are used in nuclear power plants to provide electrical separation between safety and non-safety circuits and systems. Major fault testing in an earlier program indicated that some energy may pass through an isolation device when a fault at the maximum credible potential is applied in the transverse mode to its output terminals. During subsequent field qualification testing of isolators, concerns were raised that the worst case fault, that is, the maximum credible fault (MCF), may not occur with a fault at the maximum credible potential, but rather at some lower potential. The present test program investigates whether problems can arise when fault levels up to the MCF potential are applied to the output terminals of an isolator. The fault energy passed through an isolated device during a fault was measured to determine whether the levels are great enough to potentially damage or degrade performance of equipment on the input (Class 1E) side of the isolator

Features and selection of vascular access devices.

Science.gov (United States)

Sansivero, Gail Egan

2010-05-01

To review venous anatomy and physiology, discuss assessment parameters before vascular access device (VAD) placement, and review VAD options. Journal articles, personal experience. A number of VAD options are available in clinical practice. Access planning should include comprehensive assessment, with attention to patient participation in the planning and selection process. Careful consideration should be given to long-term access needs and preservation of access sites. Oncology nurses are uniquely suited to perform a key role in VAD planning and placement. With knowledge of infusion therapy, anatomy and physiology, device options, and community resources, nurses can be key leaders in preserving vascular access and improving the safety and comfort of infusion therapy. Copyright 2010 Elsevier Inc. All rights reserved.

The development of neural stimulators: a review of preclinical safety and efficacy studies.

Science.gov (United States)

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

International Nuclear Information System (INIS)

2016-01-01

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

Communication and Public Information in Development and Maintenance of Radiation Safety

International Nuclear Information System (INIS)

Huurto, L.

2003-01-01

The natural source of Non-Ionizing radiation (NIR) in our environment is the sun. Artificial NIR is widely used in medical and industrial applications and also in households. The most important medical NIR applications are phototherapy, surgical lasers and magnetic resonance imaging. In industry NIR is applied in radio frequency heaters and laser printing. NIR has applications even in entertainment and cosmetics: High power lasers are used in light shows and sun beds emit artificial ultraviolet radiation (UVR) for tanning. From the safety point of view the field is indeed very wide from harmless and common items to devices which can cause acute health hazards. The use of non-ionizing radiation needs neither any safety licence nor other kind of authorisation. The users of NIR devices varies from professionals in health care or lighting technology to those who only use them as a sideline in their main work like beauticians. Also laypersons use various NIR devices like microwave ovens, laser pointers and mobile phones. Many NIR devices are used in applications where the user does not have the knowledge to understand the health risks associated with the device. Thus the only way is to educate the users by communication and public information. (orig.)

Laser safety in design of near-infrared scanning LIDARs

Science.gov (United States)

Zhu, X.; Elgin, D.

2015-05-01

3D LIDARs (Light Detection and Ranging) with 1.5μm nanosecond pulse lasers have been increasingly used in different applications. The main reason for their popularity is that these LIDARs have high performance while at the same time can be made eye-safe. Because the laser hazard effect on eyes or skin at this wavelength region (industrial mining applications. We have incorporated the laser safety requirements in the LIDAR design and conducted laser safety analysis for different operational scenarios. While 1.5μm is normally said to be the eye-safe wavelength, in reality a high performance 3D LIDAR needs high pulse energy, small beam size and high pulse repetition frequency (PRF) to achieve long range, high resolution and high density images. The resulting radiant exposure of its stationary beam could be many times higher than the limit for a Class 1 laser device. Without carefully choosing laser and scanning parameters, including field-of-view, scan speed and pattern, a scanning LIDAR can't be eye- or skin-safe based only on its wavelength. This paper discusses the laser safety considerations in the design of eye-safe scanning LIDARs, including laser pulse energy, PRF, beam size and scanning parameters in two basic designs of scanning mechanisms, i.e. galvanometer based scanner and Risley prism based scanner. The laser safety is discussed in terms of device classification, nominal ocular hazard distance (NOHD) and safety glasses optical density (OD).

Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

Science.gov (United States)

Hoeyer, Klaus

2015-07-01

This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

The impact of different types of assistive devices on gait measures and safety in Huntington's disease.

Directory of Open Access Journals (Sweden)

Anne D Kloos