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Integrated Safety Assessment Report
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Book Synopsis Integrated Safety and Risk Assessment for Medical Devices and Combination Products by : Shayne C. Gad
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Book Synopsis Approaches for Integrating Information from Radiation Biology and Epidemiology to Enhance Low-dose Health Risk Assessment by :
Download or read book Approaches for Integrating Information from Radiation Biology and Epidemiology to Enhance Low-dose Health Risk Assessment written by and published by . This book was released on 2020 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "This Report extends the concepts and approaches discussed in NCRP Report No. 171 and Commentary No. 24 to further reduce uncertainty in radiation risk assessments at low doses and low dose rates, thereby enhancing the bases for radiation protection guidance"--
Book Synopsis Management of Project Risks in Decommissioning by : International Atomic Energy Agency
Download or read book Management of Project Risks in Decommissioning written by International Atomic Energy Agency and published by . This book was released on 2019-07-02 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: This safety report publication provides specific guidance on the management of project risks in decommissioning. The publication proposes a systematic and pro-active approach on how to identify, analyse, evaluate, and treat relevant project risks at strategic and operational levels, and provides examples of application of the proposed approach
Book Synopsis Occupational Health and Safety in the Care and Use of Nonhuman Primates by : National Research Council
Download or read book Occupational Health and Safety in the Care and Use of Nonhuman Primates written by National Research Council and published by National Academies Press. This book was released on 2003-06-13 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.
Book Synopsis Integrated Safety Management Process by : Geni Bahar
Download or read book Integrated Safety Management Process written by Geni Bahar and published by Transportation Research Board. This book was released on 2003 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rising awareness of and increased attention to sexual harassment has resulted in momentum to implement sexual harassment prevention efforts in higher education institutions. Work on preventing sexual harassment is an area that has recently garnered a lot of attention, especially around education and programs that go beyond the standard anti-sexual harassment trainings often used to comply with legal requirements. On April 20-21, 2021, the National Academies of Sciences, Engineering, and Medicine hosted the workshop Developing Evaluation Metrics for Sexual Harassment Prevention Efforts. The workshop explored approaches and strategies for evaluating and measuring the effectiveness of sexual harassment interventions being implemented at higher education institutions and research and training sites, in order to assist institutions in transforming promising ideas into evidence-based best practices. Workshop participants also addressed methods, metrics, and measures that could be used to evaluate sexual harassment prevention efforts that lead to change in the organizational climate and culture and/or a change in behavior among community members. This publication summarizes the presentations and discussion of the workshop.
Book Synopsis Format and Content of the Safety Analysis Report for Nuclear Power Plants by : International Atomic Energy Agency
Download or read book Format and Content of the Safety Analysis Report for Nuclear Power Plants written by International Atomic Energy Agency and published by IAEA. This book was released on 2004 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Safety Guide is intended primarily for use with land based stationary thermal nuclear power plants but it may, in parts, have a wider applicability to other nuclear facilities. It provides recommendations and guidance on the possible format and content of a SAR in support of a request to the State regulatory body for authorization to construct and or operate a nuclear power plant. As such, it contains recommendations on meeting the requirements of Safety guide GS-R-1 "Legal and governmental infrastructure for nuclear, radioactive waste and transport safety" (2000, ISBN 9201008007)
Book Synopsis Performing Safety Culture Self-Assessments by : International Atomic Energy Agency
Download or read book Performing Safety Culture Self-Assessments written by International Atomic Energy Agency and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication provides practical guidance on how to conduct a safety culture self assessment. The focus is on using such assessments as a learning opportunity for organizational growth and development rather than as a fault finding or find and fix exercise. The approach involves considerable engagement with all levels of the organization. Methods applied include document reviews questionnaires interviews observations and focus groups. Besides the complexity and subtleties of safety culture it also describes how to avoid common pitfalls in analyzing results. The information presented in this publication will be of interest to individuals engaged in assessing and improving safety culture.
Book Synopsis Probabilistic Safety Assessment for Seismic Events by : International Atomic Energy Agency
Download or read book Probabilistic Safety Assessment for Seismic Events written by International Atomic Energy Agency and published by . This book was released on 2021-02-28 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Probabilistic safety assessment (PSA) is considered to be an important tool for assessing the safety of nuclear installations (typically used for safety assessment of nuclear power plants) in relation to potential initiating events that can be caused by random component failure and human error, as well as internal and external hazards. The purpose of seismic PSAs performed on nuclear installations is to provide risk insights related to their seismic robustness. The methodology for seismic safety evaluations includes a combination of deterministic and probabilistic approaches. Their applications typically address the impact of beyond design basis seismic events. This publication provides a detailed methodology for seismic PSA in line with the current international practices for seismic safety assessment of nuclear installations. Taking into account recommendations provided in IAEA safety standards and information reflected in internationally recognized technical standards, it reflects the current state of practice in the area of seismic PSA.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309471699 Total Pages :207 pages Book Rating :4.3/5 (94 download)
Book Synopsis Review of the Draft Fourth National Climate Assessment by : National Academies of Sciences, Engineering, and Medicine
Download or read book Review of the Draft Fourth National Climate Assessment written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-06-18 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: Climate change poses many challenges that affect society and the natural world. With these challenges, however, come opportunities to respond. By taking steps to adapt to and mitigate climate change, the risks to society and the impacts of continued climate change can be lessened. The National Climate Assessment, coordinated by the U.S. Global Change Research Program, is a mandated report intended to inform response decisions. Required to be developed every four years, these reports provide the most comprehensive and up-to-date evaluation of climate change impacts available for the United States, making them a unique and important climate change document. The draft Fourth National Climate Assessment (NCA4) report reviewed here addresses a wide range of topics of high importance to the United States and society more broadly, extending from human health and community well-being, to the built environment, to businesses and economies, to ecosystems and natural resources. This report evaluates the draft NCA4 to determine if it meets the requirements of the federal mandate, whether it provides accurate information grounded in the scientific literature, and whether it effectively communicates climate science, impacts, and responses for general audiences including the public, decision makers, and other stakeholders.
Book Synopsis Countering Cyber Sabotage by : Andrew A. Bochman
Download or read book Countering Cyber Sabotage written by Andrew A. Bochman and published by CRC Press. This book was released on 2021-01-20 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Countering Cyber Sabotage: Introducing Consequence-Driven, Cyber-Informed Engineering (CCE) introduces a new methodology to help critical infrastructure owners, operators and their security practitioners make demonstrable improvements in securing their most important functions and processes. Current best practice approaches to cyber defense struggle to stop targeted attackers from creating potentially catastrophic results. From a national security perspective, it is not just the damage to the military, the economy, or essential critical infrastructure companies that is a concern. It is the cumulative, downstream effects from potential regional blackouts, military mission kills, transportation stoppages, water delivery or treatment issues, and so on. CCE is a validation that engineering first principles can be applied to the most important cybersecurity challenges and in so doing, protect organizations in ways current approaches do not. The most pressing threat is cyber-enabled sabotage, and CCE begins with the assumption that well-resourced, adaptive adversaries are already in and have been for some time, undetected and perhaps undetectable. Chapter 1 recaps the current and near-future states of digital technologies in critical infrastructure and the implications of our near-total dependence on them. Chapters 2 and 3 describe the origins of the methodology and set the stage for the more in-depth examination that follows. Chapter 4 describes how to prepare for an engagement, and chapters 5-8 address each of the four phases. The CCE phase chapters take the reader on a more granular walkthrough of the methodology with examples from the field, phase objectives, and the steps to take in each phase. Concluding chapter 9 covers training options and looks towards a future where these concepts are scaled more broadly.
Book Synopsis Aircraft System Safety by : Duane Kritzinger
Download or read book Aircraft System Safety written by Duane Kritzinger and published by Woodhead Publishing. This book was released on 2016-09-12 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aircraft System Safety: Assessments for Initial Airworthiness Certification presents a practical guide for the novice safety practitioner in the more specific area of assessing aircraft system failures to show compliance to regulations such as FAR25.1302 and 1309. A case study and safety strategy beginning in chapter two shows the reader how to bring safety assessment together in a logical and efficient manner. Written to supplement (not replace) the content of the advisory material to these regulations (e.g. AMC25.1309) as well as the main supporting reference standards (e.g. SAE ARP 4761, RTCA/DO-178, RTCA/DO-154), this book strives to amalgamate all these different documents into a consolidated strategy with simple process maps to aid in their understanding and optimise their efficient use. - Covers the effect of design, manufacturing, and maintenance errors and the effects of common component errors - Evaluates the malfunctioning of multiple aircraft components and the interaction which various aircraft systems have on the ability of the aircraft to continue safe flight and landing - Presents and defines a case study (an aircraft modification program) and a safety strategy in the second chapter, after which each of the following chapters will explore the theory of the technique required and then apply the theory to the case study
Book Synopsis Aircraft System Safety by : Duane Kritzinger
Download or read book Aircraft System Safety written by Duane Kritzinger and published by Woodhead Publishing. This book was released on 2006-06-30 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Demonstrating safety for the application of ever more complex technologies is a formidable task. System engineers often do not have the appropriate training, are unfamiliar with the range of safety approaches, tools and techniques, and their managers do not know when and how these may be applied and appropriately resourced. Aircraft system safety provides a basic skill set for designers, safety practitioners, and their managers by exploring the relationship between safety, legal liability and regulatory requirements. Different approaches to measuring safety are discussed, along with the appropriate safety criteria used in judging acceptability.A wealth of ideas, examples, concepts, tools and approaches from diverse sources and industries is used in Aircraft system safety to bring the theory of safety concisely together in a practical and comprehensive reference. Engineering students, designers, safety assessors (and their managers), regulatory authorities (especially military), customers and projects teams should find Aircraft system safety provides an invaluable guide in appreciating the context, value and limitations of the various safety approaches used in cost-effectively accomplishing safety objectives. - Explores the practical aspects of safety - Invaluable guide for students, designers, and safety assessors - Written by a leading expert in the field
Book Synopsis Science and Decisions by : National Research Council
Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Book Synopsis Annual Report by : U.S. Nuclear Regulatory Commission
Download or read book Annual Report written by U.S. Nuclear Regulatory Commission and published by . This book was released on 1983 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Monthly Catalogue, United States Public Documents by :
Download or read book Monthly Catalogue, United States Public Documents written by and published by . This book was released on 1994 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Review of the Department of Homeland Security's Approach to Risk Analysis by : National Research Council
Download or read book Review of the Department of Homeland Security's Approach to Risk Analysis written by National Research Council and published by National Academies Press. This book was released on 2010-09-10 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: The events of September 11, 2001 changed perceptions, rearranged national priorities, and produced significant new government entities, including the U.S. Department of Homeland Security (DHS) created in 2003. While the principal mission of DHS is to lead efforts to secure the nation against those forces that wish to do harm, the department also has responsibilities in regard to preparation for and response to other hazards and disasters, such as floods, earthquakes, and other "natural" disasters. Whether in the context of preparedness, response or recovery from terrorism, illegal entry to the country, or natural disasters, DHS is committed to processes and methods that feature risk assessment as a critical component for making better-informed decisions. Review of the Department of Homeland Security's Approach to Risk Analysis explores how DHS is building its capabilities in risk analysis to inform decision making. The department uses risk analysis to inform decisions ranging from high-level policy choices to fine-scale protocols that guide the minute-by-minute actions of DHS employees. Although DHS is responsible for mitigating a range of threats, natural disasters, and pandemics, its risk analysis efforts are weighted heavily toward terrorism. In addition to assessing the capability of DHS risk analysis methods to support decision-making, the book evaluates the quality of the current approach to estimating risk and discusses how to improve current risk analysis procedures. Review of the Department of Homeland Security's Approach to Risk Analysis recommends that DHS continue to build its integrated risk management framework. It also suggests that the department improve the way models are developed and used and follow time-tested scientific practices, among other recommendations.
