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Managing The Risks From Medical Product Use
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Author :United States. Food and Drug Administration. Task Force on Risk Management Publisher : ISBN 13 : Total Pages :172 pages Book Rating :4.:/5 (319 download)
Book Synopsis Managing the Risks from Medical Product Use by : United States. Food and Drug Administration. Task Force on Risk Management
Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Book Synopsis Crossing the Quality Chasm by : Institute of Medicine
Download or read book Crossing the Quality Chasm written by Institute of Medicine and published by National Academies Press. This book was released on 2001-07-19 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Author :United States. Food and Drug Administration. Task Force on Risk Management Publisher : ISBN 13 : Total Pages :24 pages Book Rating :4.:/5 (319 download)
Book Synopsis Managing the Risks from Medical Product Use by : United States. Food and Drug Administration. Task Force on Risk Management
Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Drug Safety by : United States. General Accounting Office
Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Cybersecurity for Connected Medical Devices by : Arnab Ray
Download or read book Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 2021-11-09 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
Book Synopsis Five Steps to Risk Assessment by : HSE Books
Download or read book Five Steps to Risk Assessment written by HSE Books and published by . This book was released on 2006 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers guidance for employers and self employed people in assessing risks in the workplace. This book is suitable for firms in the commercial, service and light industrial sectors.
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 Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
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 Managing Suicidal Risk by : David A. Jobes
Download or read book Managing Suicidal Risk written by David A. Jobes and published by Guilford Publications. This book was released on 2016-06-20 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book has been replaced by Managing Suicidal Risk, Third Edition, ISBN 978-1-4625-5269-6.
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (31 download)
Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Safe Management of Wastes from Health-care Activities by : Yves Chartier
Download or read book Safe Management of Wastes from Health-care Activities written by Yves Chartier and published by World Health Organization. This book was released on 2014 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).
Book Synopsis Textbook of Patient Safety and Clinical Risk Management by : Liam Donaldson
Download or read book Textbook of Patient Safety and Clinical Risk Management written by Liam Donaldson and published by Springer Nature. This book was released on 2020-12-14 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WHO surgical checklist, to adopt the most appropriate measures for the prevention of assistance-related risks, and to identify the potential ones using tools such as reporting & learning systems. The culture of safety in the care environment and of human factors influencing it should be developed from the beginning of medical studies and in the first years of professional practice, in order to have the maximum impact on clinicians' and nurses' behavior. Medical errors tend to vary with the level of proficiency and experience, and this must be taken into account in adverse events prevention. Human factors assume a decisive importance in resilient organizations, and an understanding of risk control and containment is fundamental for all medical and surgical specialties. This open access book offers recommendations and examples of how to improve patient safety by changing practices, introducing organizational and technological innovations, and creating effective, patient-centered, timely, efficient, and equitable care systems, in order to spread the quality and patient safety culture among the new generation of healthcare professionals, and is intended for residents and young professionals in different clinical specialties.
Author :Centers for Disease Control and Prevention CDC Publisher :Oxford University Press ISBN 13 :0190628634 Total Pages :705 pages Book Rating :4.1/5 (96 download)
Book Synopsis CDC Yellow Book 2018: Health Information for International Travel by : Centers for Disease Control and Prevention CDC
Download or read book CDC Yellow Book 2018: Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Book Synopsis Risk Management in Blood Transfusion Medicine by : J. Mills Barbeau
Download or read book Risk Management in Blood Transfusion Medicine written by J. Mills Barbeau and published by Elsevier Health Sciences. This book was released on 2019-01-03 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a quick, expert overview of risk management in transfusion medicine from Dr. James Mills Barbeau. This practical resource presents a summary of today's state-of-the-art techniques for reducing harm during all phases of transfusion practice, including blood collection, testing, processing, clinical assessment, and transfusion. It's an easy-to-read, one-stop resource for managing and mitigating the various levels of risk in a variety of transfusion settings and scenarios. - Presents a well-rounded perspective on quality assurance, blood supply testing, clinical risk, ethical and legal considerations, and transfusion-transmitted infectious diseases. - Demonstrates how transfusion risk-management programs add value to health care institutions by enhancing a culture of safety, improving the institution's reputation, and improving the bottom line. - Consolidates today's available information on risk management in blood transfusion medicine into one convenient resource.
