Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Download or read book Medical Equipment Safety written by Joint Commission on Accreditation of Healthcare Organizations and published by . This book was released on 1993-06 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices written by Bertil Jacobson and published by Elsevier Health Sciences. This book was released on 2007-02-23 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patient safety is important to all health professionals, but fatal accidents occur with medical devices every year. This is the first book for people who use medical equipment, rather than for engineers or technicians. It will help personnel within healthcare to avoid accidents by bridging the gap between the design principles and the user. The book encourages safe use of a wide range of equipment, from simple thermometers and blood-pressure cuffs to complex equipment such as pacemakers, ventilators and patient monitors. Simple explanations of basic medical devices Case histories of real-life accidents to highlight risk areas Clear, attractive illustrations "Tips" boxes identify particular problems "Basic Facts" boxes supply fundamental information needed by all readers "Technology" boxes provide more-advanced explanations for interested or experienced readers

Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Download or read book Essential Standards for Biomedical Equipment Safety and Performance written by Association for the Advancement of Medical Instrumentation and published by Association for the Advancement of Medical Instrumentation (AAMI). This book was released on 1988 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Technological Innovation written by Annetine C. Gelijns and published by National Academies. This book was released on 1989 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 2011-10-25 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.

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 396 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.

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Download or read book Medical Equipment Maintenance written by Binseng Wang and published by Morgan & Claypool Publishers. This book was released on 2012 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance.