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Medical Device Accidents
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Book Synopsis Medical Device Accidents by : Leslie A. Geddes
Download or read book Medical Device Accidents written by Leslie A. Geddes and published by Springer. This book was released on 1998-08 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication explores accidents that occur through the use of medical devices, providing critical information for attorneys, expert witnesses, clinical engineers, nurses, physicians, manufacturers, and designers of new medical devices. Each chapter follows the same format: a presentation of basic principles of a device or procedure, followed by accidents that take place through misuse or malfunction. Case studies and examples throughout the text illustrate and enliven the distinctive purpose of this singular resource.
Book Synopsis Medical Devices by : Bertil Jacobson
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
Book Synopsis Systems Theoretic Accident Model and Process Application by : Tieyu Li
Download or read book Systems Theoretic Accident Model and Process Application written by Tieyu Li and published by . This book was released on 2013 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, most manufacturers did not always attain this goal. It is a challenge to balance the demands of meeting government regulations and containing production costs, in an effort to produce the most effective, reliable and safest medical devices. The increasing complexity on product structures, production process and usage context make this task even more formidable. The increase in serious adverse events has outpaced industry growth by 8 % since 2001[1], which reflects the insufficiency of traditional quality control measures. The disastrous consequences of quality hazards usually have profound impact on customers, manufacturers, and communities. Therefore, it is imperative to look for a better way to achieve effective quality control in medical device industry. The purpose of the thesis is to compare the traditional quality control measures, which are now widely adopted in quality systems of medical device industry for designing and development, process control and non-conformance handling, with the approach of Systems Theoretic Accident Model and Process (STAMP) based System-Theoretic Process Analysis (STPA) method. Through the case study on real quality issue in manufacturing control, this work analyzes the current states of complex manufacturing process controls that are designed by utilizing traditional principles and tools, and demonstrates the improvement after the STPA techniques was applied to the same cases. The advantages of STPA technique is to model the process to system control structure without oversimplifying any possible influencing factors, and then examine the links an interaction among these factors to reveal what constraints need to be installed and are followed to ensure that the system performs in safe zone and deliver the expected outcomes. This approach can effectively reveal hidden defects and dangers in system that the traditional measures are not able to detect, and thus is very helpful to the high-stake industry such as medical device manufacturing to prevent potential serious adverse events and protect patients from injuries caused by accidents of quality hazards.
Book Synopsis New Medical Devices by : Institute of Medicine
Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Book Synopsis Patient Safety and Quality by : Ronda Hughes
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/
Book Synopsis Medical Device Safety by : G.R Higson
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
Book Synopsis Improving Patient Care by Reporting Problems with Medical Devices by :
Download or read book Improving Patient Care by Reporting Problems with Medical Devices written by and published by . This book was released on 1997 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
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 2011-06-10 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Book Synopsis Medical Device Recalls by : United States. General Accounting Office
Download or read book Medical Device Recalls written by United States. General Accounting Office and published by . This book was released on 1989 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis To Err Is Human by : Institute of Medicine
Download or read book To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
Book Synopsis Medical Management of Radiation Accidents by : Kenneth S. Cohen
Download or read book Medical Management of Radiation Accidents written by Kenneth S. Cohen and published by CRC Press. This book was released on 2001-03-28 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although radiation accidents are rare and often complex in nature, they are of great concern not only to the patient and involved medical staff, but to the media and public as well. Yet there are few if any comprehensive publications on the medical management of radiation accidents. Medical Management of Radiation Accidents provides a complete refe
Book Synopsis Medical Device Regulations by : Michael Cheng
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.
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 Medical Device Reliability and Associated Areas by : B.S. Dhillon
Download or read book Medical Device Reliability and Associated Areas written by B.S. Dhillon and published by CRC Press. This book was released on 2000-03-29 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing,
Book Synopsis Culture at Work in Aviation and Medicine by : Robert L. Helmreich
Download or read book Culture at Work in Aviation and Medicine written by Robert L. Helmreich and published by Routledge. This book was released on 2018-12-12 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1998, culture forms a complex framework of national, organizational, and professional attitudes and values within which groups and individuals function. The reality and strength of culture become salient when we work within a new group and interact with people who have well established norms and values. In this book the authors report the results of their ongoing exploration of the influences of culture in two professions, aviation and medicine. Their focus is on commercial airline pilots and operating room teams. Within these two environments they show the effect of professional, national and organizational cultures of individual attitudes and values and team interaction.
Book Synopsis Safe Medical Device Interaction Rules by : Yun Young Lee
Download or read book Safe Medical Device Interaction Rules written by Yun Young Lee and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The advent of computerized medical devices has resulted in better accuracy and increased safety for patients and clinicians, yet medical accidents are still not uncommon. With the computerized medical devices and their technical complexity, any given clinical environment is a composition of complex com- puter systems. This introduces new form of risks, not only with the usage of a single device but with the interactions of multiple devices, which increase exponentially with respect to the number of devices. Even the most advanced medical devices fail to serve their purpose if their users cannot effectively use them, or if their complexity deters the users. This thesis presents an English-like configuration language for defining device interactions rules, which makes it easier for non-programmers like clinicians and surgeons to configure a complex medical system. The user- defined rules are then automatically and formally proven for its safety, by means of a state machine and the reachability of safe states within it. The automatic checker ensures that there is no error-by-omissions and conflicts between the rules.
