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Preventing Medical Device Recalls

Author: Dev Raheja
Publisher: CRC Press
ISBN: 1466568232
Size: 70.56 MB
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A critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won’t prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks. Based on the author’s extensive experience in the medical device, aerospace, and manufacturing engineering industries, Preventing Medical Device Recalls presents a detailed structure for systems thinking that can help to prevent costly device recalls. Based on Dr. W. Edwards Deming’s System of Profound Knowledge, this structure can help medical device designers and manufacturers exceed their customers’ expectations for quality and safety. This book is among the first to demonstrate how to control safety risks—from specifications all the way through to safely retiring products without harm to the environment. Supplying an accessible overview of medical device requirements and the science of safety, it explains why risk analysis must start with product specification and continue throughout the product life cycle. Covering paradigms for proactive thinking and doing, the text details methods that readers can implement during the specification writing, product design, and product development phases to prevent recalls. It also includes numerous examples from the author’s experience in the medical device, consumer, and aerospace industries. Even in healthcare, where compliance with standards is at its highest level, more patients die from medical mistakes each week than would be involved in a jumbo jet crash. With coverage that includes risk assessment and risk management, this book provides you with an understanding of how mishaps happen so you can account for unexpected events and design devices that are free of costly recalls.

Medical Device Regulations

Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Size: 27.51 MB
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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.

Medical Device Regulatory Practices

Author: Val Theisz
Publisher: CRC Press
ISBN: 9814669113
Size: 69.43 MB
Format: PDF
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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Device Therapy In Heart Failure

Author: William H. Maisel
Publisher: Springer Science & Business Media
ISBN: 9781597454247
Size: 72.74 MB
Format: PDF
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Heart failure affects over 5 million patients in the United States alone, and is a chronic and debilitating disease. While a number of pharmacologic therapies have shown varying degrees of effectiveness, many recent advances in the treatment of heart failure has focused on device based therapies. In Device Therapy in Heart Failure, William H. Maisel and a panel of authorities on the use and implementation of device based therapies provide a comprehensive overview of the current and developing technologies that are used to treat heart failure. Individual chapters provide an in-depth analysis of devices such as CRT’s and ICD’s, while broader topics such as the pathophysiology of heart failure and its current medical therapies are also discussed. Additional topics include Pacing and Defibrillation for Atrial Arrhythmias, Atrial Fibrillation Ablation, and Percutaneous Treatment of Coronary Artery Disease.

The Danger Within Us

Author: Jeanne Lenzer
Publisher: Little, Brown
ISBN: 0316343781
Size: 13.82 MB
Format: PDF, ePub
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"Before you get anything implanted in your body, read this book." - Shannon Brownlee, author of Overtreated Did you know... - Medical interventions have become the third leading cause of death in America. - An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. - The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In THE DANGER WITHIN US, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, THE DANGER WITHIN US is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. span

Medical Device Reliability And Associated Areas

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420042238
Size: 68.89 MB
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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, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

Medical Devices

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Size: 23.89 MB
Format: PDF, ePub
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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

Medical Devices Fda Should Enhance Its Oversight Of Recalls

Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988067
Size: 57.70 MB
Format: PDF, Docs
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Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.

Smart Infusion Pumps Implementation Management And Drug Libraries

Author: Pamela K. Phelps
Publisher: ASHP
ISBN: 1585285153
Size: 51.21 MB
Format: PDF, Docs
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There are no two ways about it: smart infusion pumps have transformed the dosage delivery system by reducing errors and improving patient care. However, clinicians and nurses are crucial in making critical decisions, monitoring the systems, and managing drug libraries. It is vital that healthcare professionals have the most comprehensive expert guidance possible. ASHP's newly updated Smart Infusion Pumps: Implementation,Management, and Drug Libraries, Second Edition puts it all at your fingertips. Written by Pamela K. Phelps, with contributions from 14 other experts, it is the core handbook for selecting, implementing, and operating this essential medical technology, covering every aspect of infusion pump management, including guidance for their growing use in patient home care. Updated and expanded, with practice tips, charts, checklists, scenarios, and more, the second edition details procedures that ensure efficiency, effectiveness, and patient safety. Inside this edition you'll find: 8 updated and 5 new chapters Key Terms Practice Tips References An expanded drug library for general and pediatric use, and patient-controlled analgesia. As the essential guide for anybody who works with smart infusion pumps, you'll want to have one for each member of your team.