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Preventing Medical Device Recalls

Author: Dev Raheja
Publisher: CRC Press
ISBN: 1466568232
Size: 30.83 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: 49.42 MB
Format: PDF, ePub
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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.

Device Therapy In Heart Failure

Author: William H. Maisel
Publisher: Springer Science & Business Media
ISBN: 9781597454247
Size: 13.87 MB
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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.

Design For Safety

Author: Louis J. Gullo
Publisher: John Wiley & Sons
ISBN: 111897431X
Size: 21.18 MB
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A one-stop reference guide to design for safety principles and applications Design for Safety (DfSa) provides design engineers and engineering managers with a range of tools and techniques for incorporating safety into the design process for complex systems. It explains how to design for maximum safe conditions and minimum risk of accidents. The book covers safety design practices, which will result in improved safety, fewer accidents, and substantial savings in life cycle costs for producers and users. Readers who apply DfSa principles can expect to have a dramatic improvement in the ability to compete in global markets. They will also find a wealth of design practices not covered in typical engineering books—allowing them to think outside the box when developing safety requirements. Design Safety is already a high demand field due to its importance to system design and will be even more vital for engineers in multiple design disciplines as more systems become increasingly complex and liabilities increase. Therefore, risk mitigation methods to design systems with safety features are becoming more important. Designing systems for safety has been a high priority for many safety-critical systems—especially in the aerospace and military industries. However, with the expansion of technological innovations into other market places, industries that had not previously considered safety design requirements are now using the technology in applications. Design for Safety: Covers trending topics and the latest technologies Provides ten paradigms for managing and designing systems for safety and uses them as guiding themes throughout the book Logically defines the parameters and concepts, sets the safety program and requirements, covers basic methodologies, investigates lessons from history, and addresses specialty topics within the topic of Design for Safety (DfSa) Supplements other books in the series on Quality and Reliability Engineering Design for Safety is an ideal book for new and experienced engineers and managers who are involved with design, testing, and maintenance of safety critical applications. It is also helpful for advanced undergraduate and postgraduate students in engineering. Design for Safety is the second in a series of “Design for” books. Design for Reliability was the first in the series with more planned for the future.

Medical Device Reliability And Associated Areas

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420042238
Size: 33.76 MB
Format: PDF, Mobi
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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 Fda Should Enhance Its Oversight Of Recalls

Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988067
Size: 43.37 MB
Format: PDF, ePub
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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.

Medical Devices Fda Faces Challenges In Conducting Inspections Of Foreign Manufacturing Establishments

Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437905277
Size: 74.32 MB
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As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.

Medical Device Technologies

Author: Gail D. Baura
Publisher: Academic Press
ISBN: 012374976X
Size: 63.84 MB
Format: PDF
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The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). Key Features: The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts