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Preventing Medical Device Recalls

Author: Dev Raheja
Publisher: CRC Press
ISBN: 1466568232
Size: 13.36 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 Devices Fda Should Enhance Its Oversight Of Recalls

Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988067
Size: 24.72 MB
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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 Device Regulations

Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Size: 62.83 MB
Format: PDF
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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 Devices Fda Faces Challenges In Conducting Inspections Of Foreign Manufacturing Establishments

Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437905277
Size: 72.19 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.

The Danger Within Us

Author: Jeanne Lenzer
Publisher: Little, Brown
ISBN: 9780316343763
Size: 20.27 MB
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A shocking exposé of the dangerously under-regulated medical device industry, revealing the corruption, greed, and deceit that has helped make medical interventions a leading cause of death in America. Medical interventions have become the third leading cause of death in America, killing more Americans each year than diabetes, murders, car accidents and AIDS combined. In THE DANGER WITHIN US, award-winning journalist Jeanne Lenzer brings this horrifying statistic 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 meticulously researched and propulsive read that will fill you with anger and indignation, a stirring call for reform, and a must-read for anyone who cares about the future of American healthcare.

Validation Compliance Annual

Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824794590
Size: 22.58 MB
Format: PDF, ePub
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"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Biofilm Eradication And Prevention

Author: Tamilvanan Shunmugaperumal
Publisher: John Wiley & Sons
ISBN: 9781118043554
Size: 55.47 MB
Format: PDF, ePub
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Biofilm Eradication and Preventions presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem. Split into three parts, the first deals with the development and characterization of biofilm on the surfaces of implanted or inserted medical devices. Questions as to why biofilms form over medical device surfaces and what triggers biofilm formation are addressed. In the second section, the author discusses biofilm-mediated chronic infections occurred in various organs (eyes, mouth, wounds) and pharmaceutical and drug delivery knowledge gained from research in these area. The third part explores pharmaceutical approaches like lipid-and polymer-based drug delivery carriers for eradicating biofilm on device-related infections. In addition, this section also explores the topic of novel small molecule (like iron and its complexes/metal chelators) and a quorum-sensing inhibitors to control medical biofilm formation.