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Preventing Medical Device Recalls

Author: Dev Raheja
Publisher: CRC Press
ISBN: 1466568232
Size: 18.82 MB
Format: PDF, Kindle
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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.

Device Therapy In Heart Failure

Author: William H. Maisel
Publisher: Springer Science & Business Media
ISBN: 9781597454247
Size: 66.84 MB
Format: PDF, ePub, Docs
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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.

Medical Device Reliability And Associated Areas

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420042238
Size: 12.53 MB
Format: PDF, ePub, 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: 66.75 MB
Format: PDF, ePub, Mobi
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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: 74.17 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.

Validation Compliance Annual

Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824794590
Size: 66.95 MB
Format: PDF
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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."