According to the National Patient Safety Foundation, about 440,000 deaths from hospital mistakes are expected in 2018. These mistakes are preventable, but the number of deaths has been increasing for the last two decades instead of decreasing. This book describes how to prevent deaths at very low cost and get very high return on investment (ROI). The unique feature of this book is that it teaches the tools of innovation that anyone can master. It teaches healthcare staff how to manage innovation efficiently and quickly, because each patient life is critical. This second edition points out why the present methods are ineffective and shows how to find elegant solutions that are simple, comprehensive, and produce high return on investments. The second edition contains all updated material with the addition of a new chapter on systems engineering for robust improvements, a practice that has been applied in most high-risk industries, such as aerospace, defense, and NASA, for years. It aims at redesigning systems to make sure right things, right coordination and right integration happens in healthcare systems.
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.
The Second Edition features new content, examples,methods, techniques, and best practices Assurance Technologies Principles and Practices is based on the assertion that safety is not a cost, but an excellent investment. According to the authors, more than sixty percent of problems in complex systems arise from incomplete, vague, and poorly written specifications. In keeping with the authors' passion for safety, the text is dedicated to uniting the gamut of disciplines that are essential for effective design applying assurance technology principles, including system safety, reliability, maintainability, human engineering, quality, logistics, software integrity, and system integration. Readers familiar with the first edition of this text will recognize all the hallmarks that have made it a classic in its field. The Second Edition features a host of new examples, methods, techniques, and best practices to bring the text fully up to date with the state of the art in assurance technology. Much new content has been added as well, including four new chapters: Managing Safety-Related Risks Statistical Concepts, Loss Analysis, and Safety-Related Applications Models, Concepts, and Examples: Applying Scenario-Driven Hazard Analysis Automation, Computer, and Software Complexities The text begins with an introduction and overview of assurance technology. Next, readers are provided with fundamental statistical concepts. The chapters that follow explore in depth the approaches and disciplines that make up assurance technology applications. Each chapter is organized into major phases-design, manufacturing, test, and use phase-that help readers understand both how and when to apply particular measures. Throughout the text, readers discover detailed examples that prepare them to manage real-world challenges. References and further reading are provided at the end of each chapter leading to more in-depth discussion on specialized topics. With its extensive use of examples and highly structured approach, this is an excellent course book for students in industrial engineering, systems engineering, risk engineering, and other assurance technology domains. Design and system engineers as well as safety professionals will find the material essential in troubleshooting complex projects and ensuring product, process, and system safety.
Sujata Dev, an entrepreneur with a background in Mathematics, Statistics and Economics, and over 20 years’ experience in the Media and Entertainment industry, started the first IPTV venture in India. A speaker at several seminars and forums on M&E, Telecom and Economics worldwide, her research and white papers on the convergence of Telecom and Entertainment have been widely appreciated across Asia, Europe and USA. In 2009, she represented India at Asia Women’s Business and Economic Conference, Tokyo. A recipient of the Global Indian Achiever’s Award, in 2011, she is also Managing Director, Third Generation Mobile Pvt. Ltd., Co-chairperson, National Committee of M&E, ASSOCHAM, Founder Member & Senior Vice President, Indian Broadband Forum, member of Executive Council, International Chamber of Commerce (ICC) & Society Member of the Governing body, IIM, Shillong. Passionate about music—Indian and Western—Sujata has been a fan of Mohammed Rafi since her childhood. This book is her tribute to the legendary playback singer whose songs have marked our growing-up years. Talking Points Authorized biography of legendary singer Mohammed Rafi Foreword by Dilip Kumar Rare insight into the subject’s life and his music Several contemporaries speak on the legend Photographs from the subject’s personal archives Free documentary film with close to 50 people including composers, lyricist, actors, singers and contemporaries speaking on Rafi Worldwide readership/market Cinema buffs, music lovers and teachers, composers, singers, music conductors, lyricists, film historians, students, special-edition collectors, libraries, museums, cultural and educational institutions, general-trade readers.
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.
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