Preventing Medical Device Recalls

Based on the author's extensive experience in the medical device, aerospace, and manufacturing engineering industries, this book 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.

Dev Raheja, MS, CSP, has been an international risk management and quality assurance consultant in the healthcare, medical device, and aerospace industries for more than 25 years. He applies evidence-based safety techniques from a variety of industries to healthcare. He is a trainer, and author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to create elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, the United Kingdom, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major company in the Midwestern United States avoid going out of business and become a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance and manager of manufacturing, and at Booz-Allen & Hamilton as a risk management consultant for the nuclear and mass transportation industry. Raheja served as adjunct professor at the University of Maryland for five years in its PhD program in reliability engineering, and is currently an adjunct professor at Florida Tech for its BBA degree in healthcare management. He is associate editor for healthcare safety for the Journal of System Safety, and teaches webinars on medical device safety and reliability. He has received several industry awards including the Scientific Achievement Award and Educator-of-the-Year Award from the System Safety Society and the Austin Bonis Reliability Education Award from the American Society for Quality. He served as part of the first group of examiners for the Malcolm Baldrige National Quality Award, and served for 15 years on the board of directors of the Annual Reliability and Maintainability Conference sponsored by ten engineering societies. Currently he is a member of the Institute of Electrical and Electronics Engineers (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), the American Society of Patient Safety Professionals, and the American College of Healthcare Executives. Raheja majored in human factors engineering as a part of his master's degree in industrial engineering, is a Certified Safety Professional through the Board of Certified Safety Professionals, and serves as the chairman of the Design for Reliability Committee of the IEEE.

Overview of Medical Device Requirements. Preventing Recalls during Specification Writing. Risk Assessment and Management. Preventing Recalls during Design and Development. Preventing Recalls during Production. Preventing Software Design Recalls. Preventing Supplier Quality Defects. Preventing Recalls during Verification and Validation. Validation Testing to Discover Design and Manufacturing Errors. Preventing Recalls during Field Monitoring. Planning for Potential Recalls to Maximize Efficiency in the Event of a Recall. Role of Management in Preventing Recalls. Appendix.