Preventing Medical Device Recalls

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 experienc

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

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.