The tao of managing recalls and safety alerts

Clinical engineering staff deal with a variety of risk management issues on a daily basis. These issues range from infection control, standards compliance, recalls and safety alerts, patient safety, and incident investigations all the way up to disaster preparedness. Managing device recalls and safety alerts entails several functions, such as processing, risk assessment, distribution, rectification, tracking, and monitoring. This paper discusses the basic elements of an effective recalls and safety alerts management system, thus offering the way to an effective system. The system enabling inputs, activities, and desired outcomes are discussed. The paper also presents our experience in implementing such a system and future possibilities.