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Medical Device Risk Management from a Human Factors Perspective

This paper describes the ways in which human factors methods can help to enhance the work of established clinical engineering teams by placing a new emphasis on error reduction and patient safety. This approach in many ways represents a natural evolution for departments that are looking to enhance their usefulness and relevance to healthcare. Several examples are given of points at which the introduction of human factors methods can reveal issues related to the safe use of medical devices that are not easily accessible by other means. Adoption and implementation of these methods offers the potential for clinical engineering departments to enhance their role of helping to ensure optimal patient safety.