Human Factors Informed Failure Mode and Effects Analysis Andrea Cassano-Piché, et. al

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HumanEra @ UHN & IFMBE Clinical Engineering Division.
Failure Mode and Effects Analysis (FMEA) is an engineering method for proactively assessing vulnerabilities in a system before the risks cause harm. It was first used in the late 1940’s by the US Armed Forces to analyze various flight control systems (Amzen, 1996), as pilot error was leading to crashes and deaths. Since, FMEA has been adapted and used in several industries including military, aerospace, automotive, plastics, food service, and more recently, in healthcare. FMEA has been promoted by several national healthcare quality and safety organizations in Canada and the United States including: the Veterans Health Administration [37], the Institute for Safe Medication Practices [38], the Institute for Safe Medication Practices Canada [39], and the Institute for Healthcare Improvement [40]. Carrying out an FMEA is a means for hospitals to satisfy accreditation standards in the US and Canada including The Joint Commission’s patient safety standard LD.5.2 in the Leadership chapter of the Hospital Accreditation Manual [41] and Accreditation Canada’s Required Operating Practice that hospitals conduct at least one proactive risk assessment of a high-risk process each year.