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METHODS

The standard HFMEA methodology from the Veterans Association National Center for Patient Safety was used and is briefly summarized here [3, 9]. Of note, the spreadsheets, scoring instructions, and algorithms used in our HFMEA are all publicly available on the internet [3]. First, the topic and processes to be examined were defined. A multidisciplinary team that included methodological advisors was then assembled. Next, the process of surgical instrument sterilization was described in a flow diagram. The diagram included the process of sterilization as well as the testing and inspection of the sterilization process and instruments. A hazard analysis then iterated potential “failure modes”(ie, ways that a process step can fail) for each step in the flow diagram, iterated causes for each failure mode that met preset criteria for the probability of the failure mode occurring and the severity of its consequences for …