Human factors studies for reusable medical devices has evolved over the last few years, and again, most recently, after the release of the March 2015 FDA Guidance: “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff”.
FDA responded to recent outbreaks of hospital acquired infections, attributable to inadequate reprocessing of medical devices, with a safety alert and, shortly thereafter, followed with the release of the guidance. FDA expects more robust validation methodology incorporated into the device design, labeling, and reprocessing instructions for reusable medical devices.
Validation procedures should now include human factors studies as part of the pre-market assessment to ensure the instructions are easy for the user to understand and follow. An Institutional Review Board will need to be involved in order to ensure the safety and welfare of the study participants is considered. Study participants should be reflective of real-world end-users, and are typically required to sign an Informed Consent Form as in any clinical trial. The documentation of the reprocessing method validation, along with the reprocessing instructions, will be reviewed by the FDA to evaluate potential user risk for pre-market submissions.
Human factors and usability is a critical component in the validation of medical device reprocessing to ensure clinicians and consumers are safe and protected. Manufacturers are expected to incorporate the study summaries in their pre-market submissions to the FDA.
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