FDA Working to Enforce Medical Device Adverse Event Reporting in Hospitals

    View Authors November 2016

    On October 24, 2016, the US Food & Drug Administration (FDA) reported on its blog that it had issued Form 483s to 15 of 17 hospitals it inspected in December 2015. Form 483 is a report issued at the time of an FDA inspection that identifies observed deficiencies with respect to FDA regulations. The FDA selected the hospitals based on knowledge of high-profile safety issues occurring in hospitals and reports of medical device adverse events without corresponding reports from the selected hospitals. Based on the findings of the 17 inspections, the FDA decided it would work with the hospital community on the role hospitals should play in assuring ensuring the safe use of medical devices. On October 25, FDA announced it will hold a public workshop on the role of the hospital in reporting device-related adverse events in device surveillance.