FDA 483 - Indiana University Hospital - February 03, 2016

This FDA Form 483 details observations from an inspection, citing deficiencies in the facility's Medical Device Reporting (MDR) procedures and record-keeping. The written MDR procedure lacks an internal system for timely identification, communication, and evaluation of reportable events. Specifically, policies #EC 4.04, #ADM 1.51, and #RM 1.01 are inadequate.

Two adverse events involving a redacted infection, potentially contributing to patient deaths, were not reported to the FDA and device manufacturer via MedWatch 3500A within ten working days. Additionally, twelve incidents between 1/1/2014 and 12/15/2015, classified as Category E (temporary patient harm requiring intervention) by the NCC MERP Index, were not documented as reported to device manufacturers.

The procedures also lack provisions for mandatory MedWatch 3500A reporting to the FDA or manufacturers, with personnel stating a policy of voluntary reporting via the MedWatch portal, but without objective evidence. Furthermore, required information (patient, event, device, reporter, user facility) is not consistently included in reports.

Finally, MDR event files have not been established or maintained to include reasonably known information regarding potentially reportable events, information utilized in evaluations, or decisions on reportability to the FDA or manufacturers via MedWatch Form 3500A.