The General Hospital Corporation – FDA 483, Dec 18, 2015

The General Hospital Corporation received an FDA Form 483 following an inspection by the Food and Drug Administration conducted from December 15-18, 2015. This document detailed four significant observations concerning the facility's adherence to medical device reporting (MDR) regulations, as mandated by the Federal Food, Drug and Cosmetic Act. Primary violations included the lack of comprehensively developed, maintained, and implemented written MDR procedures. Existing policies were found deficient in specifying timeframes for reporting medical device incidents to manufacturers or the FDA, and did not adequately outline complete documentation and record-keeping requirements for these reports. Additionally, the hospital failed to submit required FDA Form 3500A reports within ten working days when a device was reasonably suspected of causing or contributing to a patient's death. One critical instance involved an 18-month delay in reporting a patient death. Similar non-compliance was identified for serious injury reports where the device manufacturer remained unknown. The inspection also highlighted that MDR event files were incomplete. They notably lacked adverse event information such as evaluations from departments like Biomedical Engineering, detailed root cause analyses, and documented deliberations regarding an event's reportability. While observations two and three were reportedly corrected during the inspection, the facility committed to addressing observations one and four. This FDA 483 underscores the necessity for user facilities to maintain robust internal quality system controls and ensure timely, thorough adverse event reporting.