FDA 483 - University Of Rochester Medical Center - January 29, 2016

On January 29, 2016, the FDA issued a Form 483 to Dr. Robert J. Panser, Chief Quality Officer of the University of Rochester Medical Center, a hospital located at 601 Elmwood Ave, Box 608, Rochester, NY 14642-0001. The inspection, conducted from January 26-29, 2016, identified one observation.

The observation noted that the written Medical Device Reporting (MDR) procedure lacked documentation and recordkeeping requirements to ensure access to information for timely follow-up and FDA inspection. Specifically, the MDR procedures for collecting information to determine reportable events, which included an internal incident reporting and risk management application system, along with concurrent and retrospective reviews, were found to be incomplete. Examples provided included a lack of contact with Clinical Engineering for event numbers (b)(6) and (b)(6), a user error for event number (b)(6) on 5/16/15 still listed as an equipment error, event #(b)(6) on 3/6/11 involving an ankle tag, and event (b)(6) where necessary review equipment had not been sequestered. Additionally, MDR reportable event files were listed under the New York State Department of Health (NYPORTS) detail code 938 with occurrence ID numbers (b)(6) and (b)(6).