The 17 inspected hospitals all dealt with cases of patients acquiring uterine cancer from the use of morcellators or infections linked to contaminated duodenoscopes, said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, who authored the post. However, they did not appear to report the adverse events to the FDA.
In some cases, the hospitals lacked adequate procedures for reporting the events or failed to properly educate staff members on the FDA’s medical device reporting requirements.
“Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” wrote Dr. Shuren. “We want to work with all hospitals to address these issues.”
The FDA will hold a public workshop on Dec. 5 for input from hospital stakeholders regarding hospitals’ role in monitoring the safety and efficacy of medical devices, according to the report.
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