October 31, 2016

FDA: Hospitals are under-reporting adverse events linked to medical devices

Daily Briefing

FDA on Monday said inspections at 17 hospitals revealed widespread under-reporting of injuries and deaths linked to medical devices.

As a result of the findings, FDA is seeking to increase hospitals' reporting of such events.

Investigation findings

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, detailed the investigation's findings in a blog post.

Why most hospitals aren't using unique device identifiers to their full advantage

FDA launched the investigation in December 2015 and reviewed 17 hospitals where there had been reports of infections associated with duodenoscopes or uterine cancer linked to the use of morcellators.

According to Shuren, the investigation found many adverse events linked to medical devices that the hospitals should have reported to FDA but did not, which violated federal law that "requires hospitals and other user facilities to report when they become aware of information reasonably suggesting that a medical device has or may have caused or contributed to a death or serious injury to a patient." Shuren wrote that hospital staff members often did not know of FDA's medical device reporting requirements or were not trained on how to comply with the requirements.

FDA believes hospitals throughout the United States are under-reporting such events, according to Shuren. He wrote, "We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers."

FDA seeks to bolster hospital reporting

Shuren wrote that FDA "will work with the hospital community on what role they should play in assuring the safe use of medical devices." He added, "This work will include how [hospitals] can effectively participate in  the National Evaluation System for Health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers."

In addition, FDA will hold a workshop on Dec. 5 to gather input on how to improve hospital-based surveillance systems and how hospitals can improve medical device evaluations in clinical settings. FDA will hold the workshop in collaboration with the Association of American Medical Colleges and the American Hospital Association (Clarke, Reuters, 10/24; Shuren, FDA blog post, 10/24; Jones Sanborn, Healthcare Finance News, 10/26; Budryk, FierceHealthcare, 10/25; Bean, Becker's Infection Control & Clinical Quality, 10/25). 

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