FDA seeks to intervene in device harm reporting

In the wake of a series of antibiotic-resistant infection outbreaks caused by contaminated medical devices, the Food and Drug Administration is stepping up its efforts to improve hospital reporting of device-associated deaths or injuries.

Inspections of 17 hospitals found serious deficiencies in adverse event reporting, according to a blog posted on the agency’s website. The inspections uncovered numerous events that were never reported in violation of agency requirements, according to Jeffrey Shuren, M.D., who heads the FDA’s device division. In many cases, failure to report came down to simple ignorance or lack of training in reporting requirements on the part of hospital staff, according to the post.

“In order to effectively address these issues, we will work with the hospital community on what role they should play in assuring the safe use of medical devices,” Shuren wrote. “This work will include how they 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.”

The agency also plans to hold a public workshop in December in collaboration with the Association of American Medical Colleges and the American Hospital Association. At this forum, the agency plans to solicit input on ways it can improve hospital surveillance and improve hospitals’ ability to assess how well devices work in practice. This follows guidance released by the agency in June to improve device-related data-sharing.