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Not Reporting Harms

A number of institutions have not reported injuries or deaths caused by medical devices to the US Food and Drug Administration, the Cancer Letter reports.

"While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event database," Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, wrote in a blog post in October.

The FDA investigated 17 institutions because of concerns regarding power morcellation, which can spread uterine cancer, and other devices. They found that that most of the hospitals hadn't reported injuries or deaths in a timely fashion, the Cancer Letter's Matthew Bin Han Ong writes. One hospital, Brigham & Women's Hospital, says it didn't think the events there met the mandatory reporting criteria.

Despite its findings, Ong reports the agency isn't penalizing the hospitals. The FDA tells him that the "hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action … is necessary."

Ong adds that Rep. Mike Fitzpatrick (R-Pa.), whose district is home to a patient harmed by power morcellation, has been calling for strengthening reporting requirements. One bill he introduced, the Medical Device Guardians Act, would require individual practitioners, not just hospitals and manufacturers, to report adverse outcomes. While Fitzpatrick is leaving Congress, the Cancer Letter notes that his brother Brian Fitzpatrick has won his seat and plans to continue the push on increasing safety standards.

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