FDA to take more aggressive stance on medical device safety warnings

WASHINGTON — The Food and Drug Administration said on Wednesday that it plans to take a far more aggressive stance in reporting on possible medical device hazards, in some cases issuing early warnings about safety risks even before those concerns have been validated.

The move follows several high-profile lawsuits involving safety risks and medical devices, as well as a string of warnings from the FDA about various products. Among them: a hip implant that was reported to leak metal parts into patients’ bloodstreams, an internal defibrillator that was reported to stop working, and a mesh implant used to prevent female incontinence that was reported to erode.

The FDA will officially announce its plans on Thursday but noted the changes in its position in the Federal Register a day early.

article continues after advertisement

The FDA already has an established system of issuing public warnings about safety hazards involving medical devices. But historically the agency has waited to release information about reported deaths, complications, and other problems until after it has analyzed “adverse event” reports, hundreds of thousands of which are submitted each year.

In draft guidance, the FDA said that wasn’t enough.

“We believe there also is a need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations,” the FDA said in the draft.

“Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated,” it added.

Device makers and others will have 60 days to comment on the proposal. After that, FDA will publish its final report, called guidance, on the issue.

Although that document does not carry the weight of law and will not compel device makers to provide more information to the FDA, it does mean the agency will in some cases issue warnings about devices that could, in theory, later be deemed to be safe.

Medical device makers are likely to argue that the FDA will hurt both their businesses and consumers by creating doubt about the safety of good products.

Critics have also argued that the FDA already maintains a publicly accessible database on adverse events connected to medical devices. Consumer safety advocates say that database is difficult to interpret, and FDA officials caution that adverse events are grossly underreported.

Subscribe to our
new hospitals newsletter,
On Call

Your guide to the people and ideas shaping hospitals and transforming the delivery of health care

Recommended Stories