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Hidden Harm

FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

FDA Commissioner Scott Gottlieb announced in a Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

鈥淲e鈥檙e now prioritizing making ALL of this data available,鈥 Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an 鈥渆xemption鈥 from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Gottlieb鈥檚 tweet also referenced the challenge in opening the database, saying it 鈥渨asn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.鈥

The agency made changes to the 鈥渁lternative summary reporting鈥 program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients and device-safety researchers who say they could use it to detect problems.

Gottlieb鈥檚 announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

鈥淭hat鈥檚 the best news I鈥檝e heard in years,鈥 said Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. 鈥淚鈥檓 really happy that they鈥檙e taking notice and realizing that physicians who couldn鈥檛 see this data before were using devices that they wouldn鈥檛 have used if they had this data in front of them.鈥

Since September, KHN has filed Freedom of Information Act requests for parts or all of the 鈥渁lternative summary reporting鈥 database and for other special 鈥渆xemption鈥 reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of 鈥渃ompelling need鈥 for the public to have the information. Officials noted that it might take up to two years to get such records through the FOIA process.

As recently as Friday, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was , which is reviewing the safety of such devices. The panel, which met Monday and Tuesday, saw a chart showing hundreds of more accounts of harm or malfunctions than had previously been acknowledged.

Dr. Michael Carome, director of Public Citizen鈥檚 health research group, said his initial reaction to the news is 鈥渂etter late than never.鈥

鈥淚f [Gottlieb] follows through with his pledge to make all this data public, then that鈥檚 certainly a positive development,鈥 he said. 鈥淏ut this is safety information that should have been made available years ago.鈥

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