Mar 11, 2019

FDA responds to report of secret database

The FDA publicly swung into action Friday after Kaiser Health News illuminated a secret database that kept serious safety issues out of the public eye.

How it works: The FDA maintains a public database of injuries or other problems caused by medical devices. It's a valuable tool for researchers, and also for doctors, who want to assess devices' safety before using them in patients.

  • But KHN reported last week that the FDA also has a separate reporting system, whose contents are not publicly available. Roughly 100 products are allowed to use that channel, which has collected more than 1 million reports since 2016.
  • Doctors and researchers don't know about issues raised in those reports; a former FDA commissioner told KHN he didn’t even know the system existed.

Driving the news: A mountain of reports about surgical staples and staplers have piled up in the secret system, outside of public view, leaving doctors unaware of the products' risks.

  • "I don't want to sound overdramatic here, but it seemed like a cover-up," said one doctor who queried the FDA's public database — and came up empty — after experiencing problems with a surgical stapler.

A day after that story ran, the FDA sent a letter to doctors saying it's concerned about the safety of surgical staples and staplers.

The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions.

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