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FDA responds to report of secret database
Source: Axios
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.
-snip-
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.
-snip-
Read more: https://www.axios.com/fda-medical-devices-secret-database-a9919450-897f-40b9-83f9-28127d4b85f5.html