Fact Based List:
Kaiser Health News: 7 Things to Know About the FDA's Hidden Medical Device Database
Submitted by Charlene Ice on Tue, 07/16/2019 - 11:18
- 5.7 million medical device injury and/or malfunction incidents bypassed FDA's public database into an alternative summary reporting system over 20 years. The FDA recently released its data.
- Blood glucose meters for patients with diabetes had the most incidents in the database, with 2.4 million reports over the past 20 years.
- There were 2.1 million reports for bad dental implants, 114,200 of which were reported last year.
- There were 176 deaths reported through the alternative summary reporting system.
- Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.
- Breast implant injuries and malfunctions accounted for nearly half a million reports over 20 years, including implants that leaked, deflated or migrated.
- The FDA is replacing alternative summary reporting with the Voluntary Summary Reporting Program. Over 5,600 device types (87%) are eligible for summary reporting of device malfunctions.
Notes: from the article, "Five Things We Found In The FDA’s Hidden Device Database," by Sydney Lupkin
Source: Kaiser Health News, June 27, 2019
Source URL: https://khn.org/news/five-things-we-found-in-the-fdas-hidden...
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