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FDA to tighten medical device safety regs
The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. The move was prompted, in part, by concerns over last year's massive defibrillator recalls, which concerned more than 200,000 devices. Among other steps, the FDA would like to see devices marked with a unique number, making it easy to track them during recalls. It also plans to begin using data-mining techniques to detect potential problems, and collect real-time safety data from government and private hospitals.
Find out more about the upcoming regulations:
- read this Associated Press piece
ALSO: When patients with implantable defibrillators die, most are buried with the devices still in their chests despite the fact that they could be returned to the manufacturer. Report
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