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Medical devices Problems on the rise.(CR Health)
Surgically implanting a device to help a damaged organ can seem like a great convenience--or even a lifesaver. Implanted infusion pumps, for example, automatically deliver doses of drugs, replacing daily injections or pills. Tiny stents can be used to prop open coronary arteries. But how well do medical devices work, and are they being given to the right patients?
We commissioned the nonprofit National Institute for Computer-Assisted Reporting to help analyze reports from the Food and Drug Administration's database of adverse events involving all types of medical devices. The reports are collected by the agency from such sources as manufacturers, hospitals, and health-care providers. While the reports list devices as "suspect" they do not prove they caused the adverse event.
Our analysis shows that reports of deaths linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double the number in 1997. Reports of hospitalizations linked to those devices are also up since 1997, though the categories might overlap.
In September the FDA issued its own report for its fiscal year 2006, saying it had seen a 25 percent increase in adverse events linked to medical devices over FY 2005, including 2,830 deaths, 116,086 injuries, and 96,485 device malfunctions.
Heart devices were cited in a relatively high number of 2006 fatality reports in our analysis. They included some types of drug-eluting coronary stents, graft systems used to repair bulging arterial walls, and implantable cardioverter defibrillators.
Certain infusion pumps that deliver drugs were linked to reports of hospitalizations. And so were drug-eluting coronary stents, which some research has implicated in heart attacks and death when used "off-label," or in ways not approved by the FDA.
The agency "recognizes that the number of adverse-event reports is increasing," said a spokeswoman for the FDA by e-mail. She said that possible explanations include rapid industry growth, increasingly complex devices, and moreresponsible reporting.
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