FDA To Monitor Medical Device Use More Closely

The Daily Health Policy Report from the Kaiser Network focuses on the need for increased vigilance of the performance of medical devices, such as the Guidant cardiovascular defibrillators, after they are introduced into the market. When the market includes my body I say bring on the vigilance.

FDA officials on Thursday held a “rare media briefing” to detail “problems they face in monitoring” medical devices after they have been approved, the Minneapolis Star Tribune reports.

Daniel Schultz, director of the FDA Center for Devices and Radiological Health, said the center has been challenged by the growth in the medical device industry, the complexity of devices, their increasing popularity, and the competing interests of safety and approving new technology that could benefit patients. “As we approve more and more products with more and more technological complexities, basically there’s less margin for error,” he said, adding, “I think that’s sort of one of the lessons that we learned” from the recent problems with Guidant. Minnesota-based Guidant in the past year has recalled an estimated 300,000 implantable cardioverter defibrillators because of the possibility that the devices could malfunction.

According to the Star Tribune, the doctors of an ICD patient who died “went public with their concerns” after learning that Guidant was aware of the possibility of malfunction “but did not notify physicians and patients about the potential problem.” In the briefing on Thursday, Schultz said, “We need to be even more vigilant, if that’s possible, in terms of how we monitor these devices once they get to market.”