FDA Stops Expansion of Computer Network To Monitor Safety of Medical Devices

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Article Date: 15 Jul 2005 - 0:00 PDT

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FDA "for the next several years" will not fund the expansion of a computer reporting system through which the federal government monitors malfunctions and misuses of medical devices, the Boston Globe reports. FDA estimates that problems with medical devices result in 300,000 deaths and injuries annually. Under the reporting system, which is one of the most widely used, doctors alert the manufacturers of the devices to any problems they discover and manufacturers then must notify regulators of the problem. Some critics of the process say it "allows device makers to downplay bad news" to FDA, the Globe reports. The system -- the Medical Product Surveillance Network, or MedSun -- was established in 2002 to improve reporting of problems with medical devices to FDA and help regulators track patterns of problems. Originally, the agency sought to connect 500 of 5,000 eligible U.S. hospitals to the network, allowing doctors to report problems directly to the federal government. However, despite plans to expand MedSun in response to problems with cardiac stents made by Johnson & Johnson and Boston Scientific in 2004, FDA now has proposed to freeze enrollment of hospitals at 350 and limit the program's budget to $5.1 million for fiscal year 2006. According to the Globe, it costs about $20,000 to add a hospital to the system, and FDA does not plan to enroll new facilities for several years.

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FDA official Marilyn Flack said the 350 hospitals currently participating in the program are enough to identify patterns and problems and said that FDA plans to make technical improvements to the system. "Within my budget, this is absolutely a success story," Flack added. Rep. Maurice Hinchey (D-N.Y.) said the lack of additional funding for MedSun's budget is "consistent with the pattern of the FDA under this administration, to act in a way that is complicit with the entities they're supposed to regulate." Geri Amori, past president of the American Society for Healthcare Risk Management, said, "We're all affected by undiscovered, latent device problems," adding that some medical device safety issues could remain undetected if MedSun does not add more hospitals (Kerber, Boston Globe, 7/14).

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