FDA To Improve Guidelines For Medical Devices

Main Category: Medical Devices / Diagnostics
Article Date: 24 Jan 2006 - 0:00 PDT

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FDA last week announced that it will take steps to improve its monitoring of medical devices after they have been approved, the New York Times reports (Meier, New York Times, 1/21). Under the "Postmarket Transformation Initiative" the agency said it will develop an electronic reporting system for adverse reactions, standardize the identification process, obtain medical records of patients who use the devices, and increase communication with professional organizations and the medical device industry (CQ HealthBeat, 1/20). According to the Wall Street Journal, the program was addressed in an FDA report prepared internally that critiqued the agency's handling and safety practices of medical devices such as defibrillators and pacemakers. The report concluded that the current monitoring system at FDA's Center for Devices and Radiological Health lacks "quality information" on approved devices, while at the same time the volume of information received "exceeds the center's ability to consistently enter or review the data in a routine matter." A number of concerns have arisen in recent months in the wake of safety problems with medical devices, according to the Journal (Wilde Mathews, Wall Street Journal, 1/20). Daniel Schultz, director of FDA's device center, said the new guidelines will include plans to make information on devices available to the public. "There are a lot of things we are doing," Schultz said, adding that "there are still some things that fall through the cracks" (New York Times, 1/21).

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