Regulation Would Require Medical Device ID System
An FDA proposal to require device manufacturers and hospitals to adopt a universal bar code system or other technology to identify individual devices is expected to be published in Wednesday's Federal Register, the New York Times reports. The proposed regulation follows identification requirements issued by FDA in 2004 on drugs and biological agents such as vaccines and is intended to address problems observing malfunctions in devices after product recalls.
Previous proposals to include medical devices in the 2004 rule were defeated by manufacturers who argued that the requirement was impractical for the industry, but FDA and hospital officials since then have worked to gather information on products that are needed to develop the identification system.
According to Larry Kessler, director of the Office of Science and Engineering Laboratories at FDA Center for Devices and Radiological Health, compiling such information might help a device identification system address existing challenges with product compatibility. For instance, some hospitals might not use advanced magnetic resonance imaging scanning on patients with metal or battery-operated implants for fear they could be harmed by the scanner's radiation.
The proposal's publication in the Federal Register will begin a 90-day comment period. A final regulation is not expected until 2007, according to Kessler (Feder, New York Times, 8/9).