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RCED-95-96R 1 (1995-03-17)

handle is hein.gao/gaobacktz0001 and id is 1 raw text is: United States Pj() General Accounting Office Washington, D.C. 20548 Resources, Community, and Economic Development Division B-260205 March 17, 1995 The Honorable Carolyn B. Maloney Ranking Minority Member Subcommittee on Government Management, Information, and Technology Committee on Government Reform and Oversight House of Representatives Dear Ms. Maloney: As requested, we are providing you with information on electromagnetic interference from signals sent by devices such as cellular telephones and portable radios that could cause sensitive medical devices to fail. Specifically, we are providing information on (1) the oversight roles of the Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) regarding electromagnetic interference with medical devices, (2) the extent to which cases of such interference have been reported to FDA and FCC, and (3) the extent to which FDA and FCC have conducted or reviewed key research on such interference. In summary, federal oversight responsibilities lie primarily with FDA, which is responsible for ensuring that medical devices marketed in the United States are safe and effective. FCC has a more limited role; it can issue regulations to limit interference from radio frequency emissions, but generally only to prevent interference with transmissions by authorized users of the radio spectrum. FDA officials estimated that FDA's records from 1984 to 1994 could include 1,000 possible cases of electromagnetic interference with medical devices. However, these officials added that such incidents are underreported because not everyone is required to report them and because electromagnetic interference may not be recognized as the cause of a malfunction. FDA has conducted tests on the susceptibility of certain types of medical equipment to electromagnetic interference, but, according to FCC officials, FCC has not. FDA and FCC officials said that GAO/RCED-95-96R, Electromagnetic Interference With Medical Devices

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