Electromagnetic Interference with Medical Devices

RCED-95-96R: Published: Mar 17, 1995. Publicly Released: Mar 17, 1995.

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Pursuant to a congressional request, GAO provided information on electromagnetic interference with medical devices, focusing on the Food and Drug Administration's (FDA) and the Federal Communications Commission's (FCC) oversight roles. GAO noted that: (1) FDA is responsible for ensuring that medical devices are safe and effective, while FCC is responsible for limiting interference from radio frequency emissions; (2) FDA estimated there were 1,000 possible cases of electromagnetic interference with medical devices from 1984 to 1994; (3) incidents of electromagnetic interference may be underreported because not everyone is required to report them and electromagnetic interference may not be recognized as the likely cause of malfunctions; and (4) FCC has not conducted tests on the susceptibility of different types of medical equipment to electromagnetic interference.

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