Medical Devices:

Early Warning of Problems Is Hampered by Severe Underreporting

T-PEMD-87-4: Published: May 4, 1987. Publicly Released: May 4, 1987.

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GAO discussed the Food and Drug Administration's (FDA) monitoring of the safety of medical devices through its postmarketing surveillance system. For the 10 devices studied, GAO found that: (1) hospital personnel reported a 37-percent chance of serious injury or death to hospital patients due to device-associated problems; (2) defective components, design flaws, and deterioration were major problems with hospital medical equipment; (3) hospital personnel reported only 51 percent of the problems associated with defective equipment to device manufacturers; (4) there was a certain amount of selective reporting when the problem involved injury to a patient or equipment deterioration; and (5) hospitals transmitted 83 percent of the reports on device-related problems orally, but did not formally document them. GAO concluded that a medical-device reporting rule may be necessary to improve the underreporting of medical-device problems and increase the overall effectiveness of the FDA communication network, and recommended that FDA establish a voluntary, postmarketing surveillance system for hospitals to report directly to device manufacturers.

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