Medical Devices: Early Warning of Problems Is Hampered by Severe Underreporting

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.