Medical Devices:

Early Warning of Problems Is Hampered by Severe Underreporting

PEMD-87-1: Published: Dec 19, 1986. Publicly Released: Jan 20, 1987.

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In response to a congressional request, GAO provided information on the communications network and its flow patterns for problems associated with medical devices that the Food and Drug Administration (FDA) has reviewed or approved for marketing, specifically: (1) how hospitals report problems that occur in the use of medical devices; (2) how hospitals, manufacturers, and FDA respond to these problems; and (3) how other federal programs monitor the safety of selected technologies and identify promising practices that FDA might apply to medical devices.

GAO found that: (1) hospitals were aware of most medical device problems; (2) 9 percent of the problems identified with the 10 devices GAO studied involved actual injuries; (3) wear or deterioration of devices was the major cause of problems in one-third of the hospital reports, while other causes were defective components, design flaws, and improper use; (4) hospitals reported only 51 percent of identified medical device problems to such outside organizations as device manufacturers, distributors, and independent distributors; (5) hospitals made 83 percent of their reports orally and without documentation; (6) hospitals reported more manufacturer-related problems than user-related problems; (7) hospitals repaired or replaced defective components to avoid a recurrence of 85 percent of the problems they experienced; (8) 52 percent of the problems hospitals reported to manufacturers and distributors resulted in the repair or replacement of a failed device; (9) hospitals did not report problems to FDA, preventing an effective postmarketing surveillance (PMS) system; and (10) 53 percent of surveyed health care professionals were not aware of the FDA system for reporting problems. GAO believes that: (1) the information loss will not improve significantly, despite a new rule that requires manufacturers to report to FDA problems that have caused or may cause injury or death, since hospitals fail to report many of those problems to the manufacturers; and (2) representative sampling would be an efficient way to obtain necessary monitoring information.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: Current legislation is under consideration in Congress which includes a provision that will be completely responsive to this recommendation.

    Recommendation: The Secretary of Health and Human Services should correct the underreporting of medical device problems by requiring independent distributors of medical devices to report information about problems with devices to manufacturers, as manufacturers are required to report to FDA under the medical device reporting (MDR) rule.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: HHS established a PMS steering committee and the post of Assistant Director of PMS to coordinate and manage PMS databases and activities.

    Recommendation: The Secretary of Health and Human Services should correct the underreporting of medical device problems by establishing a more effective cooperative relationship with professional health organizations to develop and distribute educational materials for health-care professionals on the FDA need for early warning information and on how to report medical device problems.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Not Implemented

    Comments: Legislation is under consideration by Congress to require medical device problem reporting by hospitals which would override this recommendation.

    Recommendation: The Secretary of Health and Human Services should correct the underreporting of medical device problems by recommending that FDA explore the possibility of establishing a voluntary, PMS system involving a representative sample of hospitals that would report directly to device manufacturers. This recommendation is made in light of the void of information on problems with medical devices, the potential harm to people that could ensue, and recent developments indicating a more cooperative attitude by hospitals.

    Agency Affected: Department of Health and Human Services

 

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