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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 1. 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.
Closed - Not Implemented
Current legislation is under consideration in Congress which includes a provision that will be completely responsive to this recommendation.
Department of Health and Human Services 2. 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.
Closed - Implemented
HHS established a PMS steering committee and the post of Assistant Director of PMS to coordinate and manage PMS databases and activities.
Department of Health and Human Services 3. 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.
Closed - Not Implemented
Legislation is under consideration by Congress to require medical device problem reporting by hospitals which would override this recommendation.

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