VA Central Office Needs To Exercise Better Oversight of Cardiac Pacemaker Recalls

HRD-84-33: Published: Apr 16, 1984. Publicly Released: Apr 16, 1984.

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GAO reviewed the actions taken by the Veterans Administration (VA) in response to recalls of defective pacemakers.

The Food and Drug Administration (FDA) has the authority to ban or recall medical devices, including pacemakers, that present "unreasonable risks or substantial harm," and it informs VA when pacemakers have been recalled. GAO found that, at the VA centers it visited, pacemaker recalls were not effectively managed. GAO learned that the VA computerized pacemaker registry indicated that some recalled pacemakers are still implanted in VA patients. VA guidance regarding pacemakers deals primarily with the removal of recalled pacemakers from stock and has not defined when a recalled pacemaker should be considered critically unreliable. GAO also questioned the accuracy, completeness, and reliability of the computerized pacemaker registry and, therefore, its current usefulness.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The clinical registry has been developed and was placed in service in 1986. Operating instructions for the registry will be included in the revised circular. The revised circular was issued in May 1989.

    Recommendation: The Administrator of Veterans Affairs should direct the Chief Medical Director to establish a timetable for development of the clinical pacemaker registry and, in the interim, take steps to improve the completeness and reliability of data contained in the existing registry.

    Agency Affected: Veterans Administration

  2. Status: Closed - Implemented

    Comments: The circular containing program requirements was issued in May 1989.

    Recommendation: The Administrator of Veterans Affairs should direct the Chief Medical Director to identify all VA patients using recalled pacemakers and ensure that: (1) they have been informed of the recall or that the reasons for not informing the patient are documented in the patients' medical records; and (2) all actions taken in response to the recalls are documented in affected patients' medical records.

    Agency Affected: Veterans Administration

  3. Status: Closed - Implemented

    Comments: The circular containing program requirements was issued in May 1989.

    Recommendation: The Administrator of Veterans Affairs should direct the Chief Medical Director to revise program guidance to require that medical centers: (1) inform patients of pacemaker recalls unless the reasons for not informing the patient are documented in the medical record; and (2) document the actions taken in response to the recall in the patients' medical records.

    Agency Affected: Veterans Administration

  4. Status: Closed - Implemented

    Comments: Issuance of the circular containing the program guidance was delayed for technical details by the Chairman, DRD Council, and the Office of Acquisition and Material Management. It has been revised incorporating their changes and issued in May 1989.

    Recommendation: The Administrator of Veterans Affairs should direct the Chief Medical Director to establish criteria, as part of program guidance, to define when a recalled pacemaker should be considered critically unreliable.

    Agency Affected: Veterans Administration

  5. Status: Closed - Implemented

    Comments: The program circular was issued in May 1989.

    Recommendation: The Administrator of Veterans Affairs should direct the Chief Medical Director to establish a program to monitor the actions taken by medical centers in response to pacemaker recalls.

    Agency Affected: Veterans Administration

 

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