Medical Technology:

For Some Cardiac Pacemaker Leads, the Public Health Risks Are Still High

PEMD-92-20: Published: Sep 23, 1992. Publicly Released: Oct 23, 1992.

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Pursuant to a congressional request, GAO investigated: (1) the Food and Drug Administration's (FDA) actions preceding the recall of a cardiac pacemaker lead; and (2) continuing threats to public health posed by 14 other pacemaker lead models that had the same technological characteristics as the recalled lead.

GAO found that: (1) FDA recalled the lead model after receiving estimates of the numbers of deaths that could occur as a result of lead failure, but did not request that the manufacturer provide its clinical failure rate data; (2) FDA did not collect or request appropriate data to evaluate risks posed by polyurethane insulation in the leads still on the market; (3) FDA erroneously believed that it lacked authority to require manufacturers to collect such data; (4) before product recall, the manufacturer notified physicians of the lead's potential for failure, but marketed a modified model without notifying FDA; (5) FDA failure to fully implement legislative requirements regarding pacemaker registry limits the usefulness of the registry, and FDA has not validated information or assessed the quality of data; (6) FDA failure to collect or require the collection of clinical data during postmarket surveillance delays the product recall process and extends the period of time that patients may be exposed to a hazardous product; and (7) since most pacemaker recipients are elderly and eligible for Medicare coverage, defective leads can pose a considerable cost to the government.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: HHS cited potential difficulties and prohibitive expenses involved in implementing this recommendation.

    Recommendation: The Administrator of the Health Care Financing Administration (HCFA) should conduct an analysis to determine the costs associated with defective pacemaker leads, and if so indicated, invoke section 518(b) of the Federal Food, Drug and Cosmetic Act, as amended, or other appropriate statutes for reimbursement of such costs to the federal government.

    Agency Affected: Department of Health and Human Services: Health Care Financing Administration

  2. Status: Closed - Implemented

    Comments: FDA has published regulations on device tracking and implementation of the tracking requirement and will address this recommendation.

    Recommendation: To ensure the safety and effectiveness of polyurethane-insulated pacemaker leads, the Commissioner, FDA, should fully implement the discretionary provisions of Public Law 98-369 in conjunction with the Health Care Financing Administration and with pacemaker and pacemaker lead manufacturers to develop a comprehensive, high-quality system to identify and track patients and device performance.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: An internal working group was formed in November 1992 to initiate the process of establishing a benchmark survival standard for pacemaker leads.

    Recommendation: To ensure the safety and effectiveness of polyurethane-insulated pacemaker leads, the Commissioner, FDA, should establish a minimum standard for pacemaker lead performance or other appropriate benchmark to measure postmarket performance.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Implemented

    Comments: FDA completed this work. Appropriate actions were taken by FDA in response to GAO recommendations.

    Recommendation: To ensure the safety and effectiveness of polyurethane-insulated pacemaker leads, the Commissioner, FDA, to include in the development of regulations to implement the postmarket surveillance provisions of the Safe Medical Devices Act of 1990, a requirement that manufacturers conduct retrospective studies of postmarket performance of pacemaker leads currently on the market or in use, using criteria similar to those delineated in the act.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  5. Status: Closed - Implemented

    Comments: HHS cited previous problems satisfying the statutory threshold. There has been no action or response on a delegation of authority to HCFA.

    Recommendation: The Department of Health and Human Services should pursue any legislative changes necessary to implement the recommendation to HCFA. Further, since HCFA has not been delegated the authority to invoke section 518(b), the Secretary of Health and Human Services should so delegate.

    Agency Affected: Department of Health and Human Services

 

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