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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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Highlights

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.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 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.
Closed – Implemented
FDA completed this work. Appropriate actions were taken by FDA in response to GAO recommendations.
Food and Drug Administration 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.
Closed – Implemented
An internal working group was formed in November 1992 to initiate the process of establishing a benchmark survival standard for pacemaker leads.
Food and Drug Administration 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.
Closed – Implemented
FDA has published regulations on device tracking and implementation of the tracking requirement and will address this recommendation.
Health Care Financing Administration 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.
Closed – Not Implemented
HHS cited potential difficulties and prohibitive expenses involved in implementing this recommendation.
Department of Health and Human Services 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.
Closed – Implemented
HHS cited previous problems satisfying the statutory threshold. There has been no action or response on a delegation of authority to HCFA.

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Topics

Cardiovascular diseasesConsumer protectionData collectionFood and drug lawMedical equipmentMedical technologyMedicareProduct evaluationProduct recallsSafety regulationPublic health