Medical Technology

GAO's analysis shows that the health risks associated with defective pacemaker leads, which transmit electrical impulses between the heart and the pulse generator, are real and potentially deadly. Many patients are concerned about the safety and effectiveness of their pacemakers and believe that they have a right to know about any problems with their devices and to participate in decisions concerning their health care. More postmarket performance monitoring, early problem identification, and notification of all affected individuals and organizations could minimize or even prevent the harmful effects of defective pacemaker leads. Both experts and the technical literature generally agree that failure rate analysis is useful in spotting pacemaker leads with manufacturing or design problems. The Food and Drug Administration (FDA), however, has no formal performance standard requiring the agency or manufacturers to begin remedial action as a result of such analyses, and FDA has no comprehensive data system in place to identify and track how the devices perform in patients. Having such information, as well as Medicare's pacemaker expenditure data, would help in estimating the costs reimbursable to the government and to patients for flawed devices.

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

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Team: Phone: