FDA recalls: how do pacemaker manufacturers compare?
To evaluate an apparent perception that there is no difference in reliability among the products of the major cardiac pacing system manufacturers, an extensive review of US Food and Drug Administration regulatory actions was performed. The study period was July 1974 through June 1987. The total number of affected devices was collected for each manufacturer. Available sales data were used to calculate their percentage of recalled products during two time periods. The percentage of potentially high-risk devices (Food and Drug Administration class I and II recalls) was high for one company, moderate for one, and relatively low for the rest. Potential biases in some other sources of reliability information, as well as implications for regulatory policies, are discussed. The data reported establish that there have been past deficiencies in recall management. Although further pacing device recalls are probable, appropriate early regulatory and manufacturer action should help to assure that both the immense cost and patient distress caused by pacer and related product problems in the past can be minimized in the future.
Tyers
G F
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Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
D004868:Equipment Failure; D006801:Humans; D010138:Pacemaker, Artificial; D014481:United States; D014486:United States Food and Drug Administration