Medical Devices

Pursuant to a congressional request, GAO reviewed: (1) the number of complaints involving patient deaths associated with an apnea monitor; (2) whether the device's manufacturer complied with Food and Drug Administration (FDA) problem reporting regulations and procedures; and (3) how FDA responded to information that the monitor had been associated with numerous deaths.

GAO found that: (1) between January 1983 and January 1989, the manufacturer documented 82 complaints concerning the monitor, of which 70 complaint files listed patient death as the reason for the return of the device; (2) the remaining 14 complaint files included allegations of either hazards or safety injuries; (3) FDA did not begin to take compliance action until after the manufacturer failed to report 51 of 56 death complaints; (4) FDA cited the manufacturer for noncompliance and reviewed the manufacturer's problem policy; (5) the manufacturer maintained the required record of complaints, but did not fully comply with the reporting requirements; and (6) although FDA inspected the manufacturer on many occasions, it took nearly 4 years for FDA to identify and attempt to resolve the underreporting.

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.

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