Medical Device Problem Reporting:

A Case Study of a Home Apnea Monitor

T-PEMD-90-10: Published: Jul 17, 1990. Publicly Released: Jul 17, 1990.

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GAO discussed the Food and Drug Administration's (FDA) implementation of the medical device reporting regulation, focusing on reporting problems involving a home apnea monitor. GAO noted that: (1) the monitor's manufacturer received at least 70 complaints associating the monitor with patient deaths between 1983 and 1989; (2) although the manufacturer maintained records of complaints, it did not fully comply with the regulation's reporting requirements; (3) although FDA conducted eight formal inspections between 1984 and 1989, it did not identify or attempt to resolve underreporting problems until 4 years after the regulation went into effect; (4) FDA cited the manufacturer for noncompliance, reviewed the manufacturer's original problem-reporting policy, and concluded that its revised policy was adequate; (5) primary users of the monitors were not always adequately informed of the device's limitations and risks; (6) the manufacturer attributed its noncompliance to differences in interpreting the reporting regulation; (7) FDA inspection procedures did not include any systematic evaluation of trends in the frequency, type, or severity of complaints made to the manufacturer; and (8) FDA did not compare the rates of complaints among manufacturers of similar devices.

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