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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. To improve the effectiveness of medical device problem reporting and to ensure the overall safety and effectiveness of medical devices, FDA should conduct a comprehensive good manufacturing practices and medical device reporting regulation compliance inspection of Aequitron Medical, Inc., giving special attention to all complaints listed in the hazard, injury, and death file.
Closed - Implemented
FDA conducted a good manufacturing practices inspection of Aequitron in December 1989. In addition, the Safe Medical Devices Act of 1990 contained provisions that address this and other issues covered in this report.
Food and Drug Administration 2. To improve the effectiveness of medical device problem reporting and to ensure the overall safety and effectiveness of medical devices, FDA should review its medical device reporting regulation and its guidance to device manufacturers on problem reporting for clarity and effectiveness and consider developing specific guidance for the manufacturers of any devices, such as apnea monitors, for which determining reportability is thought to present special difficulties.
Closed - Implemented
FDA established a medical device review study group, and revised reporting instructions and education for device manufacturers.

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