Medical Devices:

Underreporting of Serious Problems With a Home Apnea Monitor

PEMD-90-17: Published: May 31, 1990. Publicly Released: Jul 17, 1990.

Contact:

Kwai-Cheung Chan
(202) 512-3652
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Implemented

    Comments: FDA established a medical device review study group, and revised reporting instructions and education for device manufacturers.

    Jul 29, 2014

    Jul 23, 2014

    Jul 16, 2014

    Jul 15, 2014

    Jul 10, 2014

    Jun 30, 2014

    Jun 25, 2014

    Jun 24, 2014

    Jun 23, 2014

    Looking for more? Browse all our products here