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Software Used in Medical Devices Needs Better Controls To Avoid Compromising Patient Safety

AFMD-81-95 Published: Aug 05, 1981. Publicly Released: Aug 05, 1981.
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Highlights

Computer technology is becoming more and more an internal part of many medical devices and is providing many benefits in the diagnosis and treatment of patients' illnesses. GAO reviewed the use of computerized medical devices to determine if they are dependable enough to avoid compromising patient safety and, if not, how the controls being developed by the Bureau of Medical Devices will address this area of computer technology.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of the Food and Drug Administration should direct the Bureau of Medical Devices to establish, as one of the task group's primary goals, the identification and evaluation of alternatives to performance standards to ensure that software in medical devices operates as it is expected to operate.
Closed
Please call 202/512-6100 for additional information.
Food and Drug Administration The Commissioner of the Food and Drug Administration should direct the Bureau of Medical Devices and its task group to enlist the support and participation of the medical device industry, the medical profession, and interested Government agencies.
Closed
Please call 202/512-6100 for additional information.

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Topics

Business Regulation and Consumer Protection
Electronic data processingEmployee medical benefitsMedical equipmentMedical information systemsMedical researchMedical devicesPerformance measuresPatient careSoftwareComputer technologies