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. The 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.
The GAO found that advances in computer technology have brought about far more reliable hardware. However, software has been and remains a problem area, regardless of whether it is used in medical or business applications. The GAO believes the use of software in medical devices is emerging as a troublesome area and requires the attention of the Bureau of Medical Devices. The use of performance standards, as authorized by the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, is a possible mechanism to help control the performance of software in computerized medical devices.
Unfortunately, the time-consuming process for developing standards together with the large number of standards to be developed makes it very unlikely that any standards will be available soon. This, coupled with the relatively fast pace at which computer technology changes, makes it unlikely that the standards, when developed, will be timely enough to validate software in medical devices. The GAO believes that the Bureau's recent establishment of the task group is a wise and timely initiative.
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. 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.