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AFMD-81-95 1 (1981-08-05)

handle is hein.gao/gaobabcgo0001 and id is 1 raw text is: UNITED STATES GENERAL ACCOUNTING OFFICE WASHINGTON, D.C. 20S48 HUMAN RESOURCES AUGUST 5, 1981 DIVISION B-204011 Dru Adinstrtio UiIIIIi III Dr. Arthur Hull Hayes, Jr. Commissioner, Food and 116037 Drug Administration Dear Dr. Hayes: Subject: LSoftware Used in Medical Devices Needs Better Con- trols To Avoid Compromising Patient Safety-i (AFMD-81-95) ) Computer technology is becoming more and more an integral part of many medical devices and is providing many benefits in the diag- nosis and treatment of patients' illnesses. We have looked into 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. As a result of our inquiry we believe controls are needed to ensure that the software used in medical devices operates as expected. We understand the goals and objectives of the Bureau's recently formed Task Group on Computers and Associated Software as Medical Devices will be established later, but that part of the group's efforts will include assessing the performance of software used for medical purposes. We believe this is a step in the right direction because it will address the type of problems our review has indicated are of emerging significance. Therefore, we plan no further work in this specific area at this time. To assist the task group in formulating its objectives and approach, we are summarizing below the information we developed and offering our suggestions for addressing software reliability. During our review, we looked at various reports from the Bureau's medical device reporting system, legislation, regulations, publications, and Bureau procedures. We interviewed Food and Drug Administration (FDA) and'Bureau officers, other Government agency officials, representatives from various medical organizations, health care professionals, and medical device manufacturers. COMPUTER SOFTWARE IN MEDICAL DEVICES NEEDS TO BE VALIDATED Although computerized medical devices provide many benefits, the software used in them can sometimes be troublesome. We found (913460) &//2 ,.,3

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