Year 2000 Computing Crisis

Leadership Needed to Collect and Disseminate Critical Biomedical Equipment Information Gao ID: T-AIMD-98-310 September 24, 1998

Biomedical equipment that relies on computers or computer chips, from cardiac monitoring systems to electronic imaging machines, may be adversely affected by the Year 2000 problem. Although this situation has serious implications for the delivery of health care to the nation's veterans, the Veterans Health Administration (VHA) still does not know the full extent of its Year 2000 problem or the cost to overcome it. This is because it has yet to receive compliance information from 27 percent of the biomedical equipment manufacturers on its list of suppliers or from the nearly 100 other manufacturers that VHA discovered were no longer in business. According to VHA, most manufacturers reporting noncompliant equipment cited incorrect display of date or time as problems--albeit ones that health care providers can work around. Some manufacturers, however, cited more serious problems that could jeopardize patient safety. For example, a miscalculation by a radiation therapy planning computer could cause a patient to receive a hazardous radiation dose. The Food and Administration (FDA), which oversees and regulates medical devices, has sent letters to biomedical equipment manufacturers asking for information on products affected by the Year 2000 problem. The response rate to FDA has been disappointing. It is critical that such information be obtained and publicized. This testimony summarizes the September 1998 report, GAO/AIMD-98-240.

GAO noted that: (1) VHA has made progress in implementing its year 2000 strategy for biomedical equipment, but it still does not know how pervasive the problem is; (2) this is because it has not received compliance and cost information from many of the manufacturers on its list suppliers, as well as from nearly 100 additional manufacturers no longer in business; (3) like VHA, FDA has sent letters to biomedical equipment manufacturers, requesting information on products affected by the year 2000 problem; (4) the response rate to FDA has been disappointing; (5) failure to obtain timely compliance information from the manufacturers increases the risk to health care providers and biomedical equipment users that such equipment may not operate properly after the turn of the century; and (6) it is critical that such information be obtained and publicized; while many reported noncompliant equipment items do not present a risk to patient safety, some could present such risks.



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