Year 2000 Computing Crisis

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. GAO summarized this report in testimony before Congress; see: Year 2000 Computing Crisis: Leadership Needed to Collect and Disseminate Critical Biomedical Equipment Information, by Joel C. Willemssen, Director of Civil Agencies Information Systems Issues, before the Subcommittee on Oversight and Investigations, House Committee on Veterans' Affairs. GAO/T-AIMD-98-310, Sept. 24 (25 pages).

GAO noted that: (1) VHA has made progress in implementing its year 2000 strategy for biomedical equipment, which relies on compliance information from the manufacturers; (2) as of July 29, 1998, VHA had received information on biomedical equipment compliance from 73 percent of the 1,490 manufacturers on its list of suppliers; 701, or 47 percent, of these manufacturers reported that their products are year 2000 compliant; (3) in spite of this, VHA does not yet know the full extent of the year 2000 problem on its biomedical equipment and the associated costs to address this problem; (4) among the manufacturers that had yet to respond or complete their assessments is one that supplies high-dollar value equipment, such as radiology systems and electronic imaging systems equipment, to VHA; (5) according to VHA's Year 2000 Project Manager, most of the manufacturers reporting that they had noncompliant equipment cited incorrect display of date or time as problems; (6) date or time display problems should not present a risk to patient safety because health care providers can work around them; (7) however, some manufacturers cited problems that could pose a risk to patient safety; (8) to the extent that noncompliant biomedical equipment has to be replaced or repaired, the cost estimate reported by the Department of Veterans Affairs (VA) to the Office of Management and Budget is incomplete; (9) to assist health care facilities in the public and private sectors, FDA issued a letter in January 1998 to biomedical equipment manufacturers, requesting information on products affected by this computer problem; (10) in contrast to VHA, as of July 30, 1998, FDA had only received responses from 1,975, or about 12 percent, of the approximately 16,000 biomedical equipment manufacturers to which its letter was sent; (11) FDA has made information from biomedical equipment manufacturers available through a world wide web site; (12) VHA, however, has not yet done so because: (a) when VHA requested the information from the manufacturers, VHA did not tell them that it intended to release the information outside the federal government; and (b) VHA said it had concerns regarding whether it would be proper for it to release some of the information provided by the manufacturers because the information may be proprietary; and (13) VHA, on the advice of VA's Acting General Counsel, informed manufacturers in June 1998 that it plans to release information that the manufacturers said was not confidential commercial information.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Team: Phone: