The first letter was sent to approximately 1,600 manufacturers on September 9, 1997. According to VHA officials, most of the manufacturers that reported one or more of their biomedical equipment products as noncompliant cited incorrect display of date and/or time as problems. VHA officials have informed us that they will be relying on the biomedical equipment manufacturers to validate, test, and certify that replacement equipment is Year 2000 compliant. Uncertainty Over Year 2000 Compliance Status Increases Risk

Despite VHA’s progress in implementing its Year 2000 strategy, as of July 29, 1998, it still did not know the full extent of the Year 2000 problem on its biomedical equipment because it has not received compliance and cost information from 27 percent of the manufacturers on its list of suppliers, as well as from nearly 100 additional manufacturers that are no longer in business. Among the manufacturers that had not yet responded or completed their assessments as of July 29, 1998, is one that supplies high-dollar value equipment, such as radiology systems and electronic imaging systems equipment, to VHA. Specifically, the VISNs and facilities reported to the Year 2000 Project Office the number of noncompliant and/or conditional-compliant equipment items in their inventories and the replacement or repair cost for this equipment using information provided to VHA by the manufacturers and posted on its intranet web site in January 1998. As of July 30, 1998, FDA had received 1,975 responses from biomedical equipment manufacturers and posted them on its web site. VHA Plans to Make Compliance Information Available to the Public

In contrast to FDA, VHA had not been making information obtained from biomedical equipment manufacturers on the Year 2000 compliance status of their products available to the public through an Internet World Wide Web site. VHA has not yet done so because (1) when VHA requested this information from the manufacturers, VHA did not tell them that it intended to release the information outside the federal government and (2) VHA said that 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. Although VHA has made progress in assessing its biomedical equipment, it does not yet know the full extent of the Year 2000 problem with this equipment and the associated costs to address this problem because it has not received compliance information from many of the manufacturers. Comments From the Department of Veterans Affairs

The following are GAO’s comments on the Department of Veterans Affairs’ letter dated August 25, 1998. 3. 4.
Why GAO Did This Study

Pursuant to a congressional request, GAO provided information on the status of the Veterans Health Administration's (VHA) and the Food and Drug Administration's (FDA) Year 2000 biomedical equipment programs.

What GAO Found

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.