United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Accounting and Information Management Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1998-09-18 monographic deposited born digital 47 p. GA 1.13:AIMD-98-240 https://www.govinfo.gov/app/details/GAOREPORTS-AIMD-98-240 P0b002ee1803797a6 f:ai98240 DGPO 2010-08-12 2011-03-28 GAOREPORTS-AIMD-98-240 machine generated eng fdlp REPORT GAOREPORTS-AIMD-98-240 AIMD-98-240 Computer software verification and validation Strategic information systems planning Systems compatibility Medical equipment Health care services Embedded computer systems Computer software Medical information systems Systems conversions Proprietary data Y2K VA Veterans Integrated Service Network Magnetic Resonance Imaging VA Year 2000 Program Letter Report AIMD

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.<p/>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. https://www.govinfo.gov/content/pkg/GAOREPORTS-AIMD-98-240/html/GAOREPORTS-AIMD-98-240.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-AIMD-98-240/pdf/GAOREPORTS-AIMD-98-240.pdf GAO/AIMD-98-240 https://www.govinfo.gov/app/details/GAOREPORTS-AIMD-98-240 Letter Report GAO/AIMD-98-240; Year 2000 Computing Crisis: Compliance Status of Many Biomedical Equipment Items Still Unknown; Computer software verification and validation Strategic information systems planning Systems compatibility Medical equipment Health care services Embedded computer systems Computer software Medical information systems Systems conversions Proprietary data Y2K VA Veterans Integrated Service Network Magnetic Resonance Imaging VA Year 2000 Program Title 21 Section 301 Title 21 Section 321 21 U.S.C. 301 21 U.S.C. 321 Public Law 101-629 Title 21 Part 806 21 CFR Part 806