Biomedical equipment, such as magnetic resonance imaging (MRI) systems, X-ray machines, cardiac monitoring systems, cardiac defibrillators, and various other tools for laboratory analysis, are critical to health and medical treatment and research in federal and private sector health care facilities. This equipment may use a computer for calibration or day-to-day operation. The computer could be either a personal computer that connects to the equipment remotely or a microprocessor chip embedded within the equipment. In either case, the controlling software may be susceptible to the Year 2000 problem if any type of date or time calculation is performed. This could range from the more benign—such as incorrect formatting of a printout—to the incorrect operation of the equipment with the potential to adversely affect patient care or safety. The degree of risk depends on the role of the biomedical equipment in the patient’s care. VHA manages health care delivery to veterans within 22 regional areas known as Veterans Integrated Service Networks (VISN). These VISNs encompass 172 VHA medical centers, 376 outpatient clinics, 133 nursing homes, and 30 domiciliaries—a total of 711 facilities. VHA’s biomedical equipment inventory—with its acquisition cost valued at almost $3 billion—can be found at these facilities. As the largest centrally directed civilian health care system in the United States, VHA is a key stakeholder in determining the Year 2000 compliance of biomedical equipment. VHA’s CIO has overall responsibility for planning and managing the Year 2000 compliance program. The CIO created a VHA Year 2000 Project Office, which directs and oversees the Year 2000 assessment and renovation activities in the VISNs. Another key player in determining the Year 2000 compliance of biomedical equipment is FDA. Under provisions of the Federal Food, Drug, and Cosmetic Act, as amended, FDA protects public health through oversight and regulation of medical devices. FDA regulates medical devices that use computers or software pursuant to applicable FDA medical device regulations. In September 1997, we testified that both VHA and FDA had just begun efforts to assess biomedical equipment for Year 2000 compliance. VHA had sent letters to approximately 1,600 biomedical equipment manufacturers that supply VHA, requesting compliance information for their products. We also testified that FDA had sent a letter to about 13,000 medical device manufacturers in July 1997, reminding them of their responsibility to ensure that their products will not be affected by the century change. The objective of this review was to assess the status of VHA’s and FDA’s Year 2000 biomedical equipment programs. In performing this review, we applied criteria from our Year 2000 Assessment Guide and Year 2000 Business Continuity and Contingency Planning Guide. In assessing the status of VHA’s Year 2000 biomedical equipment program, we reviewed and analyzed VHA documents, including the March 25, 1998, VISN Assessment Feedback Reports; the January 30, 1998, Assessment Phase Report; the July 1997 Year-2000 Product Risk Program; the April 30, 1997, and October 31, 1997, versions of the Year-2000 Compliance Plan; and the May 15, 1998, and August 15, 1998, quarterly reports to OMB. We did not independently verify data contained in these documents. We met with Year 2000 project teams in three VISNs—VISN 4, VISN 5, and VISN 12—and in VHA medical facilities in Pittsburgh; Philadelphia; Wilmington, Delaware; Washington, D.C.; Baltimore; Martinsburg, West Virginia; and Chicago. We also discussed VA biomedical equipment assessment and renovation plans and efforts with members of the Year 2000 Project Office at VHA headquarters in Washington, D.C. To assess the status of FDA’s Year 2000 biomedical equipment program, we reviewed FDA documents on this issue, including those on its Internet World Wide Web site. We met with HHS’ Director of Policy and Evaluation in Washington, D.C., and the Director of FDA’s Division of Electronics and Computer Science at the Center for Devices and Radiological Health, located in Rockville, Maryland. We also met with biomedical engineers, who were attending the 1998 annual meeting of the Association for the Advancement of Medical Instrumentation. At this meeting, both VHA and FDA officials presented their respective Year 2000 biomedical equipment programs. We performed our work from July 1997 through June 1998, in accordance with generally accepted government auditing standards. We requested written comments on a draft of this report from the Secretary of Veterans Affairs and the Secretary of Health and Human Services. These comments are reprinted in appendixes I and II. Since our September 1997 testimony, VHA has made progress implementing its Year 2000 strategy for biomedical equipment. This strategy, which depends on compliance information from the manufacturers, consists of five steps. These are (1) increase awareness and continually educate VHA CIOs, VISNs, and health care facilities on biomedical issues, (2) establish an expert working group to provide guidance, (3) develop a database of biomedical equipment manufacturers that supply equipment to VHA, (4) survey these manufacturers to identify the compliance status of biomedical equipment and solutions for noncompliance, and (5) communicate survey results to the field for use in determining the compliance status of biomedical equipment at the medical facilities. Each month, these facilities are expected to report to the VHA Year 2000 Project Office their strategies for dealing with noncompliant and conditional-compliant equipment in their inventories and the cost to accomplish this. To increase awareness, VHA has established an intranet web site containing compliance information from the manufacturers. This web site is also used to educate VHA CIOs, VISNs, and health care facilities on biomedical issues. VHA has also established an expert working group to assist the Year 2000 Project Office in identifying, assessing, and evaluating biomedical equipment at risk from the Year 2000 problem. VHA developed a database of biomedical equipment manufacturers by using an existing database, which tracks service manuals of both medical devices and scientific and research instruments purchased by its medical facilities. The expert working group reviewed the database to ensure that key manufacturers in specialty areas were included. To survey biomedical equipment manufacturers, the VHA Year 2000 Project Office sent a series of letters to them requesting information on the Year 2000 compliance status of their products. The first letter was sent to approximately 1,600 manufacturers on September 9, 1997. Two follow-up letters were sent to those that did not respond on October 6, 1997, and November 12, 1997. Upon receipt of responses to these letters, VHA categorized the compliance status provided by the manufacturers for the equipment, as illustrated in table 1. Of the nearly 1,600 manufacturers in VHA’s initial mailing, VHA determined that about 100 were no longer in business. Accordingly, VHA revised its list of manufacturers to 1,504 as of June 1, 1998, and reported that it received compliance information from 1,070, or 71 percent, of these manufacturers. Just under half of the 1,504 manufacturers reported that all of their devices are Year 2000 compliant. As shown in table 2, the manufacturers have provided VHA with compliance information on a wide range of biomedical equipment. VHA’s data, as of June 1, 1998, indicated that for those manufacturers that reported, at least 80 percent of the equipment types are compliant. According to VHA’s Year 2000 Project Manager, the expert working group reviews the information provided by the manufacturers for reasonableness. The Year 2000 Project Office has provided this information to its medical facilities through VHA’s intranet web site, and the facilities are to use the information to assess the compliance status of their equipment. 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. For example, a noncompliant electrocardiograph machine, used to monitor heart signals, would print charts with two-digit dates, showing the year 2000 as “00.” According to the Diagnostic Services Chief of VHA’s Technology Division, these cases do not generally lead to the equipment failing to operate and do not present a risk to patient safety because health care providers, such as physicians and nurses, are able to work around this problem. For example, a physician or technician would note the correct year on the printout from the electrocardiograph machine when the equipment imprints “1900” on the printout. However, VHA recognizes that incorrect date-time representation or use could pose a risk when the date is used in a calculation or when records generated by the equipment is sorted automatically to present a patient’s condition, over a period of time, to a physician for diagnosis and treatment. Specifically, when records are sorted by date of recording, the accuracy of such dates can be critical to a physician’s monitoring of patient progress in, for example, the case of blood sugar readings. If readings were taken on December 25, 27, and 30, 1999, and again on January 1, 2000, for example, the ordering might appear with the last entry first, if it were abbreviated as “00” and read as January 1, 1900. If the physician or other clinician did not pay close attention, a faulty diagnosis or treatment decision could be made based on a misreading of the data. VHA also recognizes that an equipment function that depends on a calculation involving a date and that is performed incorrectly as a result of a date problem, could present a risk to the patient. One example reported by a manufacturer is a product used for planning the delivery of radiation treatment using a radioactive isotope as the source. An error in the calculation of the radiation source’s strength could result in inappropriate treatment—either too low or too high a dosage—and could have an adverse effect on the patient on or after January 1, 2000. This noncompliant equipment is currently in the inventory of several VHA medical facilities.