Year 2000 Computing Crisis:

Compliance Status of Many Biomedical Equipment Items Still Unknown

AIMD-98-240: Published: Sep 18, 1998. Publicly Released: Sep 24, 1998.

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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.

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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to take prompt action to complete and issue as soon as possible to the VISNs and medical facilities a Year 2000 guidebook on how to address contingency planning and other related issues for biomedical equipment for incorporation in their individual Year 2000 plans.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: VHA issued the VHA Year 2000 Guidebook for Medical Equipment in September 1998, and provided copies to each VISN and medical facility. The guidebook, in conjunction with the VA National Symposium held in September 1998, provided medical facilities a framework to develop contingency plans tailored to their individual needs.

    Recommendation: The Secretary of Veteran Affairs should direct the Under Secretary for Health to take prompt action to require that each VISN director ensure that medical facilities within the VISN complete development of a Year 2000 business continuity and contingency plan for biomedical equipment in its inventory. This plan should address the steps the facility will take on: (1) biomedical equipment produced by the manufacturers from which VHA has not received compliance information and the nearly 100 manufacturers no longer in business; (2) noncompliant equipment that has date-time problems but can still be safely used on and after January 1, 2000; and (3) equipment that manufacturers have certified as compliant but that may cease to function or malfunction on and after January 1, 2000.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: VA agreed with this recommendation and addressed it, in part, through VHA Directive 99-016, of April 21, 1999. Under this directive, VA health care facilities were to review all medical devices whose Y2K compliance status was unknown or noncompliant for disposition by June 1, 1999. Medical centers could replace, retire or continue to use as-is medical equipment in the unknown or noncompliant category. If a medical center elected to continue to use medical equipment as is, the center director had to approve such usage. The directive further requires medical facilities to review all conditional compliant medical devices for disposition no later than September 1, 1999. The directive did not address actions to be taken on equipment that manufacturers certified as Y2K compliant but may cease to function or malfunction on or after January 1, 2000. However, VHA medical center business continuity and contingency plans are to cover this subject matter.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services should work jointly to develop immediately a single data clearinghouse that provides compliance information to all users of biomedical equipment. Development of this clearinghouse should involve representatives from the health care industry, such as the Department of Defense's Health Affairs, American Hospital Association, American Medical Association, and Health Industry Manufacturers Association. At a minimum, the clearinghouse should contain: (1) information on the compliance status of all biomedical equipment by make and model; (2) the identity of manufacturers that are no longer in business, including the types of equipment, makes and models produced by these manufacturers; (3) the identity of manufacturers that have and have not provided VHA or FDA with test results certifying that their equipment is Year 2000 compliant; and (4) the identity of manufacturers that have not provided compliance information to VHA or FDA.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: In response to the recommendation, VA, FDA, and DOD, with the assistance of the Health Industry Manufacturers' Association, established the Federal Y2K Biomedical Clearinghouse database. In March 1999, VA provided medical device compliance information it had received from manufacturers to FDA. This information is now publicly available through the clearinghouse. In addition, VA had resolved Y2K compliance issues with all but eight nonresponsive manufacturers. VHA has recommended to the seven VHA medical facilities that had devices produced by these manufacturers in their inventories to replace the devices or develop specific contingency plans for them.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services should work jointly to develop immediately a single data clearinghouse that provides compliance information to all users of biomedical equipment. Development of this clearinghouse should involve representatives from the health care industry, such as the Department of Defense's Health Affairs, American Hospital Association, American Medical Association, and Health Industry Manufacturers Association. At a minimum, the clearinghouse should contain: (1) information on the compliance status of all biomedical equipment by make and model; (2) the identity of manufacturers that are no longer in business, including the types of equipment, makes and models produced by these manufacturers; (3) the identity of manufacturers that have and have not provided VHA or FDA with test results certifying that their equipment is Year 2000 compliant; and (4) the identity of manufacturers that have not provided compliance information to VHA or FDA.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: In response to the recommendation, FDA, VA, DOD, with the assistance of the Health Industry Manufacturers' Association established the Federal Y2K Biomedical Clearinghouse database. As part of this effort, VA provided compliance information on medical devices that it had received from equipment manufacturers to FDA in March 1999. This information is available through the clearinghouse. Manufacturer compliance information provided by VA is identified in the clearinghouse to alert users to the source of the data. The clearinghouse lists compliance status of equipment by make and model, and manufacturers from whom no information is available. The clearinghouse does not identify manufacturers that have or have not provided FDA with test results certifying that their products are Y2K compliant. However, FDA has recently begun a separate effort, utilizing the services of a contractor, to audit a sample of medical device manufacturers' Y2K certification processes.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with the Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what actions, if any, should be taken regarding biomedical equipment manufacturers that have not provided VHA or FDA with compliance information.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: VA agreed with the recommendation and followed up with nonresponsive manufacturers to obtain product compliance information. Its efforts have reduced to eight the number of nonresponsive manufacturers, and these manufacturers produce a total of eight devices that are included in VHA's inventory. VHA's Y2K Project Office has informed the seven VA medical facilities that employ these devices to take action to either replace this equipment or develop specific contingency plans if they plan to continue using these devices. Continued use of these devices at a VA medical facility requires review and certification by qualified medical center clinical and biomedical engineering staff to assure that such use presents no risk to patient health and safety, and the signature of the medical center director.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with the Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what actions, if any, should be taken regarding biomedical equipment manufacturers that have not provided VHA or FDA with compliance information.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: The department concurred that it would be necessary to determine what further action should be taken regarding manufacturers who failed to respond to the Food and Drug Administration's request for compliance information. However, it stated that it had no authority to require all device manufacturers to submit reports on product compliance. The department did state that the Food and Drug Administration would encourage manufacturers to cooperate with the Federal Y2K Biomedical Equipment Clearinghouse.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with VA's Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what actions, if any, are needed to address biomedical equipment produced by manufacturers no longer in business.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: The department concurred that the identity of defunct biomedical equipment manufacturers, along with the known types, makes and models of devices they manufactured, should be included in the clearinghouse. It further stated that it would explore possible approaches to acquiring additional information on defunct manufacturers' products. However, further action did not occur.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with VA's Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what actions, if any, are needed to address biomedical equipment produced by manufacturers no longer in business.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: VA agreed with the recommendation and directed medical centers on April 21, 1999, to replace, retire, or continue to use as is any medical device which they have not been able to assess due to a lack of information because manufacturers of such devices have been determined to no longer be in business. The VHA Y2K Project Office provided the medical centers with a list of these manufacturers. The medical centers are to identify any equipment in their inventories from these manufacturers and make a decision on the disposition of this equipment.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with VA's Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should take prudent steps to review the test results for critical care/life support biomedical equipment, especially that equipment once determined to be noncompliant but now deemed compliant, and that for which there are concerns about the determination of compliance, and make the results of these reviews publicly available through the single data clearinghouse.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: Following discussions between the department and GAO, the department agreed that FDA would employ the services of a contractor to review Y2K compliance activities of a sample of 80 manufacturers of potentially high-risk devices. The contractor carried out on-site assessments of these firms' Y2K activities in six key areas and prepared a report on concerns identified in each area. The six areas were executive leadership and control, risk management, corrective and preventive actions, test planning and procedures, communication with users of the firms' products, and implementation and contingency planning. FDA made the results of this review available through the Federal Y2K Biomedical Equipment Clearinghouse.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with VA's Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should take prudent steps to review the test results for critical care/life support biomedical equipment, especially that equipment once determined to be noncompliant but now deemed compliant, and that for which there are concerns about the determination of compliance, and make the results of these reviews publicly available through the single data clearinghouse.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: The department deferred to the Department of Health and Human Services, which took action on this recommendation.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services in conjunction with the Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what legislative, regulatory, or other changes are necessary to obtain assurances that the manufacturers' equipment is compliant, including performing independent verification and validation of the manufacturers' certification.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: The Department of Health and Human Services stated that existing legislation places the oversight and regulatory responsibility for domestic and imported medical devices with the Food and Drug Administration (FDA). Therefore, there was no need for legislative or other regulatory changes to obtain assurances that the manufacturers' equipment is compliant. It further stated that solutions to Y2K biomedical equipment problems could be achieved through other approaches such as the Federal Y2K Biomedical Equipment Clearinghouse. However, in 1999, the FDA under existing authority, conducted a review of a statistical sample of 80 biomedical equipment manufacturers Y2K compliance activities. They found the vast majority of manufacturers' activities were effective and promised to follow up with those that needed improvement.

    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to take prompt action to ensure that the Veterans Integrated Service Networks (VISN) and medical facilities use the new reporting system to provide the VHA Year 2000 Project Office with up-to-date and more complete information on the cost to replace and/or repair noncompliant and conditional-compliant biomedical equipment.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: VA agreed with this recommendation and addressed it through the VISN Chief Information Officer Council. The council discussed the recommendation at meetings and conducted follow-up conference calls between meetings to resolve shortcomings in the reporting process for Y2K compliance of biomedical equipment. However, not all medical centers used the reporting process to provide the VHA Y2K Project Office with accurate reports.

    Recommendation: The Secretary of Veterans Affairs and the Secretary of Health and Human Services in conjunction with the Under Secretary for Health and the Acting Commissioner of the Food and Drug Administration, should determine what legislative, regulatory, or other changes are necessary to obtain assurances that the manufacturers' equipment is compliant, including performing independent verification and validation of the manufacturers' certification.

    Agency Affected: Department of Veterans Affairs

    Status: Closed - Implemented

    Comments: VA stated that it has no regulatory authority in this area, and deferred to HHS. VA did not pursue additional regulatory authority but rather relied on the efforts of the FDA to address this issue. In 1999, FDA conducted a review of a statistical sample of 80 biomedical equipment manufacturers' Y2K compliance activities and found the vast majority of manufacturers' activities were effective. FDA promised to follow up with those manufacturers that needed to improve their compliance activities.

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