Year 2000 Computing Crisis: Compliance Status of Many Biomedical Equipment Items Still Unknown
Published: 1998-09-18T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Biomedical equipment is important to the Veterans Health Administration’s (VHA) role of providing health care services to the nation’s veterans. This equipment includes medical devices, such as cardiac defibrillators, cardiac monitoring systems, and pacemakers, which can record, process, analyze, display, and/or transmit medical data, and some of which may be implanted in patients, as well as scientific and research instruments, such as blood gas and glucose analyzers. Biomedical equipment may employ computers or computer chips to operate and/or may be adversely affected by the Year 2000 problem. In addition, the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) has responsibility for oversight and regulation of medical devices, including the impact of the Year 2000 problem.
As you requested, and based on subsequent discussions with your office, we assessed the status of VHA’s and FDA’s Year 2000 biomedical equipment programs. Our assessments of other aspects of the Veterans Benefits Administrations’ and VHA’s Year 2000 programs, including their mission-critical systems, locally developed software applications, commercial off-the-shelf software products, and facility systems, were reported to you separately.
subsections: section_title: Background
paragraphs: 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.
section_title: Objective, Scope, and Methodology
paragraphs: 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.
section_title: VHA Has Made Progress in Implementing Its Year 2000 Strategy
paragraphs: 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. In commenting on a draft of this report, VA noted that VHA has identified three facilities that use this specific equipment, and the noncompliant equipment will be taken out of service.
Given the above case scenarios, it is crucial that biomedical equipment manufacturers provide VHA with information on the compliance status of their equipment. This information is necessary for VHA medical facilities to formulate safe and effective solutions to address Year 2000 problems.
Between November 1997 and January 1998, VHA’s medical facilities completed inventories of their biomedical equipment and reported the results to the Year 2000 Project Office. Using data on the facility’s biomedical equipment inventory from VHA’s equipment database, each facility was to conduct a physical inventory of its biomedical equipment and check this inventory against compliance information submitted by the manufacturers, which the Year 2000 Project Office had posted on the VHA intranet web site.
According to VHA’s January 30, 1998, Year 2000 Assessment Phase Report, the medical facilities noted that based on the information from the manufacturers, some of the noncompliant biomedical equipment at VHA sites included defibrillator monitors, noninvasive blood pressure machines, vital signs monitors, and cardiology monitors. VHA officials have stressed that noncompliant equipment of one type reported by certain manufacturers does not indicate that all equipment of the same type in use at its medical facilities is noncompliant. VHA officials told us that there are other manufacturers of this equipment type that have reported that their equipment is compliant.
The VHA Year 2000 Project Office has directed VHA medical facilities to regularly check the web site for updates on the compliance status of biomedical equipment reported by manufacturers. This is important for the medical facilities because, in some cases, the manufacturers have subsequently changed the compliance status of their equipment after their initial reports to VHA. The changes have ranged from some equipment previously reported as conditional-compliant that is now being reported as compliant to equipment previously reported as compliant that is now considered noncompliant. According to VHA’s Year 2000 Project Manager, the project office monitors the medical facilities’ Year 2000 activities through periodic reports and site visits.
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. This is because some manufacturers have informed them that VHA should not attempt to conduct in-depth testing by manipulating the software embedded inside the equipment. According to the Diagnostic Services Chief of VHA’s Technology Division, such testing may void the manufacturer’s certification to FDA that the equipment is safe for use on patients, thereby exposing VHA to legal liability in the event that a patient’s health is harmed by equipment that malfunctions following VHA testing. VHA’s Year 2000 Project Manager told us that the medical facilities will perform limited functional testing of replacement equipment and of manufacturer modifications to conditional-compliant equipment. He stated that the medical facilities will test equipment performance in accordance with locally established acceptance testing procedures for new equipment.
section_title: Uncertainty Over Year 2000 Compliance Status Increases Risk
paragraphs: 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. This situation impedes VHA’s medical facilities from promptly developing strategies to deal with equipment with potential patient safety problems. In addition, the current cost estimate of $40 million reported to OMB to replace or repair noncompliant equipment is incomplete. Also, given the uncertainties surrounding the compliance status of many VHA biomedical equipment items, it is critical that medical facilities develop contingency plans to ensure patient care in the event of Year 2000-related failures. However, the medical facilities have not completed such plans.
subsections: section_title: Some Manufacturers Have Not Provided Compliance Information on Their Equipment
paragraphs: VHA does not currently know how much of its biomedical equipment is Year 2000 compliant because, as shown in table 3, it has not yet received compliance information from 398 manufacturers. This information is critical to VHA because, like other health care providers, it relies on the manufacturers to validate, test, and certify that their equipment is compliant.
Letters sent to more than half of the nonresponsive manufacturers—227 out of 398—were returned to VHA by the U.S. Postal Service marked with no forwarding addresses. In addition, as noted in table 3, an additional 47 manufacturers that did respond are in the pending category because they reported that they had not completed their assessments, and, therefore, did not yet know if their products were compliant. 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.
According to the Year 2000 Project Manager, VHA will continue its efforts to obtain compliance information from nonresponding manufacturers. Consistent with this strategy, on June 24, 1998, VHA sent another letter to nonresponsive manufacturers requesting that they provide VHA with Year 2000 compliance information on their products. The Project Manager said VHA will continue to work through October 1998 to obtain compliance information from the manufacturers. Further, he said at that time, VHA’s medical facilities must be ready to put contingency plans into effect for noncompliant and conditional-compliant equipment and for that equipment, the status of which is unknown.
section_title: Year 2000 Cost Estimate for Biomedical Equipment Is Incomplete
paragraphs: VHA’s Year 2000 cost estimate for replacing and/or retiring noncompliant biomedical equipment is incomplete. In its August 15, 1998, quarterly report to OMB, VA estimated the Year 2000 cost to replace or repair this equipment at $40 million. It also reported that VA expects the costs to replace or repair noncompliant biomedical equipment to increase as manufacturers continue to disclose their compliance status. The VHA Year 2000 Project Manager told us that VHA expects to manage these costs within the department’s budget. However, the $40 million estimate is not based on updated cost information from the medical facilities, and VHA does not know the replacement and repair cost for biomedical equipment for the manufacturers that have not reported compliance and cost information, as well as the nearly 100 manufacturers that are no longer in business.
VHA’s Year 2000 Project Manager informed us that three quarters of the $40 million estimate was calculated based on cost information provided by the VISNs and medical facilities. 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. The remaining $10 million was calculated based on the VHA Year 2000 Project Office’s estimate of the number of such equipment items at VHA medical facilities and any cost information provided by manufacturers during the period February through April 1998.
VHA’s Year 2000 Project Manager has acknowledged the shortcomings of the current cost estimate. Accordingly, the VISNs were to begin using a new reporting process, effective July 31, 1998. The new process will use a recently developed software package to track the status of noncompliant and conditional-compliant equipment at the medical facilities and the associated costs to replace, repair, or retire it. In commenting on a draft of this report, VA stated that this software was released on July 10, 1998, and the Under Secretary for Health signed an information letter, providing direction and instruction on the software to VHA medical facilities on July 20, 1998.
section_title: VHA Has Not Yet Completed Business Continuity and Contingency Plans for Biomedical Equipment
paragraphs: To assist agencies in their business continuity and contingency planning efforts, we have prepared a guide that discusses the scope of the Year 2000 challenge and offers a step-by-step approach for reviewing an agency’s risks and threats as well as how to develop backup strategies to minimize these risks. This business continuity and contingency planning process safeguards the agency’s ability to produce a minimally acceptable level of outputs and services in the event of failures of internal or external mission-critical information systems and services. A business-level contingency plan would address how each VHA medical facility would handle various types of Year 2000 problems caused by business partner problems, such as nonresponsive manufacturers and the nearly 100 manufacturers that VHA determined were no longer in business.
Despite the uncertainties surrounding the compliance status of many of VHA’s biomedical equipment and the potential health risks to patients of certain equipment, VHA medical facilities have not yet completed business continuity and contingency plans on actions they must take to address potential Year 2000-related failures. The Year 2000 Project Manager informed us that these plans need to be ready for implementation by October 31, 1998. He did not know the status of these plans because the project office had not reviewed them. The Project Manager told us that he expects to review these plans when Year 2000 Project Office representatives visit the VISNs and medical facilities later in 1998.
Our review of the March 25, 1998, VISN Assessment Feedback Reports for the three VISNs we visited showed that these VISNs had reported that they did not have business continuity and contingency plans to deal with 76 of the 89 noncompliant biomedical equipment items identified in their inventories. The CIOs at two of these VISNs informed us that they are currently in the process of developing these plans. The third CIO said the VISN’s medical facilities have prepared business continuity and contingency plans. However, our review of four of the five plans for this VISN disclosed that these plans did not specifically address Year 2000-related failures of biomedical equipment. Instead, they focused on preventative maintenance inspections and general system and equipment failures.
In light of the uncertainties surrounding the compliance status of VHA’s biomedical equipment and their potential effect on patient health and safety, it is crucial that medical facilities be prepared in the event of Year 2000 failures. An official in VHA’s Year 2000 Project Office told us that the office is in the process of developing a guidebook to assist the VISNs and medical facilities in addressing Year 2000 business continuity and contingency planning for biomedical equipment and other related issues. The Year 2000 Project Manager said the guidebook will discuss VHA’s strategy for obtaining information from nonresponsive manufacturers and address issues such as replacing, repairing, and/or retiring noncompliant biomedical equipment and equipment produced by the nearly 100 manufacturers no longer in business; using the new reporting software for biomedical equipment; procuring compliant biomedical equipment; and having adequate facility staff available on the weekend of January 1, 2000. In commenting on a draft of this report, VA noted that a draft of the guidebook was completed on August 6, 1998, and it expects to issue a final guidebook by September 1998.
section_title: FDA Is Also Relying on Biomedical Equipment Manufacturers for Compliance Information
paragraphs: FDA, the agency with oversight and regulatory responsibility for domestic and imported medical devices, is also trying to determine the Year 2000 compliance status of these devices, as well as some scientific and research instruments. Its goal is to provide a comprehensive, centralized source of information on the Year 2000 compliance status of biomedical equipment used in the United States and make this information publicly available on an Internet World Wide Web site.
On January 21, 1998, HHS, on FDA’s behalf, issued a letter to approximately 16,000 domestic and foreign biomedical equipment manufacturersrequesting information on the Year 2000 compliance of their complete product line. The letter stated that all information received would be made available to the public through FDA’s web site. Manufacturers were asked to identify any noncompliant products by type and model number and provide a brief description of the date-related problems and the solutions for mitigating the problems. If all the manufacturer’s products were considered compliant, the manufacturer was asked to provide a statement certifying such compliance. In this case, the manufacturer did not have to provide information on the compliant device’s make and model. Manufacturers were instructed to forward their responses in writing or electronically to FDA’s Center for Devices and Radiological Health.
FDA acknowledges that the response rate to date to the January 1998 letter is disappointing. As of July 30, 1998, FDA had received 1,975 responses from biomedical equipment manufacturers and posted them on its web site. The Director of FDA’s Division of Electronics and Computer Science cited several reasons for the low response rate, including manufacturers not yet completing their assessments and the manufacturers’ responses to FDA’s request being voluntary. He also indicated that the vast majority of manufacturers that received letters from FDA do not make products with any sort of electronic components, and he believed that many of these manufacturers chose not to respond because the request did not pertain to them.
On June 29, 1998, FDA sent a second request to 1,935 medical device manufacturers that had not previously responded to its inquiry and that FDA believes have products that might employ computers or embedded systems. According to the Director, as of July 30, 1998, 628 manufacturers reported that their products employ a date/time function. Of these, about 100 indicated that one or more of their products were not compliant. “Inclusion of information in this database indicates that the manufacturer has certified that the data is complete and accurate. The Food and Drug Administration, however, cannot and does not make any independent assurances or guarantees as to the accuracy or completeness of this data.”
The Director informed us that except for diagnostic X-ray equipment, FDA does not test new medical devices entering the market. In addition, he said that FDA has performed about 8 to 10 tests per year involving forensic investigations of problem devices. In commenting on a draft of this report, HHS stated that FDA tests this equipment during the premarket review process to ensure that it is in compliance with a mandatory federal performance standard for X-ray equipment. It also indicated that the testing of this equipment does not include compliance with Year 2000 requirements.
According to the Director, FDA reviews the test results submitted by manufacturers requesting premarket approval of their medical devices to see if the manufacturers have demonstrated that products are safe and effective for intended use. When asked if FDA will request test reports from manufacturers that have renovated medical devices that are not Year 2000 compliant, the Director informed us that FDA will not. He said that correcting a date problem does not change the design of the device, and it is the manufacturers’ responsibility to ensure proper device design. We disagree with the Director that the date change will not change the design of the device. Correcting the date problem will change the software design of the device and may alter the internal logic of the software. The Director also cited staff limitations as another reason for not requesting and reviewing test results from the manufacturers.
subsections: section_title: Some Users Question Usefulness of Current FDA Biomedical Equipment Web Site
paragraphs: While FDA is making an effort to assemble information on biomedical equipment compliance and making this information available to the public, some biomedical engineers attending a June 1998 meeting of the Association for the Advancement of Medical Instrumentation expressed concern that information on the FDA web site is not detailed enough to be useful. Specifically, as mentioned earlier, FDA’s list of compliant equipment contains no information on the equipment’s make and model. In contrast, VHA’s list of compliant equipment generally contains such information.
Also, a review of the FDA database for noncompliant equipment disclosed that some manufacturers have reported that they will have solutions for their equipment in late 1999. Putting off solutions until this late date is risky. However, making this information publicly available does provide hospitals and other users of biomedical equipment with the opportunity to plan alternative solutions.
Further, the Year 2000 compliance information publicly available through FDA does not include responses from many of the manufacturers that have responded to VHA. For example, we selected, on a random basis, a sample of 53 manufacturers in VHA’s database that reported their products to be Year 2000 compliant and found that 48 of them were not listed in the FDA database. We, likewise, selected a sample of 13 manufacturers in VHA’s database that reported that their products are not Year 2000 compliant, and found that 12 of them were not listed in the FDA database. These manufacturers’ products include cardiology equipment, defibrillator monitors, and ultrasound equipment.
The Director of FDA’s Division of Electronics and Computer Science acknowledged that the manufacturers were more responsive to VHA’s requests, and the VHA database, therefore, contains a higher percentage of responses. He said that he believed the primary reason for this was VHA’s position as a large volume customer that could take future action toward the manufacturer if the information was not forthcoming. He also noted that FDA requested information on the complete product line of the manufacturers, while VA requested information from the manufacturers on its list of suppliers.
section_title: New Reporting Requirements Identify Medical Devices Posing Health Risk
paragraphs: FDA implemented a new rule on May 18, 1998, requiring medical device manufacturers and importers to report promptly to FDA action to correct and remove devices that pose a health risk or that are in violation of the Federal Food, Drug, and Cosmetic Act. This rule protects public health by ensuring that FDA has current and complete information regarding actions taken on medical devices. These reports are expected to improve FDA’s ability to evaluate device-related problems, as well as enable it to take prompt action regarding devices, that pose a health risk. Under the new rule, the affected manufacturer is required to submit a report of action taken to correct the problem or remove the device from service.
According to the Director of the Center for Devices and Radiological Health, under the new rule, FDA has a better chance of learning what corrective actions, including those to address the Year 2000 computer problem, are taken by the manufacturers on medical devices that could pose health risks. The Director said that no manufacturers have yet submitted any reports under this new reporting requirement.
section_title: VHA Plans to Make Compliance Information Available to the Public
paragraphs: 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. The VHA Year 2000 Project Manager told us that VHA believed it would need the manufacturers’ permission before it could share this information. He said that VHA is concerned about the proprietary nature of the products, potential legal issues, and manufacturers’ price structure for Year 2000 compliant products. VHA had shared some of Year 2000 compliance status information provided by manufacturers with federal agencies, such as the Department of Defense and the National Institutes of Health (NIH), with the caveat that it was for federal use only. NIH then shared this information with FDA.
VHA, on the advice of the VA Acting General Counsel, has recently informed the manufacturers of its plans to make this information available to the public through an Internet World Wide Web site. Specifically, on June 17, 1998, VHA mailed letters to manufacturers that had responded to VHA’s previous requests for compliance information. It informed the manufacturers that it intended to place information they provided to VHA on a publicly-available World Wide Web site unless the manufacturers informed it otherwise. VHA included similar language in a June 24, 1998, letter to manufacturers that had not yet provided compliance data. The VHA Year 2000 Project Manager said the response from the manufacturers as of June 30, 1998, has been positive. He added that two manufacturers objected to disclosing this information to the public, citing proprietary reasons. These responses have been referred to VA’s legal department.
VA has not yet decided how and when a clearinghouse of compliance information provided to VHA from manufacturers will be made available to the public. According to VHA’s Year 2000 Project Manager, the FDA web site is one of the options being considered for the clearinghouse. The Director of FDA’s Division of Electronics and Computer Science informed us that FDA and VHA have discussed using FDA’s web site as such a clearinghouse.
VA’s Under Secretary of Health recognizes the importance of gathering compliance data and sharing them publicly. Specifically, in a July 9, 1998, press conference sponsored by the National Patient Safety Partnership,he called on biomedical equipment manufacturers to identify and address potential patient safety problems resulting from the Year 2000 problem. On behalf of the partnership, he called for (1) all health care practitioners and medical treatment facilities to survey their equipment and seek information from their relevant biomedical equipment manufacturers about their products’ Year 2000 compatibility, (2) all health care consumers who use biomedical equipment at home to check with their health care providers about the products’ Year 2000 compatibility, (3) the medical equipment manufacturers to take immediate action to determine the compliance status of their equipment, and (4) the establishment of a single, national clearinghouse from which compliance information from manufacturers can be readily accessed by the public. The Under Secretary reiterated these four items in a July 23, 1998, hearing before the Senate Special Committee on Year 2000.
section_title: Conclusions
paragraphs: Prompt correction of the Year 2000 problem for biomedical equipment is critical to VHA’s role as a health care provider. 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. This information is important because VHA relies on the manufacturers to validate, test, and certify that their equipment, including replacement equipment, is compliant. Despite these uncertainties, VHA medical facilities have not yet completed business continuity and contingency plans on actions they must take to address Year 2000-related failures. The Year 2000 Project Office also has not yet completed a Year 2000 contingency guidebook for biomedical equipment to assist the VISNs and medical facilities in their business continuity and contingency planning and other activities. Until these issues are resolved, VHA lacks adequate assurance that its delivery of medical care through the use of biomedical equipment will not be adversely affected by the Year 2000 problem.
FDA’s goal is to provide a comprehensive, centralized source of information on the Year 2000 compliance status of biomedical equipment used in the United States, and make this information publicly available on an Internet World Wide Web site. FDA, like VHA, relies on the manufacturers to validate, test, and certify that the equipment is Year 2000 compliant. However, FDA has no assurance that the manufacturers have adequately addressed the Year 2000 problem for noncompliant equipment because it does not require manufacturers to submit test results to FDA certifying compliance. Also, FDA does not have as much information in its database on the compliance status of biomedical equipment as VHA.
Finally, VHA, which currently does not make compliance information obtained from the manufacturers available to the public, now plans to do this through an Internet World Wide Web site. The sharing of this information could greatly assist all health care providers and other users of biomedical equipment in identifying noncompliant and conditional-compliant equipment in their inventories and taking prompt action to make them compliant. Sharing also could provide users with a mechanism to overcome the deficiencies in the FDA database, such as the lack of detailed information on the make and model of compliant equipment and the disappointing response rate from manufacturers to FDA’s request for compliance information.
section_title: Recommendations to the Secretary of Veterans Affairs
paragraphs: We recommend that the Secretary of Veterans Affairs direct the Under Secretary for Health to take prompt action to:
Ensure that the VISNs 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.
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.
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 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 have 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.
section_title: Recommendations to the Secretary of Veterans Affairs and the Secretary of Health and Human Services
paragraphs: We recommend that the Secretary of Veterans Affairs and the Secretary of Health and Human Services 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 and/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 and/or FDA.
We also recommend that the Secretary of Veterans Affairs and the Secretary of Health and Human Services, in conjunction with VA’s Under Secretary for Health and the Commissioner of the Food and Drug Administration, determine what actions, if any, should be taken regarding biomedical equipment manufacturers that have not provided VHA and/or FDA with compliance information; determine what actions, if any, are needed to address biomedical equipment produced by manufacturers no longer in business; take prudent steps to review the test results for critical care/life support biomedical equipment, especially 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; and 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.
section_title: Agency Comments and Our Evaluation
paragraphs: In commenting on a draft of this report, VA generally concurred with our recommendations to the Secretary of Veterans Affairs and the first of two joint recommendations to the Secretary of Veterans Affairs and the Secretary of Health and Human Services to develop a single data clearinghouse. VA stated that VHA is working closely with other federal agencies, such as the Department of Defense and FDA, to address common problems with biomedical, clinical, and laboratory equipment and facilities. VA also noted that it has joined with the American Hospital Association, the American Nurses Association, and the Joint Commission on the Accreditation of Healthcare Organizations in calling for a joint effort to create a national clearinghouse for Year 2000 information.
VA stated that the percentage of manufacturers not responding to VHA’s inquiries is now 14 percent, meaning an 86 percent response rate. However, VHA counted letters returned to VHA by the U.S. Postal Service marked with no forwarding address as responses. Because these manufacturers did not provide VHA with information on the compliance status of their products, the response rate from manufacturers, based on updated information provided to us by VA as of July 29, 1998, is 73 percent, only slightly above the 71 percent rate cited in our draft report.
VA also described actions taken and planned to implement our recommendations, as well as a number of suggested changes to this report. These comments have been incorporated into the report as appropriate and are reprinted in appendix I.
Regarding our second joint recommendation to the Secretary of Veterans Affairs and the Secretary of Health and Human Services, VA stated that it has no legislative or regulatory authority to implement this recommendation and defers to HHS. VA, however, stated that it will provide consultation or other appropriate assistance to HHS in implementing this recommendation.
HHS, in commenting on a draft of this report, also concurred with the joint recommendation to the Secretary of Veterans Affairs and the Secretary of Health and Human Services to develop a single data clearinghouse. It stated that HHS and VA are merging their efforts to provide complete information to the health care community and the general public regarding the Year 2000 compliance of biomedical equipment. It also stated that FDA will post on the web site the names of manufacturers that have not provided compliance certification. However, HHS did not believe that it is necessary or cost-effective to list all compliant products. It believed that information at the individual model level is only needed for noncompliant products. We disagree with HHS. The make and model information will provide users with detailed data on the reported compliance status of their products, especially for those 195 manufacturers that VA has determined to have merged or been bought out by other manufacturers as of July 29, 1998.
In addition, HHS concurred with two of the three components of the second joint recommendation. Specifically, it concurred with the component of the recommendation to determine the actions that should be taken regarding manufacturers who fail to respond to requests for compliance information. HHS also stated that under current regulations, FDA does not have the authority to require all device manufacturers to submit reports on whether their devices are Year 2000 compliant.
HHS also concurred that the identity of defunct manufacturers, along with the known types, makes, and models of devices they manufactured should be included in the clearinghouse database. It further stated that it would explore possible approaches to acquiring additional information regarding defunct manufacturers’ products.
HHS did not concur with the component of the recommendation to review test results supporting the medical device equipment manufacturers’ certifications that their equipment is compliant. It believed that the submission of appropriate certifications of compliance is sufficient to ensure that the certifying manufacturers are in compliance. We disagree that this is sufficient. Through independent reviews of the manufacturers’ test results, users of the medical devices are provided with a level of confidence that the devices are Year 2000 compliant. HHS also stated that it did not have the resources to undertake such a review, and there is insufficient time to complete a review of this nature. In this regard, if HHS lacks sufficient resources to review the manufacturers’ test results, it may want to solicit those of federal health care providers and professional associations, such as VA and the National Patient Safety Partnership. Additionally, to make effective use of limited resources, FDA and the health care community, at a minimum, should focus their review efforts on critical care/life support biomedical equipment that was determined to be noncompliant but is now deemed compliant and that for which there are concerns about the determination of compliance.
Regarding our recommendation on legislative or regulatory changes necessary to obtain assurances that manufacturers’ biomedical equipment is compliant, HHS believed that the solutions to the Year 2000 problems can be reached through approaches such as the clearinghouse. HHS also clarified FDA’s testing of diagnostic X-ray equipment. We have revised the report to reflect this.
Finally, HHS described actions it has taken and planned to implement our recommendations, and these are reprinted in appendix II. HHS also provided a number of technical suggestions to this report, and these comments have been incorporated into the report as appropriate.
As agreed with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution of it until 30 days from the date of this letter. We will then send copies to the Ranking Minority Member of the Subcommittee on Oversight and Investigations, House Committee on Veterans’ Affairs, and the Chairmen and Ranking Minority Members of the Subcommittee on Benefits, House Committee on Veterans’ Affairs, and the Subcommittee on Health, House Committee on Veterans’ Affairs. We will also provide copies to the Chairmen and Ranking Minority Members of the Senate and House Committees on Veterans’ Affairs; the Senate Committee on Appropriations; the Senate and House Subcommittees on VA, HUD and Independent Agencies, Senate and House Committees on Appropriations; the Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Senate Committee on Appropriations; the Senate Committee on Labor and Human Services; the Permanent Subcommittee on Investigations, Senate Committee on Governmental Affairs; the Subcommittee on Public Health and Safety, Senate Committee on Labor and Human Resources; House Committee on Appropriations; the Subcommittee on Labor, Health and Human Services, and Education, House Committee on Appropriations; the House Committee on Government Reform and Oversight; the Subcommittee on Human Resources, House Committee on Government Reform and Oversight; and the Subcommittee on Oversight and Investigations, House Committee on Commerce; and the Secretary of Veterans Affairs; the Acting Commissioner of the Food and Drug Administration; the Director of the Office of Management and Budget; and the Chair of the President’s Council on Year 2000 Conversion. Copies will also be made available to others upon request.
Please contact me at (202) 512-6253 or by e-mail at willemssenj.aimd@gao.gov if you have any questions concerning this report. Major contributors to this report are listed in appendix III.
section_title: Comments From the Department of Veterans Affairs
paragraphs: The following are GAO’s comments on the Department of Veterans Affairs’ letter dated August 25, 1998.
subsections: section_title: GAO Comments
paragraphs: 1. Discussed in “Agency Comments and Our Evaluation” section of report. 2. Report updated to reflect that only 1 of 19 manufacturers remains unresponsive. 3. Report changed to reflect agency comments.
section_title: Comments From the Department of Health and Human Services
paragraphs: The following are GAO’s comments on the Department of Health and Human Services’ letter dated September 2, 1998.
subsections: section_title: GAO Comments
paragraphs: 1. Report modified to include “1,935 manufacturers.” 2. Discussed in “Agency Comments and Our Evaluation” section of report. 3. Report revised to reflect agency comments. 4. Report revised to clarify the terms “biomedical equipment” and “medical devices.” The term biomedical equipment includes both medical devices subject to FDA regulation and scientific and research instruments which are not subject to FDA regulation.
section_title: Major Contributors to This Report
subsections: section_title: Accounting and Information Management Division, Washington, D.C.
paragraphs: Helen Lew, Assistant Director Nabajyoti Barkakati, Technical Assistant Director Tonia L. Johnson, Senior Information Systems Analyst J. Michael Resser, Business Process Analyst-in-Charge The first copy of each GAO report and testimony is free. Additional copies are $2 each. Orders should be sent to the following address, accompanied by a check or money order made out to the Superintendent of Documents, when necessary. VISA and MasterCard credit cards are accepted, also. Orders for 100 or more copies to be mailed to a single address are discounted 25 percent.
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