United States General Accounting Office

GAO Report to the Chairman, Subcommittee

on Oversight and Investigations,

Committee on Veterans’ Affairs, House

of Representatives

September 1998 YEAR 2000

COMPUTING CRISIS

Compliance Status of

Many Biomedical

Equipment Items Still

Unknown

GAO/AIMD-98-240

GAO United States

General Accounting Office

Washington, D.C. 20548

Accounting and Information

Management Division

B-280584 

September 18, 1998

The Honorable Terry Everett

Chairman, Subcommittee on Oversight

 and Investigations

Committee on Veterans’ Affairs

House of Representatives

Dear Mr. Chairman:

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.1

 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.2

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.3

1

The Year 2000 problem is rooted in how dates are recorded and computed. For the past several

decades, many existing computer systems have used a two-digit date field to represent the current

year—such as “98” for 1998. However, such a format does not distinguish between 2000 and 1900.

Computer programs that are not corrected to accommodate the 2000 date could process information

incorrectly, possibly affecting the medical care and safety of patients.

2

The Federal Food, Drug and Cosmetic Act grants FDA authority to regulate medical devices. The term

medical “device” is defined in 21 U.S.C. section 321 (h). For purposes of this report the term

biomedical equipment includes both medical devices subject to FDA regulation and scientific and

research instruments which are not subject to FDA regulation.

3

Year 2000 Computing Crisis: Progress Made in Compliance of VA Systems, But Concerns Remain

(GAO/AIMD-98-237, August 21, 1998).

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B-280584 

Results in Brief Since our September 1997 testimony,4 VHA has made progress in

implementing its Year 2000 strategy for biomedical equipment, which

relies on compliance information from the manufacturers. 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.

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. This is because, as of July 29, 1998, it had not received

compliance information from 27 percent of the manufacturers on its list of

suppliers, as well as the nearly 100 additional manufacturers that VHA

determined are no longer in business. 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

 Because VHA, like other health care

providers, relies on the manufacturers to validate, test, and certify that

their equipment is compliant, it is critical that they provide this

information to VHA so that it may take prompt action on noncompliant

equipment in its inventory.

According to VHA’s Year 2000 Project Manager, most of the manufacturers

reporting that they had noncompliant equipment cited incorrect display of

date and/or time as problems. Date and/or time display problems should

not present a risk to patient safety because health care providers can work

around them. However, some manufacturers cited problems that could

pose a risk to patient safety. For example, a radiation therapy planning

computer may miscalculate the radiation source strength on or after

January 1, 2000, and the resulting radiation dose may be hazardous or

ineffective for the patient.

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 (OMB) is incomplete.

This is because (1) the estimate is not based on updated cost information

from the medical facilities, (2) some manufacturers have not provided

compliance and cost information to VHA, and (3) nearly 100 manufacturers

are no longer in business. Furthermore, VHA’s medical facilities have not

4

Veterans Affairs: Action Underway Yet Much Work Remains to Resolve Year 2000 Crisis

(GAO/T-AIMD-97-174, September 25, 1997).

5

High-dollar value equipment has a purchase price in excess of $250,000.

Page 2 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

yet completed development of business continuity and contingency plans

to help ensure the health and well-being of VHA patients in the event that

some biomedical equipment items fail to operate at the turn of the century,

which poses a risk to patient safety.

To assist health care facilities in the public and private sectors, HHS, on

behalf of the Chief Information Officer (CIO) Council’s Subcommittee on

the Year 2000 for Biomedical Equipment, and FDA issued a letter in

January 1998 to biomedical equipment manufacturers, requesting

information on products affected by this computer problem. 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

manufacturers6

 to which its letter was sent. According to an FDA official,

many of these manufacturers do not produce any computerized products.

He said most of these respondents indicated that there are no Year 2000

problems with their products, but about 100 indicated that at least one of

their products is not compliant. FDA, like VHA and other health care

providers, relies on the manufacturers to validate, test, and certify that

their equipment is compliant. Accordingly, failure to obtain timely

compliance information from the manufacturers increases the risk to

health care providers and biomedical equipment users that their

equipment may not operate properly on and after January 1, 2000.

FDA has made information from the biomedical equipment manufacturers

available through an Internet World Wide Web site. VHA, however, has not

yet done so because (1) 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 (2) 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. VHA, on the advice of VA’s Acting General Counsel,

informed manufacturers in June 1998 that it plans to release information

that VHA has determined is not confidential commercial information. This

is an important step because compliance information from biomedical

equipment manufacturers is of interest to all health care providers and

users of biomedical equipment.

Background Biomedical equipment, such as magnetic resonance imaging (MRI) systems,

X-ray machines, cardiac monitoring systems, cardiac defibrillators, and

6

Biomedical equipment refers to both medical devices regulated by FDA and scientific and research

instruments not regulated by FDA.

Page 3 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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,7

 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.8 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.

7

21 U.S.C. sections 301 et. seq.

8

GAO/T-AIMD-97-174, September 25, 1997.

Page 4 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

Objective, Scope, and

Methodology

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 Guide9

 and Year 2000

Business Continuity and Contingency Planning Guide.10 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.

9

Year 2000 Computing Crisis: An Assessment Guide (GAO/AIMD-10.1.14, September 1997).

10Year 2000 Computing Crisis: Business Continuity and Contingency Planning (GAO/AIMD-10.1.19,

August 1998).

Page 5 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

VHA Has Made

Progress in

Implementing Its Year

2000 Strategy

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 group11 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.

11This group consists of physicians and engineers from the fields of radiology, nuclear medicine,

pathology and laboratory, cardiology, surgery, biomedical engineering, acquisition and materiel

management, medical research, prosthetics, and the Year 2000 Project Office.

Page 6 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

Table 1: VHA Biomedical Equipment

Compliance Categories Category Explanation

Compliant Equipment will function properly in all aspects upon the

change to the year 2000 without any modification or

revision.

Noncompliant Equipment will not function properly upon the change to

the year 2000, and no manufacturer remedy is available.

In some cases, improper function involves an incorrect

date-time stamp on the output of the equipment, but the

equipment’s clinical function is not impaired.

Conditional-compliant Equipment requires some form of user intervention to

function properly after the year 2000. Such intervention

includes the installation of manufacturer-provided

software or hardware or a one-time user action (such as

turning the equipment on and off after the year 2000).

Pending Manufacturers reported to VHA that they have not

completed the Year 2000 assessment of their product line.

Source: Veterans Health Administration.

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.

Page 7 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

Table 2: Reported Biomedical

Equipment Year 2000 Compliance

Categories, as of June 1, 1998, and

Examples Compliance category

Number of

manufacturers

Number of

equipment types

within this category

Examples of

equipment types

within this

categorya

Compliant 694 3,873 Intra-aortic balloon

pump, dialysis

machine

Noncompliant 34 182 Defibrillator monitor,

cardiology monitor

Conditional-compliant 102 673 Electrocardiograph

machine, defibrillator

Pending 53 157 Ultrasound system,

ventilator

Manufacturer merged

or bought out

187 b

Total 1,070 4,885

aInclusion of a specific type of biomedical equipment in the compliant, noncompliant,

conditional-compliant, or pending category does not necessarily mean that all equipment of this

type in VHA’s inventory was reported by the manufacturer; similar equipment made by other

manufacturers could fall into different categories.

bThe biomedical equipment reported by these manufacturers have already been accounted for in

one of the above compliance categories.

Source: Veterans Health Administration. We did not independently verify these data.

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

Page 8 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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

Page 9 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.12

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. This situation impedes VHA’s medical facilities from

promptly developing strategies to deal with equipment with potential

12These procedures generally prescribe that a systematic examination be performed to determine if the

equipment meets the electrical safety requirements of the medical facility and the manufacturer’s

performance specifications for the equipment.

Page 10 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

patient safety problems. In addition, the current cost estimate of

$40 million13 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.

Some Manufacturers Have

Not Provided Compliance

Information on Their

Equipment

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.

Table 3: Status of Manufacturer

Responses as of July 29, 1998 Status of manufacturer response Number of manufacturers

Compliant manufacturersa 701

Noncompliant manufacturersb 43

Conditional-compliant manufacturersc 106

Pending manufacturersd 47

Manufacturer merged or bought out 195

Nonresponsive manufacturerse 398

Total 1,490

aFor inclusion in this category, 100 percent of a manufacturer’s products had to be considered

compliant.

bFor inclusion in this category, only one of a manufacturer’s products had to be considered

noncompliant.

cFor inclusion in this category, the manufacturer has no noncompliant equipment, no pending

equipment, and at least one conditional-compliant equipment item.

dFor inclusion in this category, the manufacturer has no noncompliant equipment and at least one

equipment item that is pending.

eFor inclusion in this category, VHA had not received compliance information from the

manufacturer.

Source: Veterans Health Administration. We did not independently verify these data.

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

13We did not independently verify the $40 million cost estimate.

Page 11 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.

Year 2000 Cost Estimate

for Biomedical Equipment

Is Incomplete

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

Page 12 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.

VHA Has Not Yet

Completed Business

Continuity and

Contingency Plans for

Biomedical Equipment

To assist agencies in their business continuity and contingency planning

efforts, we have prepared a guide14 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.

14GAO/AIMD-10.1.19, August 1998.

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Our review of the March 25, 1998, VISN Assessment Feedback Reports15 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.

FDA Is Also Relying

on Biomedical

Equipment

Manufacturers for

Compliance

Information

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.

15These reports, prepared by VHA’s Year 2000 Project Office, provide feedback to each VISN on its

reported January 1998 assessment results and suggest actions that should be taken to enhance the

Year 2000 assessment and renovation process at the facility and VISN level.

Page 14 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

On January 21, 1998, HHS, on FDA’s behalf, issued a letter to approximately

16,000 domestic and foreign biomedical equipment manufacturers16

requesting information on the Year 2000 compliance of their complete

product line.17 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.

16FDA developed its mailing list from the manufacturers that have registered their products with the

FDA and also the mailing lists of two scientific and research instrument manufacturing associations.

Accordingly, this list included manufacturers that do not employ computers or embedded systems in

their products, e.g., products such as rubber gloves, tongue depressors, and eyeglasses.

17For FDA, compliance means that the product will accurately process and store date/time data

(including but not limited to calculating, displaying, recording, and sequencing operations involving

date/time data) during, from, into, and between the 20th and 21st centuries, including the correct

processing of leap year data.

Page 15 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

According to the Director of FDA’s Division of Electronics and Computer

Science, FDA does not perform technical evaluations of the manufacturers’

responses to determine their adequacy. Rather, the Director, his secretary,

and a biomedical engineer review the manufacturers’ submissions to see if

the responses included answers to the questions in the January 1998 letter.

He said that FDA relies on the manufacturers to certify whether their

products are Year 2000 compliant. FDA’s web site includes the statement

that

“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.”18

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.

18Food and Drug Administration, Year 2000 Impact on Biomedical Equipment, (Washington, D.C.,

FDA), http://www.fda.gov/cdrh/yr2000/y2kintro.html, (cited March 19, 1998).

Page 16 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

Some Users Question

Usefulness of Current FDA

Biomedical Equipment

Web Site

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.

Page 17 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

New Reporting

Requirements Identify

Medical Devices Posing

Health Risk

FDA implemented a new rule19 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.20 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.

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. 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

1921 CFR part 806. The regulation implements provisions of the Safe Medical Devices Act of 1990 (P.L.

101-629).

2021 U.S.C., sections 301 et seq.

Page 18 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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,21

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.

Conclusions 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

21The National Patient Safety Partnership is a coalition of public and private health care providers,

including VA, the American Medical Association, the American Hospital Association, the American

Nurses Association, and the Joint Commission on Accreditation of Healthcare Organizations.

Page 19 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.

Page 20 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

Recommendations to

the Secretary of

Veterans Affairs

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.

Recommendations to

the Secretary of

Veterans Affairs and

the Secretary of

Health and Human

Services

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

Page 21 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.

Agency Comments

and Our Evaluation

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

Page 22 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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’

Page 23 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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

Page 24 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
B-280584 

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.

Sincerely yours,

Joel C. Willemssen

Director, Civil Agencies Information Systems

Page 25 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Contents

Letter 1

Appendix I 

Comments From the

Department of

Veterans Affairs

28

Appendix II 

Comments From the

Department of Health

and Human Services

36

Appendix III 

Major Contributors to

This Report

43

Tables Table 1: VHA Biomedical Equipment Compliance Categories 7

Table 2: Reported Biomedical Equipment Year 2000 Compliance

Categories, as of June 1, 1998, and Examples

8

Table 3: Status of Manufacturer Responses as of July 29, 1998 11

Abbreviations

CIO chief information officer

FDA Food and Drug Administration

HHS Department of Health and Human Services

MRI magnetic resonance imaging

NIH National Institutes of Health

OMB Office of Management and Budget

VA Department of Veterans Affairs

VHA Veterans Health Administration

VISN Veterans Integrated Service Network

Page 26 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Page 27 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

Note: GAO comments

supplementing those in the

report text appear at the

end of this appendix.

See comment 1.

See comment 2.

See comment 1.

Page 28 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

See comment 1.

Page 29 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

Page 30 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

Page 31 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

See comment 1.

See comment 3.

Now on pp. 2 and 9.

Page 32 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

Now on pp. 2 and 3.

See comment 3.

Now on page 3.

See comment 3.

Now on page 4.

See comment 3.

Page 33 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

Now on pp. 11 and 12.

See comment 3.

Now on page 14.

See comment 3.

Now on page 18.

See comment 7.

Now on page 18.

See comment 3.

See comment 3.

Page 34 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix I 

Comments From the Department of

Veterans Affairs

The following are GAO’s comments on the Department of Veterans Affairs’

letter dated August 25, 1998.

GAO Comments 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.

Page 35 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

Note: GAO comments

supplementing those in the

report text appear at the

end of this appendix.

Page 36 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

See comment 1.

See comment 2.

Page 37 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

See comment 3.

See comment 4.

Page 38 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

See comment 2.

See comment 2.

Page 39 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

See comment 2.

See comment 2.

Page 40 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

See comment 2.

See comment 2.

Page 41 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix II 

Comments From the Department of Health

and Human Services

The following are GAO’s comments on the Department of Health and

Human Services’ letter dated September 2, 1998.

GAO Comments 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.

Page 42 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
Appendix III 

Major Contributors to This Report

Accounting and

Information

Management Division,

Washington, D.C.

Helen Lew, Assistant Director

Nabajyoti Barkakati, Technical Assistant Director

Tonia L. Johnson, Senior Information Systems Analyst

J. Michael Resser, Business Process Analyst-in-Charge

(511247) Page 43 GAO/AIMD-98-240 Biomedical Items Year 2000 Compliance
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