GAO

United States General Accounting Office

Testimony

Before the Subcommittee on Oversight and Investigations 

and the Subcommittee on Health and Environment, 

Committee on Commerce, House of Representatives

For Release on Delivery

Expected at

10 a.m.

Thursday,

October 21, 1999

YEAR 2000 COMPUTING 

CHALLENGE

Compliance Status 

Information on Biomedical 

Equipment

Statement of Joel C. Willemssen

Director, Civil Agencies Information Systems

Accounting and Information Management Division

GAO/T-AIMD-00-26

Page 1 GAO/T-AIMD-00-26

Messrs. Chairmen and Members of the Subcommittees:

Thank you for inviting us to participate in today’s hearing on the Year 2000 

(Y2K) compliance status of biomedical equipment.1

 The question of 

whether medical devices, such as magnetic resonance imaging (MRI) 

systems, x-ray machines, pacemakers, and cardiac monitoring equipment, 

can be counted on to work reliably on and after January 1, 2000, continues 

to be one of critical importance to our nation’s health care. To the extent 

that biomedical equipment uses computer chips, it is vulnerable to the Y2K 

problem.2

 In the medical arena, such vulnerability carries with it possible 

safety risks.

Responsibility for oversight and regulation of medical devices, including 

the impact of the Y2K problem, lies with the Food and Drug Administration 

(FDA)—an agency within the Department of Health and Human Services 

(HHS). Since the fall of 1998, FDA has been providing information collected 

from medical device and scientific and research instrument manufacturers 

through its Federal Y2K Biomedical Equipment Clearinghouse.3

My testimony today will discuss (1) the status of FDA’s Federal Y2K 

Biomedical Equipment Clearinghouse, (2) compliance status information 

on manufacturers’ web sites referred to in FDA’s clearinghouse, (3) FDA’s 

efforts to review the Y2K activities of manufacturers of 

computer-controlled, potentially high-risk devices, (4) information on the 

compliance status of health care providers’ biomedical equipment, and 

(5) information on compliance testing of equipment.

Background Biomedical equipment is indispensable; it plays a central role in virtually all 

health care. It is defined as any tool that can record, process, analyze, 

1

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

research instruments, which are not subject to FDA regulation.

2

As is widely known by now, for the past several decades computer systems have often used 

two digits to represent the year, such as “98” for 1998, in order to conserve electronic data 

storage and reduce operating costs. In this format, however, 2000 is indistinguishable from 

1900 because both are represented as “00.” As a result, if not modified, systems or 

applications that use dates or perform date- or time-sensitive calculations may generate 

incorrect results beyond 1999.

3

This site can be accessed on the Internet World Wide Web at 

http://www.fda.gov/cdrh/yr2000/year2000.html.
Page 2 GAO/T-AIMD-00-26

display, and/or transmit medical data—some of which may include medical 

devices, such as pacemakers, that are implanted in patients—and 

laboratory research instruments, such as gas chromatographs4

 and 

microscopes. Such equipment may use a computer for calibration or for 

day-to-day operation. If any type of date or time calculation is performed, 

susceptibility to a Y2K problem exists, whether the computer is a personal 

computer that connects to the equipment remotely, or a microprocessor 

chip embedded within the equipment itself. This could range from the more 

benign—such as incorrect formatting of a printout or incorrect display of 

the date—to the most serious—incorrect operation of equipment with the 

potential to decrease patient safety. The degree of risk depends on the role 

of the equipment in the patient’s care.

As part of its oversight and regulatory responsibility for domestic and 

imported medical devices, FDA has been collecting Y2K compliance status 

information on these devices, as well as on some scientific and research 

instruments. Its goal has been to provide a comprehensive, centralized 

source of compliance information on biomedical equipment used in the 

United States, and make this information publicly available through an 

Internet World Wide Web site. In addition, the Veterans Health 

Administration (VHA)—a key federal health care provider5

—took a 

leadership role in determining the Y2K compliance status of biomedical 

equipment. Specifically, it obtained information from manufacturers on the 

compliance status of biomedical equipment in its inventory, and shared this 

information with FDA.

FDA has also acted to identify products within the array of medical devices 

used in health care for which Y2K problems could pose a risk to patient 

health and safety. It identified 90 types of products that it refers to as 

computer-controlled, potentially high-risk devices (PHRD).6

 These medical 

devices are characterized by their potential for immediate and serious 

adverse health consequences for a patient if they fail to function as 

designed or expected, including a failure to initiate or continue operation. 

These devices are

4

Such instruments are used to separate the components of a solution with heat and measure 

their relative quantities.

5

A component of the Department of Veterans Affairs (VA).

6

Appendix I lists the 90 PHRD product types.
Page 3 GAO/T-AIMD-00-26

• used in the direct treatment or therapy of a patient, the failure of which 

could result in patient injury or failure of an intended treatment;

• used in the monitoring of vital patient parameters, information that is 

needed immediately for effective treatment; or

• necessary to support or sustain life during treatment or patient care.

PHRD products identified by FDA include breathing frequency monitors, 

electroanesthesia apparatus, hemodialysis systems and accessories, and 

fetal ultrasonic monitors and accessories.7

 Also included on the list of 

PHRD products is equipment used to collect human blood and manufacture 

blood products.8

Biomedical Equipment 

Status Information 

Available Through FDA 

Clearinghouse 

HHS, on FDA’s behalf, initiated action to collect biomedical equipment 

information in January 1998 by issuing a letter to domestic and foreign 

manufacturers requesting information on the Y2K compliance of their 

product lines. All information received from these manufacturers was then 

to be made available to the public through an FDA web site. 

As we reported in September 1998, FDA’s database did not include product 

compliance information from many manufacturers who had already 

provided such information to VHA;9

 further, VHA was not making this 

information available to the public. We therefore recommended that HHS 

and VHA jointly develop a single data clearinghouse containing information 

on the Y2K compliance status of biomedical equipment, and make this 

information publicly available.10 In response to our recommendation, 

FDA—in conjunction with VHA— established the Federal Y2K Biomedical 

Equipment Clearinghouse.

7

An electroanesthesia apparatus uses electricity to induce and maintain anesthesia during 

surgical procedures. Hemodialysis systems cycle blood from a patient’s body to filter out 

body waste before returning the blood to the patient. Fetal ultrasonic monitors use sound to 

measure the heart rate of the fetus and uterine contractions of the mother during pregnancy 

and childbirth.

8

Examples of such equipment include automated blood cell and plasma separators for 

therapeutic purposes and instruments used to screen the blood supply for blood-borne 

pathogens.

9

Year 2000 Computing Crisis: Compliance Status of Many Biomedical Equipment Items Still 

Unknown (GAO/AIMD-98-240, September 18, 1998).

10GAO/AIMD-98-240, September 18, 1998.
Page 4 GAO/T-AIMD-00-26

VHA, the Department of Defense, and the Health Industry Manufacturers 

Association all assisted FDA in obtaining compliance status information 

from manufacturers. According to FDA, 4,288 biomedical equipment 

manufacturers had submitted data to the clearinghouse as of October 4, 

1999.

Based on the data submitted, FDA places a manufacturer into one of four 

categories.

• Products that do not employ a date—manufacturer reported status as 

“All Products Do Not Use a Date.”

• Products that are all compliant—manufacturer reported all products 

“Y2K compliant.”

• Products with date-related problems—manufacturer reported status as 

“Products With Date-Related Problem.” 

• Product status on manufacturer’s web page—manufacturer reported 

status to be “Product Status Specified on a (Web) Page.”

As shown in figure 1, as of October 4, 1999, 61 percent of the manufacturers 

reported having products that do not employ a date, while 8 percent 

(342 manufacturers) reported having date-related problems such as 

incorrect display of date/time. According to FDA, the 342 manufacturers 

reported 1,035 specific products with date-related problems. Compliance 

data for 429 manufacturers were reported on their web sites and linked 

through the FDA clearinghouse.
Page 5 GAO/T-AIMD-00-26

Figure 1: Biomedical Equipment Compliance-Status Information Reported to FDA by 

Manufacturers as of October 4, 1999

Note: Total number of manufacturers = 4,288.

Source: FDA.

This total (4,288) excludes 132 manufacturers who, according to FDA, had 

not responded to the agency’s request for product compliance information 

as of October 4, 1999. According to a top official in FDA’s Center for 

Devices and Radiological Health, most of these manufacturers have gone 

out of business, do not make computerized products, or just cannot be 

located. This official added that FDA nevertheless continues to follow up 

with these manufacturers through letters and telephone contact. The 

clearinghouse lists the names of these manufacturers who have not 

responded to FDA’s requests for product compliance information. 
Page 6 GAO/T-AIMD-00-26

Our September 1998 report also noted that information on the FDA web 

site was not detailed enough to be useful.11 Specifically, the list of 

compliant equipment contained no information on equipment make or 

model. We therefore recommended that VA and HHS include in the 

clearinghouse information on the compliance status of all biomedical 

equipment by make and model. FDA agreed, subsequently requesting this 

information from manufacturers; users can now find specific information 

on the make and model of compliant medical devices on-line. 

Quality of Compliance 

Information on 

Manufacturers’ Web 

Sites Varies 

Significantly

As an alternative to obtaining biomedical equipment product compliance 

information from manufacturers and posting it to the Federal Y2K 

Biomedical Equipment Clearinghouse, FDA accepts equipment 

manufacturers’ references to their own web sites for compliance 

information. The clearinghouse provides users with a direct link to these 

web sites. As of October 1, 429 manufacturers had chosen this option, 

linking their web sites through the clearinghouse. 

While FDA is aware of the number of products and their reported 

compliance status for those manufacturers providing this information to 

the clearinghouse, in testimony before these Subcommittees this past May, 

officials stated that they did not know the total number of biomedical 

equipment products reported by manufacturers on their web sites, or how 

many of them were noncompliant. We subsequently reviewed information 

available through these web sites and reported in June that the quality of 

information available through them varied significantly.12 Specifically, while 

most sites contained compliance information on at least one product, some 

contained insufficient information or did not clearly distinguish biomedical 

equipment from nonbiomedical products. 

Because of the Subcommittees’ interest in the compliance information on 

the manufacturers’ web sites, we reviewed this information to identify the 

total number of biomedical equipment products reported, and categorized 

11GAO/AIMD-98-240, September 18, 1998.

12Year 2000 Computing Challenge: Concerns About Compliance Information on Biomedical 

Equipment (GAO/T-AIMD-99-209, June 10, 1999).
Page 7 GAO/T-AIMD-00-26

their compliance status.13 We also reviewed these sites to assess the clarity 

and completeness of the information reported.

As of October 1, 1999, FDA’s clearinghouse listed 429 manufacturers 

referring users to their web sites. Of this total, 

• 354 manufacturers reported compliance status information for at least 

32,598 individual biomedical equipment products;14

• 71 manufacturers’ web sites either contained insufficient information on 

the number of products and their compliance status, or did not clearly 

distinguish biomedical equipment from nonbiomedical products; 

• 3 web sites were those of vendors or distributors, not manufacturers; 

and

• 1 manufacturer’s web-site link in FDA’s clearinghouse did not work.15 

Because of the limitations cited above for many of the manufacturers’ web 

sites, our ability to determine the total number of biomedical equipment 

products reported and their compliance status was impaired. Accordingly, 

the actual number of products reported by these manufacturers could be 

higher than the 32,598 that we counted.

As shown in figure 2, of the 32,598 products that we were able to identify 

on manufacturers’ web sites, about 54 percent reportedly do not employ a 

date, about 29 percent of the products are considered compliant, and about 

12 percent are reportedly noncompliant. The compliance status of the 

remaining 5 percent of products was unknown, for reasons such as the 

manufacturer’s ongoing assessment of the product.

13We summarized the results of our review in four compliance categories—products that do 

not employ a date, products that are compliant, products that are noncompliant, and 

products whose compliance status is currently unknown. This last category includes those 

manufacturers who reported that they have not completed an assessment of their products, 

have discontinued a product, or have a product that is now obsolete.

14This includes medical devices, scientific and research instruments, and other supporting 

products, such as printers and software. 

15According to FDA, the contractor assisting it with the clearinghouse verified that this web 

site link was operable.
Page 8 GAO/T-AIMD-00-26

Figure 2: Biomedical Equipment Compliance-Status Information Reported on 

Manufacturers’ Web Sites as of October 1, 1999

Note: Total number of products = 32,598.

Source: GAO analysis of manufacturers’ web sites.

The 4,053 noncompliant products that we identified were from the web 

sites of 214 manufacturers. This number of noncompliant products is about 

four times the number reported directly by FDA in its clearinghouse 

(1,035). Examples of these noncompliant products included a bedside 

monitor, film digitizer, ultrasound systems, radiology information systems, 

and laboratory information systems. Included among noncompliant PHRDs 

were ventricular assist devices and hemodialysis equipment.16

In addition to supplying information on noncompliant products, most of 

the manufacturers with noncompliant products also provided solutions for 

correcting the problem. At least one solution to correcting a problem was 

16A ventricular assist device is a small electromechanical pump that helps maintain blood 

circulation in patients suffering from end-stage heart disease. Hemodialysis equipment 

cycles blood from a patient’s body to filter out body waste before returning the blood to the 

patient.
Page 9 GAO/T-AIMD-00-26

offered by 190 of the 214 manufacturers we identified with noncompliant 

products. The solutions generally involved upgrades to hardware or 

software, manual action (such as turning the equipment on and off on 

January 1, 2000), or workarounds.17 We also noted that for these 

190 manufacturers, at least 29 offered Y2K solutions to all their products at 

no charge, 9 offered no-charge solutions for more that 50 percent of their 

product line, 13 offered no-charge solutions to less than 50 percent of their 

product line, and 12 offered no solutions free of charge. For the remaining 

127 of the 190 manufacturers, we were unable to determine if Y2K solutions 

were available to users free of charge.

Our review disclosed that the quality of the information on manufacturers’ 

web sites continued to vary significantly. It ranged from general assurances 

of compliance to detailed information on specific product make and model. 

For example: 

• A manufacturer reported that its products had no Y2K issues, but it did 

not identify the products.

• A manufacturer reported that it was still assessing its products, and did 

not provide any detailed information on its web site.

• A manufacturer did not list theY2K readiness of products but did report 

that the only Y2K problem it was having was with the software it used to 

run its business.

• A manufacturer listed about 65,000 products, but did not sort them by 

type so that the biomedical products could be easily identified. 

• A manufacturer reported that for its 282 products, 79 were compliant, 

50 were noncompliant, the status of 43 was currently unknown, and 

110 were not affected by the Y2K problem. It also provided solutions for 

its reported noncompliant products. 

• A manufacturer reported compliance information for 97 products, by 

make and model. Of these, 72 were compliant, 17 were noncompliant, 

1 product was currently under assessment, and Y2K did not apply to 

7 products. It also provided solutions for various noncompliant 

products, including information on the availability of solutions and 

whether to replace the noncompliant product.

Because both the quality of and access to compliance information are 

critical to biomedical equipment users, any problems with information on 

17An example of a workaround is noting on the printout of an EKG machine the year “2000” 

instead of “1900.”
Page 10 GAO/T-AIMD-00-26

manufacturers’ web sites could have a direct bearing on the ability of 

health care providers to identify and correct any noncompliant equipment 

in their inventories. Accordingly, we believe that FDA should request that 

manufacturers that are providing information through their web sites 

clearly identify product make and model, compliance status, and 

availability of solutions for noncompliant equipment.

FDA Is Now Reviewing 

Manufacturers’ Y2K 

Activities 

While compliance information is available through FDA’s Federal Y2K 

Biomedical Equipment Clearinghouse, we have raised concerns in the past 

year about the lack of independent verification and validation of 

biomedical equipment that manufacturers have certified as compliant. In 

addition to making sure that manufacturers provide detailed information 

on their products, we believe that it is essential that FDA provide some 

level of confidence that critical care and life support medical devices will 

work as intended.

In response to our previously reported concerns, FDA is now reviewing a 

sample of biomedical equipment manufacturers’ Y2K activities, such as risk 

management, test planning and procedures, and implementation and 

contingency planning. In September 1998, we first reported that FDA did 

not require manufacturers to submit test results certifying product 

compliance.18 Rather, we noted, FDA relies on the manufacturer to validate, 

test, and certify that it has adequately addressed any Y2K problem. As a 

result, we stated that FDA lacked assurance that biomedical equipment 

manufacturers had adequately addressed the Y2K problem for 

noncompliant equipment. 

Accordingly, we recommended that HHS take prudent steps to review 

manufacturers’ compliance test results for critical care/life support 

biomedical equipment, especially equipment once determined to be 

noncompliant but now deemed compliant, and that for which concerns 

about the determination of compliance remain. At the time, HHS and FDA 

did not concur with our recommendation. They reasoned that submissions 

of appropriate certifications were sufficient, further stating that they did 

not have the resources to undertake such reviews.

18GAO/AIMD-98-240, September 18, 1998.
Page 11 GAO/T-AIMD-00-26

As mentioned, HHS and FDA have now changed this position. In a May 25, 

1999, hearing before these Subcommittees, FDA’s Acting Deputy 

Commissioner for Policy testified that FDA proposed reviewing 

manufacturers’ test results supporting compliance certifications for a 

sample of critical devices. FDA’s proposal consisted of two phases. In the 

first phase FDA would 

• develop a list of the manufacturers of these devices;

• from this list of manufacturers, select a sample of 80 for review; and

• hire a contractor to develop a program to assess manufacturers’ 

activities to identify and correct Y2K problems with PHRDs.

The goal of the first phase of the survey is to extrapolate from the 

80 assessments a level of overall confidence in the biomedical equipment 

industry’s Y2K compliance activities. According to FDA, the second phase 

of the evaluation would be undertaken only if the results of the first phase 

indicated a need for further review of manufacturer Y2K activities because 

of concerns about how manufacturers are addressing the issue of product 

compliance. 

In carrying out its plan to assess manufacturers’ Y2K activities, FDA issued 

a task order on July 1, 1999, for a contractor, assisted by two 

subcontractors, to perform assessments of the Y2K compliance activities 

for a sample of PHRD manufacturers. FDA identified 803 PHRD 

manufacturing sites that produce equipment sold in the United States.19

These were composed of 726 biomedical equipment manufacturing sites 

and 77 manufacturing sites of blood and blood products equipment that 

manufacture product types listed in appendix I. 

FDA’s contractor then randomly selected 325 of the 803 sites for possible 

assessment. These manufacturing sites were then contacted and asked if 

they would volunteer to participate in the assessment process. As of 

October 4, 1999, of the 325 randomly selected sites, 

• 197 were identified as producing no computer-controlled equipment,

• 80 agreed to participate,

19The 803 consisted of those manufacturers among the 90 types of PHRDs identified that had 

registered PHRD products with FDA. 
Page 12 GAO/T-AIMD-00-26

• 26 declined to participate,20

• 18 were duplicates,21 and 

• 4 did not respond. 

To carry out the on-site assessments of manufacturing sites, the contractor 

developed a guide for its examiners. This guide focused on the firm’s Y2K 

activities in six areas: (1) executive leadership and control, (2) risk 

management, (3) corrective and preventive actions, (4) test planning and 

procedures, (5) communication with the consignee (user of the products), 

and (6) implementation and contingency planning.

After completing these assessments at the manufacturers’ sites, examiners 

were required to prepare a report of concerns in each of the six areas 

reviewed. Concerns were identified as high, medium, or low, as defined 

below: 

• high—actions that are not timely, inadequate planning, inadequate or 

incomplete resources, incomplete or inaccurate deliverables, inability to 

validate results, and/or inadequate due diligence;

• medium—actions that are somewhat late, incomplete planning, 

insufficient or incomplete resources, deficiencies in deliverables, and/or 

incomplete validation of results; and 

• low—actions that are on schedule and have adequate resources.

According to FDA’s PHRD survey project manager, as of October 15, 1999, 

examiners had completed all 80 manufacturer site assessment visits, and 

had prepared 62 assessment reports.

We reviewed the 25 manufacturer site visit reports that were completed by 

the examiners and available to us as of September 10, 1999. For 20 of these 

assessments, the examiners’ assessed concern was low. At the five 

remaining manufacturing sites, the examiner found at least one item of 

moderate concern in the six areas, such as test planning and procedures. 

According to the PHRD survey project manager, the areas identified in the 

20According to FDA, reasons given by manufacturers for declining to participate included 

scheduling or resource limitations and recent regular FDA site inspections. Five 

manufacturing sites declined without giving a reason.

21These sites involved large, multisite manufacturers where the FDA contractor had already 

selected two or more of the same manufacturer’s sites. According to FDA, the contractor did 

not assess duplicates if they came up in later samples. 
Page 13 GAO/T-AIMD-00-26

site visit reports as medium risk do not constitute a risk to patient health or 

safety. 

Until recently, none of the site visit reports submitted to FDA contained a 

concern assessed as high. However, earlier this week, the PHRD survey 

project manager informed us that FDA had just received a site visit report 

with concerns assessed as high in two areas—leadership and control, and 

test planning and procedures. The report stated that the manufacturer’s 

policies and procedures were found to be inconsistent, ambiguous, and 

were not followed in a manner that would meet due diligence 

requirements. It also noted that the qualifications of the manufacturer’s 

personnel for specified tasks were not well defined, and that some 

personnel assigned to tasks identified in the policies and procedures were 

not qualified to perform those tasks. The report concluded that the 

manufacturer’s procedures for Y2K assessment and corrective and 

preventive action were less than adequate, and that assessment procedures 

had not been applied consistently. The manufacturer subsequently told the 

examiner that action would be taken on the issues raised. FDA officials 

told us that they plan to follow up with the manufacturer.

The project manager also told us that FDA’s contractor is in the process of 

preparing a final report summarizing the overall findings from the 80 site 

visit assessment reports, detailing any problems encountered during the 

project. This individual indicated that FDA expects to receive the final 

report from the contractor later this month. Although FDA initially 

expected to submit a final report to HHS by October 1, it has not yet 

established a date for when this will occur. 

To assess how the contractor was executing FDA’s task order, we observed 

selected site assessments. At the five manufacturing site assessments we 

observed, examiners generally followed the contractor-developed audit 

guide and were knowledgeable about information technology management, 

Y2K testing, and risk assessment. During our two initial visits, we noted 

that examiners sometimes could not answer questions from the 

manufacturers relating to the FDA clearinghouse and the processing of the 

final report on the site assessments. We subsequently shared these 

observations with FDA officials. FDA agreed to consider our suggestions, 

such as better communicating to the firms the final reporting process and 

how the FDA Federal Y2K Biomedical Equipment Clearinghouse works. 

During the later three visits, we did not observe any similar areas of 

concern. 
Page 14 GAO/T-AIMD-00-26

Many of the 803 PHRD manufacturing sites identified by FDA are in foreign 

locations. Specifically, our review of the 803 sites on FDA’s list showed that 

203 were located in 27 foreign countries (appendix II lists these countries). 

Of the 325 randomly selected for assessment, 233 were in the United States 

and 92 were in 22 foreign countries. Finally, of the 80 locations where 

manufacturers agreed to be assessed by FDA, 65 are located in the United 

States and 15 are located in 8 other countries—Canada (1 site), Finland (2), 

Germany (4), the Netherlands (1), Norway (1), Sweden (2), Switzerland (1), 

and the United Kingdom (3).

Information on 

Biomedical Equipment 

Compliance of Health 

Care Providers 

Incomplete

While information is available on the Y2K compliance status of biomedical 

equipment through the FDA clearinghouse and other sources, it is not clear 

at this time how extensively health care providers are using this 

information to determine their Y2K readiness. According to FDA, it has 

taken steps to make users aware of the clearinghouse. For example, FDA 

has published articles in professional trade journals and participated in 

conferences aimed at health care facilities. 

FDA also informed us that the Federal Y2K Biomedical Equipment 

Clearinghouse had received about 317,000 inquiries between April 1998 and 

September 1999. However, according to FDA, it is not possible to 

determine the sources of the inquiries.

To determine whether health care providers were using the FDA 

clearinghouse to assess the Y2K compliance status of their biomedical 

equipment, we reviewed readiness surveys sent to providers by several 

federal agencies and professional health care associations.22 For example, 

the American Medical Association (AMA) surveyed a random sample of 

7,000 of its members in July/August 1999 on whether they were aware of 

the FDA clearinghouse; only 17 percent of respondents indicated that they 

were. 

In addition, a July 1999 HHS Office of Inspector General (OIG) survey sent 

to hospitals, nursing facilities, home health agencies, and physicians 

contained three questions on FDA’s clearinghouse. These questions related 

to awareness, usage, and whether the clearinghouse was helpful. 

22These include HHS’ Office of the Inspector General, American Hospital Association (AHA), 

and AMA.
Page 15 GAO/T-AIMD-00-26

Responses to the HHS OIG survey varied significantly. For example, about 

80 percent of the hospitals responding stated that they were aware of the 

clearinghouse, but less than half of the nursing facilities, home health 

agencies, and physicians responding stated this same awareness. Further, 

while about 60 percent of the responding hospitals reported that they used 

the clearinghouse, 25 percent or fewer of the responding nursing facilities, 

home health agencies, and physicians reported using the clearinghouse to 

obtain readiness information about their biomedical equipment.

The HHS OIG survey noted that there was general agreement among the 

respondents that the clearinghouse information was helpful. Specifically, 

100 percent of the physicians, 95 percent of the nursing facilities, 

91 percent of the hospitals, and 87 percent of the home health agencies that 

said they had used clearinghouse data said they found the information to be 

helpful.

Although compliance information on biomedical equipment is available 

through FDA’s clearinghouse, theY2K readiness status of equipment at 

health care providers’ offices is not known because a significant number of 

providers did not respond to the surveys. As shown in table 1, the response 

rates to the July survey from the HHS OIG to nursing facilities, home health 

agencies, and physicians were all less than 50 percent. The response rates 

to surveys from AHA and AMA on this subject were even less, at 29 and 

8 percent, respectively. Lastly, the response rate to a survey from the 

American Health Care Association (AHCA)23 was even more disappointing, 

at less than 3 percent. 

23This is a federation of 50 state health organizations that represent nearly 12,000 nonprofit 

and for-profit assisted living, nursing facility, long-term care, and subacute-care providers.
Page 16 GAO/T-AIMD-00-26

Table 1: Reported Survey Results of Y2K Readiness of Biomedical Equipment

Source: Organizations listed. We did not independently verify this information.

a

The number of respondents who selected “not applicable” for the question were excluded from the 

number of responses.

b

This organization represents approximately 45,000 physicians in more than 230 medical groups 

across 40 states.

c

According to the survey results, 67 percent of responding physicians rent or lease biomedical 

equipment that will be affected by Y2K; 62 percent of them were confident that their vendors have 

prepared the equipment for Y2K. Data were not provided on the remaining 33 percent of responding 

physicians.

d

The survey did not have “Don’t Know” as a response choice. 

e

Twenty-eight percent of the respondents said this question was not applicable to them.

The survey results also indicated that much work remains in making 

biomedical equipment Y2K-ready. Table 1 shows that less than one-third of 

the hospitals responding to HHS’ OIG survey stated that all of their 

biomedical equipment was currently compliant, and only 6 percent of the 

hospitals responding to the AHA survey stated that their biomedical 

equipment was currently compliant.

Entity performing 

survey/group surveyed

Number

surveyed

Number of

responses

Percentage

responding

currently

compliant

Percentage

responding

don’t know

HHS Office of the Inspector 

General (July 1999)

Hospitals 1,000 537a 27 5

Nursing facilities 1,000 230a 50 25

Home health agencies 1,000 159a 48 27

Physicians 1,000 79a 56 22

American Hospital 

Association (AHA)

(February 1999) 2,000 583 6 2

American Medical 

Association (AMA) 

(July/August 1999) 7,000 544 c d

American Health Care 

Association (AHCA)

(March 1999) 12,000 342e 24 d

American Medical Group 

Association (AMGA)b

(March 1999) 230 99 42 d
Page 17 GAO/T-AIMD-00-26

Manufacturers Vary on 

User Testing of 

Biomedical Equipment

The question of whether to test their biomedical equipment for Y2K 

compliance is a difficult one that confronts many users, such as hospitals 

and physicians’ offices. FDA has taken the position that manufacturers’ 

submissions of Y2K compliance certifications provide sufficient assurance 

of product compliance, and that such testing on the part of users is not 

necessary. VA and the Emergency Care Research Institute (ECRI)24 have 

also stated that manufacturers are best qualified to analyze embedded 

systems or software to determine Y2K compliance. Accordingly, they do 

not encourage user testing of biomedical equipment for Y2K compliance. 

ECRI guidelines, however, suggest that health care facilities should 

consider testing interfaces between medical devices in cases where the 

facility cannot determine theY2K compliance of the interface from the 

device manufacturers. 

In contrast to VHA’s and FDA’s positions, some hospitals in the private 

sector believe that testing biomedical equipment is necessary to prove that 

they have exercised due diligence in the protection of patient health and 

safety. We have testified that officials at three hospitals told us that their 

biomedical engineers established their own test programs for biomedical 

equipment and, in many cases, contacted the manufacturers for their test 

protocols.25 Several of these engineers informed us that their testing 

identified some noncompliant equipment that the manufacturers had 

earlier certified as compliant. According to these engineers, the equipment 

found to be noncompliant all had display problems and was not critical 

care/life support equipment. We were told that equipment found to be 

incorrectly certified as compliant included a cardiac catheterization unit, a 

pulse oxymeter, medical imaging equipment, and ultrasound equipment. 

Our review of manufacturers’ web sites disclosed that manufacturers’ 

opinions vary on whether users should test their biomedical equipment. We 

noted that at least 37 manufacturers provided information on their web 

sites about Y2K testing. Of these, 30 encouraged testing; 15 provided end 

users with information such as test protocols and instructions. Fifteen 

manufacturers also encouraged users to test their devices in configuration 

24ECRI is an international, nonprofit health services research agency. It believes that 

superficial testing of biomedical equipment by users may provide false assurances, as well 

as create legal liability exposure for health care institutions.

25Year 2000 Computing Crisis: Action Needed to Ensure Continued Delivery of Veterans 

Benefits and Health Care Services (GAO/T-AIMD-99-136, April 15, 1999).
Page 18 GAO/T-AIMD-00-26

with related equipment to ensure that the devices operate as intended. 

Seven manufacturers did not encourage testing; two of these stated that 

such testing could disrupt operation of software.

As we testified in May, the question of whether to independently verify and 

validate biomedical equipment that manufacturers have certified as 

compliant is one that must be addressed jointly by medical facilities’ 

clinical staff, biomedical engineers, and corporate management.26 The 

overriding criterion should be ensuring patient health and safety.

In summary, compliance status information on biomedical equipment can 

be found in FDA’s clearinghouse or on manufacturers’ web sites. The 

quality of the compliance information on the web sites, however, varies 

significantly, ranging from general assurances of compliance to detailed 

information on specific product make and model. Given the criticality of 

having medical devices function as intended on and after January 1, it is 

important that FDA encourage manufacturers to provide detailed 

information on the product make and model, compliance status, and 

availability of solutions for noncompliant equipment.

To its credit, FDA has assessed the Y2K compliance activities of 80 PHRD 

manufacturing sites. Although most appeared to have been assessed as 

having low degrees of concern, one site had a concern in two areas 

assessed at high. FDA is currently reviewing this site to make sure that 

there are no unresolved issues affecting patient safety. 

Because a significant number of health care providers are not responding 

to Y2K surveys sent by federal agencies and professional associations, the 

public lacks information on the readiness of providers. Such information 

would help alleviate public concerns about the Y2K readiness of health 

care providers and the biomedical equipment they use in patient care. 

Lastly, although there are varying views on whether end users should test 

their biomedical equipment for Y2K compliance, the overriding criterion 

should be ensuring patient health and safety. 

We performed this assignment in accordance with generally accepted 

government auditing standards, from July 1999 through October 1999. We 

26Year 2000 Computing Challenge: Much Biomedical Equipment Status Information 

Available, Yet Concerns Remain (GAO/T-AIMD-99-197, May 25, 1999).
Page 19 GAO/T-AIMD-00-26

reviewed and analyzed information listed in the Federal Y2K Biomedical 

Equipment Clearinghouse. We also reviewed and analyzed information 

listed on the web sites of biomedical equipment manufacturers referred to 

in FDA’s Federal Y2K Biomedical Equipment Clearinghouse. In addition, we 

reviewed and analyzed FDA documentation on the agency assessments of 

PHRD manufacturing sites, including selected contractor’s final reports to 

FDA on the manufacturers. We also visited five PHRD manufacturing sites 

and observed FDA’s contractor examiners carrying out the assessment of 

the firms’ Y2K compliance activities. We interviewed FDA officials 

responsible for the Federal Y2K Biomedical Equipment Clearinghouse and 

oversight and management of the agency’s survey of PHRD manufacturer 

Y2K compliance activities.

Messrs. Chairmen, this concludes my statement. I would be pleased to 

respond to any questions that you or other members of the Subcommittees 

may have at this time.

Contact and 

Acknowledgments

For information about this testimony, please contact Joel Willemssen at 

(202) 512-6253 or by e-mail at willemssenj.aimd@gao.gov. Individuals 

making key contributions to this testimony included Gwen Adelekun, 

Dr. Nabajyoti Barkakati, Michael Fruitman, James Houtz, Robert Kershaw, 

Helen Lew, Barbara Oliver, Michael Resser, Glenn Spiegel, and Glenda 

Wright.
Page 20 GAO/T-AIMD-00-26

Appendix I

FDA’s List of Computer-Controlled Potentially 

High-Risk Medical Device Types ApendxIi

Classification Name

Anesthetic vaporizer

Arrhythmia detector and alarm

Autotransfusion apparatus

Automated blood cell and plasma separator for therapeutic purposes

Automated blood grouping and antibody test system

Blood and plasma warming device

Blood storage refrigerator and blood storage freezer

Breathing frequency monitor

Breathing gas mixer

Cardioconverter, implantable

Cardiopulmonary bypass heart-lung machine console

Cardiopulmonary bypass on-line blood gas monitor

Cardiopulmonary bypass pulsatile flow generator

Cardiopulmonary bypass pump speed control

Centrifugal chemistry analyzer for clinical use

Continuous flow sequential multiple chemistry analyzer for clinical use

Continuous ventilator

DC-defibrillator low energy (including paddles)

Defibrillator, automatic implantable cardioconverter

Defibrillator, implantable, dual-chamber

Device, thermal ablation, endometrial

Discrete photometric chemistry analyzer for clinical use

Electroanesthesia apparatus

Environmental chamber for storage of platelet concentrate

External counter-pulsating device

External negative pressure ventilator

External pacemaker pulse generator

External programmable pacemaker pulse generator

Fetal ultrasonic monitor and accessories

Gas machine for anesthesia or analgesia

Glucose test system

Hemodialysis systems and accessories

High permeability hemodialysis systems

Hyperbaric chamber

Hysteroscopitc insufflator

Continued
Appendix I

FDA’s List of Computer-Controlled 

Potentially High-Risk Medical Device Types

Page 21 GAO/T-AIMD-00-26

Classification Name

Implantable pacemaker pulse-generator

Implanted cerebellar stimulator

Implanted diaphragmatic/phrenic nerve stimulator

Implanted electrical urinary continence device

Implanted intracerbral/subcortical stimulator for pain relief

Implanted nueromuscular stimulator

Implanted peripheral nerve stimulator for pain relief

Implanted spinal cord stimulator for bladder evacuation

Implanted spinal cord stimulator for pain relief

Indwelling blood carbon dioxide partial pressure (PCO2) analyzer

Indwelling blood oxygen partial pressure (PO2) analyzer

Infant radiant warmer

Infusion pump

Instruments used to screen the blood supply for bloodborne pathogens

Intermittent mandatory ventilation attachment

Intra-aortic balloon and control system

Isolated kidney perfusion and transport system and accessories

Kit, test, alpha-fetoprotein for neural tube defects

Laproscopic insufflator

Lipoprotein, low density, removal

Lung water monitor

Medical charged-particle radiation therapy systema

Medical Neutron radiation therapy systema

Membrane lung (for long term pulmonary support)

Micro chemistry analyzer for clinical use

Neonatal incubator

Neonatal transport incubator

Nonroller-type cardiopulmonary bypass blood pump

Oxygen-uptake computer

Pacemaker programmers

Peritoneal dialysis system and accessories

Portable oxygen generator

Powered emergency ventilator

Processing system for frozen blood

Pulse-generator, dual chamber, implantable

Pulse-generator, program module

Pulse-generator, single chamber

Continued from Previous Page
Appendix I

FDA’s List of Computer-Controlled 

Potentially High-Risk Medical Device Types

Page 22 GAO/T-AIMD-00-26

a

These device classifications include radiation treatment planning systems that are accessories to 

these device types.

Source: FDA.

Classification Name

Pulse-generator, single chamber, sensor driven, implantable

Pump, drug administration, closed loop

Pump, infusion, implanted, programmable

Radionuclide radiation therapy systema

Remote controlled radionuclide-applicator systema

Roller type cardiopulmonary bypass blood pump

Software, blood bank, stand alone products

Separator for therapeutic purposes, membrane automated blood cell/plasma

Sorbent hemoperfusion system

Stimulator, cortical, implanted (for pain)

Stimulator, electrical, implanted, for Parkinsonian tremor

Stimulator, sacral, nerve, implanted 

Stimulator, spinal-cord, totally implanted for pain relief

Stimulator, subcortical, implanted for epilepsy

System, pacing, temporary, acute internal atrial defibrillation

Ventilator, high frequency

Ventricular bypass (assist) device

X-ray radiation therapy systema

Continued from Previous Page
Page 23 GAO/T-AIMD-00-26

Appendix II

Listing of Foreign Countries With PHRD 

Manufacturing Sites ApendxiI

Argentina

Australia

Belgium

Brazil

Canada

Costa Rica

Denmark

Finland

France

Germany

Ireland

Israel

Italy

Japan

Malaysia

Mexico

Netherlands

New Zealand

Norway

Pakistan

People’s Republic of China

Republic of Korea

Singapore

Sweden

Switzerland

Thailand

United Kingdom 

(511772) Letr

United States

General Accounting Office

Washington, D.C. 20548-0001

Official Business

Penalty for Private Use $300

Address Correction Requested

Bulk Mail

Postage & Fees Paid

GAO

Permit No. GI00