For Release on Delivery

Expected at 10:00 a.m.

Tuesday, June 27, 2000

GAO/T-HEHS-00-143

MEDICAL DEVICES

Reprocessing and Reuse of

Devices Labeled SingleUse

Statement of Janet Heinrich, Associate Director

Health Financing and Public Health Issues

Health, Education, and Human Services Division

Testimony

Before the Committee on Health, Education, Labor, and

Pensions, U.S. Senate

United States General Accounting Office

GAO
Page 1 GAO/T-HEHS-00-143

Mr. Chairman and Members of the Committee:

I am pleased to have the opportunity to testify as the committee considers

issues relating to the reprocessing and reuse of medical devices marketed

for single use. As you know, medical devices approved for sale in the

United States as single-use devices (SUD) sometimes are reprocessed and

used again on other patients.1 Reprocessing involves cleaning and

sterilizing a device and verifying that it functions properly. The practice of

SUD reprocessing reduces the costs of medical devices for hospitals and

other health care facilities, but it also raises public health concerns,

primarily regarding the potential risks of infection and device malfunction,

and has led to complaints that the Food and Drug Administration (FDA)

has failed to provide consistent oversight. You asked us to discuss the

results of our recent report on this issue.2

I will summarize the key findings of our report, which focuses on (1) the

extent of SUD reprocessing, (2) the health risks associated with SUD

reprocessing, (3) the cost savings from SUD reprocessing, and (4) FDA’s

oversight of SUD reprocessing. We looked only at the practice of

reprocessing SUDs for use on another patient; we did not examine devices

approved for marketing as reusable, the resterilization of opened but

unused devices, or devices reprocessed for additional use on the same

patient. SUDs are those devices for which manufacturers have not

submitted evidence to FDA that they can be used multiple times; this does

not necessarily mean that they cannot be used more than once if

appropriately reprocessed.

It is clear that some health care facilities have chosen to reprocess and

reuse some kinds of SUDs, but accurate and comprehensive information

about the number of facilities that use reprocessed SUDs and the types of

SUDs that are reprocessed is not available. According to various surveys,

approximately 20 to 30 percent of American hospitals reported that they

reuse at least one type of SUD and at least one-third of the hospitals that

do so contract with third-party reprocessing companies. The results of

clinical studies show that selected devices can be reprocessed safely if

appropriate procedures are followed and closely monitored, a view shared

by many professional organizations and infection control experts.

However, this does not mean that SUD reprocessing is always safe.

1SUDs are also referred to as disposable devices because they are intended to be discarded after one use.

2Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted

(GAO/HEHS-00-123, June 20, 2000).

Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 2 GAO/T-HEHS-00-143

Current medical device surveillance systems almost certainly do not

detect all infections and injuries resulting from the use of reprocessed

SUDs, or from the use of medical devices in general, and there is general

agreement that many types of SUDs cannot be effectively cleaned and

sterilized. Reprocessing SUDs can produce substantial cost savings, with

independent reprocessing firms charging hospitals approximately one-half

the price of a new device for a reprocessed device, while the in-house cost

of reprocessing some devices can be less than 10 percent of the price of a

new device. FDA is about to institute a new regulatory framework for SUD

reprocessing that will require independent reprocessing firms and

hospitals to obtain FDA’s approval before they can reprocess many

devices labeled for single use. The framework will provide FDA with more

information and strengthen its oversight of reprocessing. However, there

are significant barriers to the framework’s successful implementation.

FDA is responsible for ensuring the safety and effectiveness of medical

devices sold in the United States, ranging from bandages and

thermometers to cardiac catheters and artificial hearts. Approximately

80,000 to 100,000 models of medical devices are currently in use in the

United States, and the domestic market for medical devices totaled

roughly $56 billion in 1999. FDA regulates the safety and effectiveness of

medical devices, the packaging and labeling that describe how they should

be used, and the facilities that manufacture them. FDA’s requirements for

approving devices for marketing depend on the devices’ potential for

harming patients, with greater data and documentation required for

higher-risk devices.

Generally, FDA can evaluate applications to market new devices only in

terms of a device’s intended use as described on its label.3 Manufacturers

that wish to market a device for single use need to convince FDA only that

it can be used safely and effectively once—they do not need to

demonstrate that the device cannot be used more than once. Thus, FDA’s

approval of a device for single use means that a device can be used safely

and reliably once, not necessarily that it cannot be used safely and reliably

more than once if it is appropriately reprocessed. Conversely,

manufacturers that wish to market a device as reusable must either

provide data demonstrating that the device will be safe and effective for a

specified number of uses, or provide a measure to determine whether it

will still meet performance specifications after reprocessing.

3Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), §205(b), adding §513(i)(1)(E)(i) to

the Federal Food, Drug, and Cosmetic Act.

Background
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 3 GAO/T-HEHS-00-143

Manufacturers must show that the device can be cleaned and sterilized

and that its function will not degrade with repeated uses. Devices that are

not marketed as reusable are sold for single use.4

Third-party reprocessing firms and some hospitals and other health care

facilities reprocess SUDs. While the exact size of the reprocessing industry

is unknown, it is clearly only a small part of the medical device industry.

For example, FDA has identified only 13 third-party reprocessing

companies, although it suspects that more are in operation. Last year, a

trade association representing major third-party reprocessing firms said

that its members collectively received about $20 million annually for their

services. Evidence indicates that only a minority of the approximately

6,000 hospitals and 2,700 ambulatory surgery centers in the United States

reprocess SUDs in-house.

While it is clear that some health care facilities have chosen to reprocess

and reuse some kinds of SUDs, neither FDA nor any other organization

has accurate and comprehensive information about the number of

facilities that use reprocessed SUDs or the types of SUDs that are

reprocessed. We found six surveys about SUD reprocessing conducted by

professional associations and other groups. The surveys typically asked

members of selected professional groups to describe the SUD

reprocessing practices at the institution with which they are affiliated.

Most surveys found that approximately 20 to 30 percent of American

hospitals reused at least one type of SUD and that at least one-third of the

surveyed hospitals that reused SUDs contracted with independent

reprocessing companies. While the results of the various surveys are fairly

consistent, it is difficult to assess the validity of the findings because the

response rates for the surveys are low, with only one survey having a

response rate greater than 50 percent, and health care facilities that use

reprocessed SUDs may have disproportionately declined to respond to the

surveys. The surveys also may not completely capture the use of

reprocessed SUDs in ambulatory surgery centers, physicians’ practices, or

other nonhospital facilities.5

The frequency of reprocessing varies widely among different devices, and

most hospitals that reuse SUDs reuse only a few types of devices. For

example, electrophysiology (EP) catheters, devices inserted into the heart

4FDA also has the authority to require a manufacturer to change the label of a device that it markets for an

intended use other than that on the label and that poses a health risk.

5This is because some of the surveys did not include nonhospital facilities.

The Extent of

Reprocessing
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 4 GAO/T-HEHS-00-143

to measure and correct cardiac rhythm disorders, have been reprocessed

for 20 years, even though all models of them were approved for single use

only. Some types of EP catheters are relatively easy to clean, sterilize, and

test. They also are expensive enough for hospitals to consider the cost

savings from reprocessing sufficient to warrant considering reuse. Several

hospitals told us that EP catheters were among the very few SUDs they

reused. Conversely, gastrointestinal (GI) biopsy forceps are more difficult

to reprocess. The forceps are long and have hollow tubes and delicate

mechanisms that make them harder to clean and sterilize, and none of the

gastroenterology centers we contacted said that they reused these devices.

The safety of reprocessing some types of devices has been established by

well-developed clinical studies. Studies have shown both that reprocessing

procedures can be safely accomplished and that patient outcomes are not

adversely affected by the use of reprocessed SUDs. For example, several

studies have documented the safe reprocessing and reuse of EP catheters.

One study of more than 14,000 EP procedures found that the overall rate

of patient infections was very low and did not differ between clinical

centers that reused EP catheters and centers that used each catheter only

once.6

The hospital infection control practitioners, risk management executives,

and patient safety experts we interviewed told us that careful reprocessing

of the types of SUDs that can be properly cleaned and sterilized does not

pose an additional risk to patient health. Hospital infection experts at the

Centers for Disease Control and Prevention told us that the evidence

showed that SUD reprocessing poses minimal public health risk. Risk

management professionals told us that the hospitals they worked with had

not received any claims of patient injury caused by the use of reprocessed

SUDs. With the exception of groups representing device manufacturers, all

of the professional organizations with positions on SUD reuse that we

contacted or that submitted comments to FDA on the agency’s regulatory

proposal expressed at least qualified support for SUD reprocessing and

reuse. None sought to ban SUD reprocessing, although some supported

FDA’s plan to more closely regulate SUD reprocessing. These

organizations included groups representing physicians, nurses, in-hospital

sterilization professionals, infection control practitioners, and health care

facilities.

6S. O’Donoghue and E.V. Plata, “Reuse of Pacing Catheters: A Survey of Safety and Efficacy,” Pacing and

Clinical Electrophysiology, Vol. 11, No. 9 (1988), pp. 1279-80.

Available Evidence

Suggests That Some

Types of SUDs can be

Safely Reprocessed
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 5 GAO/T-HEHS-00-143

We found little indication in reports of adverse events related to medical

devices that SUD reprocessing is unsafe. Only a very small percentage of

the reports FDA has received through its Medical Device Reporting (MDR)

program concerned patient adverse outcomes associated with reused

SUDs, although this program probably underestimates the number of

injuries from reprocessed SUDs.7 For a roughly 3-year period ending in

December 1999, FDA’s Manufacturer and User Facility Device Experience

database received nearly 125,000 reports of patient injuries, device

malfunctions, or other potential problems associated with SUDs. FDA told

us that 1,131 (less than 1 percent) of those reports involved SUDs that had

been reprocessed but that nearly 700 of the reports concerned dialysis

equipment that was reprocessed for use on the same patient. Only 49 of

the reports were for SUDs included on FDA’s list of frequently

reprocessed SUDs, and it is not known whether those injuries and

malfunctions were caused by reprocessing, by device failure unrelated to

reprocessing, or by some other aspect of the medical procedure.8

Several of the public reports we identified of patient adverse events

allegedly related to SUD reprocessing were inaccurate, did not involve the

type of reprocessing discussed here, or were difficult to interpret. For

example, it was alleged that SUD reuse caused increased rates of

pneumonia in one group of children.9 This was supported by a study of

home use of tracheostomy tubes in children with breathing difficulties.10

This is not relevant to the current discussion because the reused tubes

were cleaned at home with hydrogen peroxide, vinegar, or soap and water

for use on the same child, not reprocessed by hospitals or third-party

companies for use on other patients. Likewise, FDA received a report that

the tip of a reused EP catheter broke off and lodged in a patient’s heart.

However, FDA also received two reports of similar injuries resulting from

procedures with new EP catheters.

7This is because the information on MDR reports that identifies SUDs as reused is inconsistent and probably

incomplete. For example, an FDA official told us that FDA had received only six MDR reports that mentioned a

third-party reprocessing firm by name and that three of them were for the same incident.

8The remaining reports were for devices other than those on FDA’s list of frequently reprocessed devices or for

devices that were reused on the same patient.

9Statement of Robert H. O’Holla, before the Oversight and Investigations Subcommittee, House Commerce

Committee (Feb. 10, 2000).

10S.C. Bahng and others, “Parental Report of Pediatric Tracheostomy Care,” Archives of Physical Medicine

and Rehabilitation, Vol. 79, No. 11 (1998), pp. 1367-69.
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 6 GAO/T-HEHS-00-143

It is also clear that some SUDs cannot be safely reprocessed, procedures

for safe reprocessing are not always followed, and the limitations of the

information available about SUD reprocessing argue for monitoring the

practice. FDA researchers, original device manufacturers, and third-party

reprocessors all agree that many types of SUDs cannot be reprocessed

safely. There is also agreement that, even for some categories of SUDs that

can be reprocessed, some models can be thoroughly cleaned and sterilized

while others cannot. For instance, two third-party reprocessing firms told

us that they distinguish for clients particular device models that can, or

cannot, be successfully reprocessed.

For devices that can be reprocessed safely, cleaning and sterilization

procedures are not always followed correctly. For example, a 1997 survey

of gastrointestinal endoscopy physicians found that about one-quarter of

endoscopic facilities failed to follow all of a professional association’s

guidelines for cleaning and sterilizing endoscopic instruments.11 Also

underscoring the potential risks of SUD reprocessing, infection outbreaks

occur occasionally that are due to sterilization failures for devices

approved for marketing as reusable.12

Device manufacturers have forwarded to FDA reports of allegedly

damaged, unclean, or nonsterile reprocessed SUDs taken from hospital

stocks that had been reprocessed by third-party reprocessing firms. FDA

found that at least one of these claims had merit. In March 1999, a

manufacturer told FDA that six reprocessed GI biopsy forceps it retrieved

from a Florida hospital were not sterile. The devices were labeled for

single use only and had been reprocessed by a third-party reprocessing

company. These biopsy forceps are nearly 8 feet long, and the sterility

testing procedure used by the manufacturer involved cutting the devices

into segments to allow better access to the center portions of the hollow

tubing. Using established test procedures that did not segment the biopsy

forceps, both FDA and the reprocessing firm subsequently tested devices

from the same lot and found them to be sterile. FDA now believes that the

sterility test protocol it used was not the best one for these devices, and it

is preparing a new protocol. Although there is no evidence that these

reprocessed devices have harmed patients, this case demonstrates the

11R.J. Cheung and others, “GI Endoscopic Reprocessing Practices in the United States.”

12CDC, “Nosocomial Infection and Pseudoinfection from Contaminated Endoscopes and Bronchoscopes—

Wisconsin and Missouri,” Morbidity and Mortality Weekly Report, Vol. 40, No. 39 (1991), pp. 675-78; and

CDC, “Bronchoscopy-Related Infections and Pseudoinfections—New York, 1996 and 1998,” Morbidity and

Mortality Weekly Report, Vol. 48, No. 26 (1999), pp. 557-60.

SUD Reprocessing Not

Always Safe
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 7 GAO/T-HEHS-00-143

possibility that some reprocessed SUDs sterilized according to current

protocols might not be free of bacterial contamination.

Current surveillance systems for medical errors and adverse events almost

certainly do not detect all infections and injuries resulting from the use of

reprocessed SUDs, or from the use of medical devices in general. It is well

known that surveillance systems based on spontaneous reports by health

care providers and manufacturers are plagued by underreporting,

incomplete reports, and other problems.13 In addition, FDA officials and

infection control experts told us that it is often difficult to identify the

source of infections in individual patients, and it can be particularly

difficult to trace infections back to the use of specific medical devices.

Reprocessed SUDs cost less than new devices. Independent reprocessing

firms charge hospitals and ambulatory surgery centers approximately onehalf of the price of a new device for each reprocessed SUD, while three

hospitals that reprocess EP catheters in-house told us that their

reprocessing costs were less than 10 percent of the price of a new device.

Although there is some debate about how to calculate the true costs of

reprocessing, hospitals that use reprocessed SUDs told us that they save

money by doing so. For example, hospitals gave us estimates for their

savings from reusing EP catheters ranging from $115,000 to $1 million

annually.

The exact prices paid for new SUDs are arrived at during negotiations

between individual manufacturers and individual purchasers. The

competitive alternative offered by SUD reprocessing appears to have

affected negotiations between manufacturers and purchasers and may

have caused some manufacturers to lower their prices to some

purchasers. For example, we obtained copies of marketing materials from

a manufacturer of single-use sequential compression devices offering to

reduce prices if the purchasing hospital signed a contract stipulating that it

would not reprocess the devices. For two hospitals we contacted,

manufacturers offered to reduce the price of new EP catheters by as much

as one-half, matching the price of third-party reprocessing, if the facilities

would agree to not reprocess the devices. A major third-party reprocessing

firm told us that some hospitals stopped using its services when offered

this arrangement by manufacturers. We were not able to determine how

often manufacturers offer these price breaks.

13See Adverse Events: Surveillance Systems for Adverse Events and Medical Errors (GAO/T-HEHS-00-

61, Feb. 9, 2000).

SUD Reprocessing

Reduces Hospital

Costs for Medical

Devices
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 8 GAO/T-HEHS-00-143

FDA categorizes all entities that reprocess SUDs—including third-party

reprocessing firms, hospitals, and ambulatory surgery centers—as device

manufacturers, and therefore they are technically required to comply with

good manufacturing practices, FDA inspection, and manufacturers’

adverse events reporting regulations. FDA has enforced these provisions

for third-party reprocessing firms but not for hospitals and other health

care facilities that reprocess SUDs. Currently, manufacturers that want to

market a reusable device must submit data to FDA that convinces the

agency that a device can be safely reprocessed for a set number of times

without compromising its function. While third-party firms must register

with FDA and meet FDA’s standards for good manufacturing practices,

they can reprocess SUDs without seeking premarket approval from FDA.

A difficulty with the current policy has been FDA’s inability to inspect all

third-party reprocessors because it has been unable to identify them. This

month, FDA officials told us that FDA had identified 14 reprocessing

facilities operated by 13 different reprocessing firms and that the agency

had inspected all but two of those facilities. FDA suspects that there are

more third-party reprocessors that have not registered with the agency.

FDA has proposed a new regulatory framework that will make major

changes to the oversight of SUD reprocessing. The framework will extend

enforcement of all of FDA’s requirements for device manufacturers to

hospitals that reprocess SUDs and third-party reprocessing firms.14 There

will be three major changes. First, hospitals will be expected to satisfy all

the requirements now faced by third-party reprocessing firms, such as

registering with FDA, telling FDA which devices they reprocess, fulfilling

the MDR reporting requirements for manufacturers, using reprocessing

procedures that meet the standards for good manufacturing practices, and

facing inspection by FDA. Second, hospitals that reprocess SUDs and

third-party reprocessing firms will be required to meet all applicable

premarket requirements. That is, they will have to submit relevant

documentation to FDA as if they were seeking to market a new device.

Finally, all reprocessors will be required to follow general requirements

for labeling SUDs, including providing adequate instructions for use.15 FDA

14FDA, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals

(Rockville, Md.: FDA, Feb. 2000).

15Neither the hospitals nor the third-party reprocessors we contacted now include instructions for use on their

labels because reprocessed devices ordinarily are returned to facilities that already have instructions from the

manufacturer’s original labeling of the device. To the extent that these required instructions infringe on the

copyrighted instructions of the original manufacturers, it may be difficult for reprocessors to meet this

requirement.

FDA’s Proposed

Regulatory

Framework Will

Extend Requirements

Faced by

Manufacturers to

Most SUD

Reprocessors
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 9 GAO/T-HEHS-00-143

plans to issue a final guidance document in July 2000, with the new

requirements taking effect over an 18-month period starting then.

FDA’s proposed regulatory framework specifically exempts opened but

unused SUDs. The proposed framework also does not apply to health care

facilities other than hospitals that reprocess SUDs in-house. By at least

temporarily excluding ambulatory surgery centers and other nonhospital

health care facilities from regulation, the proposal maintains the

inconsistency of the current policy by exempting some reprocessors from

FDA oversight.

FDA’s proposed regulatory framework imposes a structure designed to

oversee the manufacture of new medical devices onto the different

enterprise of SUD reprocessing. Implementation of this new framework

will face a number of barriers, including SUD reprocessors’ inexperience

with FDA’s regulations for medical device manufacturers. Hospitals that

reprocess SUDs have no experience with FDA’s regulation of medical

devices and device manufacturers, even though FDA technically considers

them to be device manufacturers now. And, while third-party reprocessing

firms already collect some of the data FDA will require for premarket

approval of reprocessed SUDs, their ability to adjust to the new

requirements is not assured.

FDA will probably not be able to identify all of the reprocessors that will

be subject to the new regulatory framework, at least in the short term. In

addition, although it is engaged in an outreach effort to educate hospitals

that reprocess SUDs in-house about the new requirements, we believe that

FDA will find it difficult to identify reprocessing hospitals unless they

voluntarily register with the agency.

The potentially large number of additional premarket applications and

manufacturing facilities to inspect could overburden FDA’s already

stretched resources. The number and complexity of marketing

applications that will be submitted for reprocessing is unknown, as is the

number of hospitals that will register with the agency. But FDA could

receive many premarket applications because applications are required

from each entity for each device that it wishes to reprocess. A large

number of applications may impede FDA’s ability to oversee reprocessing

and may compromise its work in other areas. Premarket submissions for

reprocessing will be placed in the same queue as marketing applications

for new medical devices and an FDA official told us that this additional

work may decrease the percentage of marketing applications for new

devices that are reviewed in a timely manner.

SUD Reprocessors and

FDA May Have Difficulty

Implementing the New

Framework
Medical Devices: Reprocessing and Reuse of

Devices Labeled Single-Use

Page 10 GAO/T-HEHS-00-143

FDA’s proposed framework imposes significant new requirements on

institutions that reprocess SUDs. FDA officials, hospital administrators,

physicians, and device manufacturers all told us that hospitals will be

much less likely to maintain in-house SUD reprocessing operations under

the new framework. Some hospitals that currently reprocess in-house are

likely to contract with third-party reprocessing firms for that work. At

least some third-party firms anticipate an increase in business.

The evidence suggests that some SUDs can be safely reprocessed if

appropriate cleaning, testing, and sterilization procedures are carefully

followed. However, SUD reprocessing is not invariably safe, and relatively

little is known about the practice of SUD reprocessing in health care

facilities. For this reason, FDA has taken steps to increase its oversight of

SUD reprocessing. Nonetheless, the new framework is cumbersome and

will be difficult to implement.

This concludes my prepared statement, Mr. Chairman. I will be happy to

respond to any questions that you or Members of the Committee may

have.

For future contacts regarding this testimony, please call Janet Heinrich at

(202) 512-7119. Key contributors include Lisanne Bradley, Marcia Crosse,

Martin T. Gahart, Janina R. Johnson, and Stefanie Weldon.

(201074)

FDA’s New Framework

May Decrease SUD

Reprocessing in Hospitals

Conclusions

Contacts and

Acknowledgments
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