GAO

United States General Accounting Office

Report to Congressional Requesters

June 2000 SINGLE-USE 

MEDICAL DEVICES

Little Available 

Evidence of Harm 

From Reuse, but 

Oversight Warranted

GAO/HEHS-00-123

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Contents

Letter 3

Appendixes Appendix I: FDA’s List of Frequently Reprocessed SUDs 28

Appendix II: Comments From the Department of Health and Human 

Services 30

Table Table 1: Surveys of SUD Reprocessing 9

Abbreviations

CDC Centers for Disease Control and Prevention

EP electrophysiology

FDA Food and Drug Administration

GI gastrointestinal

HCFA Health Care Financing Administration

HHS Department of Health and Human Services

HIV human immunodeficiency virus

JCAHO Joint Commission on Accreditation of Healthcare Organizations

MDR Medical Device Reporting

PMA premarket approval

SUD single-use device

VA Department of Veterans Affairs
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United States General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-284135 Letr

June 20, 2000

The Honorable James M. Jeffords

Chairman

The Honorable Edward M. Kennedy

Ranking Minority Member

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Bill Frist

Chairman

Subcommittee on Public Health 

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Mike DeWine

The Honorable Christopher Dodd

The Honorable Richard Durbin

The Honorable Mike Enzi

The Honorable Patty Murray

The Honorable Jack Reed

United States Senate

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. Some reprocessed devices are relatively simple items 

for external use, such as sequential compression devices (inflatable sleeves 

to improve blood circulation), while others are complex and invasive, such 

as catheters that are inserted into the heart to monitor cardiac functioning. 

Some devices, both SUDs and those marketed as reusable, have been 

reprocessed in-house by hospitals and other treatment facilities for 

decades. An industry of third-party medical device reprocessing companies 

has developed within the last 10 years. The practice of SUD reprocessing 

raises public health concerns, primarily regarding the potential risks of 

infection and device malfunction, and has led to complaints by the original 

1

SUDs are also referred to as disposable devices because they are intended to be discarded 

after one use.
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device manufacturers that the Food and Drug Administration (FDA), the 

federal agency within the Department of Health and Human Services (HHS) 

that approves medical devices for marketing, has not maintained 

consistent regulatory standards for different types of medical device 

companies. 

When manufacturers seek approval to market a device as single-use, FDA 

cannot require them to show that reusing the device would be 

inappropriate or hazardous. Manufacturers that intend to market a device 

as reusable must give FDA supporting data demonstrating to the agency’s 

satisfaction that a device can be cleaned and sterilized without impairing 

its function. All other devices are intended for single-use. Thus, a device 

may be marketed for single-use because the manufacturer believes that it 

cannot be safely and reliably used more than once or because the 

manufacturer chooses not to conduct the studies needed to prove that the 

device should be labeled as reusable. In effect, because FDA can only 

evaluate a device relative to the use intended for it by its manufacturer, its 

approval of a device as 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.

You asked us to review the practice of SUD reprocessing in the United 

States. We focused our work 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. To conduct our work, we reviewed the 

relevant scientific literature, met with FDA officials, reviewed FDA 

documents and documents submitted to FDA by interested parties; 

interviewed officials at the Centers for Disease Control and Prevention 

(CDC) and the Health Care Financing Administration (HCFA); gathered 

information from other experts in government and industry; contacted 

third-party reprocessing companies; and interviewed physicians, hospital 

administrators, and other health care providers. We conducted our work 

between November 1999 and May 2000 in accordance with generally 

accepted government auditing standards.

Results in Brief While it is clear that some health care institutions have chosen to reprocess 

and reuse some kinds of SUDs, accurate and comprehensive information 
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about the number of facilities that use reprocessed SUDs and the types of 

SUDs that are reprocessed is not available. Surveys by professional 

associations and other groups have found that approximately 20 to 30 

percent of American hospitals reported that they reuse at least one type of 

SUD and that at least one-third of the hospitals that do so contract with 

third-party reprocessing companies. Most hospitals using reprocessed 

SUDs reuse only a few types of devices. It is likely that some hospitals do 

not report their use of reprocessed SUDs, and the estimates do not fully 

include ambulatory surgery centers or physicians’ practices that also may 

reuse SUDs. 

Although SUD reprocessing does pose theoretical health risks, clinical 

evidence shows that certain devices can be reprocessed safely. In addition, 

some infection control experts told us that the careful reprocessing of 

appropriate SUDs has not been demonstrated to be a public health risk. 

Almost all of the professional associations we contacted believe that 

selected devices can be reprocessed safely if appropriate procedures are 

followed and closely monitored. We found that several reports of patient 

adverse events allegedly due to SUD reprocessing that we identified were 

inaccurate or not relevant to the debate. However, this does not mean that 

SUD reprocessing is always safe. Current 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). 

Furthermore, FDA, device manufacturers, and third-party reprocessors 

generally agree that many types of SUDs cannot be safely cleaned and 

sterilized, and even for devices that usually can be reprocessed, some 

models are impossible to clean and sterilize effectively. 

Substantial cost savings can be achieved by reprocessing SUDs. 

Independent reprocessing firms charge 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. The competition created by SUD reprocessing appears to have 

caused some original device manufacturers to reduce their prices to certain 

purchasers. 

FDA’s regulation of SUD reprocessing for different types of device 

manufacturers has been inconsistent, but the agency is about to institute a 

new regulatory framework intended to address this concern. Currently, 

although third-party reprocessing firms are considered by FDA to be 

manufacturers of reusable medical devices, they are not required to seek 

premarket approval to reprocess SUDs, and FDA until now has chosen not 
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to exercise its jurisdiction over hospitals and other health care institutions 

that reprocess SUDs in-house. Under the revised framework, independent 

reprocessing firms and hospitals will have to obtain FDA’s approval before 

they can reprocess many devices labeled for single-use. The revised 

regulatory framework will give FDA more information about SUD 

reprocessing and strengthen its oversight of reprocessing. However, there 

are significant barriers to the framework’s successful implementation. FDA 

told us that the additional work involved in reviewing applications for SUD 

reprocessing may interfere with the agency’s ability to complete timely 

reviews of premarket applications for new medical devices. Also, the 

framework will involve the agency in regulating SUD reprocessing 

practices in hospitals. To get help with the monitoring of reprocessing in 

these facilities, FDA has asked HCFA and the Joint Commission on 

Accreditation of Healthcare Organizations (JCAHO) to include SUD 

reprocessing in their hospital quality-of-care standards. Neither HCFA nor 

JCAHO has committed to do this in the near term.

Background 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 describes how they should be used, and the 

facilities that manufacture them. FDA’s requirements for approving devices 

for marketing depend on the device’s potential for harming patients. Class 

I, or low-risk, devices include such things as elastic bandages and 

orthopedic saw blades. Medium-risk devices, class II, include items like 

urethral catheters and blood pressure cuffs. Class III devices, such as heart 

valves and balloon angioplasty catheters, support or sustain human life and 

present significant risk of patient injury. Most class I devices can be 

marketed without obtaining prior approval from FDA. FDA requires the 

manufacturers of most class II and class III devices to submit either a 

premarket notification application (510(k)) to show that the device is 

substantially equivalent to one already on the market or an application for 

premarket approval (PMA), which provides evidence, often including 

clinical data, demonstrating that the device is safe and effective. FDA
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requires a satisfactory inspection of a manufacturer’s facilities before a 

PMA is approved.2

 FDA received 4,458 510(k) applications and 72 PMAs for 

medical devices in fiscal year 1999. Manufacturers are required to register 

with FDA, list the devices they produce, follow good manufacturing 

practices, and inform FDA about problems with their marketed devices. 

Manufacturers also are subject to inspection by FDA. In fiscal year 1999, 

FDA inspected 30 percent of the nearly 3,500 domestic manufacturers of 

class II and class III medical 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

 Thus, 

manufacturers that wish to market a device as 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. 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 or not a 

reprocessed device still meets performance specifications. They 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 intended for single-use.4

The Extent of 

Reprocessing 

Single-use device reprocessing is a small part of the large and varied 

medical device industry. FDA has confirmed the existence of only a small 

number of third-party reprocessing firms, although it suspects there are 

more. Surveys by professional associations and other groups have 

consistently found that roughly 20 to 30 percent of American hospitals 

reported reusing at least one type of SUD. Many health care professionals 

told us that they believe manufacturers market devices with a single-use 

2

Manufacturers submitting 510(k)s for class III devices must have been inspected by FDA in 

the 2 years preceding the 510(k) application. Facility inspection is not required for other 

510(k) applications. 

3

Food 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. 

4

FDA did not require manufacturers of reusable devices to include cleaning and sterilization 

instructions with them until 1995, following the release of reprocessing standards for 

reusable devices by an industry association. FDA 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. 
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label because of the economic benefits of doing so and that they therefore 

believe many SUDs can be reused. 

SUD Reprocessing Is a 

Small Part of the Medical 

Device Industry

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

institutions 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 firms said that its 

members collectively received about $20 million annually for their services. 

Although there are many hospitals (more than 6,000) and ambulatory 

surgery centers (about 2,700) in the United States, evidence indicates that 

only a minority of them reprocess SUDs in-house. Furthermore, 

reprocessors (both third-party firms and hospitals) each typically 

reprocess only a few types of SUDs. 

A Minority of Hospitals 

Report Reusing SUDs to 

Some Extent

While it is clear that some health care institutions 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. 

Table 1 presents the results of six surveys about SUD reprocessing 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 were affiliated. Most of the 

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. The only survey with a response rate greater than 

50 percent, from the Metropolitan Chicago Healthcare Council, 

unfortunately does not have separate results for the reprocessing of SUDs 

used on patients—its findings combine SUD reprocessing and the 

resterilization of opened but unused devices. 
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Table 1: Surveys of SUD Reprocessing

a

ECRI, Special Report: Reuse of Single-Use Medical Devices: Making Informed Decisions (Plymouth 

Meeting, Pa.: ECRI, 1997), pp. 85-86.

b

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

Gastrointestinal Endoscopy, Vol. 50, No. 3 (1999), pp. 362-68.

c

GI endoscopic instruments only.

d

Question not included in survey. 

e

ASHCSP, presentation at conference, “The Re-Use of Single-Use Devices: Practice, Patient Safety 

and Regulation,” May 5-6, 1999. 

f

OR Manager, Vol. 15, No. 9 (1999), pp. 1, 11, 14.

g

Includes opened but unused SUDs in addition to SUDs that have been used on a patient.

h

Metropolitan Chicago Healthcare Council survey.

i

J.W. Birk and others, “A National Survey on the Re-Use Patterns of ‘Single Use Only’ ERCP Supplies,” 

Gastrointestinal Endoscopy, Vol. 49, No. 4 (1999), p. AB139.

Source Sample Date Response rate

Percentage of

institutions that

reprocess SUDs used

on patients

Percentage of

institutions that

have third-parties

reprocess SUDs

ECRIa Hospital subscribers to 

ECRI publications

1996 7%

(N=more than 280)

31 7

R.J. Cheung and othersb Random sample of 

membership of the 

American Society for 

Gastrointestinal 

Endoscopy

1997 40%

(N=294)

29c d

American Society for 

Healthcare Central 

Service Professionalse

ASHCSP members 1998 22%

(N=214)

21 7

OR Managerf Random sample of 

readers of publication

1999 44%

(N=132)

Between 18 and 31 24g

Metropolitan Chicago 

Healthcare Councilh

Member hospitals 1999 72%

(N=71)

20g 17g

J.W. Birk and othersi Membership of the 

Society of 

Gastroenterology Nurses 

and Associates

1999 46%

(N=223)

16c d
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The estimate of 20 to 30 percent may be low because some hospitals and 

other health care facilities do not report this practice. For example, 

representatives of manufacturers told us that their examination of SUDs 

that malfunctioned indicated that devices from some hospitals had clear 

evidence of reprocessing, even though the institutions denied reusing 

SUDs. Similarly, an official of the Department of Veterans Affairs (VA) told 

us that some VA hospitals reuse single-use cardiac catheters, even though 

SUD reprocessing is contrary to VA policy.5

 The surveys also may not 

completely capture the use of reprocessed SUDs in ambulatory surgery 

centers, physicians’ practices, or other nonhospital institutions.6

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 

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 (because they 

do not have long, hollow tubes), sterilize, and test. They also are expensive 

(ranging roughly from $100 to $1,500), and a typical EP procedure could 

involve the use of several catheters. In the course of our work, we 

contacted representatives of nine EP centers; seven of them acknowledged 

using reprocessed EP catheters. 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. We contacted physicians from 17 gastroenterology 

centers, and none of these physicians said that their facilities reused GI 

biopsy forceps. (A list compiled by FDA of frequently reprocessed SUDs is 

in app. I.) 

5

The same VA official told us that there had been no reported problems with reused 

catheters.

6

This is because some of the surveys did not include nonhospital institutions.
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Many Health Care 

Professionals Question 

Single-Use Label 

Many health care personnel believe that some SUDs can be reused. They 

told us they distrust the single-use label for some devices because (1) FDA 

cannot require manufacturers to support the designation of a device as 

single-use, (2) they perceive that manufacturers have an economic 

incentive to market devices as single-use that could just as well be sold as 

reusable, and (3) FDA’s approval requirements for SUDs are less extensive 

than those for reusable devices. In addition, the application of the singleuse label to noncritical medical devices erodes its meaning for some health 

care personnel.7

On occasion, manufacturers have contributed to the sense that compliance 

with the single-use label is not always necessary. We found three examples 

of this. First, a major manufacturer of pulse oximeter sensors (devices that 

measure blood oxygen levels) has a program to “recycle” the sensors, 

essentially offering to sell “remanufactured” sensors for reduced prices to 

health care institutions that return their used single-use sensors to the 

company. These SUDs are also reprocessed by third-party reprocessing 

firms, which cite the manufacturer’s recycling program as evidence that the 

single-use label on these devices is not meaningful. Second, in a 1998 U.S. 

District Court case, the judge found that the manufacturer’s only purposes 

in labeling a device for single-use were to comply with FDA’s requirements 

and to limit its own liability from reuse, not to prevent a hospital from using 

it more than once.8

 Third, manufacturers have written letters to hospitals 

containing detailed instructions for the sterilization of SUDs. The letters 

typically caution against resterilizing the SUD and then give detailed 

sterilization instructions. Some of the letters note that the sterilization 

procedures may be used for open but unused devices, but others do not 

include that restriction. One letter volunteered that the manufacturer had 

verified that the device could be resterilized three times, although the 

manufacturer had not tested devices that had been used on patients. One 

hospital we talked with used the instructions in the letters as guidelines for 

its in-house reprocessing program.

7

In addition, we repeatedly heard two claims that we were unable to verify. Health care 

personnel told us that they believed that some SUDs were identical to reusable devices. 

Similarly, FDA officials and health care personnel told us that they recalled that the labels of 

some devices were changed from reusable to single-use in years past without significant 

design changes.

8

United States Surgical Corp. v. Orris, Inc., 5 F. Supp.2d 1201 at 1207.
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Evidence Indicates 

That Safe Reprocessing 

of Certain Devices Is 

Possible 

While SUD reprocessing does pose some theoretical health risks, the 

available evidence indicates that some SUDs can be safely reprocessed and 

reused on other patients. The safety of reprocessing some types of devices, 

such as some types of EP catheters, is supported by a well-developed 

clinical literature. The infection control and patient safety experts we 

consulted told us that the reprocessing of certain SUDs is not a 

demonstrated public health risk, and SUD reprocessing is seen as safe by 

many associations representing health care professionals. Several reports 

of patient adverse events allegedly related to SUD reprocessing that we 

investigated were inaccurate, not relevant to the debate, or difficult to 

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

safe. For example, some reports of nonsterile reprocessed SUDs merit 

further investigation, and current surveillance systems are unlikely to 

detect all infections or injuries caused by reprocessed SUDs. 

Reprocessing Procedures To successfully reprocess a device that has been used on a patient, 

institutions must be able to clean it thoroughly, sterilize it to acceptable 

standards, and ensure that reprocessing and reuse will not degrade its 

functioning. Cleanliness is important because even measurably sterile 

devices can harbor biological material from previous uses that may prove a 

health risk for subsequent patients. Potentially, this biological residue by 

itself can prove toxic to new patients, and it also can form a crust to shield 

harmful bacteria from sterilization procedures. For these reasons, 

reprocessors assert that they choose devices to reprocess carefully, 

rejecting those that cannot be cleaned thoroughly or that are damaged by 

sterilization or reprocessing procedures.

The reprocessors we contacted, both third-party firms and hospitals, 

followed similar reprocessing procedures. Devices to be reprocessed are 

collected following established procedures and are frequently rinsed or 

otherwise cleaned soon after use, before they are sent to the reprocessing 

facility. There the devices are cleaned, refurbished, inspected, and 

sterilized. The third-party reprocessors told us that they check the function 

of every device before it is sterilized and returned to the client. These firms 

also told us that they do not mix devices from different hospitals—each 

hospital receives only devices from the batch it sent to the reprocessor. 

According to the reprocessors, many devices are rejected during 

reprocessing because they have been damaged, even among device models 

that are especially amenable to reprocessing. The reprocessors also told us 

that they or their client health care facilities set limits on the maximum 
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number of times an individual device can be reused. They also said that 

they keep track of the number of uses for each device and discard the 

devices when the limit is reached. 

Reprocessors also resterilize open but unused SUDs. These are devices 

that were opened in preparation for a surgical procedure—and are 

therefore no longer sterile—but were not used on a patient. FDA, device 

manufacturers, and hospitals all agree that there is less risk in reprocessing 

these devices. Manufacturers told us that hospitals frequently ask them for 

sterilization instructions for opened but unused SUDs and that the 

manufacturers either provide instructions or advise the hospitals that the 

devices cannot be resterilized.

Available Evidence Suggests 

That Some Types of SUDs 

Can Be Safely Reprocessed

To assess the health risks of reprocessed SUDs relative to the risks from 

new devices, it would be best to compare the rates of patient injuries and 

illnesses caused by each. Unfortunately, neither comprehensive data about 

the numbers of adverse events caused by medical devices nor data about 

the numbers of patients exposed to particular devices exist today. 

Furthermore, new medical devices are not always perfect, and some 

patient injuries or infections are caused by SUDs at their first use. This 

means that individual cases of adverse events associated with reprocessed 

SUDs are not informative because we do not know how often these events 

occur with new SUDs. Therefore, to assess the safety of reprocessed SUDs, 

we evaluated information from a variety of complementary, but less than 

ideal, data sources. 

Four types of information indicate that some devices labeled for single-use 

can be reprocessed safely and used again on other patients. First, the safety 

of reprocessing some types of devices has been established by welldeveloped 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
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that reused EP catheters and centers that used each catheter only once.9 A 

later study of 69 EP catheters used in 336 procedures concluded that 

carefully reprocessing one model of single-use catheter up to 5 times posed 

no increase in health risks.10 Similarly, some evaluations of the 

reprocessing of single-use endoscopic instruments published in peerreviewed scientific journals found that those SUDs could be reused at least 

several times without increasing patient risk.11

Second, the hospital infection control practitioners, risk management 

executives, and patient safety experts we interviewed all told us that 

careful reprocessing of the types of SUDs that can be properly cleaned and 

sterilized does not pose a risk to patient health. For example, the hospital 

infection control practitioners we contacted told us that all types of 

infectious bacteria and some key viruses (including human 

immunodeficiency virus (HIV) and hepatitis C) can be destroyed if devices 

are properly cleaned and sterilized and that they were not aware of any 

infections resulting from the reuse of SUDs in their hospitals. Hospital 

infection experts at CDC told us that the evidence showed that SUD 

reprocessing poses minimal, if any, public health risk. The CDC experts 

said that they were not aware of patient illnesses caused by SUD reuse in 

the last decade.12 The head epidemiologist of CDC’s Hospital Infection 

Program told us that although CDC does not specifically monitor SUD 

reuse, he was confident hospital infection surveillance systems would have 

uncovered infections resulting from SUD reuse if they had occurred. 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. An official of a health quality consulting organization told us that his 

firm could find no evidence in its databases that treating patients with 

reprocessed SUDs was more dangerous than using new devices. 

9

S. 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.

10B. Avitall and others, “Repeated Use of Ablation Catheters: A Prospective Study,” Journal 

of the American College of Cardiology, Vol. 22, No. 5 (1993), pp. 1367-72.

11J. Cohen and others, “A Prospective Study of the Repeated Use of Sterilized Papillotomes 

and Retrieval Baskets for ERCP: Quality and Cost Analysis,” Gastrointestinal Endoscopy, 

Vol. 45, No. 2 (1997), pp. 122-27; and R.A. Kozarek and others, “Reuse of Disposable 

Sphincterotomes for Diagnostic and Therapeutic ERCP: A One-Year Prospective Study,” 

Gastrointestinal Endoscopy, Vol. 49, No. 1 (1999), pp. 39-42.

12However, CDC is aware of infections caused by hemodialyzers that were reprocessed for 

reuse on the same patient.
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Partly because of the clinical literature and expert opinion just described, 

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 this practice. 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.13 Some of these 

associations and other organizations have issued guidelines to help 

hospitals develop SUD reprocessing programs. The guidelines usually give 

advice about assessing the costs and benefits of reprocessing SUDs, 

choosing devices that can be reprocessed safely, and evaluating the 

services offered by third-party reprocessing companies.

Third, 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 with reprocessed SUDs.14

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 of those reports involved 

SUDs that had been reprocessed but that nearly 700 of them concerned 

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

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

reprocessed devices (36 for malfunctions, 9 for injuries, and 4 for other

13The organizations included the American College of Cardiology, the North American 

Society for Pacing and Electrophysiology, the American College of Surgeons, the American 

Society for Gastrointestinal Endoscopy, the Association of periOperative Registered Nurses, 

the Society of Gastroenterology Nurses and Associates, the American Society for 

Healthcare Central Service Professionals, the International Association of Healthcare 

Central Service Material Management, the Association for Professionals in Infection Control 

and Epidemiology, and the American Hospital Association.

14This 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.
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reasons), and it is not known whether those injuries were caused by 

reprocessing, by device failure unrelated to reprocessing, or by some other 

aspect of the medical procedure.15

Fourth, several of the reports we identified of patient adverse events 

allegedly related to SUD reprocessing were inaccurate, not relevant to the 

debate, or difficult to interpret. For example, it was reported that a recent 

patient death occurred in a Colorado hospital as a result of an infection 

transmitted by a reprocessed cardiac catheter. CDC officials told us that 

this incident occurred some time ago in a hospital that did not use 

reprocessed cardiac catheters. The infection ultimately was traced to 

improperly sterilized glass medicine cups. Similarly, it was alleged that 

SUD reuse caused increased rates of pneumonia in one group of children.16

This was supported by a study of home use of tracheostomy tubes in 

children with breathing difficulties.17 This is not relevant to the current 

debate 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, not reprocessed, EP catheters. In addition, a published report of 

blindness caused by the broken tip of a reused EP catheter migrating to a 

retinal artery is difficult to interpret because of the year and location of the 

case. It occurred overseas in 1984, and the sterilization procedures used on 

the catheter were different from the ones used today in the United States. 

SUD Reprocessing Is Not 

Always Safe

While the evidence shows that carefully controlled reprocessing of some 

SUDs is safe, 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 of the practice. FDA researchers, original device 

15The 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. 

16Statement of Robert H. O’Holla, before the Oversight and Investigations Subcommittee, 

House Committee on Commerce (Feb. 10, 2000).

17S.C. Bahng and others, “Parental Report of Pediatric Tracheostomy Care,” Archives of 

Physical Medicine and Rehabilitation, Vol. 79, No. 11 (1998), pp. 1367-69. 
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manufacturers, and third-party reprocessors all agree that many types of 

SUDs cannot be reprocessed safely. For example, the largest third-party 

reprocessing firm told us that it reprocesses only 15 “families” of devices 

and that many of these involve only the resterilization of opened but 

unused devices. 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 identify for clients particular device models that can 

be successfully reprocessed. Thus, the hospitals and ambulatory surgery 

centers that contract with these reprocessing firms can, in purchasing new 

devices that they intend to reuse, avoid ones that the firms will not 

reprocess. 

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.18 Four 

percent of the respondents to that survey reported patient infections 

associated with endoscopic procedures, although there was no indication 

that the infections resulted from the use of reprocessed SUDs. Also, 

underlining the potential risks of SUD reprocessing, infection outbreaks 

occur occasionally that are due to sterilization failures for devices 

approved for marketing as reusable. The outbreaks are detected in 

hospitals when unusually high numbers of patients become ill with the 

same infectious agent. For example, CDC reported that the failure of 

automatic cleaning machines to properly clean bronchoscopes and 

endoscopes led to at least five infectious outbreaks.19

For reprocessed SUDs, device manufacturers have forwarded to FDA 

reports of allegedly damaged, unclean, or nonsterile devices 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 of its reprocessed GI biopsy forceps it 

18R.J. Cheung and others, “GI Endoscopic Reprocessing Practices in the United States.”

19CDC, “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.
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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 

possibility that some reprocessed SUDs sterilized according to current 

protocols may 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.20 As we have previously reported, 

FDA’s surveillance system for medical devices—the MDR program—is no 

exception.21 For example, when FDA conducted a pilot test of a sentinel 

system for gathering adverse event reports for medical devices (working 

closely with selected health care institutions to increase reporting rather 

than trying to maximize reporting among all institutions), it received 

adverse event reports at a rate 10 times greater than the MDR program, 

even though MDR regulations mandate the reporting of the same types of 

events. 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 is particularly difficult to trace infections back to the use of specific 

medical devices. 

20See Adverse Events: Surveillance Systems for Adverse Events and Medical Errors (GAO/THEHS-00-61, Feb. 9, 2000).

21See Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring 

Problems With Approved Devices (GAO/HEHS-97-21, Jan. 29, 1997).
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SUD Reprocessing 

Reduces Hospital 

Costs for 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 (including, for example, the staff time needed to study the 

safety and cost-effectiveness of reprocessing particular devices and to 

perform quality-control functions), hospitals that use reprocessed SUDs 

told us that they save money by doing so. For example, one group of 

hospitals that uses reprocessed SUDs estimated that their annual savings 

per hospital were $44,000 for sequential compression devices, $17,000 for 

pulse oximeter sensors, and $115,000 for EP catheters. Other hospitals with 

active cardiology services gave us higher estimates for their savings from 

reusing EP catheters, ranging from $200,000 to $1 million annually. 

The exact prices paid for new SUDs result from negotiations between 

individual manufacturers and individual purchasers. The competitive 

alternative offered by SUD reprocessing has affected negotiations between 

manufacturers and purchasers and may have caused some manufacturers 

to lower their prices to some purchasers. For example, we found evidence 

that manufacturers sometimes offer lower prices to facilities that agree not 

to reprocess. 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.

The overall prices of some SUDs that are reprocessed appear to have 

decreased in recent years, even for health care institutions that do not 

reuse them, although we were unable to attribute the price drops to 

reprocessing. For instance, one third-party reprocessing firm showed us 

evidence that the prices its clients paid for new GI biopsy forceps, pulse 

oximeter sensors, and sequential compression devices had declined 20 

percent or more over the last few years. A manufacturer of one of these 

devices confirmed to us that its prices had declined, although the company 
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cited reasons other than reprocessing. Similarly, a majority of the 

gastroenterologists we contacted told us that the prices their facilities paid 

for new single-use GI biopsy forceps had decreased, and none of them 

reprocessed these devices. 

FDA’s Proposed 

Regulatory Framework 

Will Extend 

Requirements Faced by 

Manufacturers to Most 

SUD Reprocessors 

FDA’s current regulatory scheme results in uneven requirements for FDA 

review. Its proposed revisions would treat most SUD reprocessors as 

manufacturers. The proposed framework also would give FDA more 

information about SUD reprocessing and strengthen its oversight of 

reprocessing. However, there are significant barriers to the framework’s 

successful implementation.

Limitations of FDA’s Current 

Regulatory Scheme

FDA’s current regulation of SUD reprocessing represents a balance 

between its regulatory obligations, its judgment that SUD reprocessing has 

not posed a significant risk to the public health, and its limited resources. 

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

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

manufacturers,22 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 institutions that reprocess SUDs. In addition, because FDA has not 

required reprocessors to seek premarket approval for reprocessing SUDs, 

technically all reprocessors are engaged in the practice of selling 

adulterated medical devices. However, because FDA has judged that SUD 

reprocessing has not posed a significant risk to the public health, it has 

exercised “regulatory discretion” to allow SUD reprocessing to continue 

and to focus its limited enforcement resources in other areas. FDA has the 

authority to immediately halt any practice that threatens the public’s health 

and has not done so with SUD reprocessing because it believes there has 

been no evidence that the public health has been threatened.

Some manufacturers have complained that FDA’s inconsistent enforcement 

of premarket requirements has disadvantaged them relative to 

2221 C.F.R. 820.3 (o). All reprocessors of SUDs are considered manufacturers. 
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reprocessors. Manufacturers that want to market a reusable device must 

submit data to FDA, through a 510(k) or PMA, that convinces the agency 

that a device can be safely reprocessed for a set number of times without 

compromising its function. Currently, 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. FDA 

has not regulated hospitals and other health care institutions that reprocess 

SUDs in-house.

Another difficulty with the current policy has been FDA’s inability to 

inspect all third-party reprocessors because it has been unable to identify 

them. In early June 2000, 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 discovered 

two of the third-party reprocessors only when the firms identified 

themselves to the agency by submitting comments on FDA’s proposed 

regulatory framework. In the course of our work, we found one third-party 

reprocessing firm that was not known to FDA, and we forwarded 

information about it to the agency. FDA suspects that there are more thirdparty reprocessors that have not registered with the agency. 

FDA’s Proposed Regulatory 

Framework Will Enforce 

Current Requirements for 

Reprocessors

FDA’s proposed regulatory framework 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.23 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 (in addition to current 

user facilities’ MDR requirements),24 using reprocessing procedures that 

meet the standards for good manufacturing practices, and facing 

inspection by FDA. Second, both hospitals that reprocess SUDs and thirdparty reprocessing firms will be required to meet all applicable premarket 

23FDA, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and 

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

24MDR reporting requirements for manufacturers include reporting deaths, serious injuries, 

and malfunctions to FDA within 30 days; reporting events that require immediate remedial 

action to FDA within 5 days; and filing baseline reports to communicate basic data about 

each device that is the subject of a report. 
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requirements. That is, they will have to conduct the appropriate studies and 

submit relevant documentation to FDA as if they were seeking to market a 

new device. Thus, for many devices, SUD reprocessors will be required to 

submit a 510(k) demonstrating that the reprocessed device is substantially 

equivalent to a device already on the market, presumably the same device 

before it has been reprocessed. For other devices with higher risk, SUD 

reprocessors will be required to conduct clinical trials and gather other 

information to submit a PMA to show that the device is safe and effective. 

For example, among reprocessed devices, GI biopsy forceps will require a 

510(k), and cardiac ablation catheters (a type of EP catheter) will require a 

PMA. Finally, all reprocessors will be required to follow general 

requirements for labeling SUDs, including providing adequate instructions 

for use. Neither 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.25

FDA’s proposed regulatory framework for SUD reprocessing specifically 

exempts opened but unused SUDs. The proposed framework also does not 

apply to health care facilities other than hospitals that reprocess SUDs inhouse. By at least temporarily excluding ambulatory surgery centers, 

physicians’ practices, and other nonhospital health care institutions from 

regulation, the proposal maintains the inconsistency of the current policy 

by exempting some categories of reprocessors from FDA oversight. 

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

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

that reprocess SUDs will be subject to FDA’s manufacturer facilities 

requirements (registration, listing, inspection, and MDR reporting) 

6 months after the final guidance is issued. Premarket approval 

requirements for frequently reprocessed SUDs will also begin to take effect 

6 months after the final instructions are issued for devices FDA considers 

high risk, in 12 months for moderate-risk devices, and in 18 months for lowrisk devices. FDA is phasing in the enforcement of these requirements for 

several reasons: (1) it believes that its regulatory activities should be 

implemented in accordance with the potential health risk associated with 

the reprocessed device; (2) the potential exists for unintended and 

unpredictable consequences if FDA enforces all requirements immediately, 

25To the extent that these instructions infringe on the copyrighted instructions of the original 

manufacturers, it may be very difficult for reprocessors to meet this requirement. 
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Page 23 GAO/HEHS-00-123 Medical Device Reprocessing

such as shortages of reprocessed SUDs in certain hospitals; (3) hospitals 

need time to learn about and comply with FDA regulations; and (4) FDA 

lacks the resources to immediately enforce all regulatory requirements. 

SUD Reprocessors and FDA 

May Have Difficulty 

Implementing the New 

Framework 

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. For example, third-party reprocessors may 

find it difficult to conduct the clinical studies needed to submit PMAs. FDA 

and some third-party reprocessors are working together to develop 

prototype premarket applications for reprocessing. 

Important details about the operation of the new framework that will affect 

its implementation have yet to be finalized by FDA. For instance, the extent 

to which FDA will accept premarket applications for groups of similar 

devices, rather than for each model of a device, has yet to be determined. 

Similarly, some manufacturers have told FDA that some class I devices that 

are exempt from premarket approval would pose risks if reprocessed. The 

number of SUDs requiring FDA approval to be reprocessed could increase 

if FDA agrees with that assessment. 

Another implementation hurdle is that 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. FDA has not yet located all of the 

third-party reprocessing firms that it suspects operate today. In addition, 

although it is engaged in an outreach effort to educate hospitals that 

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

find it difficult to identify reprocessing hospitals unless they voluntarily 

register with the agency. 

Furthermore, the potentially large number of additional premarket 

applications and manufacturing facilities to inspect could overburden 

FDA’s already stretched resources. FDA officials told us that the agency has 
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about 500 staff involved in reviewing premarket applications for medical 

devices and inspecting device manufacturers. These staff reviewed about 

5,000 premarket applications and completed approximately 1,050 

inspections of medical device manufacturing facilities in fiscal year 1999. 

FDA’s fiscal year 2001 budget request includes an additional 5 staff years 

for work on reprocessing issues. The number and complexity of 510(k)s 

and PMAs that will be submitted for reprocessing are 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. For example, premarket submissions 

for reprocessing will be placed in the same queue as 510(k)s and PMAs for 

new medical devices. 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. 

Recognizing its resource constraints, FDA has asked HCFA and JCAHO for 

assistance in monitoring SUD reprocessing in hospitals.26 We found that 

neither HCFA nor JCAHO plans to make a substantial contribution to this 

effort in the near term. HCFA could potentially affect SUD reuse in two 

ways—by altering its coverage policies or by changing the terms of 

participation for hospitals to participate in Medicare. Regarding coverage 

policies, Medicare generally does not cover medical devices that are not 

approved by FDA, and HCFA has agreed that it will not pay for SUDs 

reprocessed without FDA’s approval. In commenting on a draft of this 

report, HHS stated that HCFA will review Medicare coverage and payment 

rules once FDA’s new framework takes effect. However, HCFA currently 

lacks the means to determine whether it is paying for a new or a 

reprocessed device because it pays for the treatment of particular 

conditions, not for individual pieces of equipment that may be used in 

treatment. For the terms of participation, a HCFA official told us that it has 

no plans to include requirements about the reuse of SUDs in any of its 

standards for Medicare conditions of participation for health care facilities. 

26HCFA administers Medicare and its related facility survey and certification programs. 

JCAHO is a private organization that inspects and accredits hospitals for participation in 

Medicare. JCAHO surveys hospitals every 3 years. 
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Page 25 GAO/HEHS-00-123 Medical Device Reprocessing

FDA has consulted with JCAHO with the hope that it could eventually 

perform inspections to FDA’s standards for SUD reprocessing in hospitals.27

This would include providing hospital identifying information to FDA so 

that FDA could take enforcement actions. As of mid-May 2000, JCAHO had 

agreed to inform hospitals about FDA’s policy on SUD reuse and to ask 

three questions about in-house SUD reprocessing on FDA’s behalf during its 

hospital surveys for a 6-month period: (1) Does the hospital reprocess and 

reuse devices labeled for single-use, and if so, which devices does it 

reprocess or reuse? (2) Is the hospital aware of FDA’s requirements for 

registration and listing of the devices it chooses to reprocess and reuse? (3) 

Does the hospital intend to continue to reprocess and reuse such devices? 

JCAHO will provide the answers to FDA on an aggregate basis, without 

identifying individual hospitals. FDA is paying JCAHO a small fee for this 

service. In the long term, JCAHO’s suitability for conducting inspections on 

FDA’s behalf has not been established. For example, JCAHO’s survey 

practices and policies for protecting confidential hospital information may 

conflict with FDA’s need to take public enforcement actions.28 In addition, 

if their collaboration proceeds, FDA may need to pay JCAHO for these 

inspections. 

FDA’s New Framework May 

Decrease SUD Reprocessing 

in Hospitals

FDA’s proposed framework imposes significant new requirements on 

institutions that reprocess SUDs, but it also grants specific FDA approval 

for SUD reprocessing. Because of these conflicting consequences, the net 

effect on SUD reprocessing is uncertain. It may lead to an overall decrease 

in the number of SUDs that are reprocessed, at least until the new 

regulatory system is functioning well. If this happens, there is a chance that 

the price of new devices will increase as the competitive alternative of SUD 

reprocessing becomes less viable. Also, an FDA official expressed concern 

that temporary shortages of reprocessed SUDs may occur in some 

hospitals, causing the hospitals to seek devices from other sources. 

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 third27In lieu of inspections by FDA, manufacturers can now pay to be inspected by independent 

organizations that are acceptable to FDA.

28HHS, Office of Inspector General, The External Review of Hospital Quality: Holding the 

Reviewers Accountable, OEI-01-97-00053 (Washington, D.C.: HHS, July 1999). 
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Page 26 GAO/HEHS-00-123 Medical Device Reprocessing

party reprocessing firms for that work. This shift may ease FDA’s task of 

inspecting hospitals that reprocess SUDs. It also could increase the costs of 

reprocessing to hospitals, because, according to the hospitals we 

contacted, third-party firms are more expensive than their internal 

reprocessing operations. At least some third-party firms anticipate an 

increase in business, both because of the expected shift in reprocessing 

from hospitals and because they expect that FDA’s formal approval of the 

reprocessing of particular SUDs will improve their marketing success. 

Conclusions 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 

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

of SUD reprocessing. Nonetheless, the new framework does not treat all 

types of reprocessors consistently and will be difficult to implement. 

Furthermore, because the demonstrated health risks from SUD 

reprocessing are small, it may have only a limited impact on public health.

Agency Comments In its comments on a draft of this report, HHS said that the report 

accurately describes current reuse practices, the potential health risks of 

SUD reprocessing, and current and planned regulatory approaches to SUD 

reprocessing. HHS also emphasized that FDA is the lead agency for the 

regulation of medical devices and that HCFA will review its policies when 

FDA’s new regulatory framework takes effect. HHS also provided technical 

comments, which we incorporated where appropriate. (HHS’ comments 

are in app. II.)

As arranged with your offices, unless you publicly announce its contents 

earlier, we plan no further distribution of this report until 30 days after its 

issue date. We will then send copies to the Honorable Donna E. Shalala, 

Secretary of Health and Human Services, and the Honorable Jane E. 

Henney, Commissioner of FDA. We will also make copies available to 

others who request them.
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Page 27 GAO/HEHS-00-123 Medical Device Reprocessing

The major contributors to this report were Elizabeth A. Bradley, Marcia 

Crosse, Martin T. Gahart, Janina R. Johnson, and Stefanie Weldon. If you or 

your staffs have any questions, please contact me at (202) 512-7119.

Janet Heinrich

Associate Director, Health Financing and

Public Health Issues
Page 28 GAO/HEHS-00-123 Medical Device Reprocessing

Appendix I

FDA’s List of Frequently Reprocessed SUDs ApApenednxidexiIs

Cardiovascular Devices Angiography catheter

Blood pressure cuff

Cardiac ablation catheter

Cardiac guidewire

Compressible limb sleeve

Electrophysiology recording catheter

Intra aortic balloon catheter

Needle

Percutaneous transluminal coronary angioplasty (PTCA) catheter

Percutaneous transluminal angioplasty (PTA) catheter

Syringes

Trocar

Respiratory Devices Breathing mouthpiece

Endotracheal tubes

Masks

Oral and nasal catheters

Respiratory therapy and anesthesia breathing circuits

Tracheobronchial suction catheter

Gastroenterology/Urology 

Devices

Biliary sphincterotomes

Biopsy needles

Endoscopic guidewires

Endoscopic staplers

Extraction balloons/baskets

Non-electric biopsy forceps

Trocar

Urethral catheters

Nephrology Devices Hemodialysis blood tubing

OB-GYN Devices Laparoscopic dissectors

Laparoscopic graspers
Appendix I

FDA’s List of Frequently Reprocessed SUDs

Page 29 GAO/HEHS-00-123 Medical Device Reprocessing

Laparoscopic scissors

Trocar

Orthopedic Devices Arthroscopy instruments

Carpal tunnel blade

Drill bits

External fixation device

Flexible reamers/drills

Saw blades

Surgical drills

Surgery Devices Biopsy forceps

Biopsy needles

Burr

Electrosurgical electrodes/handles/pencils

Endoscopes

Endoscopic blades

Endoscopic guidewires

Endoscopic staplers

Fascia holders

Laproscope

Laser fiber delivery systems

Scissor tips, removable inserts

Surgical cutting accessories

Trocar

Other Medical Devices Stapler

Glucometer lancets

Keratome blade

OR drapes

Phacoemulsification needle

OR gowns

Sharps containers

Syringes, piston

Infusion pump, implanted

Syringe, irrigating

Source: FDA, Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme (Feb. 8, 

2000).
Page 30 GAO/HEHS-00-123 Medical Device Reprocessing

Appendix II

Comments From the Department of Health 

and Human Services ApendxiI

Note: A GAO comment 

supplementing those in the 

report text appears at the 

end of this appendix.

See comment 1.
Appendix II

Comments From the Department of Health 

and Human Services

Page 31 GAO/HEHS-00-123 Medical Device Reprocessing
Appendix II

Comments From the Department of Health 

and Human Services

Page 32 GAO/HEHS-00-123 Medical Device Reprocessing

The following is GAO’s comment on the Department of Health and Human 

Services’ letter dated June 12, 2000.

GAO Comment 1. We have added language to the report to indicate that HCFA will review 

Medicare coverage and payment policies once FDA’s new regulatory 

framework takes effect.

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