Medical Devices: Reprocessing and Reuse of Devices Labeled Single-Use
(Testimony, 06/27/2000, GAO/T-HEHS-00-143).

Pursuant to a congressional request, GAO discussed the reprocessing and
reuse of medical devices marketed for single use, focusing on: (1) the
extent of single-use devices (SUD) reprocessing; (2) the health risks
associated with SUD reprocessing; (3) the cost savings from SUD
reprocessing; and (4) the Food and Drug Administration's (FDA) oversight
of SUD reprocessing.

GAO noted that: (1) 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; (2) 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; (3) 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; (4) however,
this does not mean that SUD reprocessing is always safe; (5) 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; (6) 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; (7) 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 labelled for single use; (8) the framework
will provide FDA with more information and strengthen its oversight of
reprocessing; and (9) there are significant barriers to the framework's
successful implementation.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-HEHS-00-143
     TITLE:  Medical Devices: Reprocessing and Reuse of Devices Labeled
	     Single-Use
      DATE:  06/27/2000
   SUBJECT:  Medical equipment
	     Consumer protection
	     Health hazards
	     Health care cost control
	     Product safety
	     Health resources utilization
	     Safety standards
	     Reporting requirements
IDENTIFIER:  FDA Medical Device and Laboratory Problem Reporting
	     Program

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GAO/T-HEHS-00-143

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.

1 SUDs are also referred to as disposable devices because they are intended
to be discarded after one use. 2 Single- 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.

3 Food and Drug Administration Modernization Act of 1997 (P. L. 105- 115),
sect.205( b), adding sect.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

4 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.

5 This 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.

6 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.

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.

7 This 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.

8 The 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.

9 Statement of Robert H. O'Holla, before the Oversight and Investigations
Subcommittee, House Commerce Committee (Feb. 10, 2000).

10 S. 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

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

12 CDC, “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.

13 See Adverse Events: Surveillance Systems for Adverse Events and Medical
Errors( GAO/ T- HEHS- 0061, 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

14 FDA, Enforcement Priorities for Single- Use Devices Reprocessed by Third
Parties and Hospitals (Rockville, Md.: FDA, Feb. 2000).

15 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. 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

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