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entitled 'Reprocessed Single-Use Medical Devices: FDA Oversight Has 
Increased, and Available Information Does Not Indicate That Use 
Presents an Elevated Health Risk' which was released on March 3, 2008.

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Report to the Committee on Oversight and Government Reform, House of 
Representatives: 

United States Government Accountability Office: 
GAO: 

January 2008: 

Reprocessed Single-Use Medical Devices: 

FDA Oversight Has Increased, and Available Information Does Not 
Indicate That Use Presents an Elevated Health Risk: 

GAO-08-147: 

GAO Highlights: 

Highlights of GAO-08-147, a report to the Committee on Oversight and 
Government Reform, House of Representatives. 

Why GAO Did This Study: 

Within the Department of Health and Human Services (HHS), the Food and 
Drug Administration (FDA) is responsible for reviewing the safety and 
effectiveness of medical devices. The decision to label a device as 
single-use or reusable rests with the manufacturer. To market a 
reusable device, a manufacturer must provide data demonstrating to 
FDAs satisfaction that the device can be cleaned and sterilized 
without impairing its function. Alternatively, a single-use device 
(SUD) may be marketed without such data after demonstrating to FDA that 
the device is safe and effective if used once. Even though labeled for 
single-use, some SUDs are reprocessed for reuse with FDA clearance. 
This report addresses (1) the SUD reprocessing industrythe number of 
reprocessing establishments, the types of devices reprocessed, and the 
extent to which hospitals use reprocessed SUDs, (2) the steps FDA has 
taken to strengthen oversight of reprocessed SUDs, both on its own and 
in response to legislative requirements, and (3) the safety of 
reprocessed SUDs compared with other types of medical devices. 

GAO reviewed FDA data on reprocessors, reprocessed SUDs, and device-
related adverse events, as well as FDA documents and inspection 
reports, studies published in peer-reviewed journals, and relevant 
statutes and regulations. GAO interviewed FDA officials and officials 
from associations of manufacturers, reprocessors, and providers. 

What GAO Found: 

FDA has information on domestic reprocessing establishments, but it 
does not have data on the extent of actual production or on where the 
devices are being used. FDA officials identified 11 establishments that 
reported planning to market or actively marketing more than 100 types 
of reprocessed SUDs in the United States as of July 2007. Reprocessed 
SUDs ranged from devices used external to the body, such as blood 
pressure cuffs, to surgical devices used to repair joints. While many 
hospitals were believed to be reprocessing their own SUDs in 2000, FDA 
identified only one hospital in 2007 that was reprocessing SUDs. 
Reprocessed SUDs are being used in a variety of hospitals throughout 
the nation, including military hospitals. However, the Department of 
Veterans Affairs, which operates one of the nations largest health 
care systems, prohibits their use entirely. 

Since 2000, FDA has taken a number of stepson its own and in response 
to legislationto enhance its regulation of reprocessed SUDs both 
before they go to market (called premarket review) and afterwards 
(called postmarket oversight). In 2000, FDA published guidance that 
clarified its policies on the regulation of reprocessed SUDs. This 
guidance was directed at third-party entities and hospitals engaged in 
reprocessing SUDs for reuse. Following legislation passed in 2002, FDA 
imposed additional requirements for about 70 types of reprocessed 
devices and implemented new labeling requirements so that users would 
recognize those devices that had been reprocessed. In terms of 
postmarket review, FDA now inspects reprocessors and monitors reports 
of adverse events involving reprocessed SUDs. Seven of the 10 
reprocessing establishments that FDA inspected in the last 3 years had 
problems requiring corrective actions. Regarding adverse event 
reporting, FDA modified its reporting forms in 2003 to enable FDA to 
better identify and analyze those adverse events involving reprocessed 
SUDs. 

Neither existing FDA data nor studies performed by others are 
sufficient to draw definitive conclusions about the safety of 
reprocessed SUDs compared to similar original devices. While FDA has 
made changes to its data collection process regarding reprocessed SUD-
related adverse events, the data are not suitable for a rigorous 
comparison of the safety of reprocessed SUDs compared to similar 
original SUDs. The other studies published since 2000 that GAO 
identified are likewise insufficient to support a comprehensive 
conclusion on the relative safety of reprocessed SUDs. FDA officials 
have concluded that the cost of conducting rigorous testing would not 
be an efficient use of resources, especially given that the available 
data, while limited, do not indicate that reprocessed SUDs present an 
elevated health risk. FDA has analyzed its data on reported adverse 
events related to reprocessed SUDs and has concluded that there are no 
patterns that point to these devices creating such risks. After 
reviewing FDAs processes for monitoring and investigating its adverse 
event data, we found no reason to question FDAs analysis. HHS provided 
language to clarify several sentences of a draft of this report which 
GAO generally incorporated. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.GAO-08-147]. For more information, contact 
Randall B. Williamson at (202) 512-7114 or williamsonr@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Varied Information Available on Reprocessed SUD Industry: 

FDA Has Increased Its Oversight of SUD Reprocessing: 

Available Data Lack Rigor for Definitive Comparisons but Do Not 
Indicate That Reprocessed SUDs Pose an Elevated Health Risk: 

Agency Comments: 

Appendix I: Scope and Methodology: 

Appendix II: Reprocessing Establishments, Types of Reprocessed Devices 
Listed, and FDA Inspection Results: 

Appendix III: FDA's Review of Premarket Requirements for Reprocessed 
SUDs Following MDUFMA: 

Appendix IV: Reporting Requirements for Device-Related Adverse Events: 

Appendix V: Comments from the Department of Health and Human Services: 

Appendix VI: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Table: 

Table 1: Summary of MDR Mandatory Reporting Requirements for Device- 
Related Adverse Events: 

Figure: 

Figure 1: Overview of FDA's Implementation of MDUFMA's Premarket Review 
Requirements for Reprocessed SUDs, April 2003 through September 2005: 

Abbreviations: 

AMDR: Association of Medical Device Reprocessors: 

FDA: Food and Drug Administration: 

FDCA: Federal Food, Drug, and Cosmetic Act: 

HHS: Department of Health and Human Services: 

MDR: Medical Device Reporting: 

MDUFMA: Medical Device User Fee and Modernization Act of 2002: 

MedSun: Medical Product Safety Network: 

SUD: single-use device: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

January 31, 2008: 

The Honorable Henry A. Waxman: 
Chairman: 
The Honorable Tom Davis: 
Ranking Member: 
Committee on Oversight and Government Reform: 
House of Representatives: 

The federal government, through the Food and Drug Administration (FDA) 
within the Department of Health and Human Services (HHS), takes the 
lead in ensuring that the thousands of types of medical devices sold 
for use in surgeries and other medical procedures are reasonably safe 
and effective and do not pose a threat to public health.[Footnote 1] 
These devices range from bandages and surgical clamps to complicated 
devices such as heart pacemakers. Unless exempt, all devices are 
subject to FDA review--referred to as premarket review--before they may 
be legally marketed in the United States. 

Using many types of devices, such as tongue depressors, a second time 
is not feasible, while others, such as stethoscopes, are specifically 
designed and sold to be used more than once. The decision to label a 
device as single-use or reusable rests with the manufacturer. If a 
manufacturer intends to label a device as reusable, it must provide 
data demonstrating to FDA's satisfaction that the device can be cleaned 
and sterilized without impairing its function. Thus, a device may be 
labeled as 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 demonstrate that the 
device can be labeled as reusable. 

Some devices fall into another category--they are labeled and marketed 
by the original manufacturer as single-use devices (SUD), but with 
clearance from FDA are marketed after being reprocessed for reuse--that 
is, they are cleaned, sterilized, and performance-tested by one of 
numerous entities that are in business to reprocess them for reuse. 
These reprocessed SUDs[Footnote 2] can range from relatively simple 
items for external use, such as inflatable sleeves to improve blood 
circulation, to complex items placed inside the body, such as catheters 
inserted into the heart to monitor cardiac function. 

For more than two decades, establishments such as hospitals and private 
companies have reprocessed various types of SUDs, citing lower 
purchasing and in-house sterilization costs and reduced medical waste. 
This development followed an increase in the number of devices labeled 
as single-use. Because these devices were intended to be discarded 
after one use, manufacturers did not develop appropriate cleaning, 
sterilization, and testing methods or provide instructions to health 
care providers about how to clean and sterilize them while still 
maintaining performance. 

Concerns have been raised by the committee and others about the 
potential risks of infection from reprocessed SUDs or their failure to 
function properly. The original manufacturers of the SUDs, in 
particular, have objected to SUD reprocessing, saying that the 
reprocessed SUDs are inherently unsafe because these devices are not 
designed to facilitate cleaning and sterilization. Reprocessing firms, 
on the other hand, contend that reprocessed SUDs are indeed safe, 
citing a lack of data that show otherwise. In a June 2000 report on SUD 
reprocessing, we found that although there was little available 
evidence of harm from the use of reprocessed SUDs, FDA oversight of SUD 
reprocessing was inconsistent.[Footnote 3] Since that time, Congress 
has acted to strengthen oversight requirements. The Medical Device User 
Fee and Modernization Act of 2002 (MDUFMA) required that the labeling 
of all reprocessed SUDs specifically state that they are reprocessed 
SUDs as well as identify the reprocessor. The act also directed FDA to 
increase its oversight of these devices by identifying reprocessed SUDs 
that should not be marketed unless the reprocessing establishment first 
provided data demonstrating effective cleaning, sterilization, and 
functional performance.[Footnote 4] 

In light of action taken since our last report, you asked us to review 
how the reprocessing industry and FDA's oversight of reprocessed SUDs 
had changed since June 2000. Specifically, our report addresses the 
following three questions: 

* What is known about the reprocessing industry--the number of 
reprocessing establishments, the types of devices they are 
reprocessing, and the extent to which hospitals are using reprocessed 
SUDs? 

* What steps has FDA taken to strengthen oversight of reprocessed SUDs 
on its own initiative and to implement requirements set forth in 
MDUFMA? 

* What is known about the extent to which the safety of reprocessed 
SUDs compares favorably or unfavorably with the safety of similar 
original SUDs? 

To address these questions, we examined and evaluated available 
information on the SUD reprocessing industry in the United States and 
FDA's oversight of this industry. In conducting our work, we (1) 
reviewed available data on the types and characteristics of, FDA 
guidance and standards pertaining to, and FDA inspection reports on, 
SUD reprocessing establishments; (2) reviewed FDA-generated data and 
analyses on reported adverse events involving reprocessed SUDs; (3) 
interviewed FDA officials, representatives of the device reprocessing 
and manufacturing industry, including professional associations 
representing device manufacturing establishments[Footnote 5] and the 
Association of Medical Device Reprocessors (AMDR), which represents two 
firms that operate three large reprocessing establishments in the 
United States,[Footnote 6] and officials representing provider 
associations and medical facilities of the Departments of Veterans 
Affairs and Defense; (4) reviewed relevant statutes, regulations, and 
Federal Register notices; and (5) conducted a literature search of peer-
reviewed periodicals and reviewed other information to determine what 
is known about the safety of reprocessed SUDs. 

In some cases, FDA data were not available or sufficiently reliable to 
allow us to develop detailed information or perform analyses. For 
example, we determined that FDA's data were not sufficiently reliable 
to determine the number of domestic establishments reprocessing SUDs 
prior to July 2007 or the number of foreign establishments reprocessing 
SUDs. As a result, we were unable to analyze trends in the number of 
reprocessing establishments or the types of devices they were 
reprocessing since 2000 and we were limited to reporting on domestic 
reprocessing establishments. Also, neither industry nor FDA 
representatives were able to provide comprehensive information on the 
size of the reprocessed SUDs market in the United States--in terms of 
volume and value--compared to the overall U.S. market for medical 
devices. See appendix I for additional information on our methodology 
and data limitations. 

We conducted our work between November 2006 and January 2008 in 
accordance with generally accepted government auditing standards. 

Results in Brief: 

FDA has information on domestic reprocessing establishments, but it 
does not have data on the extent of actual production or where the 
reprocessed SUDs are being used. According to FDA officials, as of July 
2007, 11 establishments reported they were planning to market or 
actively marketing more than 100 types of reprocessed SUDs in the 
United States. The types of reprocessed SUDs ranged from compression 
sleeves used externally to maintain circulation during and after 
surgery to invasive devices used to lift and stabilize the heart during 
open-heart surgery. In terms of relative volume among the reprocessing 
establishments, 3 of the establishments account for about 90 percent of 
the SUD reprocessing business, according to AMDR. The extent of actual 
production of reprocessed SUDs by the 11 establishments is largely 
unknown, however, because FDA does not gather these data and because 
many reprocessing establishments, for business reasons, treat their 
production numbers as proprietary information. When we last reported on 
the reprocessing industry in 2000, many hospitals were believed to be 
reprocessing their own SUDs, but FDA identified only one hospital that 
was reprocessing SUDs in July 2007. Our inquiries with representatives 
of private and federal hospitals indicated that reprocessed SUDs are 
being used across a wide spectrum of the nation's hospitals, including 
military hospitals. The Department of Veterans Affairs, one of the 
nation's largest health care providers, prohibits their use entirely 
however. 

FDA has taken a number of steps to increase its oversight of 
reprocessed SUDs since 2000, both on its own initiative and in response 
to requirements established by MDUFMA in 2002. FDA has changed its 
approach to premarket review and postmarket surveillance: 

* Premarket review. This aspect of oversight involves FDA's review of 
manufacturer submissions related to specifications, proposed labeling, 
and other information about a device to assess its safety and 
effectiveness before allowing it to be marketed. Shortly after our June 
2000 report, FDA issued guidance clarifying its policies on the 
regulation of reprocessed SUDs, which was directed at hospitals and 
third-party reprocessing establishments. Also, in response to MDUFMA's 
requirements for increased oversight, FDA identified more than 70 types 
of reprocessed SUDs that would be subject to additional premarket 
submission requirements. For example, to obtain FDA clearance to market 
many types of reprocessed SUDs, such as scalpel blades and drill bits, 
reprocessing establishments must submit additional data to FDA on the 
processes used to clean, sterilize, and test the devices. Also in 
response to MDUFMA, FDA began reviewing the labeling accompanying 
reprocessed SUDs as well as the markings on the devices themselves for 
compliance with new requirements that they clearly indicated the device 
was reprocessed and identified the reprocessing establishment. 

* Postmarket surveillance. This aspect of oversight involves inspecting 
establishments that reprocess SUDs and collecting and analyzing data 
about device-related adverse events that occur when a device is used, 
such as infections, injuries to patients or providers, or breakage. 
With the issuance of its August 2000 guidance, FDA intended to make 
clear its plans to subject hospitals and other third-party 
establishments that reprocess SUDs to FDA inspection for compliance 
with applicable regulatory requirements just like other establishments 
manufacturing medical devices. According to FDA, 10 of the 11 
establishments it identified as engaged in reprocessing in the United 
States in July 2007 were inspected during the period August 2004 
through October 2007; the remaining establishment registered with FDA 
in 2006 as a reprocessing establishment and is scheduled for inspection 
in 2008. During inspections at 7 of the establishments, FDA identified 
compliance issues that required corrective action. For example, one 
inspection revealed that the establishment had reprocessed two models 
of a type of SUD before it had received FDA clearance to market those 
particular models of reprocessed SUDs. However, the establishment had 
stopped reprocessing these models of SUDs prior to FDA's inspection and 
FDA inspectors determined that the establishment had voluntarily taken 
the corrective actions that were required. With respect to adverse 
event data, FDA modified its forms in 2003 for reporting device-related 
adverse events to indicate whether a reprocessed SUD was involved. This 
change, required by MDUFMA, was designed to enable FDA to differentiate 
those adverse events involving reprocessed SUDs from those involving 
other devices. In addition, an FDA workgroup is studying whether 
refinements, such as additional instructions, could further improve the 
device-related adverse event reports involving reprocessed SUDs. 

Neither existing FDA data nor studies performed by others are 
sufficient to draw definitive conclusions about the safety of 
reprocessed SUDs compared to similar original devices. While FDA has 
made changes to its data collection process regarding reprocessed SUD- 
related adverse events, the data are not suitable for a rigorous 
comparison of the safety of reprocessed SUDs compared to similar 
original SUDs. For such a comparison to be definitive, FDA would have 
to collect additional data that would identify the type of device and 
adverse event, the number of original and reprocessed SUDs of that type 
in use, the number of times each reprocessed SUD was used, and the rate 
of adverse events associated with the original devices. With regard to 
safety-related data outside of FDA, the limited number of peer-reviewed 
studies related to reprocessing published since 2000 was insufficient 
to support a comprehensive conclusion on the relative safety of 
reprocessed SUDs. FDA officials have concluded that the cost of 
conducting rigorous testing would not be an efficient use of resources, 
especially given that the available data, while limited, do not 
indicate that reprocessed SUDs present an elevated health risk. FDA has 
analyzed its data on reported adverse events related to reprocessed 
SUDs and has concluded that there are no patterns that point to these 
devices creating such risks. After reviewing FDA's processes for 
monitoring and investigating its adverse event data, we found no reason 
to question FDA's analysis. 

In commenting on a draft of this report, HHS provided language to 
clarify several sentences which we generally incorporated. We also 
incorporated HHS's technical comments as appropriate. 

Background: 

Under the Federal Food, Drug, and Cosmetic Act (FDCA), FDA is 
responsible for reviewing the safety and effectiveness of medical 
devices before they go to market (premarket review) and ensuring that 
they remain safe and effective afterwards (postmarket oversight). 
Manufacturers intending to sell medical devices in the United States, 
including reprocessed SUDs, must register with FDA and provide 
information listing the devices they intend to market.[Footnote 7] FDA 
considers establishments engaged in reprocessing (that is, any activity 
needed to render a used SUD ready for use on a subsequent patient) to 
be the manufacturers of those reprocessed SUDs.[Footnote 8] 
Establishments, including reprocessing establishments, are required to 
update their registrations annually and their device listings twice 
each year. 

FDA's premarket review activities for devices--that is, for reusable 
devices, for originally manufactured SUDs, and for reprocessed SUDs-- 
mainly involve analyzing information submitted by those establishments 
that plan to market devices, including clinical or engineering 
documents and proposed labeling and instructions for use. Devices 
encompass a wide range of complexity and potential risk, and higher- 
risk or innovative devices require a more rigorous level of premarket 
review than lower-risk devices. For example, many relatively simple, 
low-risk devices, such as scissors used for medical purposes, are 
exempt from premarket review requirements. For other devices, such as 
catheters, manufacturers are required to submit documentation for FDA's 
review and receive clearance before they may be marketed. 

For all devices, FDA has assigned about 1,700 device types[Footnote 9] 
into one of three classes based on the level of risk posed and controls 
necessary to ensure their safety and effectiveness.[Footnote 10] Class 
I (low-risk) devices include such things as elastic bandages. Class II 
(medium-risk) devices include items like powered bone drills. Class III 
(high-risk) devices include those that support or sustain human life 
such as balloon angioplasty catheters. Most class I devices are exempt 
from premarket submission requirements set forth in Section 510(k) of 
the FDCA (premarket notification).[Footnote 11] For most class II 
devices, manufacturers are required to submit a premarket notification 
report. The premarket notification report must provide evidence that 
the device is substantially equivalent to a device already on the 
market before FDA will allow it to be marketed.[Footnote 12] For class 
III devices, manufacturers are required to submit an application for 
premarket approval, which must provide evidence, including clinical 
data, demonstrating that the device is safe and effective.[Footnote 13] 

FDA's postmarket surveillance activities mainly involve inspecting 
device establishments and collecting and analyzing reports about device 
safety. FDA inspects registered device establishments, including 
reprocessing establishments, to assess compliance with applicable 
quality control and adverse event reporting regulations, among 
others.[Footnote 14] In addition to inspecting device establishments, 
FDA's postmarket activities include collecting and analyzing reports of 
device-related adverse events to ensure that devices already on the 
market remain safe and effective. Manufacturers are required to report 
device-related deaths, serious injuries, and certain malfunctions to 
FDA. In addition, user facilities, such as hospitals and nursing homes, 
are required to report device-related deaths to FDA and to the device 
manufacturer, and to report serious injuries to the manufacturer or, if 
the manufacturer is unknown, to FDA. Both manufacturers and user 
facilities may also voluntarily report to FDA less-serious device- 
related events that are not likely to result in subsequent serious 
injuries if the malfunction were to recur.[Footnote 15] FDA maintains 
databases that include both mandatory and voluntary reports of device- 
related adverse events, which agency officials can search to conduct 
research on trends or emerging problems with device safety. FDA 
scientists review these reports, request follow-up investigations, and 
determine whether further action is needed to ensure patient 
safety.[Footnote 16] Such action may include product recalls, public 
health advisories to notify health care providers and the public of 
potential device-related health and safety concerns, or requiring a 
manufacturer to change the instructions in its device labeling. FDA 
officials told us that the vast majority of reports involve a device 
malfunction that has the potential to cause a death or serious injury 
if the malfunction were to recur, even though there was no death or 
serious injury in the reported event.[Footnote 17] 

Varied Information Available on Reprocessed SUD Industry: 

FDA has information on domestic reprocessing establishments and the 
devices they are reprocessing or considering for reprocessing, but it 
does not have data on the extent of actual production or on where the 
devices are being used. Collectively, according to FDA, 11 
establishments were actively reprocessing or planning to reprocess more 
than 100 different types of SUDs in the United States as of July 
2007.[Footnote 18] (See app. II for a list of the types of SUDs that 
have been listed by reprocessing establishments.) While definitive 
information on the size of the reprocessed SUD market is not available, 
representatives of the reprocessing industry estimate that 3 of the 11 
registered reprocessing establishments (2 of which are owned by the 
same firm) account for the vast majority of the total reprocessing 
business in the United States. Only one hospital was included among the 
11 active reprocessing establishments identified by FDA. Our inquiries 
with hospital representatives and federal agencies that administer 
hospitals, such as the Department of Veterans Affairs, indicated use of 
reprocessed SUDs among hospitals varies. 

Eleven Active Reprocessing Establishments Collectively May Be 
Reprocessing More than 100 Types of SUDs: 

FDA identified 11 establishments actively reprocessing SUDs in the 
United States as of July 2007, 1 of which was a hospital. Seven 
establishments engaged exclusively in reprocessing or in reprocessing 
and one other activity, such as contract sterilizer. According to 
representatives of the reprocessing industry, 3 of these 7 account for 
about 90 percent of all SUD reprocessing. Four of the 11 reprocessing 
establishments registered with FDA to undertake three or more FDA- 
regulated activities including distribution or manufacturing. For 
example, 1 reprocessing establishment manufactures over 80 different 
types of medical devices but reprocesses only one type of SUD that it 
also manufactures. Four of the 11 establishments, including the 
hospital, have each listed only one type of reprocessed SUD.[Footnote 
19] 

The more than 100 types of devices that reprocessing establishments 
reported actively reprocessing or planning to reprocess represent 
devices with a range of intended uses, some more invasive than others. 
For example, compression sleeves, which are used to provide 
intermittent compression to a patient's limbs to help prevent 
postoperative blood clots from forming, are intended to make contact 
with patients' skin only, not to enter the body. In contrast, surgical 
devices such as orthopedic drill bits or surgical saw blades are 
intended for use in internal parts of the body. Electrophysiology 
catheters are inserted into the heart to measure cardiac rhythm and 
have been reprocessed for over 20 years. While we found no reliable 
data on the volume of reprocessed SUDs by device type, representatives 
of 3 large reprocessing establishments have stated that noninvasive 
devices such as compression sleeves account for the greatest volume of 
their overall business, with surgical devices representing a much 
smaller share of their business. 

Information on the Size of the Reprocessed SUD Market Is Not Available: 

Data on the exact size of the SUD reprocessing industry--in terms of 
the volume or value of reprocessed SUDs sold--and how it compares to 
the original SUD industry or the overall medical device industry are 
not available. FDA neither collects nor reports on the volume or value 
of reprocessed SUDs sold; the agency also does not maintain data on the 
volume or value of original SUDs or on all medical devices sold. 
Regarding private sector data sources, we found that data on the SUD 
reprocessing industry were either not available or were considered 
proprietary by industry sources. Similarly, representatives of trade 
associations that represent establishments that manufacture original 
SUDs and reusable devices could not provide data on the proportion of 
the overall medical device industry that consists of devices labeled 
for single-use and could be reprocessed. 

Hospital Use of Reprocessed SUDs Varies: 

Two FDA studies indicate that hospital use of reprocessed SUDs varies. 
In 2002, FDA reported that about one-fourth of U.S. hospitals used at 
least one type of reprocessed SUD, with larger hospitals being more 
likely to do so.[Footnote 20] To develop this estimate, FDA surveyed 
more than 5,000 hospitals.[Footnote 21] Nearly half of responding 
hospitals with more than 250 beds reported using reprocessed SUDs, 
compared with 12 percent of responding hospitals with fewer than 50 
beds.[Footnote 22] This information was supplemented by a more recent 
study in 2005. In this study, which focused on hospitals' level of 
satisfaction with reprocessed SUDs, FDA received information from 102 
representatives of hospitals across the nation. About 40 percent 
indicated they used a third party to reprocess SUDs. FDA followed up 
with focus groups to obtain more detailed information on the differing 
perspectives of various types of hospital personnel about the 
hospitals' use of reprocessed SUDs. In general, participating hospitals 
that reported using reprocessed SUDs indicated their facilities had 
specific policies regarding reprocessing, used a variety of types of 
reprocessed SUDs, and believed that reprocessing provides substantial 
cost savings. 

In our discussions with representatives of reprocessing establishments 
and a managed care organization that runs several hospitals, we were 
told that hospitals or hospital systems generally set their own 
policies regarding whether to use reprocessed SUDs, which reprocessing 
establishment to use, and which reprocessed SUDs are acceptable to the 
hospitals' physicians and other clinical personnel. This holds true for 
some federal hospitals as well. The Department of Defense, for example, 
allows individual medical facilities the option of using SUDs that are 
reprocessed by establishments that are registered with FDA as 
reprocessors.[Footnote 23] According to Department of Defense 
officials, as of October 2007: 

* 3 of the Navy's 22 medical centers and hospitals reported using 
reprocessed SUDs; 

* 4 of the Army's 26 medical centers and hospitals reported using, or 
planning to use, reprocessed SUDs; and: 

* 1 of the Air Force's 17 medical centers and hospitals reported using 
reprocessed SUDs. 

In contrast to the Department of Defense policy, the Department of 
Veterans Affairs has had an agencywide policy prohibiting the use of 
reprocessed SUDs in any of its medical centers since at least 1991. 
According to Department of Veterans Affairs officials, the agency could 
not determine whether reprocessed SUDs are safe or not. However, the 
agency does not allow the use of reprocessed SUDs because manufacturers 
did not design SUDs to be used more than once and, as a consequence, do 
not provide instructions on cleaning and sterilizing these devices. 
These officials told us that the department's policy has remained 
largely unchanged, although the agency has reconsidered it at various 
times. 

FDA Has Increased Its Oversight of SUD Reprocessing: 

FDA has taken actions, both on its own initiative and in response to 
legislation, to strengthen the agency's oversight of reprocessed SUDs. 
These actions include (1) requiring additional premarket data 
submissions for 72 types of reprocessed SUDs and (2) conducting 
postmarket activities such as inspections of reprocessing 
establishments to ensure compliance with regulatory requirements and 
other surveillance to assess whether reprocessing is associated with an 
increased public health risk. 

FDA Identified More than 70 Types of SUDs That Require Additional 
Premarket Review: 

FDA's premarket oversight of reprocessed SUDs has increased, beginning 
with actions FDA took on its own initiative in 2000. In August of that 
year, FDA issued guidance that clarified its policies on the regulation 
of reprocessed SUDs. This guidance was directed at hospitals and third- 
party entities engaged in reprocessing SUDs for reuse. At the time, a 
sizeable minority of U.S. hospitals were thought to be reprocessing 
their own SUDs without FDA oversight.[Footnote 24] FDA recognized that 
hospitals were not likely to be familiar with its regulations, so the 
guidance included time frames for these reprocessing establishments to 
comply.[Footnote 25] According to FDA officials, the agency intended to 
subject each type of reprocessed SUD to the same level of premarket 
review as required of original SUDs. For example, if the SUD was exempt 
from premarket requirements before it was used for the first time, the 
reprocessed SUD would also be exempt. 

MDUFMA, enacted in 2002, directed FDA to review the premarket 
submission requirements for reprocessed SUDs and identify those devices 
for which FDA would require additional validation data to document 
cleanliness, sterility, and performance following reprocessing. This 
meant that reprocessing establishments had to submit additional 
premarket documentation for certain types of reprocessed SUDs to 
demonstrate that they remain safe and effective or substantially 
equivalent to another device already on the market. MDUFMA directed FDA 
to identify devices that fell into the following two categories and to 
determine whether additional information was needed to determine their 
continued marketability: 

* The first category consisted of reprocessed SUDs that had been exempt 
from premarket notification at the time MDUFMA was enacted.[Footnote 
26] For these reprocessed SUDs, FDA was required to determine whether 
the devices' premarket notification exemptions should be terminated to 
provide reasonable assurance of their safety and effectiveness. 
Manufacturers of devices identified by FDA were required to provide 
premarket notification with validation data on cleaning, sterilization, 
and functional performance to ensure that the reprocessed SUDs remained 
safe and effective after the maximum number of reprocessing 
cycles.[Footnote 27] FDA, in response, identified 20 types of 
reprocessed SUDs that met these criteria and revoked their premarket 
notification exemptions. Examples of types of reprocessed SUDs that had 
their exemptions terminated and that were required to submit the 
additional validation data included noncompression heart positioners 
(devices intended to move, lift, and stabilize the heart during open 
heart surgery), nonelectric biopsy forceps (devices used to remove a 
specimen of tissue for microscopic examination), and various surgical 
devices such as specialized needles and catheters. 

* The second category consisted of reprocessed SUDs that were already 
subject to premarket notification at the time MDUFMA was enacted. FDA 
was required to determine whether additional documentation on cleaning, 
sterilization, and performance was necessary to ensure that the device 
remained safe and effective after the maximum number of reprocessing 
cycles. FDA, in response, identified 52 types of reprocessed SUDs that 
met those criteria and required that premarket submissions for them 
include such data. Examples of device types that were subject to the 
additional validation data requirement included electric biopsy 
forceps, surgical drills and accessories, and oximeters (devices used 
to measure the level of oxygen in a patient's blood). 

Appendix III summarizes FDA's methodology for identifying the 72 types 
of reprocessed SUDs for which the agency has required additional 
premarket data submissions in accordance with MDUFMA.[Footnote 28] 

As part of its premarket review, FDA evaluates not only the devices 
themselves but the accompanying labeling and instructions for use. 
MDUFMA required that the labeling of all reprocessed SUDs state that 
the device had been reprocessed and the name of the establishment that 
reprocessed it. This provision took effect in January 2004 and applies 
to devices marketed after that date. MDUFMA and subsequent legislation 
also required that reprocessed SUDs or an attachment to such devices 
"prominently and conspicuously" bear the reprocessing establishment's 
name, abbreviation, or symbol.[Footnote 29] FDA issued guidance that 
first became effective on August 1, 2006, to help reprocessing 
establishments comply with this requirement.[Footnote 30] 

FDA Actions for Postmarket Oversight of Reprocessed SUDs Have Taken 
Several Forms: 

FDA's actions regarding its postmarket oversight of reprocessed SUDs 
have included (1) clarifying that SUD reprocessing establishments are 
subject to the same inspection requirements as other device 
manufacturing establishments and (2) updating reporting forms to better 
identify those device-related adverse event reports involving 
reprocessed SUDs. 

FDA Clarified Oversight Policies and Plans for Inspecting Reprocessing 
Establishments: 

With the issuance of its August 2000 guidance, FDA intended to make 
clear its plans to subject hospitals and other third-party 
establishments that reprocess SUDs to FDA inspection for compliance 
with applicable regulatory requirements just like other establishments 
manufacturing medical devices. For the 11 U.S. establishments actually 
reprocessing SUDs as of July 2007, FDA had inspected 10 at least once 
during the period August 2004 through October 2007. These included 
multiple inspections of the 3 reprocessing establishments that industry 
representatives estimate to account for about 90 percent of all U.S. 
SUD reprocessing. FDA had not inspected 1 of the 11 reprocessing 
establishments. This establishment was first registered as a 
reprocessing establishment in 2006, and FDA officials told us that the 
agency plans to inspect it in 2008.[Footnote 31] 

We reviewed FDA summaries and other documents related to inspections 
conducted from August 2004 through October 2007 for the 10 inspected 
reprocessing establishments. For 3 establishments, none of the 
inspections indicated that corrective actions were needed. That is, no 
objectionable conditions or practices were found during the inspection. 
For the remaining 7 reprocessing establishments, at least one FDA 
inspection for those establishments during this period found that 
corrective actions were needed. This means that the inspection 
identified objectionable conditions or practices through which the 
establishment failed to meet either regulatory or administrative 
requirements. In general, in cases like these, depending upon the 
severity of the objectionable conditions identified, FDA determined 
whether the establishments could take corrective actions voluntarily, 
or whether conditions warranted issuance of FDA warning letters or more 
severe enforcement actions such as product seizures or 
injunctions.[Footnote 32] In the cases we reviewed that involved 
corrective actions, we found the following: 

* For 6 establishments, FDA investigators determined that actions taken 
by the establishments were adequate to address the deficiencies 
identified during the establishment inspections. FDA considers these 
inspections to be resolved. For example, one inspection revealed that 
the establishment had reprocessed two models of SUDs before it received 
FDA approval to reprocess them. The firm stopped reprocessing these 
models of SUDs prior to FDA's inspection and FDA inspectors determined 
that the establishment had voluntarily taken the corrective actions 
that were required. In another instance, FDA investigators found that 
the establishment had not maintained complaint files appropriately. 
Specifically, the establishment received a complaint from one hospital 
that five blood pressure cuffs reprocessed by that establishment did 
not function properly. However, the establishment listed all five 
devices as a single complaint rather than documenting each 
nonfunctioning device separately as required. At the end of the 
inspection, the establishment agreed to make each device a separate 
complaint rather than group several devices under one complaint number. 

* The inspection for 1 establishment was open and under investigation 
as of November 2007. For this establishment, FDA inspectors identified 
a number of objectionable conditions, including instances in which the 
establishment did not adequately investigate reported problems 
associated with reprocessed SUDs or submit reports of device problems 
to FDA within the required time. In September 2007, FDA conducted a 
meeting with officials representing the establishment to discuss the 
inspection findings in detail. The establishment subsequently provided 
a written response to FDA containing the actions it proposed to take in 
order to correct the deficiencies identified by FDA investigators. FDA 
officials told us that the agency will not consider the inspection 
deficiencies to be resolved until FDA investigators reinspect the 
establishment. As of November 2007, FDA had not scheduled a 
reinspection of this establishment. 

FDA Has Taken Steps to Improve Adverse Event Reports Related to Use of 
Reprocessed SUDs: 

MDUFMA directed FDA to modify its forms for mandatory and voluntary 
reporting of incidents involving devices to indicate when device- 
related adverse event reports involved reprocessed SUDs. Since fall 
2003, FDA has included a check box in its mandatory and voluntary 
adverse event reporting forms to indicate whether the device associated 
with the adverse event was a reprocessed SUD.[Footnote 33] 

In addition to the change already made, an FDA workgroup is 
investigating whether further refinements in the device-related adverse 
event reporting forms, such as additional instructions, could further 
improve the accuracy of the adverse event reports associated with 
reprocessed SUDs. FDA officials told us that, while the new labeling 
and marking requirements for reprocessed SUDs, as well as the updated 
reporting forms, may eventually enhance their ability to identify 
device-related adverse event reports involving reprocessed SUDs, as of 
July 2007, agency officials had not detected an appreciable change in 
the reports submitted involving reprocessed SUDs. 

Available Data Lack Rigor for Definitive Comparisons but Do Not 
Indicate That Reprocessed SUDs Pose an Elevated Health Risk: 

While FDA has made changes to its data collection process regarding 
reprocessed SUD-related adverse events, the data are not suitable for a 
rigorous comparison of the safety of reprocessed SUDs relative to 
original SUDs of the same type on their initial use. Such a comparison 
would require collecting additional data such as the type of device and 
adverse event and the number of original and reprocessed SUDs of that 
type in use. The limited number of peer-reviewed studies related to 
reprocessing that we identified were insufficient to support a 
comprehensive conclusion on the relative safety of reprocessed SUDs. 
Despite the limitations of available data, FDA's analysis of reported 
device-related adverse events does not show that reprocessed SUDs 
present an elevated health risk. 

Rigorous Safety Comparisons Not Possible through Current or Planned 
Adverse Event Reporting: 

While FDA's database of device-related adverse events is designed to 
provide information about trends such as infection outbreaks or common 
user error caused by inadequate instructions, it is not comprehensive. 
That is, the system cannot generate sufficient data on device 
performance that would be required to compare the safety of reprocessed 
SUDs with either original SUDs on their initial use or to other devices 
in general.[Footnote 34] Such a study, at a minimum, would require data 
that would identify the type of device and adverse event, the number of 
original and reprocessed SUDs of that type in use, the number of times 
each reprocessed SUD was used, and the rate of adverse events 
associated with the original devices. FDA officials, including the 
Director of the Center for Devices and Radiological Health, have 
described the effort that would be required and acknowledged the 
shortcomings of the current adverse event reporting system to generate 
comparative safety data. FDA officials indicated to us, however, that 
such studies would not be an efficient use of agency resources given 
the existing level of FDA oversight. 

To supplement our review of the safety information developed and 
analyzed by FDA, we conducted a review of the scientific literature 
related to SUD reprocessing published in peer-reviewed journals since 
2000. We identified six studies that addressed the safety of 
reprocessed SUDs. On examination, none of the six studies were 
comprehensive enough to support an overall conclusion about the 
relative safety of reprocessed SUDs compared to SUDs on their initial 
use. They were limited in that they tested relatively few devices, and 
the reprocessing establishments had not been inspected by FDA. 

FDA Has Found No Causative Link between a Reprocessed SUD and Reported 
Patient Injury or Death: 

FDA has reviewed available adverse event reports associated with 
reprocessed SUDs and has not identified a causative link between the 
adverse event and the fact that the devices involved were reprocessed. 
In September 2006, the Director of FDA's Center for Devices and 
Radiological Health testified that based on available adverse event 
data, FDA had identified 434 reports submitted from October 2003 to 
July 2006 in which reprocessed SUDs were identified on the reporting 
form. With respect to these reports, FDA determined that the majority 
of the reports, including all 15 of the reports involving deaths, did 
not involve a reprocessed SUD. For example, FDA determined that many of 
the reported events involved reusable devices such as magnetic 
resonance imaging machines or SUDs on their initial use. Of the 434 
reports, FDA further reviewed the 65 events that it found actually 
involved or were suspected to involve a reprocessed SUD and that the 
reprocessed SUD was one of several possible causal factors in the 
adverse event. In reviewing these 65 reports, FDA found that the types 
of adverse events reported to be associated with the use of reprocessed 
SUDs were the same types of events that are reported for new, 
nonreprocessed devices. 

In 2005, FDA consulted hospitals participating in the agency's Medical 
Product Safety Network (MedSun) about their experiences, including 
adverse events or safety concerns, with reprocessing.[Footnote 35] None 
of the representatives of MedSun hospitals who participated in the FDA 
focus groups reported being aware of any infections related to the use 
of reprocessed SUDs. However, hospital representatives noted that if an 
infection occurred, it would be very difficult to discern if a 
reprocessed SUD was the cause. Similarly, none of the hospital 
representatives expressed significant concerns about potential 
malfunctions with reprocessed SUDs, even though some of them indicated 
that malfunctions of reprocessed SUDs occurred on occasion (for 
example, surgical blades and other tools sometimes may not have been 
sharpened properly).[Footnote 36] Overall, however, participating 
hospital representatives generally expressed confidence in reprocessed 
SUDs, with some participants stating that there were actually fewer 
performance problems with reprocessed SUDs than with new SUDs. 
According to FDA, all participants believed that reprocessing 
establishments are more stringently regulated by FDA than are the 
manufacturers of the original devices, and this provided them a sense 
of confidence in the reprocessing process. 

After reviewing the available evidence--including FDA's process for 
identifying and investigating device-related adverse events reported to 
involve reprocessed SUDs, peer-reviewed studies published since 2000, 
and the results of our and FDA's consultations with hospital 
representatives--we found no reason to question FDA's analysis 
indicating that no causative link has been established between reported 
injuries or deaths and reprocessed SUDs. That is, the available 
information regarding safety, while not providing a rigorous safety 
comparison between reprocessed SUDs and other devices, does not 
indicate that reprocessed SUDs currently in use pose an increased 
safety threat. 

Agency Comments: 

In commenting on a draft of this report, HHS provided language to 
clarify several sentences which we generally incorporated. We also 
incorporated HHS's technical comments as appropriate. HHS's written 
comments appear in appendix V. 

As arranged with your offices, unless you publicly announce the 
contents of this report earlier, we plan no further distribution of it 
until 30 days after its issue date. At that time, we will send copies 
of this report to the Secretary of Health and Human Services, the 
Commissioner of FDA, appropriate congressional committees, and other 
interested parties. We will also make copies available to others on 
request. In addition, this report is available at no charge on the GAO 
Web site at [hyperlink, http://www.gao.gov]. If you or your staff have 
questions about this report, please contact me at (202) 512-7114 or 
williamsonr@gao.gov. GAO staff who made major contributions to this 
report are listed in appendix VI. 

Signed by: 

Randall B. Williamson: 
Acting Director, Health Care: 

[End of section] 

Appendix I: Scope and Methodology: 

To address the report objectives, we (1) reviewed relevant laws, 
regulations, and agency guidance; (2) interviewed Food and Drug 
Administration (FDA) officials, representatives of professional 
associations of manufacturing establishments,[Footnote 37] and the 
Association of Medical Device Reprocessors (AMDR); (3) interviewed 
officials from a provider association, private hospitals, and the 
Departments of Defense and of Veterans Affairs regarding their policies 
on the use of reprocessed single-use devices (SUD); and (4) reviewed 
FDA data, market research, and peer-reviewed studies. We conducted our 
work between November 2006 and January 2008 in accordance with 
generally accepted government auditing standards. 

We consulted a variety of sources, including FDA officials who track 
industry trends, professional associations representing device 
manufacturers and reprocessing establishments, and hospitals. We found 
that neither industry nor FDA representatives were able to provide 
comprehensive information on the number and volume of devices 
manufactured for the United States, or on the subset of devices that 
are SUDs or reprocessed SUDs. 

To determine the number of reprocessing establishments, we reviewed FDA 
data on the number of registered reprocessing establishments. FDA data 
indicated that more than 40 establishments were registered as 
reprocessing establishments as of March 2007, including 13 located 
outside the United States. After we determined that the FDA list did 
not match information provided by two FDA district offices, FDA 
officials determined that many of the establishments had registered as 
reprocessing establishments in error and subsequently identified 11 
establishments in the United States that, as of July 2007, were engaged 
in reprocessing SUDs. We determined FDA's information on the number of 
establishments reprocessing SUDs in the United States as of July 2007 
was sufficiently reliable for our purposes. However, given the errors 
in the FDA list of registered reprocessing establishments in 2007 and 
the lack of information on foreign establishments registered as 
reprocessors, we determined that FDA's data were not sufficiently 
reliable to determine the number of establishments reprocessing SUDs 
prior to July 2007 or the number of foreign reprocessing establishments 
at any time.[Footnote 38] As a result, we were unable to analyze trends 
in the number of reprocessing establishments or the types of devices 
being reprocessed since 2000, and we were limited to reporting on 
domestic reprocessing establishments. 

Regarding the types of SUDs being reprocessed, our ability to provide 
precise information was limited because although FDA maintains 
databases of the types of devices the reprocessing establishments 
listed with FDA, it does not confirm that all listed devices are 
currently available. As a result, FDA's data may include types of SUDs 
that the reprocessing establishments no longer reprocess, types of SUDs 
they plan to reprocess, or types of SUDs they listed in error--in 
effect, overstating the types of SUDs the establishments are 
reprocessing or plan to reprocess.[Footnote 39] In addition, 
representatives of one reprocessing establishment identified one device 
type listed in the FDA database that the establishment never 
reprocessed, but only resterilized and repackaged in unused form. While 
we were unable to determine their reliability, we used FDA's data 
listing the types of SUDs being reprocessed for the limited purpose of 
portraying the types of SUDs that the reprocessing establishments were 
reprocessing or planned to reprocess as of July 2007. 

To determine available research published about the safety of 
reprocessed SUDs since we last reported on the topic in 2000, we 
reviewed FDA documents related to adverse events involving reprocessed 
SUDs and an FDA-sponsored survey of the experience of some hospitals 
related to SUDs, reviewed summaries of, and other documents related to, 
FDA inspections of reprocessing establishments conducted from August 
2004 through October 2007, and conducted a literature search of studies 
(which we call articles) published in peer-reviewed journals from 
January 2000 through January 2007. We performed the literature review 
of peer-reviewed articles by searching the following databases: BIOSIS, 
EMBASE, Medline, ProQuest, and the Science Citation Index.[Footnote 40] 

Of the more than 30 articles located through the literature search, we 
identified a total of 6 articles that were published in peer-reviewed 
journals and that addressed the safety of reprocessed SUDs.[Footnote 
41] These articles are listed below: 

Colak, T.; Ersoz, G.; Akca, T.; Kanik, A.; Aydin, S. "Efficacy and 
Safety of Reuse of Disposable Laparoscopic Instruments in Laparoscopic 
Cholecytectomy: A Prospective Randomized Study." Surgical Endoscopy 18, 
no. 5 (2004): 727-731. 

daSilva, M.; Ribeiro, A.; Pinto T. "Safety Evaluation of Single-Use 
Devices After Submission to Simulated Reutilization Cycles." Journal of 
AOAC International 88, no. 3 (2005): 823-829. 

Fedel, M.; Tessarolo, F.; Ferrari, P.; et al. "Functional Properties 
and Performance of New and Reprocessed Coronary Angioplasty Balloon 
Catheters." Journal of Biomedical Materials Research 78, no. 2 (2006): 
364-372. 

Lipp, M.; Jaehnichen, G.; Golecki N.; et al. "Microbiological, 
Microstructure, and Material Science Examinations of Reprocessed 
Combitubes After Multiple Reuse." Anesthesia & Analgesia 91 (2000): 
693-397. 

Roth, K.; Heeg, P.; Reichl, R. "Specific Hygiene Issues Relating to 
Reprocessing and Reuse of Single-Use Devices for Laparascopic Surgery." 
Surgical Endoscopy 16, no. 7 (2002): 1091-1097. 

Wilson, S.; Everts, R.; Kirkland, K.; et al. "A Pseudo-Outbreak of 
Aureobasidium Species Lower Respiratory Tract Infections Caused by 
Reuse of Single-Use Stopcocks During Bronchoscopy." Infection Control 
and Hospital Epidemiology 21, no. 7 (2000): 470-472. 

On examination, none of these studies were comprehensive enough to 
support an overall conclusion about the relative safety of reprocessed 
SUDs compared to SUDs on their initial use. Several limitations in the 
articles we identified through our literature review make it difficult 
to support an overall statement comparing the safety of reprocessed 
SUDs with the safety of other devices. These limitations include the 
following: 

* Five of the six articles described studies that were conducted 
outside of the United States, so we could not determine whether the 
reprocessing methods and facilities would have met FDA's approval. The 
remaining article, while conducted in the United States, was published 
prior to MDUFMA's enactment in 2002 and subsequent FDA actions to 
implement new requirements. 

* The articles reported on studies that tested few types of devices. 
Because each study used different types of devices, it is not possible 
to compare and aggregate their results to support general conclusions 
regarding the relative safety of reprocessed SUDs. 

[End of section] 

Appendix II: Reprocessing Establishments, Types of Reprocessed Devices 
Listed, and FDA Inspection Results: 

Table 1: 

Establishment: A; 
Number of device types listed[A, B]: 20; 
Examples of types of devices[B]: Blood pressure cuff Cardiac stabilizer 
Laparoscopic instruments; 
Years of Inspections conducted from August 2004 through October 2007; 
2006, 2005; 
Inspection finding: 2006, Corrective action indicated; 2005, Corrective 
action indicated; 
Inspection finding status: 2006, Open investigation; 2005, Resolved. 

Establishment: B; 
Number of device types listed[A, B]: 40; 
Examples of types of devices[B]: Curette External fixation device 
Electrophysiology catheter; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2005; 
Inspection finding: 2007, Corrective action indicated; 2005, No action 
indicated; 
Inspection finding status: 2007, Resolved; 2005 [Empty]. 

Establishment: C; 
Number of device types listed[A, B]: 11; 
Examples of types of devices[B]: Tracheal tube stylet Protective 
restraint Bite block for endoscope; 
Years of Inspections conducted from August 2004 through October 2007: 
2006, 2005; 
Inspection finding: 2006, Corrective action indicated; 2005, No action 
indicated; 
Inspection finding status: 2006, Resolved; 2005, [Empty]. 

Establishment: D; 
Number of device types listed[A, B]: 43; 
Examples of types of devices[B]: Surgical saw blade Nonelectric biopsy 
forceps Orthopedic knife, burr; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2005; 
Inspection finding: 2007, Corrective action indicated; 2005, No action 
indicated; 
Inspection finding status: 2007, Resolved; 2005 [Empty]. 

Establishment: E; 
Number of device types listed[A, B]: 11; 
Examples of types of devices[B]: Oxygen mask Oximeter Compression 
sleeve; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2005, 2005; 
Inspection finding: 2007, No action indicated; 2005, No action 
indicated; 2005, No action indicated; 
Inspection finding status: [Empty]. 

Establishment: F; 
Number of device types listed[A, B]: 29; 
Examples of types of devices[B]: Oxygen mask Nonelectric biopsy forceps 
Arthroscopic accessories Pneumatic tourniquet; 
Years of Inspections conducted from August 2004 through October 2007: 
2006, 2005; 
Inspection finding: 2006, No action indicated; 2005, No action 
indicated; 
Inspection finding status: [Empty]. 

Establishment: G; 
Number of device types listed[A, B]: 1; 
Examples of types of devices[B]: External fixation clamp; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2006; 
Inspection finding: 2007, Corrective action indicated; 2006, Corrective 
action indicated; 
Inspection finding status: 2007, Resolved; 2006, Resolved. 

Establishment: H; 
Number of device types listed[A, B]: 14; 
Examples of types of devices[B]: Orthopedic cutting instrument, bone 
tap Reamer, burr, drill bit; 
Years of Inspections conducted from August 2004 through October 2007: 
[C]; 
Inspection finding: n.a.; 
Inspection finding status: [Empty]. 

Establishment: I; 
Number of device types listed[A, B]: 1; 
Examples of types of devices[B]: Disposable surgical instrument kit; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2006, 2005; 
Inspection finding: 2007, No action indicated; 2006, Corrective action 
indicated; 2005, No action indicated; 
Inspection finding status: 2007, [Empty]; 2006, Resolved; 2005, 
[Empty]. 

Establishment: J; 
Number of device types listed[A, B]: 1; 
Examples of types of devices[B]: Disposable surgical instrument kit; 
Years of Inspections conducted from August 2004 through October 2007: 
2007, 2006; 
Inspection finding: 2007, Corrective action indicated; 2006, Corrective 
action indicated; 
Inspection finding status: 2007, Resolved; 2006, Resolved. 

Establishment: K; 
Number of device types listed[A, B]: 1; 
Examples of types of devices[B]: Compression sleeve; 
Years of Inspections conducted from August 2004 through October 2007: 
2004; 
Inspection finding: No action indicated; 
Inspection finding status: [Empty]. 

Source: GAO analysis of Food and Drug Administration (FDA) data. 

Notes: n.a. = not applicable. 

[A] Device types indicate all devices assigned to a distinct product 
code by FDA. Each device type may include a variety of actual 
instruments, manufacturers, and models. For example, some device types 
include the device itself, such as a powered saw, and its accessories. 

[B] These data are provided for illustrative purposes to show the types 
of devices FDA data indicated that the 11 reprocessing establishments 
were reprocessing or planned to reprocess as of July 2007. Available 
data were limited because the FDA data on listed devices are not 
regularly verified and, as a result, the data may include types of SUDs 
that the reprocessing establishments no longer reprocess or plan to 
reprocess or that reprocessing establishments listed in error--in 
effect, overstating the types of SUDs establishments are reprocessing 
or plan to reprocess. 

[C] The establishment first registered as a reprocessing establishment 
in 2006; as of July 2007 no inspections had been conducted but FDA 
officials reported plans to inspect the establishment in 2008. 

[End of table] 

[End of section] 

Appendix III: FDA's Review of Premarket Requirements for Reprocessed 
SUDs Following MDUFMA: 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
required the Food and Drug Administration (FDA) to identify reprocessed 
single-use devices (SUD) that should be subject to additional premarket 
data submission requirements to ensure their safety and effectiveness. 
To identify these reprocessed SUDs, FDA analyzed the risks of infection 
or inadequate performance for 229 types of SUDs that the agency 
identified as either actually or potentially being reprocessed. For 
purposes of implementing MDUFMA, FDA took into account such factors as 
the physical characteristics of each type of SUD, including coatings 
that could be damaged by reprocessing, the type of contamination 
associated with the type of SUD's intended use, and the severity of 
potential injuries that could result if that type of SUD fails after 
reprocessing. FDA published the results of its review in a series of 
Federal Register Notices between April 2003 and September 
2005.[Footnote 42] These devices were either: (1) previously exempt 
from premarket notification and have had their exemptions revoked, and 
now also require validation data on cleaning, sterilization, and 
functional performance; or (2) already subject to premarket 
notification and now also require the additional validation data. 

Reprocessing establishments that did not provide the required premarket 
notification and validation data by the deadlines established in these 
notices could no longer legally market those devices. Figure 1 
summarizes the results of FDA's review in chart form. 

Figure 1: Overview of FDA's Implementation of MDUFMA's Premarket Review 
Requirements for Reprocessed SUDs, April 2003 through September 2005: 

[See PDF for image] 

This figure is a flow chart of the FDA's Implementation of MDUFMA's 
Premarket Review Requirements for Reprocessed SUDs, April 2003 through 
September 2005. 

The following information is depicted: 

FDAs implementation of MDUFMA: Total number of single-use device types 
reviewed: 229. 

Premarket requirements for reprocessed SUDs: Situation before MDUFMA: 
FDAs implementation of MDUFMA: Originally subject to premarket review: 
102; 
FDAs implementation of MDUFMA: Originally exempt: 127. 

Premarket requirements for reprocessed SUDs: MDUFMA requirement: review 
exempt device types: 
FDAs implementation of MDUFMA: Currently subject to premarket review: 
122; 
FDAs implementation of MDUFMA: Currently exempt: 127; 
Reprocessed SUDs affected by MDUFMA: Effect of new requirement: 
termination of 20 exemptions. 

Premarket requirements for reprocessed SUDs: MDUFMA requirement: review 
need for additional validation data on cleaning, sterilization, and 
performance: 
FDAs implementation of MDUFMA: New data requirements added: 72; 
FDAs implementation of MDUFMA: No new data requirements added: 50; 
FDAs implementation of MDUFMA: Not applicable; 
Reprocessed SUDs affected by MDUFMA: Effect of new requirement: 
additional data needed for 72 device types. 

Source: GAO. 

[End of figure] 

As of May 30, 2007, FDA had received a total of 6 premarket 
notification submissions with additional validation data for 2 types of 
reprocessed SUDs that had their exemptions revoked following enactment 
of MDUFMA. Of these 6 submissions, 4 were cleared by FDA and 2 were 
pending as of May 30, 2007. FDA also received 88 submissions of 
premarket validation data for 16 types of reprocessed SUDs that had not 
been exempt at the time MDUFMA was enacted but that were subsequently 
required to submit additional validation data. Of these 88 submissions, 
74 were cleared by FDA, 4 were found not substantially equivalent and 
therefore not marketable, and 10 were either withdrawn or pending as of 
May 30, 2007. 

[End of section] 

Appendix IV: Reporting Requirements for Device-Related Adverse Events: 

The Food and Drug Administration's (FDA) reporting framework for device-
related adverse events includes both mandatory and voluntary 
components, depending on who is doing the reporting. Under FDA's 
Medical Device Reporting (MDR) regulation, device user facilities 
(including hospitals and other providers)[Footnote 43] and 
manufacturers (including reprocessing establishments) must report 
deaths and serious injuries that a device has caused or may have 
contributed to. User facilities must report deaths to FDA and the 
manufacturer, and serious injuries to the manufacturer, if known, 
otherwise to FDA, whenever they become aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the death or serious injury of a patient. Manufacturers must report 
device-related deaths and serious injuries to FDA whenever they become 
aware of information that reasonably suggests that one of their devices 
has or may have contributed to the event. Manufacturers are also 
required to submit device malfunction reports to FDA whenever they 
become aware of information that reasonably suggests that one of their 
marketed devices has malfunctioned and that the device or a similar 
device marketed by the manufacturer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur. See table 1 for a summary of MDR mandatory reporting 
requirements. 

Table 2: Summary of MDR Mandatory Reporting Requirements for Device- 
Related Adverse Events: 

Reporter: User facility; 
What: Deaths; 
To whom: FDA and manufacturer; 
When: Within 10 work days from becoming aware of relevant information. 

Reporter: User facility; 
What: Serious injuries[A]; 
To whom: Manufacturer (FDA if manufacturer unknown); 
When: Within 10 work days from becoming aware of relevant information. 

Reporter: User facility; 
What: Annual report of deaths and serious injuries[A]; 
To whom: FDA; 
When: January 1. 

Reporter: Manufacturer[B]; 
What: Deaths and serious injuries[A]; 
To whom: FDA; 
When: 30 calendar days from becoming aware of relevant information. 

Reporter: Manufacturer[B]; 
What: Malfunctions[C]; 
To whom: FDA; 
When: 30 calendar days from becoming aware of relevant information. 

Reporter: Manufacturer[B]; 
What: Events that require immediate remedial action to prevent an 
unreasonable risk of substantial harm to the public health.[D]; 
To whom: FDA; 
When: Within 5 work days of becoming aware of relevant information. 

Source: FDA. 

Notes: This table does not include the medical device reporting 
responsibilities of device importers. 

[A] FDA defines "serious injury" as an injury or illness that is life 
threatening; or results in permanent impairment of a body function or 
permanent damage to a body structure; or necessitates medical or 
surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 21 C.F.R.  803.3 
(2007). 

[B] Manufacturers are also required to submit supplemental and baseline 
reports. Supplemental reports include information that was not known or 
available when the original report was submitted. They must be filed 
within 1 month after the manufacturer becomes aware of new information. 
Baseline reports include information about the manufacturer and the 
device that is the subject of a reported adverse event. They are 
required when the manufacturer submits the adverse event report and 
must be updated annually. 

[C] Malfunctions must be reported if the device or a similar device 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur. 

[D] These reports must also be submitted when FDA notifies the 
manufacturer in writing that 5-day reports involving subsequent events 
of the same nature associated with a particular type of device or 
similar devices are needed. 

[End of table] 

In addition to its mandatory reporting component, FDA also has a 
voluntary component for reporting device-related adverse events, known 
as FDA's MedWatch program. Health care professionals can voluntarily 
report serious adverse events, product quality problems, or product use 
errors that they suspect are associated with the devices they 
prescribe, dispense, or use. Consumers and others can also voluntarily 
report adverse events, product use errors, or quality problems, that 
they suspect are associated with the use of a device. 

[End of section] 

Appendix V: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services:
Office of the Assistant Secretary for Legislation:
Washington, DC 20201: 

January 7, 2008: 

Randall B. Williamson: 
Acting Director, Health Care:
U.S. Government Accountability Office: 
Washington, D.C. 20548: 

Dear Mr. Williamson: 

Enclosed are the Department's comments on the U.S. Government 
Accountability Office's (GAO) draft report entitled, "Reprocessed 
Single-Use Medical Devices: FDA Oversight Has Increased and Available 
Information Does Not Indicate That Use Presents and Elevated health 
Risk (GAO 08-147). 

The Department appreciates the opportunity to comment on this draft 
before its publication. 

Sincerely, 

Signed by: 

Rebecca Kennard: 

For: 

Vincent J. Ventimiglia: 
Assistant Secretary for Legislation: 

General Comments of the Department of Health and Human Services (HHS) 
on the Government Accountability Office's Draft Report Entitled, 
"Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased 
and Available Information Does Not Indicate That Use Presents an 
Elevated Health Risk," (GAO-08-147): 

General Comments: 

Page 1: 

footnote one: revise as follows: 

Generally, a medical device includes items used for the diagnosis, 
cure, mitigation, treatment, or prevention of a disease or other 
condition. 21 U.S.C.  321(h). Throughout this report, the term device 
refers to a medical device that is not being regulated as a drug or a 
biological product. 

Page 5, 9th line from the bottom: 

replace the sentence beginning with "Also, in response" with: 

Also, in response to MDUFMA's requirements for increased oversight, FDA 
identified more than 70 types of reprocessed SUDs that would be subject 
to additional premarket submission requirements. 

Page 7, first sentence under Background: 

replace "ensuring that all devices are reasonably safe and effective" 
with: reviewing the safety and effectiveness of nonexempt devices. Page 
9, footnote 14: 

strike "and" in the last sentence and replace with: 

but generally do not. 

[End of section] 

Appendix VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Randall B. Williamson, (202) 512-7114 or williamsonr@gao.gov: 

Acknowledgments: 

In addition to the contact named above, Kim Yamane, Assistant Director; 
Matt Byer; Julian Klazkin; Suzanne Rubins; Stan Stenersen; and Jennifer 
Wiley made key contributions to this report. 

[End of section] 

Related GAO Products: 

Food and Drug Administration: Methodologies for Identifying and 
Allocating Costs of Reviewing Medical Device Applications Are 
Consistent with Federal Cost Accounting Standards, and Staffing Levels 
for Reviews Have Generally Increased in Recent Years. GAO-07-882R. 
Washington, D.C.: June 25, 2007. 

Food and Drug Administration: Limited Available Data Indicate That FDA 
Has Been Meeting Some Goals for Review of Medical Device Applications. 
GAO-05-1042. Washington, D.C.: September 30, 2005. 

Single-Use Medical Devices: Little Available Evidence of Harm From 
Reuse, but Oversight Warranted. GAO/HEHS-00-123. Washington, D.C.: June 
20, 2000. 

Adverse Events: Surveillance Systems for Adverse Events and Medical 
Errors. GAO/T-HEHS-00-61. Washington, D.C.: February 9, 2000. 

[End of section] 

Footnotes: 

[1] Generally, a medical device includes items used for the diagnosis, 
cure, mitigation, treatment, or prevention of a disease or other 
condition. 21 U.S.C.  321(h). Throughout this report, the term device 
refers to a medical device that is not being regulated as a drug or a 
biological product. 

[2] The term reprocessed, with respect to a SUD, means an original SUD 
that has previously been used on a patient and has been subjected to 
additional processing and manufacturing for the purpose of an 
additional single use on a patient. 21 U.S.C.  321(ll)(2). 

[3] GAO, Single-Use Medical Devices: Little Available Evidence of Harm 
From Reuse, but Oversight Warranted, GAO/HEHS-00-123 (Washington, D.C.: 
June 20, 2000). 

[4] Pub. L. No. 107-250,  302, 116 Stat. 1588, 1616-20. For additional 
information on other provisions of MDUFMA, see GAO, Food and Drug 
Administration: Methodologies for Identifying and Allocating Costs of 
Reviewing Medical Device Applications Are Consistent with Federal Cost 
Accounting Standards, and Staffing Levels for Reviews Have Generally 
Increased in Recent Years, GAO-07-882R (Washington, D.C.: June 25, 
2007). 

[5] These associations included the Advanced Medical Technology 
Association and the Medical Device Manufacturers Association. 

[6] FDA defines a device establishment as a place of business under one 
management at one general physical location at which a device is 
manufactured, assembled, or otherwise processed. 21 C.F.R.  807.3 
(2007). Medical device manufacturers may have more than one 
establishment. FDA considers reprocessing of SUDs to be manufacturing. 

[7] When establishments register with FDA, they indicate which of 
several FDA-regulated activities they plan to engage in, such as 
manufacturing, importing, relabeling and repackaging devices, or 
reprocessing SUDs. When establishments identify their devices--a 
process known as medical device listing--establishments indicate which 
devices are associated with each activity, in order to allow FDA to 
determine which devices are manufactured or imported and which are 
reprocessed, for example. By listing a device with FDA, an 
establishment does not necessarily mean it is commercially distributing 
that device. For example, some listed devices may not yet be available, 
but are being considered for the future or are awaiting premarket 
clearance, if required. 

[8] FDA does not consider the activity of resterilizing unused devices 
to be reprocessing. The need to resterilize such "open but unused" 
devices may arise when a surgical procedure is cancelled after the 
devices had been removed from their sterile packaging, and a hospital 
may send these devices out to be resterilized and repackaged by an 
outside establishment. 

[9] Throughout this report we refer to type of device or device type to 
indicate a generic category of device. Each FDA-identified device type 
has a particular intended use (for example, a scalpel is intended to 
cut tissue) and may have more specialized "indications for use" (for 
example, a scalpel designed to make incisions on the cornea). Each 
device type may include a variety of models made by different 
manufacturers. Accessories used along with a particular device may have 
their own product code or be included in the same product code as the 
main device. 

[10] Device classifications and exemptions from premarket review are 
codified in parts 862 through 892 of title 21 of the Code of Federal 
Regulations; in addition, FDA's Web site provides searchable databases 
at [hyperlink, http://www.fda.gov/cdrh/databases.html]. Class I devices 
are those for which compliance with the general controls, such as basic 
manufacturing requirements specified in FDA's quality system 
regulation, are sufficient to ensure safety and effectiveness. Class II 
devices are subject to both the general controls and special controls, 
such as postmarket surveillance, to ensure safety and effectiveness. 
Class III devices, in addition to going through premarket approval, 
which is the most rigorous premarket review, are subject to general 
controls and may be subject to special controls as well. 

[11] 21 U.S.C.  360(k). 

[12] Substantially equivalent or substantial equivalence means the 
device has the same intended use as another legally marketed device and 
the same technical characteristics, or different technical 
characteristics that are found to be as safe and effective as the 
marketed device and do not raise different questions of safety or 
effectiveness. 21 U.S.C.  360(c)(i). Most devices enter the market by 
demonstrating their substantial equivalence. New devices are 
automatically classified as class III devices and must go through 
premarket approval before they may be marketed. Manufacturers of new 
devices automatically classified into class III can petition FDA for 
reclassification. 21 U.S.C.  360c(e). 

[13] 21 U.S.C.  360e. 

[14] FDA's quality system regulation specifies quality control 
processes that all device manufacturers, including reprocessing 
establishments, must follow to ensure that devices are safe and 
effective for their intended use and otherwise in compliance with the 
FDCA. See 21 C.F.R. pt. 820 (2007). FDA inspectors document instances 
where establishments are not in compliance with the regulation but 
generally do not indicate a specific corrective action. FDA also 
conducts premarket inspections of establishments. Premarket inspections 
are conducted prior to the introduction of devices into the U.S. 
market. Postmarket inspections occur after a device has already been 
marketed. 

[15] User facilities must also submit to FDA an annual report of device-
related deaths and serious injuries that they have filed each year. 
Manufacturers must submit a supplemental or follow-up report for an 
adverse event within 1 month after receiving information that is 
required to be reported but that was not included in the initial 
adverse event report because it was either not known or not available 
at the time. Manufacturers can request alternative summary reporting 
under 21 C.F.R.  803.19(b). In addition, health care professionals, 
consumers, and others may also voluntarily report device-related 
product problems as well as device-related adverse events. See app. IV 
for additional information on specific device-related adverse event 
reporting requirements, including the time frames in which 
manufacturers and user facilities are required to submit reports. 

[16] FDA officials told us that, while the agency reviews all adverse 
event reports, it places the highest priority on reports involving 
pediatric deaths, multiple deaths or serious injuries from a single 
device, fires, burns, or highly unusual events such as radiation 
exposure, over-or underdosing of radiation, radiation being delivered 
to the wrong site, and severe allergic reactions (anaphylaxis). 

[17] However, FDA officials told us that, taken as a whole, even less- 
serious reports can provide valuable information. The review of 
malfunction reports can lead to identification of significant problems 
with devices that have the potential for serious injuries or deaths. 
FDA conducts ongoing analyses to identify emerging trends in the type 
or volume of problems that could warrant further review, for example, 
if FDA receives similar reports of user-error associated with a 
particular device. 

[18] FDA data indicated that more than 40 establishments were 
registered as reprocessing establishments as of March 2007, including 
13 located outside the United States. However, upon our request, FDA 
officials determined that many of these establishments had registered 
as reprocessing establishments in error, and FDA officials identified 
11 establishments in the United States that were engaged in 
reprocessing SUDs as of July 2007. As of October 2007, FDA officials 
were in the process of determining whether the 13 registered 
establishments located outside of the United States were actively 
engaged in reprocessing, and if so, whether they were marketing 
reprocessed SUDs in this country. The officials stated that the agency 
plans to issue assignments by March 2008 for the inspection of foreign 
establishments it identifies as actively reprocessing SUDs for the U.S. 
market but they did not specify a date by which the inspections would 
be completed. 

[19] By listing a device with FDA, an establishment does not 
necessarily mean it is actively reprocessing and commercially 
distributing that device. For example, some listed devices may not yet 
be available, but are being considered for the future or are awaiting 
premarket clearance, if required. Therefore the listed devices we 
report represent both those SUDs that are currently available as 
reprocessed and those that were being considered for reprocessing. 

[20] U.S. Food and Drug Administration, Final Report: Survey on the 
Reuse and Reprocessing of Single-Use Devices (SUDs) in U.S. Hospitals 
(Rockville, Md., 2002). Prepared for FDA by Eastern Research Group, 
Inc., Lexington, Mass., Contract 223-98-8002. 

[21] The survey response rate was 79.4 percent, which included both 
complete and partial responses. 

[22] Most of the hospitals reported contracting with other 
establishments to perform the reprocessing, but the initial results of 
the survey indicated that about 13 percent of those that used 
reprocessed SUDs reported doing their own reprocessing. FDA informed us 
that, to enforce the requirement that hospitals that do their own 
reprocessing register with FDA and comply with appropriate quality 
control regulations, inspectors visited all of the hospitals that 
reported performing their own reprocessing and a statistical sample of 
about 200 of the approximately 900 hospitals that did not respond to 
the survey. According to FDA officials, the inspectors who visited 
these hospitals determined that most were not involved in reprocessing 
and had responded to the survey question in error. FDA officials told 
us that all of the hospitals that FDA's inspectors determined were 
reprocessing SUDs indicated that they planned to stop the practice 
after the FDA inspectors' visits. 

[23] Department of Defense medical facilities are not obligated to use 
reprocessed SUDs. Medical facilities that choose to use reprocessed 
SUDs must follow Department of Defense and service-level policy, which 
is based on current FDA guidance, and can not reprocess SUDs internally 
but must utilize a third-party reprocessor registered with FDA as a 
reprocessor. 

[24] In our 2000 report, we referred to surveys in the late 1990s 
indicating that between 16 and 31 percent of hospitals reported using 
reprocessed SUDs, with at least one-third of those hospitals reporting 
contracting with independent reprocessing companies. GAO/HEHS-00-123 at 
8-9. 

[25] See U.S. Food and Drug Administration, Enforcement Priorities for 
Single-Use Devices Reprocessed by Third Parties and Hospitals 
(Rockville, Md., Aug. 14, 2000). Among other things, this guidance 
specified that hospitals and third-party establishments engaged in 
reprocessing must comply with registration and listing, quality system 
regulation, and applicable premarket requirements. 

[26] This provision of MDUFMA applied only to critical and semicritical 
reprocessed SUDs. Critical reprocessed SUDs are intended to contact 
normally sterile tissue or body spaces during use, and semicritical 
reprocessed SUDs are intended to contact intact mucous membranes and 
not penetrate normally sterile areas of the body. 21 U.S.C.  
321(mm)(1), (2). 

[27] According to FDA officials, FDA does not set a limit on the number 
of times a device type may be reprocessed; the purpose of the 
validation data is to ensure that reprocessing establishments test, and 
document to FDA's satisfaction, that a SUD may be reprocessed for at 
least the number of times the establishment has designated. 

[28] In addition to directing FDA to identify those reprocessed SUDs 
that should require additional validation data to document cleanliness, 
sterility, and performance following reprocessing, for class III 
reprocessed SUDs, MDUFMA created a new requirement. Those manufacturers 
marketing class III reprocessed SUDs would have to submit a premarket 
report, which requires among other things a full description of the 
methods used in, and the facilities and controls used for, the 
reprocessing and packaging of the device. According to FDA, the agency 
had received one premarket report for a class III reprocessed SUD as of 
July 2007, but the applicant subsequently withdrew it. 

[29] Medical Device User Fee Stabilization Act of 2005, Pub. L. No. 109-
43,  2(c), 119 Stat. 439, 441 (2005). When MDUFMA was enacted this 
requirement applied to all devices, but subsequently Public Law 109-43 
limited it to reprocessed SUDs only. In cases where the original SUD is 
not marked directly with the manufacturer's name, abbreviation, or 
symbol, the reprocessing establishment may provide a detachable 
identification label on the device's package that is intended to be 
attached to the patient's medical record. 

[30] U.S. Food and Drug Administration, Guidance for Industry and FDA 
Staff: Compliance with Section 301 of the Medical Device User Fee and 
Modernization Act of 2002, as amended - Prominent and Conspicuous Mark 
of Manufacturers on Single-Use Devices (Rockville, Md., May 1, 2006). 

[31] FDA instructs its district offices to select medical device 
establishments for inspection using the following priority order: (1) 
device manufacturers with a pending medical device premarket 
application for approval; (2) manufacturers of class III devices that 
have never been inspected; (3) follow-up inspections for previously 
conducted for-cause or compliance inspections; (4) manufacturers of 
high-risk devices identified by special assignment from FDA, such as 
manufacturers of devices with a higher frequency of recalls and adverse 
event reports or manufacturers of new devices that have not been 
manufactured and distributed for very long; and (5) SUD reprocessing 
establishments. See FDA guidance Inspection of Medical Device 
Manufacturers (June 15, 2006) [hyperlink, 
http://www.fda.gov/cdrh/comp/guidance/7382.845.html], downloaded Oct. 
25, 2007). 

[32] See app. II for additional information on the inspection results. 

[33] The number of adverse event reports associated with all devices 
increased substantially from 2000 to 2006. In 2000, FDA received about 
77,000 reports of adverse events associated with all devices. By 2006, 
this number had increased more than fourfold to about 320,000 reports. 

[34] We have reported on the limitations of FDA's adverse event data. 
For example, in 2000, we reported that all adverse event reporting 
systems, such as FDA's, that rely on health care providers to take the 
initiative to make a report experience a high level of underreporting. 
See GAO, Adverse Events: Surveillance Systems for Adverse Events and 
Medical Errors, GAO/T-HEHS-00-61 (Washington, D.C.: Feb. 9, 2000). 

[35] MedSun was launched in 2002 to collect more-detailed adverse event 
reports about devices from a network of approximately 350 large 
hospitals that report through an Internet-based system. Participating 
MedSun hospitals voluntarily provide detailed information related to 
the design and use of devices. MedSun also encourages reporting of 
"close calls" so that preventative action can be taken before patients 
are injured. 

[36] One small hospital, for example, reported that it had discontinued 
the use of a reprocessed SUD after one broke during a procedure. 

[37] These associations included the Advanced Medical Technology 
Association and the Medical Device Manufacturers Association. 

[38] FDA officials were unable to determine whether the 13 
establishments located outside of the United States that were 
registered as reprocessing establishments in 2007 were actively engaged 
in reprocessing, and if so, whether they were marketing reprocessed 
SUDs in this country. According to FDA officials, the agency is 
actively working to determine whether any of the 13 foreign 
establishments registered as reprocessors, plus an additional foreign 
establishment that FDA officials identified as potentially reprocessing 
SUDs, have imported reprocessed SUDs into the United States in the 6 
months prior to October 2007. The officials stated that the agency 
plans to issue assignments by March 2008 for the inspection of all 
foreign establishments it identifies as actively reprocessing SUDs for 
the U.S. market but they did not specify a date by which the 
inspections would be completed. 

[39] For example, an establishment might list a device for which it 
intends to obtain premarket clearance but does not yet have such 
clearance. 

[40] We performed our search using the following key words: SUD, single-
use, single-use devices, one use, disposable equipment, medical 
device(s), equipment, reprocess, reuse, use again, safety, infection, 
malfunction, contaminate, contamination, or injury. We also examined 
other articles published in peer-reviewed journals identified during 
the course of our review. 

[41] We did not review letters of opinion, news articles, commentary, 
association position statements, federal government publications such 
as FDA informational news articles or guidance documents, and previous 
GAO reports. We also excluded articles if the periodical was published 
outside of the United States; we could not confirm that the publication 
was peer reviewed; if the authors were known or thought to be 
associated with device trade associations, reprocessing establishments, 
or manufacturers; or if the study was directly sponsored by a 
manufacturer. 

[42] 70 Fed. Reg. 56911 (Sept. 29, 2005), 69 Fed. Reg. 19433 (Apr. 13, 
2004), 68 Fed. Reg. 38071 (June 26, 2003), and 68 Fed. Reg. 23139 (Apr. 
30, 2003). 

[43] For purposes of device-related adverse event requirements, a 
device user facility is defined as a hospital, an ambulatory surgical 
facility, a nursing home, an outpatient treatment facility, or an 
outpatient diagnostic facility that is not a physician's office. 21 
C.F.R.  803.3 (2007). 

[End of section] 

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