Reprocessed Single-Use Medical Devices
FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk Gao ID: GAO-08-147 January 31, 2008Within 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 FDA's 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 industry--the 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.
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 nation's largest health care systems, prohibits their use entirely. Since 2000, FDA has taken a number of steps--on its own and in response to legislation--to 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 FDA's processes for monitoring and investigating its adverse event data, we found no reason to question FDA's analysis. HHS provided language to clarify several sentences of a draft of this report which GAO generally incorporated.
GAO-08-147, Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk
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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
FDA‘s 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 industry”the 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 nation‘s largest health
care systems, prohibits their use entirely.
Since 2000, FDA has taken a number of steps”on its own and in response
to legislation”to 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 FDA‘s processes for monitoring and investigating its adverse
event data, we found no reason to question FDA‘s 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:
FDA‘s implementation of MDUFMA: Total number of single-use device types
reviewed: 229.
Premarket requirements for reprocessed SUDs: Situation before MDUFMA:
FDA‘s implementation of MDUFMA: Originally subject to premarket review:
102;
FDA‘s implementation of MDUFMA: Originally exempt: 127.
Premarket requirements for reprocessed SUDs: MDUFMA requirement: review
exempt device types:
FDA‘s implementation of MDUFMA: Currently subject to premarket review:
122;
FDA‘s 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:
FDA‘s implementation of MDUFMA: New data requirements added: 72;
FDA‘s implementation of MDUFMA: No new data requirements added: 50;
FDA‘s 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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