Reprocessed Single-Use Medical Devices: FDA Oversight Has
Increased, and Available Information Does Not Indicate That Use
Presents an Elevated Health Risk (31-JAN-08, GAO-08-147).
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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-08-147
ACCNO: A80334
TITLE: Reprocessed Single-Use Medical Devices: FDA Oversight Has
Increased, and Available Information Does Not Indicate That Use
Presents an Elevated Health Risk
DATE: 01/31/2008
SUBJECT: Cost effectiveness analysis
Data collection
Data integrity
Marketing
Medical equipment
Medical supplies
Product safety
Prosthetic devices
Reporting requirements
Risk management
Safety regulation
Safety standards
Consumer protection
Product evaluation
Medical devices
Policies and procedures
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GAO-08-147
* [1]Results in Brief
* [2]Background
* [3]Varied Information Available on Reprocessed SUD Industry
* [4]Eleven Active Reprocessing Establishments Collectively May B
* [5]Information on the Size of the Reprocessed SUD Market Is Not
* [6]Hospital Use of Reprocessed SUDs Varies
* [7]FDA Has Increased Its Oversight of SUD Reprocessing
* [8]FDA Identified More than 70 Types of SUDs That Require Addit
* [9]FDA Actions for Postmarket Oversight of Reprocessed SUDs Hav
* [10]FDA Clarified Oversight Policies and Plans for
Inspecting Re
* [11]FDA Has Taken Steps to Improve Adverse Event Reports
Related
* [12]Available Data Lack Rigor for Definitive Comparisons but Do
* [13]Rigorous Safety Comparisons Not Possible through Current or
* [14]FDA Has Found No Causative Link between a Reprocessed SUD an
* [15]Agency Comments
* [16]Appendix I: Scope and Methodology
* [17]Appendix II: Reprocessing Establishments, Types of Reprocess
* [18]Appendix III: FDA's Review of Premarket Requirements for Rep
* [19]Appendix IV: Reporting Requirements for Device-Related Adver
* [20]Appendix V: Comments from the Department of Health and Human
* [21]Appendix VI: GAO Contact and Staff Acknowledgments
* [22]GAO Contact
* [23]Acknowledgments
* [24]Related GAO Products
* [25]Order by Mail or Phone
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
Contents
Letter 1
Results in Brief 4
Background 7
Varied Information Available on Reprocessed SUD Industry 10
FDA Has Increased Its Oversight of SUD Reprocessing 14
Available Data Lack Rigor for Definitive Comparisons but Do Not Indicate
That Reprocessed SUDs Pose an Elevated Health Risk 19
Agency Comments 22
Appendix I Scope and Methodology 23
Appendix II Reprocessing Establishments, Types of Reprocessed Devices
Listed, and FDA Inspection Results 27
Appendix III FDA's Review of Premarket Requirements for Reprocessed SUDs
Following MDUFMA 29
Appendix IV Reporting Requirements for Device-Related Adverse Events 31
Appendix V Comments from the Department of Health and Human Services 34
Appendix VI GAO Contact and Staff Acknowledgments 36
Related GAO Products 37
Table
Table 1: Summary of MDR Mandatory Reporting Requirements for
Device-Related Adverse Events 32
Figure
Figure 1: Overview of FDA's Implementation of MDUFMA's Premarket Review
Requirements for Reprocessed SUDs, April 2003 through September 2005 30
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:
This is a work of the U.S. government and is not subject to copyright
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separately.
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.^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^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.
^1Generally, a medical device includes items used for the diagnosis, cure,
mitigation, treatment, or prevention of a disease or other condition. 21
U.S.C. S 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.
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.^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.^4
^2The 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. S 321(ll)(2).
^3GAO, Single-Use Medical Devices: Little Available Evidence of Harm From
Reuse, but Oversight Warranted, [26]GAO/HEHS-00-123 (Washington, D.C.:
June 20, 2000).
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:
o 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?
o What steps has FDA taken to strengthen oversight of reprocessed
SUDs on its own initiative and to implement requirements set forth
in MDUFMA?
o 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^5 and the Association of Medical
Device Reprocessors (AMDR), which represents two firms that
operate three large reprocessing establishments in the United
States,^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.
^4Pub. L. No. 107-250, S 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, [40]GAO-07-882R (Washington, D.C.: June 25,
2007).
^5These associations included the Advanced Medical Technology Association
and the Medical Device Manufacturers Association.
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.
^6FDA 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. S 807.3 (2007).
Medical device manufacturers may have more than one establishment. FDA
considers reprocessing of SUDs to be manufacturing.
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:
o 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.
o 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.^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.^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.
^7When 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.
^8FDA 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.
For all devices, FDA has assigned about 1,700 device types^9 into
one of three classes based on the level of risk posed and controls
necessary to ensure their safety and effectiveness.^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).^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.^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.^13
^9Throughout 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.
^10Device 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
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. S 360(k).
^12Substantially 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. S 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. S 360c(e).
^13 21 U.S.C. S 360e.
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.^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.^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.^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.^17
^14FDA'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.
^15User 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. S
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.
^16FDA 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).
^17However, 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.
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.^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.
^18FDA 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.
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.^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.
^19By 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.
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.^20 To develop this estimate,
FDA surveyed more than 5,000 hospitals.^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.^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.
^20U.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.
^21The survey response rate was 79.4 percent, which included both complete
and partial responses.
^22Most 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.
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.^23 According to Department of Defense officials, as
of October 2007
o 3 of the Navy's 22 medical centers and hospitals reported using
reprocessed SUDs;
o 4 of the Army's 26 medical centers and hospitals reported using,
or planning to use, reprocessed SUDs; and
o 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.
^23Department 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.
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.^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.^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:
o The first category consisted of reprocessed SUDs that had been
exempt from premarket notification at the time MDUFMA was
enacted.^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.^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.
o 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).
^24In 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. [41]GAO/HEHS-00-123 at 8-9.
^25See 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.
^24In 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. [41]GAO/HEHS-00-123 at 8-9.
^25See 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.
^26This 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. S 321(mm)(1), (2).
^27According 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.
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.^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.^29 FDA issued guidance that first became
effective on August 1, 2006, to help reprocessing establishments
comply with this requirement.^30
^28In 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.
^29Medical Device User Fee Stabilization Act of 2005, Pub. L. No. 109-43,
S 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.
^30U.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).
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.^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.^32 In the cases we reviewed that
involved corrective actions, we found the following:
o 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.
o 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.
^31FDA 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) (
[42]http://www.fda.gov/cdrh/comp/guidance/7382.845.html , downloaded Oct.
25, 2007).
^32See app. II for additional information on the inspection results.
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.^33
^33The 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.
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.^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.
^34We 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, [43]GAO/T-HEHS-00-61 (Washington, D.C.: Feb. 9, 2000).
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.^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).^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.
^35MedSun 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.
^36One small hospital, for example, reported that it had discontinued the
use of a reprocessed SUD after one broke during a procedure.
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
[27]http://www.gao.gov . If you or your staff have questions about
this report, please contact me at (202) 512-7114 or
[28][email protected] . GAO staff who made major contributions
to this report are listed in appendix VI.
Randall B. Williamson
Acting Director, Health Care
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,^1 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.^2
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.
^1These associations included the Advanced Medical Technology Association
and the Medical Device Manufacturers Association.
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.^3
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.^4
^2FDA 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.
^3For example, an establishment might list a device for which it intends
to obtain premarket clearance but does not yet have such clearance.
^4We 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.
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.^5 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(R) 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.
^5We 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.
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:
o 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.
o 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.
Appendix II: Reprocessing Establishments, Types of Reprocessed Devices
Listed, and FDA Inspection Results
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.
^aDevice 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.
^bThese 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.
^cThe 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.
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.^1 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.
^1 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).
Figure 1: Overview of FDA's Implementation of MDUFMA's Premarket
Review Requirements for Reprocessed SUDs, April 2003 through
September 2005
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.
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)^1 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.
^1For 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. S 803.3
(2007).
Table 1: 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.
^aFDA 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. S
803.3 (2007).
^bManufacturers 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.
^cMalfunctions 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.
^dThese 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.
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.
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.
Appendix VI: GAO Contact and Staff Acknowledgments
GAO Contact
Randall B. Williamson, (202) 512-7114 or [29][email protected]
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.
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.
[30]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. [31]GAO-05-1042 . Washington, D.C.: September 30,
2005.
Single-Use Medical Devices: Little Available Evidence of Harm From
Reuse, but Oversight Warranted. [32]GAO/HEHS-00-123 . Washington,
D.C.: June 20, 2000.
Adverse Events: Surveillance Systems for Adverse Events and
Medical Errors. [33]GAO/T-HEHS-00-61 . Washington, D.C.: February
9, 2000.
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Highlights of [45]GAO-08-147 , a report to the Committee on Oversight and
Government Reform, House of Representatives
January 2008
REPROCESSED SINGLE-USE MEDICAL DEVICES
FDA Oversight Has Increased, and Available Information Does Not Indicate
That Use Presents an Elevated Health Risk
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.
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.
References
Visible links
26. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-00-123
27. http://www.gao.gov/
28. mailto:[email protected]
29. mailto:[email protected]
30. http://www.gao.gov/cgi-bin/getrpt?GAO-07-882R
31. http://www.gao.gov/cgi-bin/getrpt?GAO-05-1042
32. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-00-123
33. http://www.gao.gov/cgi-bin/getrpt?GAO/T-HEHS-00-61
34. http://www.gao.gov/
35. http://www.gao.gov/
36. http://www.gao.gov/fraudnet/fraudnet.htm
37. mailto:[email protected]
38. mailto:[email protected]
39. mailto:[email protected]
40. http://www.gao.gov/cgi-bin/getrpt?GAO-07-882R
41. http://www.gao.gov/cgi-bin/getrpt?GAO/HEHS-00-123
42. http://www.fda.gov/cdrh/comp/guidance/7382.845.html
43. http://www.gao.gov/cgi-bin/getrpt?GAO/T-HEHS-00-61
44. http://www.gao.gov/cgi-bin/getrpt?GAO-08-147
45. http://www.gao.gov/cgi-bin/getrpt?GAO-08-147
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