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				 

******************************************************************
** This file contains an ASCII representation of the text of a  **
** GAO Product.                                                 **
**                                                              **
** No attempt has been made to display graphic images, although **
** figure captions are reproduced.  Tables are included, but    **
** may not resemble those in the printed version.               **
**                                                              **
** Please see the PDF (Portable Document Format) file, when     **
** available, for a complete electronic file of the printed     **
** document's contents.                                         **
**                                                              **
******************************************************************
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
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. However, because this
work may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this material
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. ï¿½ 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.
			  
			  GAO's Mission

           The Government Accountability Office, the audit, evaluation, and
           investigative arm of Congress, exists to support Congress in
           meeting its constitutional responsibilities and to help improve
           the performance and accountability of the federal government for
           the American people. GAO examines the use of public funds;
           evaluates federal programs and policies; and provides analyses,
           recommendations, and other assistance to help Congress make
           informed oversight, policy, and funding decisions. GAO's
           commitment to good government is reflected in its core values of
           accountability, integrity, and reliability.
			  
			  Obtaining Copies of GAO Reports and Testimony

           The fastest and easiest way to obtain copies of GAO documents at
           no cost is through GAO's Web site ( [34]www.gao.gov ). Each
           weekday, GAO posts newly released reports, testimony, and
           correspondence on its Web site. To have GAO e-mail you a list of
           newly posted products every afternoon, go to [35]www.gao.gov and
           select "E-mail Updates."
			  
			  Order by Mail or Phone

           The first copy of each printed report is free. Additional copies
           are $2 each. A check or money order should be made out to the
           Superintendent of Documents. GAO also accepts VISA and Mastercard.
           Orders for 100 or more copies mailed to a single address are
           discounted 25 percent. Orders should be sent to:

           U.S. Government Accountability Office 441 G Street NW, Room LM
           Washington, DC 20548

           To order by Phone: Voice: (202) 512-6000 TDD: (202) 512-2537 Fax:
           (202) 512-6061
			  
			  To Report Fraud, Waste, and Abuse in Federal Programs

           Contact:

           Web site: [36]www.gao.gov/fraudnet/fraudnet.htm E-mail:
           [37][email protected] Automated answering system: (800) 424-5454 or
           (202) 512-7470
			  
			  Congressional Relations

           Gloria Jarmon, Managing Director, [38][email protected] , (202)
           512-4400 U.S. Government Accountability Office, 441 G Street NW,
           Room 7125 Washington, DC 20548
			  
			  Public Affairs

           Chuck Young, Managing Director, [39][email protected] , (202)
           512-4800 U.S. Government Accountability Office, 441 G Street NW,
           Room 7149 Washington, DC 20548

(290574)

To view the full product, including the scope
and methodology, click on [44]GAO-08-147 .

For more information, contact Randall B. Williamson at (202) 512-7114 or
[email protected].

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
*** End of document. ***