Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk
Published: 2008-01-31T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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 can range from relatively simple items for external use,  such as inflatable sleeves to improve blood circulation, to complex items  placed inside the body, such as catheters inserted into the heart to monitor  cardiac function.
For more than two decades, establishments such as hospitals and private  companies have reprocessed various types of SUDs, citing lower  purchasing and in-house sterilization costs and reduced medical waste.  This development followed an increase in the number of devices labeled  as single-use. Because these devices were intended to be discarded after  one use, manufacturers did not develop appropriate cleaning, sterilization,  and testing methods or provide instructions to health care providers about  how to clean and sterilize them while still maintaining performance.
Concerns have been raised by the committee and others about the  potential risks of infection from reprocessed SUDs or their failure to  function properly. The original manufacturers of the SUDs, in particular,  have objected to SUD reprocessing, saying that the reprocessed SUDs are  inherently unsafe because these devices are not designed to facilitate  cleaning and sterilization. Reprocessing firms, on the other hand, contend  that reprocessed SUDs are indeed safe, citing a lack of data that show  otherwise. In a June 2000 report on SUD reprocessing, we found that  although there was little available evidence of harm from the use of  reprocessed SUDs, FDA oversight of SUD reprocessing was inconsistent.  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.
In light of action taken since our last report, you asked us to review how  the reprocessing industry and FDA’s oversight of reprocessed SUDs had  changed since June 2000. Specifically, our report addresses the following  three questions:    What is known about the reprocessing industry—the number of  reprocessing establishments, the types of devices they are reprocessing,  and the extent to which hospitals are using reprocessed SUDs?
What steps has FDA taken to strengthen oversight of reprocessed SUDs on  its own initiative and to implement requirements set forth in MDUFMA?
What is known about the extent to which the safety of reprocessed SUDs  compares favorably or unfavorably with the safety of similar original  SUDs?
To address these questions, we examined and evaluated available  information on the SUD reprocessing industry in the United States and  FDA’s oversight of this industry. In conducting our work, we (1) reviewed  available data on the types and characteristics of, FDA guidance and  standards pertaining to, and FDA inspection reports on, SUD reprocessing  establishments; (2) reviewed FDA-generated data and analyses on  reported adverse events involving reprocessed SUDs; (3) interviewed FDA  officials, representatives of the device reprocessing and manufacturing  industry, including professional associations representing device  manufacturing establishments and the Association of Medical Device  Reprocessors (AMDR), which represents two firms that operate three  large reprocessing establishments in the United States, and officials  representing provider associations and medical facilities of the  Departments of Veterans Affairs and Defense; (4) reviewed relevant  statutes, regulations, and Federal Register notices; and (5) conducted a  literature search of peer-reviewed periodicals and reviewed other  information to determine what is known about the safety of reprocessed  SUDs.
In some cases, FDA data were not available or sufficiently reliable to allow  us to develop detailed information or perform analyses. For example, we  determined that FDA’s data were not sufficiently reliable to determine the  number of domestic establishments reprocessing SUDs prior to July 2007  or the number of foreign establishments reprocessing SUDs. As a result,  we were unable to analyze trends in the number of reprocessing  establishments or the types of devices they were reprocessing since 2000  and we were limited to reporting on domestic reprocessing  establishments. Also, neither industry nor FDA representatives were able  to provide comprehensive information on the size of the reprocessed  SUDs market in the United States—in terms of volume and value— compared to the overall U.S. market for medical devices. See appendix I  for additional information on our methodology and data limitations.
We conducted our work between November 2006 and January 2008 in  accordance with generally accepted government auditing standards.
subsections: section_title: Background
paragraphs: 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. 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. Establishments, including  reprocessing establishments, are required to update their registrations  annually and their device listings twice each year.
FDA’s premarket review activities for devices—that is, for reusable  devices, for originally manufactured SUDs, and for reprocessed SUDs— mainly involve analyzing information submitted by those establishments  that plan to market devices, including clinical or engineering documents  and proposed labeling and instructions for use. Devices encompass a wide  range of complexity and potential risk, and higher-risk or innovative  devices require a more rigorous level of premarket review than lower-risk  devices. For example, many relatively simple, low-risk devices, such as  scissors used for medical purposes, are exempt from premarket review  requirements. For other devices, such as catheters, manufacturers are  required to submit documentation for FDA’s review and receive clearance  before they may be marketed.
For all devices, FDA has assigned about 1,700 device types into one of  three classes based on the level of risk posed and controls necessary to  ensure their safety and effectiveness. 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). 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. 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.
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. 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. 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. 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.
section_title: Varied Information Available on Reprocessed SUD Industry
paragraphs: 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. (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.
subsections: section_title: Eleven Active Reprocessing Establishments Collectively May Be Reprocessing More than 100 Types of SUDs
paragraphs: 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.
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.
section_title: Information on the Size of the Reprocessed SUD Market Is Not Available
paragraphs: 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.
section_title: Hospital Use of Reprocessed SUDs Varies
paragraphs: 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. To develop this estimate, FDA surveyed more than 5,000 hospitals.  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. This information was supplemented by  a more recent study in 2005. In this study, which focused on hospitals’  level of satisfaction with reprocessed SUDs, FDA received information  from 102 representatives of hospitals across the nation. About 40 percent  indicated they used a third party to reprocess SUDs. FDA followed up with  focus groups to obtain more detailed information on the differing  perspectives of various types of hospital personnel about the hospitals’ use  of reprocessed SUDs. In general, participating hospitals that reported  using reprocessed SUDs indicated their facilities had specific policies  regarding reprocessing, used a variety of types of reprocessed SUDs, and  believed that reprocessing provides substantial cost savings.
In our discussions with representatives of reprocessing establishments  and a managed care organization that runs several hospitals, we were told  that hospitals or hospital systems generally set their own policies  regarding whether to use reprocessed SUDs, which reprocessing  establishment to use, and which reprocessed SUDs are acceptable to the  hospitals’ physicians and other clinical personnel. This holds true for some  federal hospitals as well. The Department of Defense, for example, allows  individual medical facilities the option of using SUDs that are reprocessed  by establishments that are registered with FDA as reprocessors.  According to Department of Defense officials, as of October 2007    3 of the Navy’s 22 medical centers and hospitals reported using    4 of the Army’s 26 medical centers and hospitals reported using, or  planning to use, reprocessed SUDs; and   1 of the Air Force’s 17 medical centers and hospitals reported using  reprocessed SUDs.
In contrast to the Department of Defense policy, the Department of  Veterans Affairs has had an agencywide policy prohibiting the use of  reprocessed SUDs in any of its medical centers since at least 1991.  According to Department of Veterans Affairs officials, the agency could  not determine whether reprocessed SUDs are safe or not. However, the  agency does not allow the use of reprocessed SUDs because  manufacturers did not design SUDs to be used more than once and, as a  consequence, do not provide instructions on cleaning and sterilizing these  devices. These officials told us that the department’s policy has remained  largely unchanged, although the agency has reconsidered it at various  times.
section_title: FDA Has Increased Its Oversight of SUD Reprocessing
paragraphs: 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.
subsections: section_title: FDA Identified More than 70 Types of SUDs That Require Additional Premarket Review
paragraphs: 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. 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. According to FDA officials,  the agency intended to subject each type of reprocessed SUD to the same  level of premarket review as required of original SUDs. For example, if the  SUD was exempt from premarket requirements before it was used for the  first time, the reprocessed SUD would also be exempt.
MDUFMA, enacted in 2002, directed FDA to review the premarket  submission requirements for reprocessed SUDs and identify those devices  for which FDA would require additional validation data to document  cleanliness, sterility, and performance following reprocessing. This meant  that reprocessing establishments had to submit additional premarket  documentation for certain types of reprocessed SUDs to demonstrate that  they remain safe and effective or substantially equivalent to another device  already on the market. MDUFMA directed FDA to identify devices that fell  into the following two categories and to determine whether additional  information was needed to determine their continued marketability:    The first category consisted of reprocessed SUDs that had been exempt  from premarket notification at the time MDUFMA was enacted. 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. FDA, in response, identified 20  types of reprocessed SUDs that met these criteria and revoked their  premarket notification exemptions. Examples of types of reprocessed  SUDs that had their exemptions terminated and that were required to  submit the additional validation data included noncompression heart  positioners (devices intended to move, lift, and stabilize the heart during  open heart surgery), nonelectric biopsy forceps (devices used to remove a  specimen of tissue for microscopic examination), and various surgical  devices such as specialized needles and catheters.
The second category consisted of reprocessed SUDs that were already  subject to premarket notification at the time MDUFMA was enacted. FDA  was required to determine whether additional documentation on cleaning,  sterilization, and performance was necessary to ensure that the device  remained safe and effective after the maximum number of reprocessing  cycles. FDA, in response, identified 52 types of reprocessed SUDs that met  those criteria and required that premarket submissions for them include  such data. Examples of device types that were subject to the additional  validation data requirement included electric biopsy forceps, surgical drills  and accessories, and oximeters (devices used to measure the level of  oxygen in a patient’s blood).
Appendix III summarizes FDA’s methodology for identifying the 72 types  of reprocessed SUDs for which the agency has required additional  premarket data submissions in accordance with MDUFMA.
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. FDA issued guidance that first became  effective on August 1, 2006, to help reprocessing establishments comply  with this requirement.
section_title: FDA Actions for Postmarket Oversight of Reprocessed SUDs Have Taken Several Forms
paragraphs: 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.
subsections: section_title: FDA Clarified Oversight Policies and Plans for Inspecting Reprocessing Establishments
paragraphs: 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.
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. In the cases we reviewed that involved corrective actions, we  found the following:    For 6 establishments, FDA investigators determined that actions taken by  the establishments were adequate to address the deficiencies identified  during the establishment inspections. FDA considers these inspections to  be resolved. For example, one inspection revealed that the establishment  had reprocessed two models of SUDs before it received FDA approval to  reprocess them. The firm stopped reprocessing these models of SUDs  prior to FDA’s inspection and FDA inspectors determined that the  establishment had voluntarily taken the corrective actions that were  required. In another instance, FDA investigators found that the  establishment had not maintained complaint files appropriately.  Specifically, the establishment received a complaint from one hospital that  five blood pressure cuffs reprocessed by that establishment did not  function properly. However, the establishment listed all five devices as a  single complaint rather than documenting each nonfunctioning device  separately as required. At the end of the inspection, the establishment  agreed to make each device a separate complaint rather than group  several devices under one complaint number.
The inspection for 1 establishment was open and under investigation as of  November 2007. For this establishment, FDA inspectors identified a  number of objectionable conditions, including instances in which the  establishment did not adequately investigate reported problems associated  with reprocessed SUDs or submit reports of device problems to FDA  within the required time. In September 2007, FDA conducted a meeting  with officials representing the establishment to discuss the inspection  findings in detail. The establishment subsequently provided a written  response to FDA containing the actions it proposed to take in order to  correct the deficiencies identified by FDA investigators. FDA officials told  us that the agency will not consider the inspection deficiencies to be  resolved until FDA investigators reinspect the establishment. As of  November 2007, FDA had not scheduled a reinspection of this  establishment.
section_title: FDA Has Taken Steps to Improve Adverse Event Reports Related to Use of Reprocessed SUDs
paragraphs: 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.
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.
section_title: Available Data Lack Rigor for Definitive Comparisons but Do Not Indicate That Reprocessed SUDs Pose an Elevated Health Risk
paragraphs: 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.
subsections: section_title: Rigorous Safety Comparisons Not Possible through Current or Planned Adverse Event Reporting
paragraphs: 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. 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.
section_title: FDA Has Found No Causative Link between a Reprocessed SUD and Reported Patient Injury or Death
paragraphs: FDA has reviewed available adverse event reports associated with  reprocessed SUDs and has not identified a causative link between the  adverse event and the fact that the devices involved were reprocessed. In  September 2006, the Director of FDA’s Center for Devices and  Radiological Health testified that based on available adverse event data,  FDA had identified 434 reports submitted from October 2003 to July 2006  in which reprocessed SUDs were identified on the reporting form. With  respect to these reports, FDA determined that the majority of the reports,  including all 15 of the reports involving deaths, did not involve a  reprocessed SUD. For example, FDA determined that many of the  reported events involved reusable devices such as magnetic resonance  imaging machines or SUDs on their initial use. Of the 434 reports, FDA  further reviewed the 65 events that it found actually involved or were  suspected to involve a reprocessed SUD and that the reprocessed SUD  was one of several possible causal factors in the adverse event. In  reviewing these 65 reports, FDA found that the types of adverse events  reported to be associated with the use of reprocessed SUDs were the same  types of events that are reported for new, nonreprocessed devices.
In 2005, FDA consulted hospitals participating in the agency’s Medical  Product Safety Network (MedSun) about their experiences, including  adverse events or safety concerns, with reprocessing. 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).  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.
section_title: Agency Comments
paragraphs: 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  http://www.gao.gov. If you or your staff have questions about this report,  please contact me at (202) 512-7114 or williamsonr@gao.gov. GAO staff  who made major contributions to this report are listed in appendix VI.
section_title: Appendix I: Scope and Methodology
paragraphs: 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, 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. As a result,  we were unable to analyze trends in the number of reprocessing  establishments or the types of devices being reprocessed since 2000, and  we were limited to reporting on domestic reprocessing establishments.
Regarding the types of SUDs being reprocessed, our ability to provide  precise information was limited because although FDA maintains  databases of the types of devices the reprocessing establishments listed  with FDA, it does not confirm that all listed devices are currently available.  As a result, FDA’s data may include types of SUDs that the reprocessing  establishments no longer reprocess, types of SUDs they plan to reprocess,  or types of SUDs they listed in error—in effect, overstating the types of  SUDs the establishments are reprocessing or plan to reprocess. 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.
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. These  articles are listed below:  Colak, T.; Ersoz, G.; Akca, T.; Kanik, A.; Aydin, S. “Efficacy and Safety of  Reuse of Disposable Laparoscopic Instruments in Laparoscopic  Cholecytectomy: A Prospective Randomized Study.”   Surgical Endoscopy 18, no. 5 (2004): 727–731.  daSilva, M.; Ribeiro, A.; Pinto T. “Safety Evaluation of Single-Use Devices  After Submission to Simulated Reutilization Cycles.” Journal of AOAC  International 88, no. 3 (2005): 823–829.
Fedel, M.; Tessarolo, F.; Ferrari, P.; et al. “Functional Properties and  Performance of New and Reprocessed Coronary Angioplasty Balloon  Catheters.” Journal of Biomedical Materials Research 78, no. 2 (2006):  364–372.
Lipp, M.; Jaehnichen, G.; Golecki N.; et al. “Microbiological,  Microstructure, and Material Science Examinations of Reprocessed  Combitubes® After Multiple Reuse.” Anesthesia & Analgesia 91 (2000):  693–397.
Roth, K.; Heeg, P.; Reichl, R. “Specific Hygiene Issues Relating to  Reprocessing and Reuse of Single-Use Devices for Laparascopic Surgery.”  Surgical Endoscopy 16, no. 7 (2002): 1091–1097.
Wilson, S.; Everts, R.; Kirkland, K.; et al. “A Pseudo-Outbreak of  Aureobasidium Species Lower Respiratory Tract Infections Caused by  Reuse of Single-Use Stopcocks During Bronchoscopy.” Infection Control  and Hospital Epidemiology 21, no. 7 (2000): 470–472.
On examination, none of these studies were comprehensive enough to  support an overall conclusion about the relative safety of reprocessed  SUDs compared to SUDs on their initial use. Several limitations in the  articles we identified through our literature review make it difficult to  support an overall statement comparing the safety of reprocessed SUDs  with the safety of other devices. These limitations include the following:    Five of the six articles described studies that were conducted outside of  the United States, so we could not determine whether the reprocessing  methods and facilities would have met FDA’s approval. The remaining  article, while conducted in the United States, was published prior to  MDUFMA’s enactment in 2002 and subsequent FDA actions to implement  new requirements.
The articles reported on studies that tested few types of devices. Because  each study used different types of devices, it is not possible to compare  and aggregate their results to support general conclusions regarding the  relative safety of reprocessed SUDs.
section_title: Appendix II: Reprocessing Establishments, Types of Reprocessed Devices Listed, and FDA Inspection Results
paragraphs: No action indicated  No action indicated  Corrective action indicated  Corrective action indicated  n.a.
Years of Inspections  conducted from  August 2004  through  Device types indicate all devices assigned to a distinct product code by FDA. Each device type may  include a variety of actual instruments, manufacturers, and models. For example, some device types  include the device itself, such as a powered saw, and its accessories.
The establishment first registered as a reprocessing establishment in 2006; as of July 2007 no  inspections had been conducted but FDA officials reported plans to inspect the establishment in  2008.
section_title: Appendix III: FDA’s Review of Premarket Requirements for Reprocessed SUDs Following MDUFMA
paragraphs: 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. 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.
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.
section_title: Appendix IV: Reporting Requirements for Device-Related Adverse Events
paragraphs: 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) 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.
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.
section_title: Appendix V: Comments from the Department of Health and Human Services
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Acknowledgments
paragraphs: 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.
section_title: Related GAO Products
paragraphs: Food and Drug Administration: Methodologies for Identifying and  Allocating Costs of Reviewing Medical Device Applications Are  Consistent with Federal Cost Accounting Standards, and Staffing Levels  for Reviews Have Generally Increased in Recent Years. GAO-07-882R.  Washington, D.C.: June 25, 2007.
Food and Drug Administration: Limited Available Data Indicate That  FDA Has Been Meeting Some Goals for Review of Medical Device  Applications. GAO-05-1042. Washington, D.C.: September 30, 2005.
Single-Use Medical Devices: Little Available Evidence of Harm From  Reuse, but Oversight Warranted. GAO/HEHS-00-123. Washington, D.C.:  June 20, 2000.
Adverse Events: Surveillance Systems for Adverse Events and Medical  Errors. GAO/T-HEHS-00-61. Washington, D.C.: February 9, 2000.