	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). 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 indicated to us,  however, that such studies would not be an efficient use of agency  resources given the existing level of FDA oversight. 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. Agency Comments

In commenting on a draft of this report, HHS provided language to clarify  several sentences which we generally incorporated. 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, 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. 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.
Why GAO Did This Study

Within the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) is responsible for reviewing the safety and effectiveness of medical devices. The decision to label a device as single-use or reusable rests with the manufacturer. To market a reusable device, a manufacturer must provide data demonstrating to FDA's satisfaction that the device can be cleaned and sterilized without impairing its function. Alternatively, a single-use device (SUD) may be marketed without such data after demonstrating to FDA that the device is safe and effective if used once. Even though labeled for single-use, some SUDs are reprocessed for reuse with FDA clearance. This report addresses (1) the SUD reprocessing industry--the number of reprocessing establishments, the types of devices reprocessed, and the extent to which hospitals use reprocessed SUDs, (2) the steps FDA has taken to strengthen oversight of reprocessed SUDs, both on its own and in response to legislative requirements, and (3) the safety of reprocessed SUDs compared with other types of medical devices. GAO reviewed FDA data on reprocessors, reprocessed SUDs, and device-related adverse events, as well as FDA documents and inspection reports, studies published in peer-reviewed journals, and relevant statutes and regulations. GAO interviewed FDA officials and officials from associations of manufacturers, reprocessors, and providers.

What GAO Found

FDA has information on domestic reprocessing establishments, but it does not have data on the extent of actual production or on where the devices are being used. FDA officials identified 11 establishments that reported planning to market or actively marketing more than 100 types of reprocessed SUDs in the United States as of July 2007. Reprocessed SUDs ranged from devices used external to the body, such as blood pressure cuffs, to surgical devices used to repair joints. While many hospitals were believed to be reprocessing their own SUDs in 2000, FDA identified only one hospital in 2007 that was reprocessing SUDs. Reprocessed SUDs are being used in a variety of hospitals throughout the nation, including military hospitals. However, the Department of Veterans Affairs, which operates one of the nation's largest health care systems, prohibits their use entirely. Since 2000, FDA has taken a number of steps--on its own and in response to legislation--to enhance its regulation of reprocessed SUDs both before they go to market (called premarket review) and afterwards (called postmarket oversight). In 2000, FDA published guidance that clarified its policies on the regulation of reprocessed SUDs. This guidance was directed at third-party entities and hospitals engaged in reprocessing SUDs for reuse. Following legislation passed in 2002, FDA imposed additional requirements for about 70 types of reprocessed devices and implemented new labeling requirements so that users would recognize those devices that had been reprocessed. In terms of postmarket review, FDA now inspects reprocessors and monitors reports of adverse events involving reprocessed SUDs. Seven of the 10 reprocessing establishments that FDA inspected in the last 3 years had problems requiring corrective actions. Regarding adverse event reporting, FDA modified its reporting forms in 2003 to enable FDA to better identify and analyze those adverse events involving reprocessed SUDs. Neither existing FDA data nor studies performed by others are sufficient to draw definitive conclusions about the safety of reprocessed SUDs compared to similar original devices. While FDA has made changes to its data collection process regarding reprocessed SUD-related adverse events, the data are not suitable for a rigorous comparison of the safety of reprocessed SUDs compared to similar original SUDs. The other studies published since 2000 that GAO identified are likewise insufficient to support a comprehensive conclusion on the relative safety of reprocessed SUDs. FDA officials have concluded that the cost of conducting rigorous testing would not be an efficient use of resources, especially given that the available data, while limited, do not indicate that reprocessed SUDs present an elevated health risk. FDA has analyzed its data on reported adverse events related to reprocessed SUDs and has concluded that there are no patterns that point to these devices creating such risks. After reviewing FDA's processes for monitoring and investigating its adverse event data, we found no reason to question FDA's analysis. HHS provided language to clarify several sentences of a draft of this report which GAO generally incorporated.