The History of Third-Party Reprocessing:

The reprocessing of medical devices labeled for "single use" has been standard practice in United States hospitals for years. Medical device reprocessing emerged over two decades ago, when original equipment manufacturers (OEMs) began to change the labels on certain devices from "reusable" to "single use," without making significant structural changes in the devices. Hospitals recognized that the "single use" label was often motivated by economic objectives, rather than patient safety concerns. Thus, rather than needlessly discard such devices after one use, hospitals began to reprocess them.

Historically, the majority of reprocessing has been conducted at in-hospital reprocessing centers. In the last decade, however, the third-party reprocessing industry emerged, at the request of hospitals that were seeking a way to outsource their reprocessing needs. Today, third-party reprocessing is a small but expanding industry. Approximately 95% of the third-party reprocessing done in the United States is performed by two companies, which comprise the membership of the Association of Medical Device Reprocessors (AMDR).

Commonly Reprocessed Medical Devices:

Please click here for a full listing of the medical devices reprocessed by AMDR's members. You can also verify this information through FDA's listing database by searching under the reprocessing company's name.

U.S. Government Accountability Office's (GAO) Reports on Reprocessing:

In January, 2008 GAO released its report, "Reprocessed Single-Use Medical Devices -- FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk." 

In 2000, GAO released, "Single Use Medical Devices: Little Available Evidence of Harm from Reuse, but Oversight Warranted."

(Note: The list of reprocessed devices included in GAO's 2000 report is outdated.  It is not a current list of devices reprocessed in the United States today. For a listing of devices currently being reprocessed, see the above link, or see FDA's web-page to search for "Cleared Reprocessed Single-Use Devices," or search FDA's device "Listing" database.)

GAO Written Testimony, presented by Dr. Janet Heinrich, Associate Director, Health Financing and Public Health Issues, GAO (2000).

Third-Party Reprocessing - Maintaining Safety While Reducing Cost:

Third-party reprocessing offers a way to maintain in the highest quality patient care, while also achieving significant cost savings. The facts speak for themselves:

• AMDR members have collectively reprocessed tens of millions of devices with few problems. Though numerous devices labeled for "single use" can be safely reprocessed, it is AMDR's view that not every device should be. AMDR member companies reprocess only a small percentage of the numerous devices used by hospitals.


• Third-party reprocessing saves money. On average, reprocessed medical devices offer a 50% cost savings, as compared to purchasing a new device.


• Third-party reprocessing provides at least as high - and perhaps even a higher degree - of sterility assurance than in-hospital reprocessing. Because of economies of scale, third-pa rty reprocessors often have more capital available than hospitals to invest in state-of-the-art cleaning, sterilization, and testing equipment.


• Third-party reprocessing offers hospitals significant risk management benefits. Hospitals that outsource their reprocessing needs to AMDR member companies effectively free themselves from malpractice costs that could arise in connection with improper reprocessing.