From the President ...

The Association of Medical Device Reprocessors

1997 - 2007

Ten Years of Excellence in Reprocessing

Ten years ago, a new industry was born. In part to respond to device manufacturers who had changed labels on many medical devices from "reusable" to "single use," without making any real changes to the devices, a small group of start-up companies began to offer medical device “reprocessing” services to the nation’s hospitals. Hospitals had long recognized that reprocessed devices were both cost-effective and environmentally responsible, but many sought to outsource  their reprocessing operations to specialized companies who could offer expert cleaning and sterilization services. It did not take long for original equipment manufacturers (OEMs) to recognize the threat that reprocessing posed to their bottom line. And the battle lines were quickly drawn. As the OEMs began their campaign to stop or significantly curtail hospital and third-party reprocessing, the small group of third-party reprocessors banded together to form the Association of Medical Device Reprocessors, or AMDR.

A decade has passed and today with the support of AMDR, the reprocessing of “single use” devices (SUDs) is fully regulated by the U.S. Food and Drug Administration (FDA). Reprocessed devices marketed in the U.S. are as safe and as effective as original equipment.  AMDR’s members now serve all of the top ten heart hospitals and all the top ten orthopedic hospitals in the nation, as ranked by U.S. News & World Report magazine. Indeed, AMDR’s members serve 17 of the nation’s 18 “Honor Roll” hospitals, or 94 percent.   The reprocessing industry has safely reprocessed over 50 million devices and prevented over 10,000 tons of medical waste from entering our landfills. 

The nation’s third-party reprocessors have accomplished all this while maintaining a stellar safety record.   Why?  Third-party reprocessors go above and beyond. Unlike OEMs who may test or inspect a sampling of the devices they produce, AMDR’s members test or inspect 100 percent of the devices they reprocess.   AMDR’s members are committed to complete device traceability. We mark each reprocessed device so that we know it has been reprocessed, how many times, and which hospital it came from.  The OEMs do not offer the same commitment to device traceability.

Perhaps just as important, the nation’s third-party reprocessors are committed to providing hospitals and surgery centers with economically and environmentally sustainable medical device options. Health care costs in this country are skyrocketing and medical waste is an ever-increasing problem.  No other segment of the medical device industry is helping hospitals to reduce waste and costs like the nation’s third-party reprocessors. 

While there is no single solution to all of America's health care problems, AMDR's members are proud of the role reprocessing plays. In just 10 short years, reprocessing has become a critically important component of the health care community’s efforts to reduce medical waste, control rising costs, and continue to provide safe and effective medical care.

Daniel J. Vukelich, Esq.

President