From the January 2013 issue of HealthCare Business News magazine


“Back around the mid-1990s, we were asked whether SUD reprocessing was a good idea,” says Lavanchy. “Hospitals were saying, things like saw blades, drill blades, they’re still sharp after use on a patient, it seems like such a waste to throw them away. At that time, hospitals reprocessed SUD items on their own, using their existing reprocessing protocols and technologies that they would use for capital equipment that’s intended for reuse, and trying to apply it to these single-use devices.”

At that time, the ECRI Institute did worry about the safety of SUD reprocessing, Lavanchy says, because there was not any oversight or assurance that the reprocessing was being handled in any consistent manner or being properly researched. In 1996, the institute published a monograph on the topic that described considerations and precautions facilities should take before starting SUD reprocessing.


A group of small, third-party SUD reprocessors founded the Association of Medical Device Reprocessors (AMDR) in 1997. In 2000, the Governmental Accountability Office put out a study on the safety of SUD reprocessing through third parties, and found no evidence to show that reprocessed devices were any less safe than the original devices. It did, however, call attention to the unregulated SUD reprocessing that was taking place within hospitals. Soon after, in 2002, the FDA determined that hospitals performing SUD reprocessing would need to register as manufacturers and be monitored as such, at which point third-party reprocessors gained further ground. In 2007, the FDA identified only one hospital reprocessing SUDs on-site. Today, ECRI does not recommend any hospital perform SUD reprocessing itself, Lavanchy says.

If you can’t beat ‘em, join ‘em
In 2009, Stryker acquired Ascent Healthcare Solutions, the leading reprocessing company at the time, and in 2011, Ethicon Endo-Surgery took on Sterilmed, the second largest reprocessing company. The AMDR is now made up of those two companies, which perform 95 percent of the reprocessing done in the United States.

“It’s been quite a ride,” says Chase Matson, manager of government relations at AMDR. “It’s not without its share of bumps of bruises because those companies that bought us up were the same companies fighting against us and what we were doing. But eventually they wised up and realized that we had a legit operation and that we were really fitting a need in the market.”

Before the acquisitions, friction between OEMs and reprocessors could be rather scandalous. Some manufacturers would even circulate pictures of unclean devices that they said had been ineffectively reprocessed.

January 2013 Magazine

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