25 Years as Guardian and Guide for the Reprocessing Industry

This year, the single-use device reprocessing industry turns 25 years. Two events marked the beginning of single-use device reprocessing as an industry: 1) FDA regulation of single-use device reprocessing; and 2) the foundation of the Association of Medical Device Reprocessors (AMDR) as a trade association that brought together competitors to build a platform for the regulated practice of reprocessing – and to fight off the many challenges of a newly formed industry. AMDR selected as its first President Dan Vukelich, a recent graduate with a Juris Doctor degree from the American University’s Washington College of Law.

At the beginning of AMDR’s history, the association had only three members: Vanguard Medical Concepts in Florida, Alliance Medical Corporation in Arizona, and SterilMed in Minnesota. Together, these reprocessors were the only ones with any significant footprint in the emerging market of reprocessing. The formation of AMDR seemed necessary, since the legal challenges as well as the market pressure from original manufacturers could not be handled by any single reprocessor. So, the fierce competitors found a way to work together, and the first years of AMDR’s existence, the association battled State initiatives to ban reprocessing - in spite of the FDA regulation that actually allowed the practice.

In 2005, a merger between Vanguard Medical Concepts and Alliance Medical Corporation created the country’s largest reprocessor: Ascent Healthcare Solutions. With only 2 members of AMDR, the association pivoted from its primarily legal focus to a focus on changing physician perceptions and combatting attacks from original manufacturers who started to feel the impact of the reprocessing industry on their bottom line. When Ascent Healthcare Solutions was acquired by Stryker just 4 years later in 2009, many of these challenges had been overcome, and AMDR pivoted again to a focus on promoting the practice of reprocessing as a cost savings strategy for hospitals.

During the years following the Stryker acquisition, the reprocessing industry changed dramatically, and AMDR was thrown into this whirlwind of changes with the implicit role of the guide and guardian of the industry. Indeed, in my mind, during these years, AMDR and its president were the only reasons the industry retained cohesion and unity: Several new reprocessors had joined AMDR since 2005, including distributors Cardinal and Medline as well as Arjo and NorthEast Scientific, representing a fragmentation of the industry that became more diverse. The service delivery model that had shaped the industry since its inception was challenged by sales - and volume orientation, so delivery models and value became less than uniform. Different members interpreted the regulatory standards differently. And while cost control had always been the big driver of reprocessing, environmental sustainability became an arguably more important benefit of reprocessing.

...during these years, AMDR and its president were the only reasons the industry retained cohesion and unity...

All these changes forced AMDR to pivot yet again – towards a more environmental focus and towards a role as the resilient, unifying force in the industry. AMDR deserves celebrating in 2025. The association has battled one wave of opposition after the other, and it has prevailed, maybe even succeeded. I think the next few years will show. There are more challenges ahead:

There are more international reprocessors appearing, operating under regulatory regiments that are different from FDAs. Many of these have shown resistance to join AMDR, threatening the unity of the industry. Similarly, in the domestic (US) market, several smaller companies have appeared over the past two years – and they have chosen to stand outside of AMDR. The industry is strong because AMDR unifies its participants in a singular regulatory framework and code of conduct. When more and more reprocessors stand outside AMDR, the industry becomes fragmented and loses strength – and the trust associated with AMDR and its membership can crack and become less universal.

When more and more reprocessors stand outside AMDR, the industry becomes fragmented and loses strength...

Ongoing fragmentation of the industry will result in continued erosion of established standards, goals and ethics associated with single-use device reprocessing. This could be dangerous for AMDR. It is important to keep in mind that single-use device reprocessing has not only been successful due to the regulation of reprocessing, but also due to the commitment and responsible behaviors of AMDR member reprocessors. With eroding standards, the general belief that single-use device reprocessing is safe and responsible healthcare may become weaker as well and send the industry into a crisis.

However, AMDR has historically proven to be surprisingly resilient. Throughout all the turbulence, AMDR – and its 25-year president Dan Vukelich - have enabled the industry to unite and to maintain standards that protect the strong belief that single-use device reprocessing is responsible healthcare.