The Single-Use Device Reprocessing Industry

Winds Of Change Reshaping the Role of the Industry

In the 1990s, hospitals would routinely send used medical devices marked for single use to their sterile processing department, have them re-sterilized, and use them again. The single-use device reprocessing industry emerged out of the FDA regulation of this practice – making it impossible for hospitals to continue the practice, and at the same time creating room for an industry of highly advanced independent companies to clean, test, and sterilize the devices while following FDA rules. For the first half of the 2000s, the industry lived in near obscurity, with clinicians raising claims the practice of reprocessing was unsafe while many hospitals discretely worked with reprocessors to reduce costs.

From 2007 or 2008 and onward, however, single-use device reprocessing became a more celebrated practice, adopted by most leading US hospitals, and accepted by most clinicians. With the success of reprocessing inside the hospital, the role of the challenger shifted from the clinician to the original manufacturer (OEM) of the single-use devices. OEM reps and/or OEM policies have since sought to restrict the use of reprocessed devices. However, reprocessing today has such a positive and significant financial impact on hospitals, that OEMs in the long run are going to have to learn to live with it and eventually integrate the practice of device reuse in design and utilization.

In the latter half of the 2000s, another thing happened to change the role of reprocessing: hospitals and staff began looking more critically at the environmental impact of their operations, and organizations such as Practice Greenhealth and Healthcare Without Harm became vehicles for driving more sustainable purchasing practices and hospital operations. Hospitals hired sustainability coordinators and demanded their supply chain clean up their act and show commitment to reducing environmental harm. It is debatable whether the sustainability movement at this time had major impact on hospitals and healthcare in general, since most suppliers made very minimal, cosmetic changes. Today, every medical device manufacturer has a “green commitment”, but it typically doesn’t involve real change – and more and more reusable products are still re-launched as “single use”.

 

Hospitals hired sustainability coordinators and demanded their supply chain clean up their act and show commitment to reducing environmental harm.

 

In 2021, the winds have started to change around hospital operations, medical device manufacturing and reprocessing – and are now squarely in the back of the industry.

While concerns about the environment and greenhouse gas emissions have been part of public discourse for decades, the issue of climate change is now a top priority for governments and populations across the world: The environmental movement has effectively moved from the streets into parliament buildings and regulatory offices and is now the subject of bills and legislation that create transparency and accountability for industries and sectors.

Globally, healthcare is responsible for almost 5% of all carbon dioxide emissions, and over 80% of this comes from the supply chain – not from hospital operations. In other words, it is the suppliers in healthcare that produce the environmental harm, not the hospitals themselves, except for their part in making purchasing decisions. This is also known as “scope 3” emissions, and historically, regulations to drive down environmental harm have overlooked these. However, this is changing, and regulatory agencies and government offices are now focusing on these, and such focus will force manufacturers to look at the environmental footprint of the goods they sell to hospitals. A recent study in the journal Sustainability showed that a reprocessed electrophysiology catheter produces less than half the harm of a new catheter, so the impact on the environment from using reprocessed devices can be substantial.

 

Globally, healthcare is responsible for almost 5% of all carbon dioxide emissions, and over 80% of this comes from the supply chain – not from hospital operations.

 

At the same time as the climate crisis is generating wind in the back for reprocessing, the pandemic and today’s focus on the healthcare supply chain have highlighted two additional problems in healthcare – the need to reduce costs and the need to ensure supply chain resiliency – and reprocessing provides both.

This trifecta of reprocessing benefits isn’t new, it’s just that shifts in the regulatory and market environment all of a sudden are highlighting a need to pursue them, and this produces tailwinds the industry has never seen before. The Association of Medical Device Reprocessors is extraordinarily busy answering requests from government agencies and lawmakers, describing how reprocessing is a model circular economy solution that uniquely provides the benefits needed, and participating in efforts to position reprocessing as a key strategy in the pursuit of climate change and cost pressure solutions in healthcare.

While the growth of reprocessing has been moderate – sometimes even slow – over the past 20 years, I have little doubt that the industry will play a pivotal role in the next 10 years and become a poster child for a new medical technology paradigm. Those in healthcare who ignore the benefits of the practice will do so at their peril, because greenwashing no longer works, and because environmental and financial accountability is coming to the industry as well as to hospitals and providers.

 

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