The Single-Use Medical Device Industry Needs to Re-Invent itself

Reprocessing is At Risk of Being a Parenthetical Event in Healthcare

Single-use medical devices are common in healthcare. They are used across all service lines in acute care facilities and surgery centers. They are single-use because the original manufacturers chose to label them so, presumably to reduce risk to the patent from cross-contamination of reusable devices and to functionality based on the delicate nature of the devices themselves.

For decades, hospitals “cheated” and sent used single-use devices to the Central Sterile Department to get them cleaned, so they could be used one more time without incurring sometimes very high costs. Then, in the years around 2000, FDA intervened and made the practice of reprocessing single-use devices illegal, unless a reprocessing company (or a hospital) could present facts that would convince FDA that the reprocessed devices were substantially equivalent to new devices. This gave reprocessors the same “burden of proof” as original manufacturers launching new devices. In spite of this seemingly insurmountable challenge, some reprocessors dug in and prevailed. They amassed a portfolio of FDA clearances to reprocess and sell used single-use medical devices.

In the early and mid-2000s, the reprocessing industry grew to become a source of important savings for hospitals, as reprocessors offered to reprocess a growing number of devices used in electrophysiology, surgery, and patient care. At the same time, the industry grew to become a major frustration for medical device manufacturers, who saw their profits undercut by the re-use practice. The manufacturers allied themselves with clinicians and questioned the safety and functionality of reprocessed devices. However, with the years, the evidence grew, and it became still more clear that using reprocessed single-use devices did not present any additional patient risk or functional challenge.

...using reprocessed single-use devices did not present any additional patient risk or functional challenge.

In the years that followed, single-use reprocessing became more and more established as a cost control and environmental sustainability initiative. It benefitted the practice – and the industry – that re-use in general became a hot topic in the public’s mind. Everything should be re-used – from glass bottles and cans to batteries, automotive tires, print cartridges, and airplane parts. “Re-use” became an adjunct component to almost all product markets. Single-use medical device reprocessing was this adjunct re-use component to the medical device industry.

These days, 25+ years after the formation of the industry, single-use device reprocessing across all leading reprocessors saves healthcare over $400M per year. This may sound like an impressive number, but over 25 years, that really is a fairly humble result. Only a fraction of the savings that could be achieved based on FDA clearances are actually achieved. With such anemic results, are lab and OR directors going to continue fighting against the original manufacturers to save their reprocessing program? Are reprocessors going to continue investing in FDA clearances? Are doctors and nurses going to actually care enough to promote the use of reprocessed devices?

Looking at single-use reprocessing today, a few things stand out:

• Total savings of $400M ($462,493,209 in 2025 according the Association of Medical Device Reprocessors) per year from reprocessing – gained over 25 years of hard work – is hardly something to celebrate. A company that spends 25 years growing its annual revenue to $400M is hardly a very successful enterprise. This becomes even more compelling when you consider that the total value of the single-use medical device market in the US is more than $50B – making reprocessing a 0.8% adjunct reuse market in the medical device industry...
• The single-use medical device industry isn’t doing much to help itself increasing its impact in healthcare. New FDA clearances to reprocess single-use medical devices are at a record low. There are still no clearances for reprocessing therapeutic devices. And reprocessors haven’t tackled new device categories for decades.
• In spite of the fact that single-use device reprocessing reduces the profit of original medical device manufacturers – and in spite of the fact that embracing re-use as an integral part of the original device manufacturing and marketing process has been very successful in other industries - original manufacturers have still not absorbed the practice (and the industry) to make it part of a re-use value proposition that can help them grow market share and customer loyalty.

So, what can the single-use medical device industry do to remain relevant, accelerate growth, and realize the potential of reuse in medical devices? Looking at other industries in similar situations, these are some ideas:

• Align with other medical device (and beyond) re-use solutions, organization, and associations to create a bigger voice and represent a bigger financial and environmental footprint.
• Break the boundaries of single-use device reprocessing by adding more therapeutic areas, technologies, and use scenarios. This will eventually increase impact substantially.
• Develop novel, adaptable delivery solutions that allow seamless expansion of the reprocessing practice into home care and non-acute care settings. This is where most of our care ends up anyway.
• Leverage international markets, which are to this date underdeveloped in terms of single-use device reprocessing. International markets can be leveraged to develop scale, but also to encourage innovation, understand new technologies, and expand the circular network of re-use.
• Create industry alliances with manufacturers, distributors, and providers to break down barriers and speed up the rate of adoption.

Single-use device reprocessing is a groundbreaking practice that has changed the mindset and economics of healthcare – to those of us who work in the industry. To other folks in healthcare, it is a curiosity at best. To virtually everybody else, the practice is unknown. When discussing what I do with others, they commend me, because I am doing a good thing – driving down the costs and environmental impact of healthcare. Having spent decades in the industry, I would personally hate to see the medical device reprocessing practice and industry end up being a parenthetical event in healthcare – but that is where it is heading right now. I am ready to jump on new initiatives to kick-start this industry and make it as impactful as it should be.