In 2000, the Association of Medical Device Reprocessors (AMDR) was formed as the first significant step in the formation of an industry that has come to play a major role in the cost control and environmental efforts of most U.S. hospitals. That year, pressure on FDA to regulate single-use device reprocessing peaked, and FDA gave reprocessors two years to submit for and receive clearances to reprocess single-use medical devices.
Since 2000, reprocessing has evolved from a miscredited activity associated with high patient risk and zero guardrails to a highly regulated—and highly trusted—routine activity performed by most U.S. hospitals, including the top health systems. Many would describe single-use device reprocessing as a huge success and encourage the industry to take a victory lab to celebrate the 25-year anniversary. That said, anniversaries are also a good time to appreciate how far an industry still has to go, particularly as new headwinds challenge it.
In my mind, the adoption of single-use device reprocessing has been far too slow. Results are anemic given the potential of the activity, and healthcare still struggles to maintain a practice that is focused on patient care quality balanced with financial and environmental sustainability.
Fragmentation and Looming Threats
Today, the single-use device reprocessing industry is undergoing some fragmentation shifts that threaten the otherwise stable industry:
There are more international reprocessors appearing, operating under regulatory regiments that are different from those of FDA. Many of these have shown resistance to joining AMDR, threatening the unity of the industry. Similarly, in the U.S. market, several smaller companies have appeared over the past two years, and they have chosen to stand outside of AMDR.
The industry is strong partially 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 could crack and become less universal. Certainly, healthcare professionals should know that reprocessors outside of AMDR are not bound by a code of conduct and may not act in the healthcare provider’s best interest.
At the same time, technological challenges associated with cloud-based device controls and pressures from original manufacturers to stop single-use device reprocessing are growing. To an extent, technological and industry pressures have always existed, and reprocessing has always prevailed. But at this point, the industry is fragile due to fragmentation and might have a hard time withstanding the pressure and remaining intact.
Headwinds and Tailwinds in Single-Use Device Reprocessing
At these crossroads, it is important to celebrate the industry’s 25th anniversary, not just with pride, but also with some concern.
Ongoing fragmentation of the industry will result in continued erosion of established standards, goals, and ethics associated with single-use device reprocessing. 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 might become weaker.
These years, AMDR members saved hospitals about $400 million every year. This may sound like an impressive number. However, over 25 years, that really is a fairly humble result. The number should have been at least three times bigger. If you look at the average hospital’s utilization of reprocessed devices, only about a third of the savings that could be achieved with existing FDA clearances are achieved. To a hospital administrator, saving $300,000 per year is little more than pizza money for the Christmas party in the broader context of a supply spend budget of hundreds of millions of dollars. With such anemic results, are lab and OR directors going to continue fighting against the original manufacturers to save their reprocessing program?
New technology is emerging that can threaten reprocessing savings realized through the re-use of devices that plug into hospital consoles and generators. Manufacturers are working on making the software that run these in the cloud, further taking away control from the hospital to manage the equipment they own. This is illustrative of another powerful headwind in single-use device reprocessing: For 25 years, hospital administrators have continued to allow original device manufacturers to walk all over their businesses and dictate everything from what technologies they use to whether they reprocess or not. I am not seeing anything that makes me think this will change anytime soon.
Single-use device reprocessing is a market error that I never thought would survive this long. Think about it: A manufacturer designs a device, and FDA clears it to be single-use. Then the reprocessor gets a clearance from FDA saying that they can reprocess the device so it can be used more than once. The mere existence of a single-use medical device reprocessing industry should trigger the manufacturer to look at how they a) integrate reprocessing into their design and marketing activities or b) design their devices to be reusable. For 25 years, this has not happened, and I have never seen a time where manufacturers seemed less likely to truly integrate reprocessability into their operations and strategies.
These are the primary headwinds that are critical to what happens to single-use device reprocessing over the next 5-10 years. They are cause for concern. There are, however, things the industry can celebrate and trends that constitute wind in the back.
Reasons for Optimism
The increasing interest in environmental benefits of reprocessing have already done amazing things for the industry. For the past 10 years or so, increasingly the environmental benefit has played a key role as driver of reprocessing. This doesn’t remove any of the challenges, but it does mean that there are more advocates of the reprocessing program. Further, with life-cycle analyses that scientifically demonstrate the reduction in CO2 emissions from reprocessing, nurses, technologists, and physicians alike have become interested in how they can reduce their carbon footprint through reprocessing.
Almost all U.S. hospitals and many surgery centers and other healthcare facilities have a reprocessing program in place. As different as healthcare facilities are, it is hard to think of many things they all have in common, but reprocessing is one. Renowned healthcare systems were early adopters of reprocessing, and these same top U.S. health systems continue to be great advocates of the practice.
Reprocessors have continued to push the boundaries of reprocessability. At several points in the history of the industry, reprocessors tasked themselves with coming up with ideas that would make it possible to reprocess what was called “unreprocessable”—and several times they have succeeded. This entrepreneurship and impatience with status quo have become a part of the industry’s mindset, and if this is harnessed moving forward, it will continue to expand the industry—and the savings provided.
Finally, I believe AMDR is wind in the back for the reprocessing industry. AMDR initially fought legal battles in the different states. Then it had to pivot and help call out manufacturers that sowed doubt and fear about the safety of reprocessing. Lately, the organization is leveraging the environmental message to drive more awareness. Through all these shifts, AMDR has enabled the industry to unite and to maintain standards that protect the strong belief that single-use device reprocessing is responsible healthcare.
The single-use device reprocessing industry is turning 25 this year. And today, there is as much reason to be concerned about the future of the industry as there is to celebrate. The headwinds of the industry need to be addressed by healthcare leaders, lawmakers, and manufacturers, or a growingly fragmented industry will have a hard time continuing its success.
Lars Thording
Lars Thording is VP of Marketing & Public Affairs at Innovative Health LLC.
