Reprocessing Worldwide – Much More Can Be Done

Great Results, but Significant Tailwinds Expected to Drive Stronger Growth

Single-use device reprocessing is probably the most successful circular economy solution in healthcare. Moreover, the practice has been regulated by FDA for more than 20 years, and the safety record, as well as the financial and environmental results over the years paint a picture of a practice that is not only fiscally and environmentally responsible, but also aligns with our patient care goals. Today, most US hospitals use single-use device reprocessing, and some of them save well over a million dollars per year without adding patient risk or forcing physicians to change their preferred methods.

However, while US hospitals in 2021 saved more than $400M in 2021, calculations made by the Association of Medical Device Reprocessors indicate that US healthcare could reduce costs by almost $2.5B annually if all hospitals used reprocessed devices at the rate of the top 10% performing hospitals. This means that US healthcare is only leveraging 17% of the potential cost savings that can be achieved through single-use device reprocessing. Or that US healthcare every year leave more than $2B in savings on the table. Given the poor financial state of most US hospitals and the threat that it presents to the quality of care, this seems, at best, irresponsible.

...US healthcare could reduce costs by almost $2.5B annually...

From an environmental standpoint, single-use device reprocessing also seems to be a success, with more than 20M pounds diverted from landfills through reprocessing. However, once again, much more impressive results could be achieved through better utilization of single-use device reprocessing. The carbon footprint of a new medical device is high due to the extensive use of plastics, metals, and complex manufacturing methodology. Some studies have shown that the carbon footprint of a reprocessed device is half of a new device. While AMDR does not (yet) publish carbon footprint results, it is likely that the US healthcare is also missing out on an opportunity to reduce carbon emissions by large numbers, failing to align with with executive mandates and recommendations of several government agencies. 

The US FDA was the first healthcare authority in the world to regulate reprocessing, but since then, the regulated practice has been adopted in several other countries and regions of the world. The European Union has a regulatory framework, with 14 countries opted in, Japan (the world’s second-largest healthcare economy) has a regulatory framework for reprocessing, Israel regulates reprocessing, and much closer to home, Health Canada regulates single-use device reprocessing. Canada and New Zealand have regulatory frameworks in place, although reprocessing is not adopted to the extent it is in the US. In other parts of the world, like South Africa, regulation is in progress.

The vast majority of single-use device reprocessing takes place in the US, although Germany has a mature reprocessing industry with 23 out of 34 German University Hospitals using single-use device reprocessing.

Despite early regulation in the US of single-use device reprocessing, there are signs that US healthcare may soon be falling behind. In the United Kingdom, NHS has committed to net-zero goals and reprocessing plays a key role in obtaining them. Other European countries that have centralized healthcare systems, are likely to achieve mass adoption of the new practice much faster than the US.

Despite early regulation in the US of single-use device reprocessing, there are signs that US healthcare may soon be falling behind.

By contrast, in the US, not even government-controlled hospitals have broadly adopted the FDA regulated practice. While 47 US military hospitals use single-use device reprocessing to control their costs and their carbon emissions, the nation’s largest health system, the VA has a policy against reprocessing - meaning that not a single one of the VA’s 170 hospitals takes advantage of single-use device reprocessing.

So, why does US healthcare leave more than $2B in cost reductions on the table every year? Lack of federal regulatory and policy involvement certainly is a part of the problem. Additionally, US hospitals are fighting an un-even battle with the MedTech industry whose opposition to reprocessing is reflected in product designs, contractual terms, and sales approaches that are all designed to limit the hospital’s ability to reduce costs and carbon footprint through safe, regulated device re-use.

There is, however, room to be optimistic about the near future. Executive orders increasingly focus on the environment, government agencies are getting more involved in general, and hospitals are starting to push back on MedTech’s re-use stance, which is increasingly in direct and clear opposition to the hospitals’ urgent needs for fiscal and environmental responsibility. At Innovative Health, we closed 2022 with 30% growth in the number of hospitals that benefit from our reprocessing services and savings growth among our partner hospitals of 20%. These are signs that the wind may be shifting.