The Association of Medical Device Reprocessors is producing impressive results

Last month, the Association of Medical Device Reprocessors (AMDR) issued a press release that discussed the state of affairs in single-use device reprocessing – globally and in the US. In 2020 – in the midst of the pandemic with many procedures halted or reduced - reprocessing saved U.S. hospitals $372 million. Furthermore, AMDR data indicates that if all hospitals with reprocessing programs were as diligent with their reprocessing program as the top 10% performing hospitals, U.S. hospitals would have saved an additional $2.28 billion in 2020. The discrepancy here is staggering. The numbers tell us that the reprocessing savings realized in U.S. healthcare are roughly 16% of what they should be – without starting new reprocessing programs or adding more devices to reprocessing programs. In other words, U.S. Healthcare is turning away almost $2 billion per year in savings that could be realized without asking doctors to change their preferences, without reducing patient care standards, and without reducing hospital headcount. To put this in perspective, it is useful to remember that most hospital systems in the US are in dire straits financially and operationally – and presumably desperate to reduce costs without reducing quality.

Among cost reduction initiatives, circular economy solutions such as reprocessing are unique in that they represent minimal disruption to business as usual – they simply mean that the utility of devices is extended to several uses, reducing costs and environmental harm without impacting patient safety. The only operational requirement: Allow your reprocessing partner to set up a system for collecting used devices and establish routines in purchasing to ensure the maximum amount of reprocessed devices are purchased – at a lower cost. That’s all. I can understand that there are barriers to getting to 100% - sometimes physicians resist the use of reprocessed devices, sometimes original manufacturers block for the use of reprocessed. But hospitals leaving an average 84% of savings on the table is not good enough. One thing is that the service line is missing a cost reduction opportunity that could help them reach annual savings goals, but from a different vantage point, this demonstrates a scary disregard for the obligation healthcare providers have to perform the best care possible for as many patients as possible. Unrealized savings are dollars that could have been spent hiring more staff or buying new technologies – improving patient care.

The AMDR press release breaks down US reprocessing: Over 31 million devices labelled for “single-use” were reprocessed (this could have been over 186 million devices with better reprocessing practices), nearly 12 million pounds of medical waste was diverted from landfills; and over 9,000 US healthcare facilities currently use reprocessed devices, including all U.S. News & World Report “Top” hospitals.

Over 31 million devices labelled for “single-use” were reprocessed, nearly 12 million pounds of medical waste was diverted from landfills; and over 9,000 US healthcare facilities currently use reprocessed devices...

AMDR has also recently been instrumental in the development of AMI ST98, the first cleaning validation standard for medical device manufacturers. AAMI ST98 has a broader range than TIR30, the standard that it replaces, and it applies to devices that require processing before clinical use, including single-use devices that require processing by the healthcare facility prior to use. Unlike TIR30, ST98 lists actual requirements for cleaning validations. Finally, AMDR has just released its Global Regulatory Standards Document, providing global guidelines for reprocessing. Very impressive results that testify to the growing maturity of the reprocessing industry and the gradual recognition that circular healthcare economy solutions are necessary.

Twenty years ago, AMDR was busy defending the safety of reprocessed devices. 10 years ago, AMDR battled original equipment manufacturers in the US and their claims about dirty devices. Today, AMDR deserves a huge part of the credit for the fact that reprocessing has become standard practice in most US hospitals, reducing costs in the financially burdened US healthcare economy by almost $400 million.

Today, AMDR deserves a huge part of the credit for the fact that reprocessing has become standard practice in most US hospitals...

On top of this, increasingly regulated single-use device reprocessing has also spread to countries outside of the US, and again, AMDR has played a major role. The recent EU MDR paved the way for reprocessing to become a regulated activity in Europe, and several countries have opted into the legislation, including Belgium, Germany, Ireland, Netherlands, United Kingdom, Denmark, Italy, Portugal, Slovenia, Spain and Sweden (pending). There are signs that some EU countries will take even bigger steps towards adopting reprocessing than the US: Alan Wain, Chief Operating Officer for Supply Chain Coordination, National Health System UK, recently said that “the next step is to get a bigger uptake of these devices within the NHS. There is, now, a small amount of uptake, but the ambition is to get to a much larger footprint wherein 40–50% of the devices being used are remanufactured.”

In the increasingly more vocal discussion about the need to reduce costs and environmental harm in healthcare, AMDR is playing a leading role in setting the agenda. Single-use device reprocessing is arguably the most established and impactful circular solution in healthcare, and AMDR has been instrumental in placing reprocessing in the center of this discussion – in the United States and beyond.