Headwinds and Tailwinds as the Reprocessing Industry Turns 25

• Ongoing fragmentation of the industry will result in continued erosion of established standards, goals and ethics associated with single-use device reprocessing. With eroding standards, the general belief that single-use device reprocessing is safe and responsible healthcare may become weaker as well and send the industry into a crisis.

• These years, AMDR members save hospitals about $400 Million every year. This may sound like an impressive number;  but over 25 years that really is a fairly humble result. Only about a third or the savings that could be achieved with existing 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?

• 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. For 25 years, hospital administrators have continued to allow original device manufacturers to walk all over their business and impact everything from what technologies they use – and whether they reprocess or not.

• 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.

These are the primary headwinds that are critical to what happens to single-use device reprocessing over the next 5 and 10 years. And they make me concerned. There are, however, things the industry can celebrate and trends that constitute wind in the back:

• 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 move advocates of the reprocessing program.

• Almost all US 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.

• Reprocessors have continued to break the boundaries of reprocessability. At several points in the history of the industry have 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. 

• And through all the shifts in the industry, the Association of Medical Device Reprocessors has enabled the industry to unite and to maintain standards that protect the strong belief that single-use device reprocessing is responsible healthcare.

The headwinds of the reprocessing industry need to be addressed by healthcare leaders, lawmakers, and manufacturers, or a growingly fragmented industry will have a hard time continuing its success.