The Association of Medical Device Reprocessors (AMDR) is the global trade association
representing the interests of regulated, commercial medical device reprocessing companies. We
respectfully submit these comments in response to the above-referenced docket. We focus our
comments on the Department of Defense (DoD) and its procurement of healthcare products.
Over 80 percent of US Healthcare emissions come from scope 3, or the supply chain. Given
disruptions to supply chains for healthcare products, we believe circular solutions such as
medical device reprocessing offer DoD a way to build supply chain stability and reduce both
emissions and costs. We provide brief answers to requests A through C based on our experience.
We also attach a background document (The Reprocessing Solution: Reducing Greenhouse Gas
Emissions and Lowering Healthcare Costs) that offers foundational information about the
existing, regulated use of reprocessed “single-use” devices (SUDs) in over 10,000 hospitals in the
US, Canada, in a number of EU countries, the UK, and Japan.
A recently peer reviewed, published Life Cycle Assessment (LCA) examined 15 major
environmental impacts comparing the creation of virgin, or original electrophysiology catheters,
used in certain cardiovascular surgeries, to that of their FDA-regulated reprocessed alternatives.
In 12 of 15 environmental impacts, the reprocessed device was found to be superior. We review
the analysis further in our responses below but wish for it to serve as an example for the type of
complete analysis required to make the best purchasing decision now also contemplating
sustainability considerations. . .