The Association of Medical Device Reprocessors (AMDR) thanks CMS for the
opportunity to comment and appreciates the agency’s attention to addressing the
adverse environmental impacts generated by the health sector.
AMDR is the global trade association representing the interests of regulated, commercial
medical device reprocessing companies. Our members reprocess “single-use” medical
devices (SUDs) cleared by FDA or parallel regulatory authorities in other countries. In
2020, our members reprocessed over 31.6 million devices for over 10,300 healthcare
facilities in 13 countries. AMDR members represent a regulated, safe environmental
solution that reduces Scope 3 emissions, which drive 82% of all greenhouse gas
emissions from U.S. hospitals. The first of several anticipated well-designed, published
life cycle assessments showed that a reprocessed EP catheter cut greenhouse gas
emissions in half compared to using original devices with each patient.
Use of commercially reprocessed SUDs improves supply chain resiliency by keeping
devices circulating domestically. They typically cost 25 to 40% less than original
devices, resulting in nearly $438M in savings to hospitals in 2020.4 These substantial
cost savings can be used to offset the costs for environmental remediation efforts. . .