[Washington/Berlin June 7, 2022] When health systems and hospitals use regulated
reprocessed “single-use” devices, they reduce procedure costs without compromising
patient safety, build supply chain resilience and help governments and hospitals get to
net zero carbon emissions faster. Given the dual threats of disruptive pandemics and
climate change, regulators worldwide must act now to usher in responsible, regulated
medical device reuse regulation. But regulations and standards for the practice are
difficult to find and have never been available in one place.The Association of Medical Device Reprocessors is pleased to share “Global
Regulatory Standards for ‘Single-Use’ Medical Device Reprocessing and
Remanufacturing,” the first roadmap to help Notified Bodies, Ministries of Health,
and regulatory authorities of medical devices to unlock these benefits for hospitals and
health systems worldwide. The report includes all known regulations, standards, and
guidances that govern the practice of reprocessing (known as remanufacturing in
Europe), worldwide.Reprocessing single-use medical devices saves hundreds of millions of dollars a year.
But savings could go into the billions. According to a report issued by AMDR last week,
hospitals in the U.S., which has the most robust reprocessing programs in the world,
could reprocess an additional $2.28 billion, if those with existing programs reprocessed
as much as the highest 10% performing hospitals.The report is available through a simple registration process here. . .
