COVID-19 Updates
For over 20 years, AMDR-member reprocessors have played an essential role in providing hospitals with FDA-regulated or CE marked, clean, disinfected and sterile medical devices. As the world wrestles to address COVID-19, we are receiving an unprecedented volume of inquiries from healthcare systems, Ministries of Health, regulatory agencies, and other device manufacturers regarding our members’ reprocessing capabilities for medical products in urgent demand…
AMDR-member Sustainable Technologies™, a Cardinal Health business, is collaborating with Battelle to provide an end-to-end solution for collecting, decontaminating and returning N95 respirator masks…
As hospitals begin to reopen to elective procedures, the Association of Medical Device Reprocessors (AMDR) is pleased that all its members are fully operational. Single-use device (SUD) reprocessing programs are more important than ever and reprocessors are working expeditiously with our thousands of hospital and surgical center partners to ensure smooth continued collections of devices. The financial impact associated with COVID, including lost hospital revenue due to the elective procedure freeze, has left hospitals financially devastated. Now more than ever before, reprocessing programs, including collections and preparation for shipment back to reprocessing facilities, must continue and be prioritized to help hospitals save money…
The FDA has issued an Emergency Use Authorization (EUA) for Stryker Sustainability Solutions’ decontamination system for N95 respirators, allowing its use by healthcare staff. The self-contained system, which has not been granted clearance for any uses in the past, can now be used by healthcare workers to decontaminate compatible N95 respirators for reuse by multiple users. The Stryker system, which uses vaporized hydrogen peroxide, is not authorized for use with N95 respirators containing cellulose-based materials, the agency said.
March 2020
RAPS: FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment
Allison Weeda2020-04-30T12:59:47-04:00March 24th, 2020|
In light of the need to act quickly and efficiently [...]