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.
Our priority has always been — and will remain — patient safety. During the pandemic, we realize that our responsibility expands to help our heroic frontline workers be prepared to treat as many patients needing treatment as possible. While AMDR members have NOT historically reprocessed N95 masks or other personal protective equipment (PPE) used in healthcare settings, these are unprecedented times and the supply chain shortage of these products has engineers at several AMDR member companies working with deliberate speed to see if they can disinfect, reprocess and/or re-sterilize any of these items safely.
In exceptional circumstances, to speed the production of alternative products, FDA is given the authority to lower their otherwise high standards and issue what are known as “Emergency Use Authorizations (EUA).” If called on to reprocess these devices under an EUA, AMDR members will do so in accordance with FDA’s authorization and without compromising the integrity and safety that the industry has maintained while adhering to FDA and European medical device manufacturer requirements.
Further, in light of the pandemic, FDA issued new guidance for face masks and respirators as well as guidance governing premarket requirements for ventilators and accessories. AMDR will update our website if or when FDA issues EUA’s for such products from any AMDR member.
During this emergency, the growing number of patients means that the supply chain needs to do what it can to ensure that healthcare providers have access to the devices and supplies they need. AMDR members remain committed to supply FDA/CE regulated, reprocessed devices to maintain supply chain and inventory, while lowering costs for hospitals so they may free up financial resources for emergency preparedness or other areas of immediate concern.
Lastly, AMDR’s has prioritized making reprocessing an integral element of medical device technology design, development and marketing. Today we focus on helping to do what we can to help healthcare providers respond to COVID. But in due time, there will be lessons learned and AMDR will work diligently with the medical device industry, supply chain and healthcare provider networks to build reprocessing considerations into the very early design and development of such products so that we can alleviate future disruptions to the supply chain.
- Check in with your reprocessing partner in the event they begin collections of new device types for COVID response. Access to devices will help expedite their validation of reprocessing and re-sterilization procedures. AMDR will update our webpage if or when we have more information.
- Reprocessing operations continue. Reprocessing personnel are essential in this fight to ensure hospitals have access to clean, disinfected and sterile medical devices.
- As essential suppliers, please make sure your professional reprocessing partner has continued access to collection containers so that we may continue to provide reprocessed products with minimal supply chain disruption in this time of need.
Additional non-AMDR resources:
- AORN COVID-19 FAQs
- AHRMM Recommendations on COVID-19 for Health Care Supply Chain
- Practice Greenhealth COVID-19 Update and Resources
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