On June 7, 2020, the FDA issued a news release on the decontamination and reuse of N95 respirators. The agency has reissued certain emergency use authorizations based on the performance and design to withstand the decontamination process. As a reminder, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available. Staff who use a respirator (whether or not decontaminated) should always perform a user seal check when donning an N95 and not use them if it is a poor fit, has visible soiling, or damage.
If your center is decontaminating N95 respirators, please check the link below to ensure your product still meets FDA approval. It is highly recommended that when supplies of any PPE are unavailable and you resort to “substitute” products that documentation be maintained. This documentation should include:
- all communications/efforts to obtain PPE products
- daily status of PPE equipment
- the use of FDA approved, “off label” use of substitute products
- all updates to the FDA recommendations with dates of posting
This information should be maintained with the QAPI documents and be added to the meeting agenda for monthly and ad hoc meetings. Thanks, be safe, stay well and stay tuned!
Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse; June 7, 2020; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising-which-types