Technical Bulletin
July, 2021
Revision 15

Decontamination of 3M Filtering Facepiece Respirators, such as N95
Respirators, in the United States - Considerations
Description
Decontamination is no longer recommended by the U.S. CDC as a crisis strategy. Effective June 30, 2021, the US
FDA revoked the EUAs for respirator decontamination systems.
3M does not recommend decontaminating filtering facepiece respirators (FFRs). FFRs are designed to be discarded at theend of their useful life and decontaminating FFRs may void the regulatory approval.
During this COVID-19 pandemic, certain decontamination methods had been recommended by the U.S. Centers for Disease
Control and Prevention (CDC) and authorized through Emergency Use Authorizations (EUAs) by US Food and Drug
Administration (FDA) as part of a reuse approach to optimize the use of available filtering facepiece respirators (FFRs). During
the public health emergency, many healthcare institutions experienced shortages of FFRs such as N95 respirators. The CDC
Strategies for Optimizing the Supply of N95 Respirators outline recommended conventional capacity strategies, contingency
capacity strategies (during expected shortages) and crisis strategies (during known shortages). These strategies are meant tobe considered and implemented sequentially. Since certain decontamination methods had been allowed by government
agencies during crisis capacity, 3M collaborated with several equipment manufacturers and institutions to investigate ways
for hospitals to decontaminate 3M’s FFRs in line with the CDC guidance on decontamination and reuse of filtering facepiece
respirators. In these studies, 3M relied upon the method developer to confirm the germicidal efficacy of the decontamination
method and to provide information on potential hazards to the respirator user. 3M only evaluated the effect of the method on
filtration efficiency and integrity of our respiratory protection products. Damage to the FFR from a decontamination method
may result in the FFR not providing respiratory protection at the indicated level, such as N95. These results werecommunicated to help customers who chose to implement decontamination to do so in such a way that was less likely todamage FFRs.
As of April 2021 the US CDC has removed decontamination or bioburden reduction as a recommended crisis
strategy stating, “Decontamination or bioburden reduction of NIOSH-approved N95 respirators is no longer a strategy toconserve supplies as the availability to NIOSH-approved respirators has significantly increased.” CDC recommends that
healthcare facilities promptly resume conventional practices.
The FDA also recommends US healthcare facilities transition away from decontamination or bioburden reduction. Effective
June 30, 2021, the FDA revoked the EUAs for these systems. According to an FDA letter to US Health Care Personneland Facilities “As of the effective date of the revocations, these devices will no longer be authorized for use by health carepersonnel in health care settings….Based on the increased domestic supply of respirators approved by the Centers for Disease
Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), and consistent with CDC's
updated recommendations and in alignment with the Occupational Safety and Health Administration's (OSHA) recently
published Emergency Temporary Standard (ETS) to protect health care workers, the FDA believes health care facilities should
not use crisis capacity strategies any longer.”
For additional information, consult the resources and reference below.

3M Personal Safety DivisionResources and References•••••

FDA: FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems
as Access to N95s Increases Nationwide | FDA
FDA: Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators Letter to Health Care Personnel and Facilities | FDA
CDC: Strategies for Optimizing the Supply of N95 Respirators: COVID-19 | CDC
OSHA: https://www.osha.gov/coronavirus/ets
3M: https://multimedia.3m.com/mws/media/1803705O/possible-alternatives-to-surgical-filtering-facepiece-respirators-healthcare.pdf

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