Menu
Menu

Certain N95 mask substitutes can no longer be decontaminated for reuse, says FDA

June 11, 2020 14165

After reviewing tests showing that authorized respirators manufactured in China can “vary in their design and performance,” the FDA chose to remove certain products from its list of respirators that can be decontaminated for reuse during the current public health emergency.

After reviewing tests showing that authorized respirators manufactured in China can “vary in their design and performance,” the U.S. Food and Drug Administration chose to remove certain products from its list of respirators that can be decontaminated for reuse during the current public health emergency.

Over the last two months, the FDA has issued several emergency use authorizations to provide greater flexibility to health care providers during the COVID-19 pandemic. The EUAs are intended to help meet providers’ need for N95s, which are still in short supply, by allowing the use of non-NIOSH-approved respirators used in other countries as well as for the decontamination and reuse of this type of respirator.

The FDA on June 7 announced it has reissued its EUAs for:

  • Non-NIOSH-approved disposable filtering facepiece respirators manufactured in China.  Authorized respirators in Appendix A will no longer be authorized if decontaminated.
  • Multiple decontamination systems. The systems are no longer authorized to decontaminate respirators manufactured in China, where applicable. In addition, decontamination or reuse of respirators that have exhalation valves is no longer authorized.

The FDA reviewed the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health testing to make its determinations. 

CDA updated its resource “Respirator Decontamination Guidance” to reflect the FDA’s revisions.

The Respirator Decontamination Guidance is part of CDA’s suite of back-to-practice resources to help dentists and their staff safely return to practice.

Disclaimer

The information provided on this site is based on the most current information and data available to CDA. The contents of the site will be updated as new information and data emerges. The site provides sample written plans and forms to assist a dental practice in compliance with COVID-19 return to care protocols. It is designed to provide practical information in a summarized manner in regard to the subject matter covered. These guidelines are intended to help dental practices lower (but not eliminate) the risk of COVID-19 transmission during the current pandemic. Dental practices should not presume that following the guidelines will insulate them from liability in the case of infection.

The material provided is for informational purposes only and should not be construed as legal advice under any circumstance and no attorney-client relationship is formed. Neither the California Dental Association (CDA) nor any of its subsidiaries or its attorneys assume liability for the use or interpretation of information contained herein. Neither CDA nor its subsidiaries shall be liable for any loss, injury, claim, liability, or damage of any kind resulting from your use of the information contained in this site.

Reproduction, distribution, republication, and/or retransmission of material contained within this site is prohibited unless prior written permission from CDA is obtained. May 2020.