FDA Revises Rules Regarding Decontamination, Reuse Of Respirators

Based on an increased understanding of the performance and design of certain respirators, the FDA has decided that they should not be decontaminated for reuse by healthcare personnel.

In response to public health and safety concerns about the appropriateness of decontaminating certain respirators during the current COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) is reissuing certain emergency use authorizations (EUAs) to specify which ones are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the agency has decided that certain types should not be decontaminated for reuse by healthcare personnel.

respirators decontamination
(Credit: Getty Images/MJ_Prototype)

For example, the FDA has learned from the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. As such, the FDA has determined that the available information does not support their decontamination and has accordingly revised the relevant EUAs. In addition, the FDA is also revising relevant EUAs to no longer authorize decontamination or reuse of models that have exhalation valves.

“During this unprecedented global pandemic, the FDA continues to provide flexibility and adapt to the evolving needs of Americans based on data and science. We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected. As part of those efforts, we are announcing that we have revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated.”

Among other things, the FDA has reissued the EUAs for:

According to CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95, NIOSH-approved N95, or other FDA authorized respirators are not available. The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators. As such, healthcare personnel should not reuse a respirator that is incompatible with an authorized decontamination system but has nonetheless been decontaminated. Users of any respirator (whether or not decontaminated) should always assess for proper fit after placement. Those with poor fit, visible soiling, or damage should not be used.

The FDA continues to take action on imported, non-NIOSH-approved respirators to ensure healthcare personnel receive adequate protection. For instance, the FDA is also reissuing the two EUAs covering imported models by tightening criteria in the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China as well as in the Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to not only include new language related to decontamination as noted above, but also to revise the Scope of Authorization with respect to which jurisdictions are included in the criteria for eligibility in both EUAs, among other revisions.

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