In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the U.S. FDA is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by healthcare personnel.
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 the decontamination of these respirators and has accordingly revised the relevant EUAs. In addition, the FDA is also revising relevant EUAs to no longer authorize decontamination or reuse of respirators 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,” says Anand Shah, MD, 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 healthcare 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:
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
- Multiple decontamination systems so that they 1) are no longer authorized to decontaminate respirators manufactured in China, where applicable, and 2) only authorize decontamination of non-cellulose respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to be decontaminated.
According to the CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, 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. Respirators with poor fit, visible soiling, or damage should not be used.
Moreover, the FDA continues to take prompt 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 respirators 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.