FDA Revises Which Types of Respirators Can Be Decontaminated for Reuse Under COVID-19 EUAs

The US Food and Drug Administration (FDA) has issued a sizable number of emergency use authorizations since the advent of the coronavirus disease 2019 (COVID-19) epidemic in the United States. These “EUAs” have concerned diagnostics, treatments such as remdesivir, and respirators.

Due to health and safety concerns, the FDA has released a statement indicating that it is reissuing some EUAs to clarify which respirators are suited for decontamination and reuse.

“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 health care 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,” FDA said in the statement.

The FDA is also revising EUAs to discourage reuse of respirators that possess exhalation valves.

“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,” said Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs.

Among other EUAs, the FDA has reissued:

• 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.

Decontaminated respirators should now only be used when FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available.