FDA COVID-19 Ruling: Not All N95 Respirators Eligible for Decontamination and Reuse

June 9, 2020

Decontaminated respirators should only be resorted to when unused devices are not available, but that happened a lot in the last few months.

This perhaps might make infection preventionists and other healthcare professionals breathe a little easier; federal health officials placed further restrictions on exactly which N95 respirators can be decontaminated and reused. Decontamination works for some of the devices, but not all, says the US Food and Drug Administration (FDA) in an emergency use authorization (EUA). 

The EUA represents one more attempt to better regulated the use and decontamination of the devices. A host of issues raised about respirators go beyond the much-reported on and decried shortage of the devices during the COVID-19 pandemic. For instance, the US Centers for Disease Control and Prevention (CDC) at one point had to issue a warning that many respirators being sold to healthcare facilities and directly to the public do not meet the guidelines set out by the CDC’s National Institute for Occupational Safety and Health (NIOSH). In addition, there has been legal action taken by some companies against suppliers claiming to be selling their NIOSH-approved respirators, when actually they weren’t.

“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,” Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs said in the EUA. “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.”

The EUA, “Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse,” states that NIOSH  testing proves “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.”

The decontamination of respirators is an issue that cropped up as a result of the shortage of N95s that the surge in COVID-19 patients so starkly highlighted. Decontaminated respirators should only be resorted to when unused devices are not available, but that happened a lot in the last few months. And such decontamination should only apply to FDA-cleared N95s, and NIOSH-approved N95s.

“The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators,” the EUA states. “As such, health care 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.”

The FDA also revised EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, saying that “authorized respirators that are decontaminated are no longer authorized under this EUA.” In addition, the EUA for multiple decontamination systems was reissued, saying that some respirators manufactured in China should not be decontaminated and that “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.”