Once FDA-Approved Masks and Decontamination Processes Now Unapproved

Infection preventionists and other health care professionals will probably never forget the mad scramble for N95 respirators and surgical masks at the outset of the COVID-19 pandemic. At one point in March 2020, many hospitals reported having only 10-days-worth of masks on hand, and entrepreneurial companies found ways to decontaminate masks for many uses, something that some health care professionals viewed warily. The Centers for Disease Control and Prevention (CDC) issued warnings about masks that could do more harm than good.

The Food and Drug Administration (FDA) approved the reuse of masks and processes for decontaminating them under its emergency use authorization (EUA). The agency also approved the use of masks that were not stamped with the seal of approval from the National Institute for Occupational Safety and Health (NIOSH).

The FDA has decided to revoke EUAs for all non-NIOSH approved masks.

Suzanne Schwartz, MD, MBA, director of the office of strategic partnerships and technology innovation in the FDA’s Center for Devices and Radiological Health, said in a press release yesterday that the agency is “revoking EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.”

There are more than enough respirators on hand that meet NIOSH recommendations, and domestic manufacturing of those masks have ramped up considerably.

“Today, the FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country,” Schwartz said in the press release. “As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.”

About 875 respirator models manufactured by about 20 new U.S.-based companies that have been OK’s by NIOSH. Altogether, there are more than 6400 NOISH-approved respirators models on the NIOSH list which have the FDA’s EUA guidelines.

“Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators,” Schwartz said in the press release. “Today, those conditions no longer exist. Our national supply of NIOSH-approved N95s is more accessible to our health care workers every day.”