FDA revokes authorization for decontaminating and reusing Chinese-made N95 respirator masks

The FDA has revised its previous emergency authorizations for reprocessing N95 respirators, saying certain masks imported from China may not be able to withstand the decontamination process. 

The agency said it received new information on the effective reuse of different models from researchers under the Centers of Disease Control and Prevention (CDC).

More broadly, the FDA is no longer allowing the decontamination of any respirators featuring exhalation valves, and decontamination systems are only authorized by the agency to reprocess non-cellulose compatible N95 masks.

The move comes one month after the FDA revoked emergency authorizations granted to more than 50 China-based manufacturers of face masks that had not been tested and approved by the CDC’s National Institute for Occupational Safety and Health, or NIOSH. The personal protective equipment had been imported to help meet severe shortages, but the policy was reversed in early May after certain masks were found to be less than effective. 

It also comes just days after federal prosecutors charged one Chinese company with selling nearly 500,000 inferior masks to U.S. healthcare workers, falsely labeled as NIOSH-approved N95 respirators, according to a report from The Wall Street Journal.

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Certain non-NIOSH-approved respirators made in China are still authorized for one-time or disposable use, the FDA said. The CDC recommends that any decontaminated respirator only be used when new, approved masks are unavailable and that masks with a poor fit or visible damage should not be used. 

“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, the FDA’s deputy commissioner for medical and scientific affairs, in an agency statement. “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.”

Currently, the FDA’s list of N95 respirators authorized for decontamination and reuse include four models manufactured by 3M—when made in Japan, South Korea, Singapore, Turkey or the U.K.—as well as Dromex’s mask model manufactured in South Africa.