FDA revises rules for decontaminating & reusing certain face masks made in China

BOSTON — The Food and Drug Administration on Sunday revised the rules for decontaminating masks, saying certain masks made in China should not be reused.

Testing conducted by the Centers for Disease Control and Prevention found authorized respirators manufactured in China "may vary in their design and performance" and "should not be decontaminated for reuse by health care personnel."

“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, FDA Deputy Commissioner for Medical and Scientific Affairs, said in a statement. “As part of those efforts, we are announcing that we have revised and reissued a number of [emergency use authorizations] to amend which respirators are authorized to be decontaminated.”

The FDA initially granted Battelle’s system for decontaminating masks and emergency authorization at the end of March to help address a global shortage of personal protective equipment, especially N95 masks. The FDA’s announcement included several changes in emergency authorizations concerned with mask safety.

Donna Kelly-Williams, president of the Massachusetts Nurses Association, said she wasn’t surprised to see the FDA’s announcement as she first sounded the alarm in early April.

“What we said right from very beginning was this had an emergency approval as an experiment,” Williams said. “There was no proof this would kill the coronavirus or this was the safest means possible.”

Battelle’s decontamination system uses a mixture of hydrogen peroxide and alcohol.

Nurses across Massachusetts told us the chemically treated masks were making them sick.

>>RELATED: Mass. nurses saying no to decontaminated masks

“Nurses are afraid of what chemicals are being put on those masks and what they’re breathing in," Sam Fabian, a nurse at Cooley Dickinson Hospital, told 25 Investigates during an interview in May.

Another nurse, who didn’t want to be identified, said the first time she put on a decontaminated mask she felt dizzy and thought she was going to pass out.

Judith Pare, the MNA’s director of nursing education, said she also wasn’t surprised at the FDA’s announcement, adding no research exists to prove any decontamination process actually works.

“There is no reward in ‘I told you so’ when it comes to the heath and safety of not only our nurses but the public at large, but what we were asking for was evidence based information to support this practice was safe and effective and clearly the reversal of the FDA calls into question both those areas,” said Pare.

Soon after getting FDA approval, Battelle teamed up with Partners HealthCare to bring a decontamination unit to Somerville with the promise of being able to decontaminate 80,000 masks a day.

25 Investigates on Monday asked Battelle about the FDA’s revised rules. The company said, “The FDA guidance was for cellulose-based N95s and N95s with respirator valves, etc. Our system only does the standard non-cellulose N95s. So this does not impact our operations.”

“Our concerns are not wavered by their statement,” said Kelly-Williams. “I stand firm that the best and highest quality of PPE, personal protective equipment, includes a new disposal N-95 masks.”

The MNA is reminding nurses they have the right to refuse to wear decontaminated masks.

“I hope that going forward, when the nurses are the canaries in the coal mine and telling you something isn’t going right, please listen to the nurses,” Kelly-Williams said. “If we’re sounding the alarm, listen.”

In April, the federal government awarded Battelle a $400 million contract to sterilize N95 masks for reuse. In light of the FDA’s revised rules, the MNA is calling for the money to be redirected to support the production of new N95 masks in the United States.

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