The FDA sent a warning letter to Battelle Memorial Institute, a company that makes a system to decontaminate face masks, saying it doesn't have adequate procedures for identifying adverse events.
The National Nurses Union has alleged the technology is "not safe and may not work," STAT reported.
Dozens of nurses have had negative reactions to decontaminated masks, including sore throats, headaches and nausea, Judith Pare, director of the nursing and occupational health and safety for the Massachusetts Nurses Association, told the Boston Globe in May.
Masks decontaminated by Battelle have also been returned to healthcare workers with worn-out seals and respirator stains from previous users, Rick Lucas, BSN, RN, a union leader at Ohio State University Wexner Medical Center, said in June.
The FDA's warning letter doesn't mention any cases of potential patient harm from masks decontaminated using its technology, but the letter says the company has lax internal procedures for identifying adverse events, something it warned about when granting the system an emergency use authorization in March. The company's internal procedures don't include instructions on how to conduct an investigation into a potential adverse event, the FDA said.
Battelle's system can sterilize up to 10,000 masks per cycle, with each cycle taking about 150 minutes. Each mask can go through a maximum of 20 cycles. The FDA granted authorization for the system as a way to offset PPE shortages that have plagued hospitals across the country during the COVID-19 pandemic.
President Donald Trump tweeted in March urging the FDA to approve the system.
"Hope the FDA can approve Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can sterilize masks quickly," he tweeted March 29. The FDA granted authorization for the system the same day.
Battelle also received more than $400 million in federal contracts to develop the system.
The Oct. 7 warning letter doesn't carry a fine or sanction against Battelle, but if the company doesn't remedy the issue, the FDA can take more stringent measures, STAT reported.
"We appreciate the clarity that the FDA’s letter has provided, and we will be submitting our response in the coming days to continue to meet their requirements. It is of great importance to us to remain in compliance with the FDA’s emergency use authorization, a Battelle spokesperson told STAT.
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