FDA warns Battelle about mask sterilization system

” Hope the FDA can approve Mask Sterilization devices ASAP. Based On Governor @MikeDeWine, there is a business in Ohio, @Battelle, which has equipment that can decontaminate masks quickly,” he tweeted March 29. The FDA granted permission for the system the exact same day..

Battelle also received more than $400 million in federal contracts to establish the system.
The Oct. 7 warning letter doesnt bring a fine or sanction versus Battelle, but if the business does not treat the issue, the FDA can take more stringent procedures, STAT reported..

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Maia Anderson –
Thursday, October 8th, 2020

The FDAs warning letter doesnt mention any cases of possible client damage from masks decontaminated utilizing its innovation, however the letter states the company has lax internal procedures for identifying unfavorable occasions, something it alerted about when granting the system an emergency usage authorization in March. The companys internal procedures do not include directions on how to carry out an investigation into a potential negative event, the FDA said..

President Donald Trump tweeted in March advising the FDA to authorize the system..

” We value the clearness that the FDAs letter has actually provided, and we will be sending our action in the coming days to continue to meet their requirements. It is of fantastic significance to us to stay in compliance with the FDAs emergency situation usage authorization, a Battelle representative informed STAT..
Read the full article here.

Lots of nurses have had unfavorable reactions to decontaminated masks, including aching throats, headaches and nausea, Judith Pare, director of the nursing and occupational health and safety for the Massachusetts Nurses Association, informed the Boston Globe in May..

Masks decontaminated by Battelle have also been gone back to healthcare employees with worn-out seals and respirator spots from previous users, Rick Lucas, BSN, RN, a union leader at Ohio State University Wexner Medical Center, said in June..

Battelles system can decontaminate up to 10,000 masks per cycle, with each cycle taking about 150 minutes. Each mask can go through an optimum of 20 cycles.” Hope the FDA can authorize Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can disinfect masks quickly,” he tweeted March 29.

The National Nurses Union has actually declared the technology is “not safe and might not work,” STAT reported..

The FDA sent out a caution letter to Battelle Memorial Institute, a business that makes a system to decontaminate face masks, saying it doesnt have appropriate procedures for determining unfavorable events..

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Battelles system can sterilize up to 10,000 masks per cycle, with each cycle taking about 150 minutes. Each mask can go through an optimum of 20 cycles. The FDA approved permission for the system as a way to balance out PPE shortages that have plagued medical facilities across the nation during the COVID-19 pandemic..