FDA Approves Second N95 Mask Decontamination System For Hospitals

The Food and Drug Administration has approved the second system designed for decontaminating used N95 respirators. The technology helps address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus. The new emergency use authorization joins a similar one granted to Ohio company Battelle in late March.

READ: FDA approves Battelle tech for respirators

Unlike surgical masks and similar facial covers, an N95 respirator is able to filter out the majority of very fine particles and droplets that would otherwise be inhaled; in the same way, these masks help prevent the wearer from spreading their own germs, assuming the mask doesn't have a built-in flap for exhaling.

These masks are desperately needed by healthcare workers, particularly those who are dealing with ICU COVID-19 patients. The respirators are worn during 'aerosolizing' procedures, such as putting a patient on a ventilator, because these activities disperse the virus into the air and have the greatest odds of infecting a healthcare worker.

In an announcement on Friday, the FDA said that it has issued its second emergency use authorization (EUA) for a system that can decontaminate N95 masks, as well as equivalent respirators. Under this EUA, the technology will be able to decontaminate around 750,000 respirators daily in the US, joining the previously approved Battelle tech.

The EUA is specifically for the N95 Decontamination Cycle found on the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems from STERIS Corp. The tech uses vaporized hydrogen peroxide at low temperatures to clean the surface of used respirators. According to the FDA, this system can accommodate up to 10 masks at once and takes a bit less than half an hour per cleaning cycle.