The US FDA has issued an emergency use authorization (EUA) for Battelle’s Critical Care Decontamination System, which is designed to clean personal protective equipment for reuse.

The system can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance, according to Battelle. Using concentrated, vapor phase hydrogen peroxide, respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2, the company said.

The is constructed from four, 20-foot Conex boxes (similar to industrial shipping containers) with the VPHP being pumped through each box. The first system has been built in West Jefferson, Ohio and it is capable of decontaminating up to 80,000 respirator masks per system each day, Battelle says.

The FDA had issued an initial EUA for up to 10,000 masks per run but, after pressure from Ohio Governor Mike DeWine, it revised the EUA to allow the full capacity of 80,000 masks, USA Today reported.

“This will not only help Ohio’s healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping healthcare workers in hot spots throughout the country including New York and Washington state,” said Ohio Governor Mike DeWine, who helped secure the FDA EUA, according to Battelle.

Battelle is currently processing N95 respirator masks for OhioHealth and will begin processing respirator masks for three other major systems starting this week. According to media reports, the system is being installed at Partners Healthcare in Boston and in New York at Stony Brook University Hospital on Long Island.

The system involves four steps:

  • Collection
    • PPE is collected and labeled, double-bagged and boxed, and shipped via commercial carrier to Battelle location
  • Receipt
    • PPE is logged and inventoried, then prepped for decontamination
  • Processing
    • PPE is decontaminated and quality checked, then packaged.
    • Each respirator mask will be marked with the number of times that mask has been processed.
  • Return
    • PPE is returned via commercial carrier

“We are very encouraged by these new developments and are proud to support Battelle in this important work,” said Chris Clinton, vice president of Shared Services at OhioHealth. “It will have a significant impact on helping caregivers have the supplies they need to remain safe and to deliver critical care when it is needed most.”

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