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Regulatory Focus™ > News Articles > 2020 > 4 > FDA issues 2nd EUA for decontamination system for N95 masks

FDA issues 2nd EUA for decontamination system for N95 masks

Posted 10 April 2020 | By Zachary Brennan 

FDA issues 2nd EUA for decontamination system for N95 masks

The US Food and Drug Administration on Friday issued a second emergency use authorization (EUA) to help decontaminate N95 or N95-equivalent respirator masks so they can be reused by health care workers in hospitals.

FDA said this EUA, issued to Steris Corporation for a system that uses vaporized hydrogen peroxide, will support the decontamination of about 750,000 N95 respirators per day in the US. The EUA comes as shortages of the masks have pushed some hospitals to turn to construction masks or handmade masks that could put staff at risk.

FDA commissioner Stephen Hahn said this EUA “will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals.”

The system works by allowing the hydrogen peroxide vapor to fill the sterilization chamber, penetrate the device and sterilize exposed surfaces, FDA said. The company’s system is capable of processing 10 respirators at one time through a process that takes about 28 minutes, and each respirator can be processed up to 10 times for single-user reuse.

The other EUA for such a system was issued to Battelle’s CCDS Critical Care Decontamination System in late March.

The EUA initially limited the number of respirators that could be decontaminated using the system to 10,000 per day, despite Battelle’s insistence that the system could decontaminate 80,000 respirators per day.
Following backlash from Ohio Gov. Mike DeWine (R) and a request from Battelle to lift the restrictions, FDA reissued the EUA without a cap on how many respirators the system can process per day. The EUA retains a limit of 20 decontamination cycles per respirator.


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