Second EUA issued by FDA to decontaminate N95 respirators for reuse
The US Food and Drug Administration (FDA) has granted the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings.
The regulator said that the EUA will support decontamination of nearly 750,000 N95 respirators per day in the country.
The emergency use authorization has been granted by the FDA to Irish medical equipment company STERIS for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide.
According to the FDA, hydrogen peroxide sterilization is a low temperature sterilization process that uses hydrogen peroxide vapor. The vapor fills the sterilization chamber, enters into the device and sterilizes exposed surfaces.
The STERIS V-PRO Decontamination Cycle can process 10 respirators at a time through a process that takes nearly 28 minutes to complete with each respirator processed up to 10 times for single-user reuse.
Second EUA issued by FDA to decontaminate N95 respirators for reuse. Hanabishi/Wikipedia.org.
Stephen M. Hahn – FDA Commissioner said: “This EUA is another game changer. It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals.
“It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic.”
The FDA said that it continues to work 24/7 to help mitigate the coronavirus pandemic as quickly as possible. The regulator intends to continue to help find solutions to ramp up the supply of certain essential medical devices required for health care personnel to safeguard against COVID-19 and to provide the best care to COVID-19 patients.
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