Second EUA For Mask Decontamination Tech Goes To Steris
The US FDA has issued an emergency use authorization permitting the Steris V-PRO to be used to decontaminate masks used by medical professionals during the COVID-19 pandemic. The technology could get as many as 750,000 more clean N95 masks to medical personnel each day, the agency says.
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Research suggests N95 respirators used by medical staff can be safely decontaminated at least two to three times, with hydrogen peroxide vapor the most effective decontamination method.
While US regulators have ramped up the number of authorizations they’ve granted to companies on an emergency basis in response to the COVID-19 crisis, they really kicked things into high gear in just the past few days. On 10 April the agency issued a record number of EUAs in response to the pandemic.
The US FDA will allow pharmacy compounders to use non-sterile masks and gloves in cleanrooms, but risk strategies must be in place to ensure products are as contaminant-free as possible. Discretion responds to the current shortage of protective gear due to the COVID-19 pandemic.