FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

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Analyst: Re-use of N95 Respirators Reduces Risks

Ten nurses from the Providence Saint John’s Health Center in California were reportedly placed on administrative leave for refusing to treat COVID-19 patients without access to N95 respirators. At the time they were suspended, it is claimed that these nurses were instructed to wear surgical masks, despite the fact that these devices are not capable of filtering out viral particles in the air and that many of their colleagues on other wards were provided with adequate access to N95 respirators. Reports indicate that the Providence Saint John’s Health Center hospital has since revised its N95 policy due to the fact that it has managed to obtain more N95 respirators and is now able to sanitize and reuse these N95 masks.

Sales of N95 respirators in U.S. health care facilities are estimated to have grown by more than 50% between January and February 2020 and demand continues to outstrip supply in this medical device market, according to GlobalData, a leading data and analytics company.

Alison Casey, medical devices analyst at GlobalData, comments: “Due to the unprecedented demand for this form of personal protective equipment (PPE), occurring in response to COVID-19, it is unlikely that the ability to decontaminate N95 respirators will negatively impact sales of N95 respirators.”

“However, the ability to re-use these devices will ease the current burden on manufacturers of N95 respirators and improve accessibility of first responders and medical staff to PPE, thus reducing the risks being taken by those on the front lines battling this disease,” she adds.

On April 12, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) that has the potential to decontaminate up to four million N95 respirators per day. Specifically, the FDA issued EUA to STERRAD sterilization cycles for their use in decontamination compatible N95 respirators via hydrogen peroxide gas plasma sterilization. STERRAD Sterilization systems are present in the majority of U.S. hospitals, with just under 10,000 installed across the US.



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