FDA clears N95 decontamination process that could clean up to 4 million masks per day
The U.S. Food and Drug Administration (FDA) has provided an emergency use authorization (EUA) for a decontamination process provided by company Advanced Sterilization Products (ASP) that could see as many as 4 million N95 respirators per day sterilized for re-use. That’s a significant potential dent in the ongoing shortage of supplies faced by medical professionals and frontline workers at healthcare facilities.
This decontamination process would open up re-use of N95 masks originally designed for single use, and it uses vaporized hydrogen peroxide gas to clean the respirators. ASP’s STERRAD series sterilization machines, which are covered under the EUA, are in use in around 6,300 hospitals already (they’re commonly used for sterilizing other pieces of clinical equipment, but have not previously been intended for use with N95 masks) and there are around 9,930 in operation across the U.S., each with the capability of processing around 480 masks per day.
The FDA has perviously cleared another similar system for N95 decontamination: Battelle’s vaporized hydrogen peroxide process. This new clearance greatly expands the reach and potential volume of decontamination that’s possible, and should pave the way for others to follow.
Duke University was early in calling for this process to be used on N95 respirators, after demonstrating that it is safe and effective and available on a range of equipment already in use in biocontainment labs and other medical facilities.
So far, all of these clearances are EUAs, but this does seem like an area where the measures could become more permanent following the pandemic, in order to better prepare health care systems in case of other emergencies. Technologies for emergency re-use of single use equipment, and other ways to extend the viable life of crucial medical gear, seems like a wise area of further investment and study.