FDA Grants Clearance for N95 Respirator Decontamination That Could Clean 4 Million Daily

The FDA gave clearance for a sanitizing process that could clean up to 4 million single-use N95 respirators every day.
Brad Bergan
Image formatted to fit. Liliboas / iStock

The Food and Drug Administration (FDA) of the U.S. has granted emergency use authorization (EUA) for the decontamination process given by a company called Advanced Sterilization Products (ASP), which might see up to 4 million N95 respirators sterilized for reuse every day, according to an FDA News Release.


FDA clears new method of N95 respirator decontamination

With a possible 4 million N95 respirators sterilized for reuse every day, the FDA's emergency authorization could make a significant dent in the growing shortage of medical supplies that medical professionals and frontline healthcare workers face across the country, according to Tech Crunch.

The decontamination process might make it possible for N95 masks designed only for single use to be reused with the help of vaporized hydrogen peroxide gas, a sterilizing agent. ASP's STERRAD series sterilization machines — covered for use under the EUA guidelines — are already being used at roughly 6,300 hospitals (although their common use is for sterilizing clinical equipment and have not yet been used for N95 masks), and there are roughly 9,930 in operation across the country, with each sterilization machine capable of cleaning roughly 480 masks per day.

Earlier, the FDA gave permission for another, similar system for N95 contamination, called Battelle's vaporized hydrogen peroxide process. But the new authorization seriously expands the potential volume and reach of decontamination, and will likely make other steps possible.

FDA strengthens hand against coronavirus outbreak

One of the first to call for this process to be used on N95 respirators was Duke University, which demonstrated that the process is effective and safe and applicable for a wide scope of equipment already being used in biocontainment labs and additional medical facilities.

As of writing, all of the clearances to-date are EUAs, however, this clearance is among a group that could become more permanent after the COVID-19 outbreak is stopped. This would make health care systems more prepared for future emergencies. Technologies designed for emergency reuse of single-use equipment, in addition to other means of extending the life and effectivity of critical medical equipment, is an area ripe for further study and widespread investment.

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