The FDA has granted Sterilucent emergency use authorization (EUA) for its hydrogen peroxide sterilizer for use with N95 and N95-equivalent respirators — the latest in a string of mask sterilizers receiving EUAs amid the coronavirus pandemic.
Minneapolis-based Sterilucent’s HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that are in high demand among health providers treating people with COVID-19. 3M (NYSE:MMM) develops the N95 masks, while Owens & Minor (NYSE:OMI) and Honeywell (NYSE:HON) are also producing the respirators on U.S. Defense Dept. contracts.
3M has a technical bulletin that offers guidelines for decontaminating N95 respirators, including systems acceptable for mask reprocessing, and it includes the Sterilucent HC 80TT sterilizer, according to a news release.
Test results showed that filtering facepiece respirators may be reprocessed up to 10 times in the HC 80TT flexible cycle without a detrimental impact on performance or a reduction in respirator fit. The system is capable of reprocessing up to 12 respirators at one time.
In the release, Sterilucent COO Stephen Loes said the HC 80TT system uses the company’s Cycle Guardian technology to adjust the delivery of the sterilant based on the load in the chamber. Because the N95 load is light, the system delivers less chemistry, resulting in less degradation and lowering the cost per cycle, Loes said.
“We are glad to be able to help extend the safe use of PPE for healthcare staff during this time of overburdened supply chains,” Loes said. “The HC 80TT sterilizer can provide timely internal turnaround of PPE that helps extend a facility’s inventory and better manage supply disruption or unavailability.”
Last month, the DoD awarded a $415 million contract to provide 60 Battelle Critical Care Decontamination Systems that use vaporized hydrogen peroxide (VHP) to decontaminate as many as 80,000 N95 respirator masks each day for reuse.
Steris (NYSE:STE) gained EUA from the FDA earlier this month to use its own vaporized hydrogen peroxide system for N95 mask decontamination, as did Advanced Sterilization Products. Stryker (NYSE:SYK) also received EUA for decontaminating N95 masks with its Sterizone VP4 sterilizer, another hydrogen peroxide sterilizer.
Fresenius (NYSE:FMS) Helios announced today that it developed a process for sterilizing protective masks for reuse, employing the process for FFP2 and FFP3-type masks. In a news release, the company said Helios Germany’s hospitals can purify 8,000 masks daily, starting immediately. Fresenius opted not to commercialize the process and is offering information online, free of charge.
