The FDA has granted Steris (NYSE:STE) emergency use authorization (EUA) for a vaporized hydrogen peroxide system to decontaminate up to 750,000 N95 respirators and equivalent masks per day in hospitals treating COVID-19 patients.
The Steris V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems use a non-lumen decontamination cycle. Hydrogen peroxide vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The Steris V-PRO can process 10 respirators at one time in a 28-minutes cycle, and each respirator can be processed up to 10 times for single-user reuse, according to the FDA.
FDA commissioner Stephen Hahn called this EUA a “game-changer.”
“It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals,” Hahn said in a news release. “It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic.”
“Healthcare providers are on the front lines of this pandemic and are in desperate need of personal protective equipment,” said Steris president & CEO Walt Rosebrough in a company statement. “We are pleased to be able to offer a partial solution for healthcare providers during this crisis, and hope that this temporary authorization will provide some relief to them. This would not have been possible without around the clock work from Steris’s technical people and testing support from 3M, and we deeply appreciate their involvement. In addition, we appreciate the diligence, responsiveness and suggestions from the FDA reviewers. We are working on additional potential solutions and look forward to continuing to work with the agency.”
Medtech trade group AdvaMed also praised Steris and 3M.
“I agree with Commissioner Hahn: The ability to quickly decontaminate protective masks — and starting today, starting now, for every health care facility with these systems on site — truly is a game changer for our heroes on the front lines treating patients with COVID-19,” said AdvaMed president and CEO Scott Whitaker in a . Steris’ fast, innovative work, in partnership with 3M, is yet another example of the medical technology community mobilizing to save lives. We appreciate the FDA’s quick work to authorize this leap forward in our fight against the coronavirus.”
Separately, 3M said it is collaborating with several sterilization companies and institutions that are investigating ways for hospitals to safely decontaminate 3M’s N95 respirators in line with U.S. Centers for Disease Control guidance. In addition to vaporized hydrogen peroxide, the company is looking into ultraviolet and low-temperature moist heat methods, amongst others.
This is the second EUA the FDA has granted for a vaporized hydrogen peroxide system to decontaminate the type of respirators healthcare workers are wearing to protect themselves from the COVID-19 virus. The agency authorized use of the Battelle Critical Care decontamination system in March to reprocess tens of thousands of respirator masks per day so that health personnel can reuse them.
There have been widespread reports of shortages and hoarding of these masks, leading providers to wear the same mask all day or do without, drastically increasing their risk of contracting the disease.
“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said Alex Azar, secretary of the U.S. Department of Health and Human Services. “Thanks to rapid work by the men and women of the FDA and President Trump’s vision for an all-of-America response, innovators are giving our healthcare warriors new tools nearly every day to fight the COVID-19 pandemic.”
Dublin, Ireland-based Steris added a COVID-19 page to its website to provide information about the use of these systems to decontaminate respirators. Although the company no longer sells the V-PRO 1 system, it is still present in hospitals, according to company spokesman Stephen Norton.
“1 Plus was replaced by the V-PRO MaX2, but 1 is still in use,” Norton said in an email to Medical Design & Outsourcing. “Hospitals have processes in place to run this cycle on their V-PRO units and personnel are familiar with how to use it.”
Steris declined to say how many V-PRO units are in use in the U.S.