The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak.
The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen peroxide granted an EUA to reprocess N95 respirators or their equivalents for healthcare workers exposed to SARS-CoV-2 (the virus that causes COVID-19).
Showing that decontamination can work matters because authorities are increasingly turning to it to boost the supply of N95 masks amid the pandemic. The U.S. Department of Defense inked a $415 million contract in March 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 an EUA authorization from the FDA last week to use its own vaporized hydrogen peroxide system for N95 mask decontamination. The agency granted a similar EUA this week to Advanced Sterilization Products.
Normally, N95 respirators are designed for single-use, but the authors of a study released yesterday by the National Institutes of Health (NIH) determined that N95 respirators can be decontaminated effectively using any of four decontamination methods and maintain functional integrity for up to three uses. The study’s authors concluded that vaporized hydrogen peroxide was the most effective decontamination method for allowing more uses, with no virus detected after a 10-minute treatment.
The Stryker EUA allows up to two decontamination cycles per respirator, according to the FDA.
The authorization could be a boon to Stryker, whose main business is in orthopedic devices. Orthopedic surgeries have declined sharply since the coronavirus pandemic struck the United States because federal officials recommended that elective surgeries such as knee and hip replacements be postponed to free up hospital beds and personal protective equipment needed by healthcare workers caring for COVID-19 patients.
Stryker did not immediately respond to a request for comment on the emergency authorization.
