WASHINGTON, D. C. – The U.S. Food and Drug Administration has approved the use of hospital equipment sterilization systems produced by Mentor-based STERIS for sanitizing N95 masks that many hospitals are reusing because of supply shortages during the coronavirus pandemic.
FDA Commissioner Stephen M. Hahn said approximately 2,000 U.S. hospitals already use STERIS’ vaporized hydrogen peroxide sterilizers on other equipment, and described his agency’s decision to approve their emergency use on masks as a “game changer.” The FDA estimated the decision will allow decontamination of approximately 750,000 N95 respirators every day throughout the United States.
“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic health care workers on the frontlines have the protection they need,” said a statement from U.S. Department of Health and Human Services Secretary Alex Azar. The FDA’s decision follows the earlier approval of a machine produced by Columbus-based Battelle that can sanitize as many as 80,000 masks each day.
The STERIS V-PRO Decontamination devices – which are usually used on surgical equipment that can’t stand the heat or pressure of a steam sterilizer – pump vaporized hydrogen peroxide into a sterilization chamber to decontaminate exposed surfaces. Each machine can process 10 masks at a time through a process that takes roughly 28 minutes to complete, the FDA says. Each mask can be reused up to 10 times.
“Health care providers are on the front lines of this pandemic and are in desperate need of personal protective equipment,” said a statement from STERIS President and Chief Executive Officer Walt Rosebrough. “We are pleased to be able to offer a partial solution for health care providers during this crisis, and hope that this temporary authorization will provide some relief to them.”
STERIS spokesman Stephen Norton said the company has increased production of the hydrogen peroxide sterilant used in its V-PRO sterilizers to accommodate their use for mask sterilization. He declined to comment on how COVID-19 has affected STERIS’ business, but said the company is having further discussions with the FDA on other ways its technology can “provide solutions and assistance to our customers” during the pandemic.
“Hopefully, we will have more news on that front,” said Norton.