Authorization could allow for decontamination of 4 million respirators per day

WASHINGTON — As health care workers across the U.S. struggle against the Covid-19 pandemic, the FDA issued an emergency use authorization allowing use of a sterilization device to reprocess and reuse N95 respirators.

The device — the STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle) — “has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings,” the agency wrote.

On March 24 and April 3, the FDA issued emergency use authorizations allowing for the importation of non-NIOSH-approved N95 respirators from Australia, Brazil, Europe, Japan, Korea, Mexico, and China in an attempt to mitigate supply chain shortages of respirators for health care personnel on the front lines of the Covid-19 crisis. With this latest authorization, health care workers might be able to get more mileage out of this vital piece of PPE.

“Our nation’s health care workers are among the many heroes of this pandemic and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators…This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with Covid-19,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.

These sterilization devices, which are designed to disinfect both metal and non-metal medical devices, use vaporized hydrogen peroxide gas plasma to sterilize various medical instruments. And, with approximately 9,930 of these devices spread across approximately 6,300 U.S. hospitals, the FDA explained, each one should be able to reprocess approximately 480 respirators per day.

STERRAD Sterilization Cycles are manufactured by Advanced Sterilization Products.

John McKenna, Production Editor, BreakingMED™

Cat ID: 125

Topic ID: 79,125,730,933,125,190,520,926,192,927,151,928