FDA gives emergency approval to decontaminate, reuse ‘millions’ of scarce N95 masks
Amid widespread shortages of personal protective equipment for healthcare workers, the feds have granted emergency approval for the sterilization and reuse of millions of hard-to-find masks.
The U.S. Food and Drug Administration announced its latest emergency use authorization on April 12. It paves the way for the decontamination of about 4 million N95 or equivalent devices every day, officials said Sunday.
“Our nation’s healthcare 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,” FDA Commissioner Stephen Hahn, MD, said in a statement. “FDA staff continue to work around the clock, across government and with the private sector to find solutions.”
According to the announcement, the authorization applies to Advanced Sterilization Products and its STERRAD Sterilization Cycles products (including (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle). The systems use vaporized hydrogen peroxide gas plasma sterilization, and are already in place at 6,300 hospitals in the U.S., the FDA said.
Cleanup times vary by model, but generally range from 24-55 minutes. Each system can process roughly 480 respirators per day.
The FDA issued a similar emergency use authorization on Friday, April 10, to STERIS Corporation. It applies to the company’s V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems, and would pave the way for reusing 750,000 more masks daily, the FDA said.
One recent survey found that a staggering 89% of physician practice leaders are facing shortages of PPE supplies. Experts from the University of Manitoba recently explored how providers can reuse N95 masks up to 10 times with proper cleaning procedures.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.