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The U.S. Food and Drug Administration (FDA) on Sunday authorized the sterilization of used N95 masks by an Ohio-based non-profit company in an attempt to tackle the severe shortage of personal protective equipment amid the COVID-19 pandemic.
"The Battelle Decontamination System has been authorized for emergency use to decontaminate compatible N95 or N95-equivalent respirators for reuse by healthcare personnel during the COVID-19 pandemic to prevent wearer exposure to pathogenic airborne particulates," an FDA fact sheet said.
The company said their system uses concentrated "vapor phase hydrogen peroxide" to sanitize the biological contaminants kept on used masks, a process which can be conducted multiple times without degrading N95 respirator performance.
Screenshot from Battelle
According to U.S. Centers for Disease Control Prevention (CDC), an N95 mask is a respiratory protective device designed to filtrate airborne particles.
The "N95" designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks.
But the CDC doesn't recommend the general public to wear N95 respirators, stressing single-use, disposable respiratory protective devices should be used and worn by health care personnel during procedures to protect both the patient and themselves from the transfer of microorganisms, body fluids and particulate material.
All FDA-cleared N95 respirators are labeled as "single-use," disposable devices. But as the number of confirmed cases of COVID-19 continues to soar, countries worldwide are struggling to find ways to ease the supply shortage of much-needed medical equipment, including N95 respirators.
The feasibility and effectiveness of the company's solution to reuse N95 respirators was endorsed by researchers at Duke University.
"It's a method labs have used for decades to decontaminate equipment," Wayne Thomann, director emeritus of the Duke Occupational and Environmental Safety Office, told CNN.
But the team never thought they'd need it for face masks.
