The U.S. Food and Drug Administration (FDA) provided an emergency use authorization (EUA) to Advanced Sterilization Products (ASP) for sanitizing four million N95 masks per day to fight the COVID-19 pandemic.
This decontamination system would allow the reuse of single-use N95 masks. The company makes use of vaporized hydrogen peroxide gasoline to smooth the respirators. ASP's STERRAD series sterilization machines, which can be covered under the EUA, are in use in around 6,300 hospitals already. There are also around 9,930 in operation throughout the United States that are capable of processing around 480 masks per day.
The sterilization machine is typically used for sterilizing other portions of scientific equipment, but have not formerly been supposed for use with N95 masks.
The FDA says heaps of hospitals have already got the device installed and might now use them on N95 respirators, which can be in short supply.
FILE PHOTO: Various N95 respiration masks at a laboratory of 3M, that has been contracted by the U.S. government to produce extra marks in response to the country's novel coronavirus outbreak, in Maplewood, Minnesota, U.S. March 4, 2020. Picture taken March 4, 2020.
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Device to help fight face mask shortage
The sterilization device will help fight the lack of essential face masks utilized by doctors, nurses, and health care employees to defend themselves from the fight to COVID-19.
In a news release, FDA Commissioner Dr. Stephen M. Hahn said the nation's health care workers are among the many heroes of this pandemic. He added the health agency need to do everything we can to increase the availability of the critical medical devices they need, such as 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," Hahn said.
Hahn assured the public that FDA staff continue to work around the clock, across government, and with the private sector to find solutions.
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The system, called the STERRAD Sterilization System, uses vaporized hydrogen peroxide gasoline plasma sterilization, according to the agency.
At least 6,300 hospitals had installed UV sanitizers
More than 6,300 hospitals in the U.S. already have the system installed, FDA said, and each device can reprocess about 480 respirators per day.
According to the FDA's letter, the machine is limited to "a maximum of 2 decontamination cycles per respirator."
The agency has also cleared another similar machine for N95 decontamination: Battelle's vaporized hydrogen peroxide process. This new clearance dramatically expands the reach and ability extent of possible remediation that's possible. The process should pave the way for others to follow.
Duke University was the first to call for this system for use on N95 respirators. The university said sterilization is safe and effective. The equipment, according to Duke, is already available in biocontainment labs and other medical facilities.
Some hospitals also are using ultraviolet light to decontaminate masks so they could be reused. The University of Nebraska Medical Center commenced experimenting with UV-light last month to sanitize masks by hanging used masks up in rooms with ultraviolet light towers. Once they're sanitized, masks are returned to their owners, allowing health care workers to use them for up to a week longer.
Imports of essential clinical supplies have been swiftly decreasing because of factory closures in China. According to the Associated Press, producers were required to sell their inventory internally instead of exporting them.
