FDA to Decontaminate N95 Masks
There has been a widespread effort to develop and advance creative solutions to new problems, such as the shortages of necessary front-line medical equipment worldwide, during this global coronavirus pandemic. The N95 respirator masks, which are masks that with high efficacy filter out very fine particles, including shed virus is one piece of gear that’s necessary for protecting the health of medical workers treating COVID-19 patients. The supply of these masks is in extremely short. FDA opens a path to re-use the N95 masks originally intended for one-time use through a new FDA emergency use authorization.
The special emergency authorization from the U.S. healthcare regulator has been received by Battelle, the research, development and lab management company to use a system the company developed. This system uses concentrated hydrogen peroxide to decontaminate used N95 respirator masks. With a 2.5-hour decontamination process between each use, the mask can be used up to 20 times through thissystem which turns single-use respirators into reusable respirator masks.
With a decontamination capacity of up to 80,000 masks per day, the Battelle system is already in operation at its Ohio facility. As its first healthcare system partner, the company is working with Columbus -based OhioHealth and also said that beginning this week, for three other major healthcare systems, the company will start decontaminating masks.
The N95 masks collected by the Battelle for decontamination and re-use will all be sent back to the same healthcare facility from which they were collected so that it is made sure that everything is done as transparently and safely as possible. There will be serial numbers labeled on the masks that will provide tracking, which will have the number of times the masks are re-used included.
In 2015, Battelle, in anticipation specifically of a scenario where a global pandemic caused a shortage of available equipment, had worked with the FDA to develop and demonstrate this technology.
Battelle is not the only one making use of this technology. To decontaminate used respirators, Duke University is also using vaporized hydrogen peroxide.
This is not a new technology. In labs that deal with biohazardous material, this method and technology are frequently used in the decontamination of equipment used in such labs. However, using this technology to reuse single-use N95 masks is new. To help with the increase in the need for more equipment, this Emergency Authorization from the Food and Drug Administration FDA could lead to the broader, safe and authorized use of the technology.
FDA to Decontaminate N95 Masks – Source