FDA grants emergency authorization to system that decontaminates N95 respirator masks for re-use
The global coronavirus pandemic has meant that there’s a widespread effort to develop and advance creative solutions to new problems, like worldwide shortages of necessary front-line medical equipment. One piece of gear that’s necessary for protecting the health of medical workers treating COVID-19 patients are N95 respirator masks, which are masks that specifically filter out very fine particles, including shed virus, with high efficacy. These are in extremely short supply, but a new FDA emergency use authorization could help significantly lessen that burden by opening a path to re-use of N95 masks originally intended for one-time use.
Research, development and lab management company Battelle has received special emergency authorization from the U.S. healthcare regulator to put into use a system it developed to decontaminate used N95 respirator masks using concentrated hydrogen peroxide. The system is able to turn single use respirators into masks that can be used up to 20 times, with a 2.5-hour decontamination process between each use.
The Battelle system is already in operation at its Ohio facility, with a decontamination capacity of up to 80,000 masks per day. That’s a considerable dent in a supply need that will be faced by essentially every healthcare facility faced with a high concentration of COVID-19 patients. The company is working with Columbus -based OhioHealth as its first healthcare system partner, but says that it’ll also start decontaminating masks for three other new major healthcare systems in the area beginning this week.
In order to ensure that everything is done as safely and transparently as possible, the N95 masks that Battelle collects for decontamination and re-use will all go back to the same healthcare facility from which they were collected, and they’ll be labeled with a serial number that provides tracking, which will also include the number of times they’re re-used.
Battelle actually worked with the FDA in 2015 to develop and demonstrate this technology – specifically in anticipation of a scenario where a global pandemic caused a shortage of available equipment. They’re also not the only ones using this technology: Duke University is also using vaporized hydrogen peroxide to decontaminate used respirators, and it’s making the protocols that it established widely available, with compatibility with a number of existing decontamination systems already in use in healthcare facilities.
This technology and method actually aren’t new, and are frequently used in decontamination of equipment used in labs that deal with biohazardous material. Its use specifically for turning single-use N95 masks into reusable gear is new, however – but this EUA from the FDA could pave the way for broader authorized, safe use of the technology to help with the growing need for more equipment.