FDA Approves Battelle Tech For Decontaminating N95 Respirators

An important type of face mask called an N95 respirator is in critically short supply at the moment, putting medical workers in many countries at risk of contracting the novel coronavirus. Unlike surgical masks and ordinary paper masks, an N95 respirator features a tight fit and can filter out the majority of particles in the air. In light of the shortage, the FDA has granted emergency use authorization to new technology that can decontaminate used N95 respirators.

The FDA issued the authorization to an Ohio company called Battelle Memorial Institute, meaning its Battelle Critical Care Decontamination System (CCDS) can be used to decontaminate used N95 and equivalent respirators for healthcare workers. The approval comes in the form of an Emergency Use Authorization (EUA).

With the EUA, the Battelle CCDS system can be used during the current pandemic, enabling the technology to get right to the people who need it. Without the emergency use approval, the technology would take quite a while to go through testing and the overall approval processes, something that would delay getting the tech out when it is critically needed.

The general public, particularly when practicing social distancing, does not need to wear an N95 respirator, according to the Centers for Disease Control and Prevention. Nurses and doctors wear N95 respirators during times when they may be exposed to aerosolized viruses, such as when they are putting a patient on a ventilator.

Many medical workers report being told to reuse N95 respirators due to the shortage. On Sunday, March 29, the FDA granted Battelle full emergency use authorization for the respirator decontamination technology — before that, it only had granted partial authorization, prompting a tussle with Ohio governor Mike DeWine. The revised EUA was issued the next day.

With the full EUA in place, Battelle is deploying decontamination machines to hospitals in Ohio, Seattle, Washington DC, and New York.