As PPE Shortages Intensify, the FDA Approves Increased Operations at Battelle to Sterilize Masks for Reuse
Battelle, an Ohio-based company that has the technical ability to decontaminate N95 face masks, has been given authorization by the US Food and Drug Administration (FDA) to scale up operations.
The nonprofit research and development organization, which has specialized decontamination machines, was originally given approval to decontaminate 10,000 face masks per day. However, in light of the crippling shortage of face masks and other personal protective equipment (PPE) available to US healthcare workers dealing with the COVID-19 pandemic, the FDA has now issued a waiver that allows the facility to increase its supply to up to 80,000 masks a day.
Decontamination is seen as a more immediate solution than scaling up the production of single-use PPE, as health systems continue to be inundated by COVID-19 patients requiring hospitalization. Battelle's decontamination technology allows a single N95 face mask to be decontaminated and reused up to 20 times, according to a press release from the company.
Read the FDA's letter to Battelle here.
We issued a new authorization this evening to @Battelle for their decontamination system. @US_FDA staff have been working nonstop across gov and with the private sector to deliver solutions to the American public.
— Dr. Stephen M. Hahn (@SteveFDA) March 30, 2020