Confronted by a severe shortage of respirator masks and countless stories of healthcare workers on the front lines reusing face masks or using bandanas when they have none, the U.S. federal government is trying a new approach. If it can’t get enough new face masks, it will decontaminate used ones.
The Food and Drug Administration (FDA) on Saturday authorized the emergency use of a new system developed by Ohio-based R&D company Battelle that decontaminates used N95 respirator masks and rids them of biological contaminants, including the novel coronavirus. The company states that each Battelle Critical Care Decontamination System can clean up to 80,000 masks per day at full capacity.
In order to decontaminate the masks, Battelle’s system uses concentrated, vapor phase hydrogen peroxide and exposes the masks to the validated concentration level for two and a half hours. Battelle says that this system can decontaminate the same respirator multiple times without degrading its performance. Each respirator can be decontaminated up to 20 times.
N95 respirators are heavy-duty masks used by healthcare workers that filter out at least 95 percent of very small particles. They are especially in high-demand during the covid-19 pandemic because the virus spreads through respiratory droplets produced when an infected person coughs or sneezes. Currently, N95 respirators are disposed of after a single use by healthcare providers, according to the FDA.
Ohio Gov. Mike DeWine had personally appealed to the FDA to get Battelle’s system approved. On Twitter on Sunday, he explained that finding N95 masks was a problem, not only in Ohio, but also across the country.
Earlier this month, the Department of Health and Human Services told Congress that it only had one percent, or 35 million, of the estimated 3.5 billion N95 masks required to deal with a pandemic.
Although the FDA did eventually approve the use of Battelle’s system, it has limited the amount of N95 masks the company could treat to 10,000 per day. The limit upset DeWine, who called the FDA “reckless”, and prompted him to call President Donald Trump to explain the issue. Trump later posted on Twitter that the FDA had to “move quickly”.
On Sunday, DeWine tweeted that the FDA had promised to resolve the issue the same day.
“The urgency of today is because we know that we have people on the frontline today who don’t have the masks they need,” DeWine said. “They are using masks longer than they normally would, but they are doing it because they don’t have a choice.”
In a statement, Battelle said that it had started building its systems over the past week. The company announced that its first completed system was on its way to New York, which is dealing with one of the worst outbreaks in the country.