In late March, workers at a Columbus warehouse were loading Battelle’s Critical Care Decontamination Systems onto truck beds. The technology is the first of its kind – modular so they could be easily shipped to coronavirus hot spots, with the promise of being able to clean 80,000 pieces of personal protective equipment for re-use up to 20 times.
Battelle’s technology was given FDA approval after about a week of urging from Gov. Mike DeWine and even President Donald Trump.
Several Central Ohio hospitals were the first in the country to send N95 masks for decontamination, at no cost. But the units didn't work quite as expected.
"After the extended wearing and the decontamination, the mask is not as formed as it was," says Ohio State Wexner Medical Center nurse Rick Lucas."So there’s concern about the integrity of the seal on the mask."
Lucas is a union representative for the health center’s 4,000 nurses. He says he received reports of issues with the decontaminated masks.
"A couple of nurses have reported that they’ve had some irritation in their throat or some coughing after wearing one that has come back from decontamination, or noticing a smell or odor," Lucas says.
Lucas says he worries that the health system will continue to rely on old masks decontaminated by Battelle for free, instead of buying new N95 masks.
In an emailed statement, a spokeswoman for the Wexner Medical Center says they are working with Battelle to ensure the masks meet their standards. The hospital system says about 93% of the masks they send to Battelle are returned, and that they have not received reports or complaints regarding the sterilized masks.
An Ohio Health spokesman also reported some masks were misshapen and did not seal properly, but they have not seen widespread degradation of the decontaminated masks. Ohio Health is also trying to source brand new N95 masks as their primary solution.
"It’s not like this replaces the need to buy new masks," says Lou Von Thaer, CEO of Battelle. "Of course we’d like our nurses to have new masks all the time."
Von Thaer says he understands why health care union members want new masks instead of decontaminated ones.
"The system is really here for emergency purposes, to get us through this pandemic until the supply chain can catch up again," Von Thaer says.
Battelle brokered two contracts with the federal government – the first for $78 million to create 60 systems to be sent around the country, and the second with a ceiling of $400 million for a workforce to man the machines.
So far, 47 of those decontamination systems are in place, and two more are in the federal stockpile. In total, Battelle says the units have decontaminated roughly 650,000 masks for 18,000 health systems.
Von Thaer says he has only received five reports of issues with masks, which they reported to the FDA. On average, the systems are throwing away about 17% of masks.
"If the masks come in, they are inspected before we clean them and after they’re clean," Von Thaer says. "If they have lotion on them, if they have makeup, blood on them, if they’ve been severely distorted, we throw those away."
While Battelle’s promotions says masks can be reused up to 20 times, the most a single mask has been decontaminated is 11 times. Von Thaer says that’s largely because the systems haven’t been in place for that long. He says most masks from the earliest decontaminations have gone through the process five or six times so far.
Battelle’s machines can clean up to 80,000 pieces of PPE at a time. That’s a game changer, says Angela Birnbaum, director of Biosafety at Tulane University in New Orleans.
She says her lab was trying to decontaminate N95 masks, but she worried they wouldn’t be able to keep up with the demand as the city became a coronavirus hot spot.
"The capacity that Battelle brings forward is so much more than we could have done," Birnbaum says. "It supports the state of Louisiana, not just a couple of hospitals that we may have been able to handle if the supply ran out in the first place."
Across the country in Washington State, Olympic Medical Center sent their first round of PPE to a nearby Battelle machine for decontamination.
"Some people have been using the same mask for several weeks," says chief medical officer Dr. Scott Kennedy. "This is a big change. With this recycling and a little more supply of new masks, what we will be doing is not using masks beyond one shift."
Olympic Medical Center is paying less than $1 per mask for the decontamination. Kennedy says that’s a small price to pay to protect frontline workers, even if one-sixth of the masks end up in the trash.