FDA funds sites to decontaminate N95 masks
Dr. Laurie Hommema arrived home for dinner Friday, March 13, with masks on her mind. It was the day President Donald Trump declared the coronavirus a national emergency, and she worried that front-line medical staff at the 12-hospital OhioHealth system where she works wouldn’t have enough protective gear. In what turned out to be a break for medical workers, the person she confided her fears to over dinner – her husband, Kevin Hommema – is an engineer at the Battelle research institute in Columbus, Ohio. He recalled a 4-year-old study that Battelle had completed for the U.S. Food and Drug Administration. It proved it is possible to decontaminate and reuse the N95 masks that have become so crucial to protecting medical workers during the pandemic. Now, just six weeks later, Battellebuilt systems that can decontaminate a combined millions of masks per day are rolling out across the country. They’re free to use for medical providers under a $400 million federal contract. Under normal circumstances, cleaning and reusing a product that costs under a dollar and is made to be disposable makes no sense. But during the coronavirus pandemic’s protective equipment shortage, when N95 masks spark bidding wars that drive the price up and leave many empty-handed, hospitals are looking for ways to reuse them. In addition to Battelle’s system, which received FDA approval March 29, hospitals are starting their own decontamination and reuse programs. Virginia Commonwealth University spent about $10,000 to create a system that uses ultraviolet light to clean masks. In the past month, the FDA has approved four other companies to offer decontamination services for N95 masks. Ideally, recycling won’t be necessary for long, hospital leaders said, as production of new masks catches up to the demand and the price stabilizes. “Who knows what we’ll face in the future?” said Chris Clinton, vice president of shared services for OhioHealth. “It’s good to know that it’s there.” Battelle’s study was among several commissioned after the H1N1 flu and SARS outbreaks that looked at the feasibility of reusing masks in the event of a global shortage. Most studied recycling N95 respirators, the tight-fitting masks that fi lter out 95% of small particles and that are considered the standard for protecting medical workers. Some studies focused on the use of plasma cleaning technology, while others studied hydrogen peroxide vapor or some ultraviolet light. All are methods hospitals already use to clean equipment and facilities. Battelle’s study evaluated decontaminating N95 respirators using an existing hydrogen peroxide vapor machine called the Bioquell Clarus C. The researchers found it could disinfect an N95 mask up to 20 times without degrading the mask. The elastic head strap is the first part to break down with repeated cleaning. The study was published and publicly available on the FDA website, but Clinton, the OhioHealth vice president, said no one at the hospital system was
aware of the study until the Hommemas brought it to their attention. Clinton didn’t know if anyone else at the time had thought about reusing N95 masks because they were always so readily available and cheap.
Hospitals invest in methods to sterilize more expensive pieces of equipment where the economics of reuse make more sense.
“Obviously all the economics changed,” Clinton said.
On April 10, four weeks after the Hommemas’ dinner conversation, Battelle secured a $400 million contract with the Defense Logistics Agency on behalf of the U.S Department of Health and Human Services and the Federal Emergency Management Agency. Under it, Battelle is to offer mask recycling services free of charge to health care providers and first responders at up to 60 sites across the country. Each site will be able to decontaminate up to 80,000 masks per day.
Large hospitals go through thousands of masks in a normal week.
As of this week, there are eight sites up and running in eight states and 12 more are being set up.
An FDA spokesperson said Battelle’s system was operational so quickly because the FDA funded the company’s 18-month study in 2014.
The agency did not say whether the study was ever shared directly with emergency management officials at FEMA or hospitals or if mask decontamination was part of any national pandemic planning before Battelle brought it up again in March.
As far as the Hommemas know, the technology might never have been deployed to extend the life of N95 masks across the country if not for their dinner conversation.
How a hospital created its own mask recycler
In early February as hospital leaders realized they would quickly run out of N95 masks with even a small surge of COVID-19 patients, the staff at Virginia Commonwealth University Medical Center in Richmond went to work to figure out how to extend their supply.
“It became very clear we weren’t going to get masks from the federal government,” said Dr. Stephen Kates, a professor at VCU and chair of orthopedic surgery for the hospital.
They scoured every research lab in the university for masks and took in donations from the community. They still didn’t have enough.
“We realized if we had a real surge, we had about a three-day’s supply and then we were going to be in the same boat as New York and everyone else,” Kates said. “So we looked at ways that we could reuse the masks.”
The team at VCU settled on ultraviolet light instead of the hydrogen peroxide vapor Battelle uses because the hospital already owned machines that use ultraviolet light to clean hospital rooms. Most U.S. hospitals have at least one such device, Kates said. VCU has six.
The brand VCU uses is called Tru-D. Placed in a room after an infectious patient has been treated there, the machine emits ultraviolet light that kills germs, Kates said.
To clean masks instead, Kates built a frame in his home workshop that can hold dozens of masks at the proper angle to expose them to the light. They tested angles and light intensities to find a combination that can clean each mask as many as 20 times without distorting the fit.
A total of 24 staff members work on decontamination in shifts seven days a week. They clean up to 3,000 masks in a day.
“We have invited other hospital systems to come see what we’re doing,” Kates said. VCU will also publish its findings in a journal so more hospitals can replicate the system.
Both VCU and OhioHealth have a persistent problem: makeup. If staff members wear makeup and it gets on their mask, that mask must be thrown away. Germs could persist under the stain, Kates said, so there’s no way to guarantee that the mask is decontaminated.
About 1 in 10 masks that Battelle processes must be thrown away because they’re soiled, mainly from makeup. VCU loses about 1 in 8.
A stopgap measure
All the effort to get decontamination systems up and running quickly could become moot if the market for masks stabilizes and prices go back to normal.
“Eventually, I’m confident enough companies will make enough that we can start throwing them away again,” Kates said. “It would be cheaper to buy the masks for 30 cents.”
With Battelle’s estimated cost to clean each mask at $3.25 plus the shipping costs, the federal government’s contract covers only about three weeks of operation if 60 sites were to all run at full capacity. Currently, only eight sites are fully up and running and they aren’t processing the full 80,000 masks per day they are capable of handling.
But now that these systems have been proven to work, experts said, they can be quickly deployed in the event of a future mask shortage.