COLUMBUS (COLUMBUS BUSINESS FIRST) — Battelle wrapped up its year-long federal contract to decontaminate N95 masks for reuse by clinical workers because the shortage of new protective equipment is over.
The Columbus research giant brought the technology off the back burner in early weeks of the pandemic, when the medical supply chain was in flames. The form-fitting protective respirators typically cost less than 50 cents apiece, but hospitals were charged $7 or more after a virus hotspot in Italy shut down mask factories.
“We didn’t want to do this forever; we wanted to do this when there was a need,” Battelle CEO Lou Von Thaer said in an interview with Columbus Business First. “We said from the start: We would much rather nurses and doctors get a clean (new) mask every time.”
The Critical Care Decontamination System used concentrated hydrogen peroxide vapor to kill any virus or other microorganisms on the typically one-use masks. Cleaned masks could be reused as many as 20 times so long as fit didn’t degrade; otherwise hospitals discarded them.
Battelle ended the project at the end of March after cleaning about 5 million masks, Von Thaer said.
“We’re past the emergency, and we shut the program down,” he said. “It was a challenging program to run.”
The U.S. Food and Drug Administration granted emergency authorization late on a March Sunday last year, after a weekend of intense lobbying from Gov. Mike DeWine, who enlisted the help of then-President Donald Trump.
A week later, Battelle won a contract worth up to $400 million from the Defense Logistics Agency on behalf of the U.S. Department of Health and Human Services and Federal Emergency Management Agency. It authorized up to 60 systems: equipment the size of a hand cart plus drying racks set up inside shipping containers.
Battelle ended up invoicing $155 million for the work, a spokeswoman said.
The logistics agency so far has approved $86 million to purchase the equipment plus $54 million monthly for a servicing contract, but not all invoices have been processed, the agency said in response to a records request.
The average of $31 per mask indicates the depth of the emergency. N95 masks range from 68 cents to $3.40 depending on the model, according to a price sheet from manufacturer 3M. During the first case surges in spring 2020, media reports said nurses in New York had resorted to reusing masks and making gowns out of trash bags.
Prices are lower when a commodity is made in mass quantities.
Battelle had to assemble, equip and transport the units coast to coast, hire and train some 1,500 operators and pay FedEx shipping costs to get masks to and from hospitals, a spokeswoman said.
The system was based on Battelle research spanning five years. The organization tested the first units in its West Jefferson facility on previously worn equipment sent from Columbus-based OhioHealth Corp., which helped work out operations and logistics for shipping masks.
Nationally, some nursing organizations were concerned about safety, especially fit, but Von Thaer defended the system. The FDA issued a warning letter in October related to documentation of processes for reporting adverse events.
A database of adverse events lists 23 reports: Some nurses reported headaches, bad smell or dizziness. Some decontamination system workers tested positive for Covid-19, but the cases were attributed to community exposure because of many layers of protective gear worn on the job.
The FDA reauthorized emergency use in June and again in January. The agency revoked authorization last month at Battelle’s request after it ended the program.
Respirator supplies are now sufficient to stop reuse, the FDA and Centers for Disease Control and Prevention said last month.
“R&D: Is it strategic, or is there demand/pull? It’s always both,” Von Thaer said. “We’d done the study. We understood how to do it, but on a very small scale. When the nation had a need, we were able to adapt very quickly.”
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