| The Columbus Dispatch
The Food and Drug Administration sharply criticized a Columbus-based research institute this week for failing to track issues with its mask decontamination units.
Battelle received a letter from the FDA on Wednesday warning that it did not have proper protocols in place to report adverse events that occur when people use masks cleaned by the nonprofit research institute’s Critical Care Decontamination System units. Battelle’s decontamination technology, which the company says can sanitize 80,000 N95 masks per day per unit, was approved for use as a shortage of the masks hit the U.S. when the COVID-19 pandemic began in March.
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Adverse events questioned by the FDA include, but are not limited to, allergic reactions, shrunken or misshapen respirators, a poor fit or seal of N95 masks, shredding, peeling, or discoloration of the respirator, mask straps breaking, odor issues, infection in wearers of decontaminated masks and skin irritation, the letter states.
“When there is an inadequate adverse event reporting process, the ability to detect problems and address them in order to assure the safety and performance of decontaminated respirators is compromised,” Dr. Binita Ashar director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a news release. “We will hold companies accountable if they fail to fulfill their regulatory obligations.”
Battelle is required to respond within the next 15 days, according to the FDA. Failure to correct violations could cause the FDA to initiate regulatory action without any further notice.
“We appreciate the clarity that the FDA’s letter has provided, and we will be submitting our response in the coming days to continue to meet their requirements,” Battelle spokesman T.R. Massey told The Dispatch via email. “We are appreciative of the FDA’s work early in the pandemic to get this capability fielded, including Dr. Binita Ashar’s personal involvement in making this technology available to nurses, doctors and other health care professionals.”
Massey said the nonprofit research institute has been in touch with the FDA as “reporting obligations have evolved during the pandemic.”
The FDA first sent a letter to Battelle in August requesting information about the institute’s processes for reporting adverse events to the FDA after the agency became aware that there may be deficiencies in the sanitization process.
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Battelle’s mask-cleaning technology was used at some Columbus-area hospitals, including Ohio State University’s Wexner Medical Center and OhioHealth facilities.
While the reused masks were sometimes damaged, OhioHealth spokesman Colin Yoder said Battelle’s cleaning system that ensured every person who entered the room of a COVID- patient at OhioHealth’s hospitals was wearing an N95 mask.
“We did not experience widespread mask degradation, but did occasionally have a mask that changed shape enough to not fit well and, in those situations, we’d simply discard the mask and grab another mask,” Yoder said. “This was a temporary solution for OhioHealth and we continue to source new, disposable N95 masks as our ideal and primary solution.”
Issues concerning Battelle’s mask decontamination device first arose in May after reports surfaced that it was causing masks to degrade after two or three uses.
Battelle CEO and president Lou Von Thaer defended the institute’s decontamination device in May, saying “we believe our science is sound.”
In late March, as concerns mounted about a shortage of N95 masks to protect frontline health care workers during the pandemic, Battelle received emergency-use authorization from the FDA to make its system widely available.
The approval came after Gov. Mike DeWine and President Donald Trump put pressure on the agency.