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The US Food and Drug Administration (FDA) has warned mask decontamination company Battelle Memorial Institute for failing to comply with adverse event reporting rules specified in the emergency use authorization (EUA) for the company's critical care decontamination system.
The warning letter states that the company does not have adequate procedures in place for identifying adverse events, such as allergic reactions.
This is the first warning issued by the FDA for any product granted an EUA during the COVID-19 pandemic, according to FDA spokesperson Amanda Turney, Politico reports.
"It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorized systems for decontaminating respirators," Binita Ashar, MD, director, Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, said in an FDA news release.
"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. We will hold companies accountable if they fail to fulfill their regulatory obligations," Ashar said.
Battelle's Critical Care Decontamination System has an EUA for use in decontaminating certain N95 respirators for reuse by healthcare providers when there are insufficient supplies of filtering face piece respirators because of the COVID-19 pandemic.
The EUA was issued in March. That month, President Donald Trump touted Battelle's mask decontamination system on Twitter and encouraged the FDA to approve it "ASAP."
In August, however, the FDA sent a letter to the company regarding potential "deficiencies" in Battelle's process for submitting adverse events and requested more information on the process.
On the basis of information received from Battelle, the FDA determined that the company does not have an adequate process in place to report adverse events with the mask decontamination system as specified in the EUA.
These adverse events may include allergic reactions or eye, mouth, or nose irritation; evidence that a decontaminated respirator is unable to perform its essential function; events related to hydrogen peroxide residuals or user contact with hydrogen peroxide residuals; infection in respirator wearers; and malfunctions of the generator used to decontaminate the respirators.
The company has 15 days to respond to the FDA's concerns and provide details about how they will correct the violations.
"The FDA's actions today are part of the agency's ongoing commitment to evaluate devices authorized for emergency use to ensure compliance with the conditions of authorization and that the devices remain appropriate for authorization," the agency said in its statement.
Healthcare providers are encouraged to report adverse events related to this product to FDA's Adverse Event Reporting program.
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Cite this: FDA Warns Mask Decontamination Company for Skirting Safety Rules - Medscape - Oct 08, 2020.