FDA Issues Warning Letter to Manufacturer of Respirator Decontamination System

Battelle Memorial Institute failed to meet Emergency Use Authorization requirements for reporting adverse events.

The FDA issued a warning letter to Battelle Memorial Institute on October 7 for failing to comply with regulatory requirements for medical device reporting.

The institute did not meet requirements specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. Under the EUA, the Decontamination System is authorized for use in decontaminating certain N95 respirators for reuse by health care workers in the event of insufficient supplies due to the pandemic.

“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,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “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.”

This warning letter arrives after the FDA sent the institute a letter in August requesting information about their process for submitting reportable adverse events to the FDA.

The FDA advises health care professionals to report adverse events related to devices to the agency’s Adverse Event Reporting program. More information can be found at fda.gov.

About the Author

Nikki Johnson-Bolden is an Associate Content Editor for Occupational Health & Safety.

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