Today, the U.S. Food and Drug Administration issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System.

“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. 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,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “We will hold companies accountable if they fail to fulfill their regulatory obligations.”

The Battelle Memorial Institute’s Critical Care Decontamination System is authorized under an FDA EUA for use in decontaminating certain N95 respirators for reuse by health care personnel when there are insufficient supplies of Filtering Facepiece Respirators due to the COVID-19 pandemic.

The FDA sent a letter in August to Battelle Memorial Institute requesting information about their process for submitting reportable adverse events to the FDA after the FDA became aware that there may be deficiencies in Battelle’s process. In this letter, the FDA provided examples of reportable events that may be relevant to the authorized product including 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, or malfunctions of the generator used to decontaminate the respirators.

Pursuant to the conditions of the EUA, Battelle Memorial Institute must have a process in place to report adverse events as specified in the EUA. Based on the information received from Battelle, the FDA determined that this condition has not been met. As such, the FDA issued this WL and has requested a response from Battelle Memorial Institute within 15 working days with details about how the company will correct the violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.

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.

Health care professionals and consumers should report any adverse events related to devices to the FDA’s Adverse Event Reporting program. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.