FDA issues warning against Battelle mask decontamination process


Masks await sterilization at Battelle (Courtesy: Battelle)

COLUMBUS (WCMH) — The U.S. Food and Drug Administration has issued a warning letter to the Battelle Memorial Institute.

The letter, dated Oct. 7, states that Battelle does not have a process in place to report problems with the company’s Critical Care Decontamination System.

This is the system that was highly touted by Ohio Gov. Mike DeWine, President Donald Trump and others for its ability to clean thousands of N95 face masks, so they could be reusable.

In March, the FDA gave approval for the system to be used under an Emergency Use Authorization, which requires that there also be a reporting process in place.

“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 Dr. Binita Ashar, director of the FDA’s 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. We will hold companies accountable if they fail to fulfill their regulatory obligations.”

The FDA said some of the issues which may be part of the reporting process include allergic reactions, facial irritation or evidence that the N95 masks are not able to properly work.

Katy Delaney, a spokesperson for Battelle, issued the following statement, in response to the warning letter:

It is of great importance to us to remain in compliance with the FDA’s Emergency Use Authorization. As reporting obligations have evolved during the pandemic, we have stayed in contact with the agency to respond to requests for information.

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.

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.

Katy Delaney, Battelle spokeswoman

The FDA is requesting a response from Battelle within 15 days on how the company will remedy the issue. Failure to fix it could result in the FDA taking regulatory action.

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