FDA Issues Warning to PPE Decontamination Manufacturer

Angie SzumlinskiNews

Battelle Memorial Institute received a warning letter from the Food and Drug Administration (FDA) in regards to its Critical Care Decontamination System.

Battelle rose to the spotlight a few months ago when their Critical Care Decontamination System, which decontaminates N95 masks, received emergency approval for use by the FDA. Due to decontaminating PPE being fairly controversial in healthcare (PPE such as N95’s are normally single-use), the FDA relaxing requirements and allowing systems such as Batelle’s was nearly unprecedented. However, this exception was not without conditions. One requirement for the decontamination system’s emergency approval was that Battelle was supposed to have a process for reporting adverse events, and the FDA found that Battelle had no such process.

According to an article about this by Fierce Healthcare, adverse events from this system can include “allergic reactions or eye, mouth or nose irritation. Other events include residuals from the hydrogen peroxide used to reprocess the N95 mask or malfunctions in the generators used to decontaminate the PPE.” Battelle has 15 days to respond to the letter (issued October 8th), and has publicly stated that they will respond to the FDA and prioritize staying compliant with their Emergency Use Authorization.