FDA warns respirator decontamination system to comply with adverse event reporting requirements

The Food and Drug Administration yesterday warned Battelle Memorial Institute that its respirator decontamination system does not comply with the requirement in its emergency use authorization to establish internal systems that provide for timely and effective identification, communication and evaluation of adverse events, and asked the device maker to submit a correction plan within 14 days.

“The AHA is reaching out to Battelle and the FDA to ensure they realize how critical these decontamination units continue to be, especially as respirators and other supplies continue to be in shortage,” said Nancy Foster, AHA vice president for quality and patient safety. “It is important that regulatory requirements be fulfilled, and even more important that health care workers can continue to provide care safely to patients who are hospitalized.”

In a letter today to customers, Battelle said it “will work with the FDA over the next few days to supply any additional information that they require to ensure that we are meeting our obligations. We have full confidence in the safety and efficacy of our decontamination system.”