FDA alerts providers to airway device safety risk

The Food and Drug Administration is evaluating the potential for airway obstruction when using silicone-based electromyogram endotracheal tubes for patient ventilation and monitoring during surgery. The agency has received reports describing serious adverse events and deaths after airway obstruction and ventilation failure using the devices, marketed in the U.S. by Medtronic. FDA is working with the manufacturer to identify potential contributing factors and mitigation strategies, and will provide an update if new information becomes available. The agency recommends health care providers follow the device’s labeling instructions; be prepared to establish a safe airway if ventilation fails; and report any adverse events or outcomes to the agency.