FDA alerts healthcare providers of airway device potential risk

Editor's Note

In a letter to healthcare providers published on April 27, the US Food and Drug Administration (FDA) alerted it is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube) for patient ventilation and monitoring during surgery.

The agency has received reports describing serious adverse events and deaths with these devices after airway obstruction and ventilation failure. “At this time, the root cause and incidence rate of obstruction and ventilation failure with use of these devices is not known,” the letter noted. “However, information from medical device reports (MDRs) currently suggests that reported events of airway obstruction are more frequent for silicone-based EMG tubes compared to other tubes.”

In the letter, the FDA listed the following recommendations for healthcare providers in the OR setting:

• Be aware of the potential risk of airway obstruction and ventilation failure with silicone-based EMG endotracheal tubes.
• Follow the instructions for use in the device labeling to minimize the chance of ventilation failure and obstruction of the patient’s airway.
• Be prepared to take immediate steps to reestablish a safe airway if ventilation failure occurs. Do not reintubate with a silicone-based EMG endotracheal tube.
• Report adverse events and outcomes to the FDA.

The FDA is working with the manufacturer to identify potential contributing factors and provide additional information on this safety risk.