The Food and Drug Administration has updated its advice to healthcare providers about a Medtronic device that has been linked to two patient deaths.
Officials at the FDA sent out a letter about the potential risk of airway obstruction when using certain electromyogram endotracheal tubes in April. Since then, Medtronic has begun a voluntary recall of the devices, categorized as a Class I event by the FDA, and reported two patient deaths and three injuries related to airway obstruction.
The FDA has responded to the developments by providing more detailed recommendations about how to prevent and respond to airway obstruction that may occur when using Medtronic’s NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube. Healthcare professionals should review Medtronic’s letter and immediately deflate the cuff and try to ventilate in the event of airway obstruction.
If ventilation cannot be re-established, the FDA is advising healthcare professionals to remove the endotracheal tube from the patient and re-establish ventilation with a bag valve mask or laryngeal mask airway. In that event, the FDA recommended re-intubating the patient with a non-silicone tube. If an EMG endotracheal tube is needed for surgery, healthcare processionals can use a larger tube, which will require less cuff inflation volume and pressure.