Silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube) have been linked to airway obstruction and ventilation failure, according to the Food and Drug Administration (FDA).
In a new safety communication, the Agency stated that it has received reports of serious adverse events associated with these devices, including death. A review of medical device report data suggest that airway obstruction is occurring more frequently with silicone-based EMG tubes compared with other tubes (those made of polyvinyl chloride [PVC]).
Though the root cause and incidence rate of obstruction and ventilation failure are currently unknown, the FDA recommends that health care providers be aware of the increased risk, and follow the instructions for use in the device labeling to minimize the chance for these adverse events. Clinicians are also urged to be prepared to take steps to reestablish a safe airway if ventilation failure does occur; reintubation with silicone-based EMG tubes should be avoided.
Adverse events related to the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes should be reported through MedWatch.
Potential risk of airway obstruction when using certain electromyogram endotracheal tubes – Letter to health care providers. News release. April 27, 2022. https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-airway-obstruction-when-using-certain-electromyogram-endotracheal-tubes-letter-health