On April 27, 2022, the U.S. Food and Drug Administration (FDA) opened an investigation into airway obstruction risks connected with certain silicone-based electromyogram (EMG) endotracheal tubes made by Medtronic. The FDA’s investigation was initiated after severe adverse events and deaths were reported in connection with the Medtronic NIM Contact Reinforced EMG Endotracheal Tube and the Medtronic NIM Standard Reinforced EMG Endotracheal Tube. The incident reports claim that certain silicone-based electromyogram (EMG) endotracheal tubes may not have ventilated patients properly. When patients have endotracheal tubes placed and suffer ventilation problems, they can suffer oxygen deprivation, brain damage, or death.
The FDA issued a letter to health care providers warning of the silicone-based electromyogram (EMG) endotracheal tube ventilation issues. However, the rate of ventilation failures and the cause of these airway obstructions are not known at this time. Medical Device Reports (MDRs) presently suggest that airway obstruction incidents occur more frequently with silicone-based EMG tubes than with other EMG tubes. The FDA is currently working with Medtronic to examine all information on this issue to identify the root cause of the issue.
The FDA is urging medical professionals to report all negative medical events related to these silicone-based EMG endotracheal tubes to Medtronic and the FDA. Reporting all adverse events helps the FDA identify and comprehend the specific risks connected with these medical devices.
Warning Letter to Anesthesiologists, Nurse Anesthetists, and Surgeons
The FDA’s letter to health care providers recommends that medical professionals who work in the operating room, such as surgeons, anesthesiologists, and nurse anesthetists, understand the risk of ventilation failure and airway blockages while using silicone-based EMG endotracheal tubes. The FDA is also urging all medical professionals to follow all EMG endotracheal tube instructions and to be ready to take prompt actions to reestablish a safe airway should ventilation failure occur. Medical professionals should never reintubate a patient with a silicone-based EMG endotracheal tube.
EMG endotracheal tubes contain electrodes that monitor the integrity of the laryngeal musculature nerves. These types of endotracheal tubes are designed to maintain an airway for patient ventilation during surgery. These EMG endotracheal tubes also provide intraoperative monitoring of laryngeal musculature EMG activity when connected to the proper EMG monitor. The EMG endotracheal tubes have been 510(k) cleared and are manufactured with silicone or polyvinyl chloride (PVC) elastomer. The only silicon-based EMG endotracheal tubes sold in the U.S. are the Medtronic NIM Contact Reinforced EMG Endotracheal Tubes and the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes. The FDA has not received adverse medical incident reports for PVC-based EMG tubes.
The FDA is currently working with Medtronic to assess the problem and identify possible contributing factors and identify mitigation strategies. The FDA stated that it would inform the public if any meaningful information. The FDA is urging medical providers to report all adverse medical events with Medtronic NIM Contact Reinforced EMG Endotracheal Tubes and Medtronic NIM Standard Reinforced EMG Endotracheal Tubes.
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