On April 27, the FDA sent a Letter to Healthcare Providers to warn about reports of serious injuries and deaths associated with Medtronic’s silicone-based electromyogram (EMG) endotracheal tubes.
Endotracheal tubes (or ET tubes) are flexible tubes that are placed through a patient’s nose or mouth into their throat. ET tubes keep the patient’s airway open so that a doctor can give them oxygen or anesthesia during surgery or emergency situations.
Most ET tubes are made of a flexible plastic material called PVC (polyvinyl chloride), but Medtronic sells the only silicone-based ET tubes currently on the market in the U.S.
Unfortunately, the FDA has received reports of Medtronic’s silicone-based endotracheal tubes causing serious problems for patients — including airway obstruction, brain damage, oxygen deprivation or death.
Furthermore, the reported injuries and deaths were more frequent for Medtronic’s silicone-based EMG tubes compared to PVC-based endotracheal tubes, according to the FDA.
The FDA said it is currently investigating the reports in order to better understand the risks.
In the meantime, the FDA is asking healthcare professionals in the operating room setting, including anesthesiologists, nurse anesthetists, and surgeons, to “be prepared to take immediate steps to reestablish a safe airway if ventilation failure occurs. Do not re-intubate with a silicone-based EMG endotracheal tube.”