Medtronic issued updated recommendations for the potential risk of airway obstruction in its NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube, according to an FDA alert.
The FDA says Medtronic issued a follow-up customer letter with updated instructions for use (IFU), new training material, and Unique Device Identifier (UDI) information.
According to the FDA alert, if airway obstruction happens when using NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tubes, the company recommends the following:
- If airway obstruction happens, immediately deflate the cuff, and attempt to recover ventilation.
- If ventilation cannot be re-established:
- Extubate the EMG endotracheal tube from the patient.
- Re-establish ventilation with Bag Valve Mask (BVM) or Laryngeal Mask Airway (LMA).
- Re-intubate with a new non-silicone (PVC) endotracheal tube and establish airway or alternatively, if surgically needed, re-intubate with a new EMG endotracheal tube. If reintubating with a new EMG endotracheal tube, it is imperative to:
- use less than 5mL of air to inflate the cuff and verify intracuff pressure using a pressure monitoring device; or
- use Minimal Occluding Volume or Minimum Leak techniques using a 5mL syringe.
The FDA recommends healthcare providers in the operating room setting, including anesthesiologists, nurse anesthetists, and surgeons, review the follow-up customer letter from Medtronic for the latest safety information for NIM CONTACT Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes.
More information is available on the FDA website.
