Two product defect corrections: Medtronic NIM EMG Endotracheal Tubes
ANZCA has become aware of two product defect corrections issued for models of Medtronic Nerve Integrity Monitor (NIM) Electromyograph (EMG) Endotracheal Tube.
NIM EMG tubes are typically used for head and neck surgery, including thyroid surgery, and are intended to reduce the risk of laryngeal nerve injury during surgical dissection.
ANZCA asks fellows considering using these tubes to familiarise themselves with the below recalls, and to weigh the risks versus benefits of using these tubes.
NIM CONTACT Reinforced EMG Endotracheal Tube – cuff overinflation hazard
This product defect correction relates to NIM CONTACT Reinforced EMG Endotracheal Tubes with model numbers: 8229506, 8229507 and 8229508.
These tubes are made of silicone with a reinforcing wire coil in the shaft, and a silicone cuff. The defect may occur if the cuff is over-inflated, causing it to extend, herniate, or distort over the end of the tube and/or the murphy-eye, potentially causing obstruction of the patient airway and loss of ventilation.
There have been multiple serious incidents, including patient deaths, reported to be connected to this issue globally.
The manufacturer’s advice for prevention of this hazard is to avoid over-inflating the cuff by carefully following the Instructions for Use.
Emergency response if using the tube and airway obstruction occurs:
- Immediately deflate the cuff and attempt to ventilate
- If ventilation cannot be re-established:
- Extubate the endotracheal tube from the patient
- Re-establish ventilation with Bag Valve Mask (BVM) or Laryngeal Mask Airway (LMA).
- Reintubate with a new non-silicone (PVC) Endotracheal Tube or, if surgically needed, re-intubate the patient with a new, larger NIM CONTACT tube which will require less cuff inflation volume and pressure.
More information is available from the Therapeutic Goods Administration (TGA) Australia recall listing or Medsafe New Zealand recall listing.
NIM Trivantage EMG Endotracheal Tube – manufacturing fault in specific production lots
This product defect correction relates to a manufacturing fault in specific production lots which affects the electronic functioning of the device. The following events may occur:
- Difficulty passing the Electrode Check on the NIM Mainframe immediately after intubation.
- Losing connection between tube and Mainframe during a procedure, resulting in an error message on the console screen and inability to proceed with nerve monitoring.
- Excess signal noise from the NIM console due to lead-off issues.
Adverse outcomes have included aborted procedures and in one case, nerve damage.
The production lots affected by this fault were manufactured between 28 August 2019 and 25 October 2021. A listing of affected production lots is available from the United States Food and Drug Administration (FDA) Product Recall listing.
The manufacturer advises users not to use any impacted products. Remove and quarantine all unused impacted products from inventory, and return them to the manufacturer.
More information is available from the TGA Australia recall listing, the Medsafe New Zealand recall listing, and the United States Food and Drug Administration (FDA) Product Recall listing.