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Medtronic Electromyogram Endotracheal Tube Recall

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The U.S. Meals and Drug Administration (FDA) is updating the Letter to Well being Care Suppliers issued on April 27, 2022, to make sure well being care suppliers within the working room setting are conscious of the voluntary recall initiated by Medtronic for the chance of airway obstruction with the NIM CONTACT Bolstered EMG Endotracheal Tube and NIM Commonplace Bolstered EMG Endotracheal Tube.

If the tube obstructs and doesn’t ventilate correctly, sufferers could endure oxygen deprivation, mind harm, or loss of life. Medtronic issued a buyer letter and is working to replace and supply new gadget directions to be used to prospects. Moreover, the FDA issued a notification of this Class I recall, essentially the most severe sort of recall. The FDA will proceed to watch studies of airway obstruction and air flow failure with these units. 

Suggestions

The FDA recommends well being care suppliers within the working room setting, together with anesthesiologists, nurse anesthetists, and surgeons: 

  • Evaluation the buyer letter from Medtronic for NIM CONTACT Bolstered EMG Endotracheal Tubes and NIM Commonplace Bolstered EMG Endotracheal Tubes, which incorporates the next beneficial actions for when airway obstruction is encountered:
    • Instantly deflate the cuff and try and ventilate.
    • If air flow can’t be re-established:
      • Extubate the endotracheal tube from the affected person.
      • Re-establish air flow with bag valve masks or laryngeal masks airway.
      • Reintubate with a brand new non-silicone endotracheal tube or, if surgically wanted, re-intubate the affected person with a brand new, bigger NIM Commonplace Bolstered EMG Endotracheal Tube or NIM CONTACT Bolstered EMG Endotracheal Tube which would require much less cuff inflation quantity and stress. 
  • Concentrate on the potential danger of airway obstruction and air flow failure with these units. 
  • Comply with the directions to be used about tube administration, that are restated in Medtronic’s buyer letter. 
    • Use care when manipulating the tube’s place, as manipulation could cause the inflated cuff to stretch over the tube opening doubtlessly inflicting obstruction to the affected person’s airway. 
    • Deflate the cuff earlier than any manipulation or repositioning of the tube and/or affected person. 
  • Bear in mind that Medtronic is updating the directions to be used to strengthen the warnings and precautions. 
  • Report hostile occasions and outcomes to the FDA. Immediate reporting can assist the FDA establish and higher perceive the dangers related to medical units. Consult with the Reporting Issues to the FDA part under.

Background

Electromyogram (EMG) endotracheal tubes are used throughout surgical procedure to supply an airway for affected person air flow and permit for intraoperative monitoring of EMG exercise and the nerve integrity of the thyroarytenoid muscle of the larynx. These units are 510(okay) cleared and are comprised of both PVC or silicone elastomer. Within the U.S., the at the moment marketed silicone-based EMG tubes are the Medtronic NIM CONTACT Bolstered EMG Endotracheal Tubes and NIM Commonplace Bolstered EMG Endotracheal Tubes. 

FDA Actions

The FDA continues to work with the producer to additional consider the difficulty and establish potential contributing components and mitigation methods. The FDA will proceed to watch studies of hostile occasions associated to the difficulty. 

The FDA will preserve well being care suppliers and the general public knowledgeable if important, new data or suggestions develop into accessible.

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