Today,
the U.S. Food and Drug Administration (FDA) is issuing a Letter to Health
Care Providers to increase awareness about the potential risk of airway
obstruction when using silicone-based electromyogram (EMG) endotracheal tubes
(Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM
Contact Reinforced EMG Endotracheal Tube). The FDA has received reports
describing serious adverse events and deaths for these devices after airway
obstruction and ventilation failure. At this time, the root cause and
incidence rate of obstruction and ventilation failure with use of these
devices is not known. The
Letter to Health Care Providers includes important information about
silicone-based EMG endotracheal tubes, including:
Questions? If you
have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE). |
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