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:
If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).
This information has been broadcast to: Blood Banks; Community Health Centers (FQHCs); Emergency Medical Services / First Responders; Long-term Care; Health Care Facilities / Other; Health Care Organizations; Health Care Providers; Hospital Staff Directory; Hospital CEOs; Hospital Emerg Preparedness Coords; Hospital ER Medical Directors; Hospital Infection Control Practitioners; Hospital Medical Directors; Hospital Nursing Directors; Hospital Security Directors; ICU Administrator; Lab Director; Hospitals / Acute Care; Hospitals / Other; Hospitals / Veterans; Labs / Non-Sentinel; Labs / Sentinel; Occupational Health Organizations; Pharmaceutical Suppliers; NJLINCS and Local Contacts; Public Health Sector; Local Boards of Health; NJDOH Staff; NJLINCS Community; Public Health Associations; Public Health Council