February 28, 1994
Anesthesia Care Providers
Emergency Care Providers
Respiratory Care Providers
This is to advise you of a potentially serious problem associated with the use of uncuffed pediatric endotracheal tubes.
FDA has received several reports of a colorless material inside endotracheal tubes which occludes the lumen and prevents adequate ventilation of the patient. The material causing the obstruction is not easily detected by visual inspection. It can remain undetected until after the child is intubated, thereby necessitating reintubation, and potentiating a life threatening, emergency situation.
We recommend the following precautions when using pediatric endotracheal tubes:
- Check the patency of all endotracheal tubes (tube and connector) immediately prior to intubation.
- Do not allow solutions/lubricants that can form film barriers to enter the lumen of the tube.
- If it becomes necessary to reconnect the endotracheal tube and the connector, do not use solutions/lubricants that can form film barriers.
- In particular, do not use cellulose products (e.g., lidocaine jelly) as a lubricant in reconnecting endotracheal tubes and connectors, and keep this material out of the lumen of the tube. FDA laboratory analysis has determined that 2% lidocaine jelly can form a film inside a 5 mm connector that could, after sufficient "curing time," become a flexible obstruction that totally occludes the lumen of these devices.
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, send an email request to email@example.com.
Please remember that the Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illnesses and injuries associated with the use of medical devices. You may report such incidents by phoning 301-427-7500, by FAXing to 301-881-6670, or by writing FDA, CDRH, MDR User Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
Bruce Burlington, M.D.