Texas Children’s takes action following anesthesia-related FDA safety announcement


Texas Children’s takes action following FDA safety announcement

In December 2016, the U.S. Food and Drug Administration published a safety announcement regarding the long-term effects of anesthesia in children under the age of 3 and pregnant women. The warning states that a single short exposure to anesthesia appears to be safe and there is some evidence that prolonged or repeated exposures could have negative effects on behavior and learning in children under the age of 3, however more research is needed.

In January 2017, Texas Children’s Anesthesiologist-in-Chief Dr. Dean Andropoulos formed an FDA task force with leaders from Texas Children’s Departments of Anesthesiology, Surgery, Pediatrics, Radiology, Marketing and Risk Management. In addition, Andropoulos authored a perspective article in the New England Journal of Medicine (NEJM) with Dr. Michael Greene from the Department of Obstetrics and Gynecology at Massachusetts General Hospital, titled “Anesthesia and Developing Brains — Implications of the FDA Warning.”

The hospital task force followed the FDA’s recommendation that a discussion take place between parents, surgeons, anesthesiologists, and any other physicians involved in a procedure that uses anesthesia. The discussion covers the anesthesia plan and the duration of the anesthetics. After the discussion, the clinical teams assess whether the procedure should be delayed until the patient is over 3 years of age.

The task force, in collaboration with the Anesthesia Department, created and distributed educational tools and talking points about the safety announcement and the organization’s efforts for all Texas Children’s Hospital and Texas Children’s Pediatrics faculty. Family education materials also were developed and incorporated into operational workflows for distribution at all Texas Children’s campuses. All materials were made available in English and Spanish.

To further help communicate Texas Children’s plan of action, Andropoulos held lectures during surgery, neurology and pediatric grand rounds. The year ended with Texas Children’s implementing an updated state-mandated anesthesia consent form that included language regarding the FDA safety announcement.