FDA Issues Warning to King Systems about Off-Label Use of King LT-D; ITLS Editorial Board to Examine Issue in January
12/9/2009

In a warning letter, the U.S. Food and Drug Administration (FDA) has ordered King Systems, a Consort Medical company, to stop marketing its King LT(S)-D orapharyngeal airway for off-label use.

The Office of Compliance in the Center for Devices and Radiological Health reviewed King Systems' website for the King LT(S)-D oropharyngeal airway product and found that the device was being marketed as "intended for airway management in patients over four feet in height for controlled or spontaneous ventilation ... for difficult and emergency airway cases ... and as well-suited for ambulatory and office-based anesthesia."

However, the FDA said the device was solely approved for use of "controlled ventilation during anesthesia" for short procedures in adults, when patients are considered at low risk of aspiration of stomach contents.

The ITLS Editorial Board will be examining this issue and its implications for ITLS at its meeting in January 2010.

To view the complete warning letter, visit: www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm191860.htm.