SUBJECT: Removal of King LTD and LTS-D Airways from Acceptable Equipment List
The King LTD airway has been on the ALS patient treatment protocol “acceptable equipment” list (Protocol 9.1) for several years. Most states allow its use as a rescue airway and most services that use it are satisfied with its performance. However, the company (King Systems Corporation), when applying to the Food and Drug Administration (FDA) for approval for its use, asked only for approval for use in adult patients during anesthesia when there is low risk of aspiration of stomach contents. Since that time the company has been marketing the product for EMS use but did not obtain approval from the FDA for this use. The FDA has sent a warning letter to King Systems Corp. requesting that all marketing for EMS use of this airway be ceased immediately. (www.fda.gove/ICECI/EnforcementActions/WarningLetters/ucm191860.htm). While the letter does not prohibit use of the King LTD airway, it does serve notice that the airway is not approved for use by EMS. For this reason we are removing the King LTD and LTS-D airways from the acceptable equipment list until the airway is approved for EMS use.
Dennis Blair
State EMS Director
Alabama Department of Public Health
RSA Tower, Suite 750
P.O. Box 303017 (Zip) 36130-3017
201 Monroe Street (Zip) 36104
Montgomery, Alabama
