Below, you'll find the most recent clinical bulletins, which may affect you and your EMS agency. Please help us share and spread the word.
Oct. 10, 2023
In August 2023, Ambu Inc, the makers of the King Airway, were sent a letter warning that certain models of the King Airway LTS-D did not have appropriate premarket approval from the FDA or exemptions as investigational new devices (i.e., those models were not FDA approved). It also warned that the device is misbranded as a pediatric device as the FDA cleared indication for the device is for adults. As a result, Ambu Inc. has initiated a delivery stop for the affected models/ sizes and encourages users to identify appropriate alternative airway devices.
The models affected are King LTS-D models in what we would think of as pediatric sizes, i.e. promoted for patients <5 kg, 5-12kg, 12-25kg, and 25-35 kg. This corresponds to size 0, 1, 2, and 2.5. Please note that the adult models are not affected.
To KBEMS’ knowledge, no specific concerns regarding incidents of unsafe performance have been raised. The warning appears to be based specifically on not having met the regulatory requirements for these specific pediatric models. A letter from the company to users is attached.
As such, EMS services in Kentucky may wish to discontinue use of the King LTS-D for now, if even just the pediatric sizes, given that they do not appear to have FDA clearance or approval. As many services may rely on the use of the King Airway as their primary advanced airway choice, any service wishing to discontinue use of the King airway in favor of use of another blind insertion airway device (BIAD) may do so and may begin use on submission of the notification to KBEMS. Note that your service may not utilize a device-specific airway protocol, but, If necessary, protocol amendments to substitute the desired alternative airway device (namely i-gel or LMA) may be submitted, and if you are submitting an already KBEMS approved protocol without changes, that protocol may be used upon submission prior to Board ratification in this unique situation.
Note that any training required for use of an alternative BIAD is the responsibility of the service and the service medical director and must be completed prior to use of an alternative device.
Please don’t hesitate to reach out with any questions.
Aug. 2, 2019
Maine EMS has been made aware of four instances of failures of the following equipment:
- Curaplex brand Nasopharyngeal Airway (NPA), multiple sizes
The failures have been recorded over the course of the past year. In each instance, the trumpet/flange end of the airway adjunct collapsed, resulting in total migration of the adjunct into the nasal cavity. One instance required extraction in the OR. The adjuncts in question were ordered from BoundTree. Neither Maine EMS nor the reporting EMS service is aware of any recall by the manufacturer (Tri-anim). Maine EMS advises services to exercise caution as necessary when using these or any nasal airway adjuncts, and to contact BoundTree or the manufacturer if you have any questions.