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pwilliams's picture
by on Mon, 2016-05-16 10:46

At the Airway Leads Day at the RCoA in March DAS representatives presented the updated DAS guidelines and discussed FONA.  The recommendation was for departments to have one technique available, and to train all colleagues in that technique.  Based on NAP4 findings DAS are suggesting that surgical techniques are the preferred choice, with scalpel, bougie, tube being repeatedly mentioned, no doubt as the equipment should be readily available and a normal breathing circuit can be connected.
I have several concerns re scalpel, bougie, tube I would like other Leads views on:
     - Purpose made Cricothyrotomy are available, ie from Cook, which are designed and licensed for FONA
     - Bougies and endo tracheal tubes are not licensed for FONA; see their respective instructions for use
     - The MHRA states:
You should use medical devices as described by the manufacturer in the instructions. If you use the device in any other way, it’s considered ‘off-label’ use. Without the manufacturer’s approval this will be at your own risk and you or your employer could become liable for civil claims for damages from injured patients or their families if something goes wrong with the device.
In my Trust we've recently had a death associated with the correct use of a bougie to aid oral tracheal intubation in an elective patient, due to tracheal perforation.  The Coroner quizzed the anaesthetists on the use of the bougie and if it had been used correctly. 
If a bougie is used during a surgical cricothyrotomy, there must be an  increased risk of tracheal or bronchial trauma due to its long length compared with a purpose made cricothyrotomy kit.
Based on the MHRA statement, is it wise/appropriate for DAS to push scalpel/bougie/tube as a preferred technique??  What are the legal repercussions in the event of a poor outcome?  No doubt the individual anaesthetist will be left to face the consequences.
In my department I expect we will end up teaching surgical FONA with the Cricothyrotomy kit, and scalpei/bougie/tube due to differing preferences of colleagues.  They are essentially the same technique with minor differences. However off label use of equipment will leave the anaesthetist liable to civil claims for damages if harm occurs. They will need good reasons to justify their choice of technique.
Phil Williams
Airway Lead, SASH