Regulatory Focus™ > News Articles > NICE Opens Consultation on Breathing Device

NICE Opens Consultation on Breathing Device

Posted 22 March 2013 | By Louise Zornoza

The UK's National Institute for Clinical Excellence (NICE) has opened a consultation on its draft medical technology guidance recommending National Health Service (NHS) coverage of a new device offering a breakthrough advantage for surgeons experiencing unexpected difficulties in positioning a temporary tube (intubation) to keep a patient's windpipe open during surgery.

The Ambu aScope2 is a thin, single-use, flexible endoscope (with an accompanying monitor) that uses video camera technology to help health professionals see the windpipe clearly, so that the breathing tube can be correctly placed when intubating patients with difficult airways.

The evidence considered indicates that the Ambu aScope2 is an acceptable alternative when a multiple-use fibre optic endoscope (a thin flexible camera) is unavailable. The multiple-use endoscope is the current gold standard device used for managing difficult intubation. The Ambu aScope2 may also be used to replace dislodged tracheostomies, a surgical procedure in which an opening has been created through the neck at the front of the windpipe and a tube connected to an oxygen supply inserted to help with breathing.

The Ambu aScope2 system is a portable device consisting of two components: a single-use aScope (endoscope) and an accompanying aScope monitor for displaying the images.

The manufacturer claims that the benefits of using the device include improved outcomes in emergencies and unexpected scenarios of difficult airway management due to the immediate availability of a sterile fiber optic endoscope that does not need calibration, a reduced risk of cross-infection from contaminated multiple-use fiber optic endoscopes, and improved safety for patients with tracheostomies.

NICE estimates that there are approximately 22,000 instances each year in the UK where there are unexpected difficulties with endotracheal intubation in patients.


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