2.1 The Ambu aScope4 Broncho (Ambu Ltd) is a sterile, flexible, disposable device available in 3 sizes (slim, regular and large) of which the slim and regular sizes are indicated for difficulties with endotracheal intubation in patients with difficult airways. It is used to visualise the airway and then to aid in the placement of an endotracheal tube, either directly or through an intubating laryngeal mask. It is a portable device that can be used wherever a flexible fibre optic endoscope is needed for airway management. This may be in anaesthetic rooms, critical care or emergency departments or in other areas of hospitals where emergency airway management is undertaken. The Ambu aScope4 Broncho can also be used to aid percutaneous dilatational tracheostomy and to check the position and patency of airway devices such as endotracheal tubes, double lumen tubes and tracheostomy tubes. The slim version of the Ambu aScope4 Broncho can pass through an Aintree intubating catheter if one is being used. 
2.2 The Ambu aScope4 Broncho system consists of 2 components – a single‑use aScope (endoscope) and an accompanying aScope monitor for displaying the images. These are supplied together. The Ambu aScope4 Broncho uses video camera technology to create the image which is displayed on the 800×480 pixel aScope monitor. The portable monitor indicates the rechargeable battery capacity (claimed minimum of 3 hours) and also has a video output to transfer images to a larger monitor or recording device. The 2 components are used together and must therefore be available in the same location for the system to be effective. The single-use endoscopes are supplied sterile and ready for use. The monitor is re-usable. During procedures, the monitor can be powered by either battery or mains and is designed to be connected to the mains to recharge at other times. 
2.3 The Ambu aScope4 Broncho has a working channel of 1.2 mm to 2.6 mm diameter, depending on size, that can be used for instillation of fluids (saline and topical anaesthesia), suction and insertion of endoscopic accessories. The suction port is designed to remove secretions. 
2.4 The cost of Ambu aScope4 Broncho stated in the sponsor's submission was £179 (including VAT) per single-use endoscope. The monitor had a list price of £799 but was provided to NHS organisations free of charge with 5 Ambu aScope4 Broncho devices. Each monitor has a 12-month warranty and each single-use Ambu aScope4 Broncho has a 3-year shelf life.
2.5 The claimed benefits of Ambu aScope4 Broncho in the case for adoption presented by the sponsor are:
Improved outcomes in emergencies and unexpected scenarios of difficult airway management due to the immediate availability of a sterile fibre optic endoscope that does not need calibration.
Improved safety for patients with tracheostomies due to a reduction in morbidity and mortality associated with the failure to re-establish ventilation if the tracheostomy tube is displaced in a patient with a difficult airway.
Reduced risk of cross-infection from contaminated multiple-use fibre optic endoscopes.
Reduced costs associated with an improvement in clinical outcomes in emergencies and unexpected scenarios of difficult airway management including patients with tracheostomies.
Reduced costs associated with a reduction in the incidence of cross-infection.
Reduced time and resources spent on cleaning and repair and internal transfer between hospital departments as the Ambu aScope4 Broncho is delivered sterile and ready to use.
2.6 Placement of an endotracheal tube guided by a multiple-use fibre optic endoscope is the gold standard for managing difficult intubation. Using a fibre optic endoscope or a video scope allows visualisation of the vocal cords followed by accurate placement of an endotracheal tube.
2.7 The Difficult Airways Society guidelines (Henderson et al. 2004) outline the clinical pathway for unexpected difficult tracheal intubation during routine induction of anaesthesia in adults. The guidelines describe the initial tracheal intubation plan (Plan A) and the secondary tracheal intubation plan (Plan B). Plan A describes direct laryngoscopy as the initial standard technique for intubation. Plan B is recommended after 4 failed attempts at intubation. This involves placement of a supraglottic airway device: if that is successfully achieved and the patient can be ventilated, then ventilation may be maintained via the supraglottic airway device, or else tracheal intubation can be attempted with the aid of a multiple-use fibre optic endoscope.
2.8 Tracheostomy is a surgical procedure performed on a patient's neck to create an airway directly into the trachea. The placement of a percutaneous tracheostomy tube can be guided by a multiple-use fibre optic endoscope. Percutaneous tracheostomy has now replaced the traditional open operation and is considered standard technique in many intensive care units worldwide. The use of an endoscope during percutaneous tracheostomy enables the user to visualise the procedure from within the trachea, and so prevent the needle and dilators from penetrating the back of the trachea as well as ensuring that the tracheostomy tube is correctly placed.