4.1 The sponsor claimed that using the Ambu aScope2 would lead to an improvement in clinical outcomes. This may be relevant in emergencies and unexpected scenarios of difficult airway management, including those patients with tracheostomies.
4.2 The sponsor claimed that an improvement in clinical outcomes by reducing the risk of severe brain injury and death may lead to overall costs being reduced.
4.3 The sponsor claimed that because the Ambu aScope2 is single use, there would be a decrease in costs associated with a reduction in the incidence of cross-infection.
4.4 The sponsor claimed that using the Ambu aScope2 would reduce the time and resources spent on cleaning and repair of multiple-use fibre optic endoscopes, and on their internal transfer between hospital departments, because the Ambu aScope2 is delivered sterile and ready to use.
4.5 The Committee noted that multiple-use fibre optic endoscopes may be located on a different floor or in a different building to that in which emergency airway management is needed. Therefore, it may not be possible to obtain a fibre optic endoscope in time to use it in an emergency. The Committee considered that the main potential benefit of the Ambu aScope2 was its immediate availability for use in locations remote from fibre optic endoscopes. The Committee noted that the Ambu aScope2 may therefore be of particular value in a variety of clinical settings such as accident and emergency departments, isolated units within large hospitals and remote hospitals that have no fibre optic endoscopes.
4.6 The Committee received expert advice that multiple-use fibre optic endoscopes are often damaged in the intensive care unit when they are being used during percutaneous tracheostomy; costly repair or even replacement is then necessary. Use of the Ambu aScope2 has advantages in this scenario because the scopes are single use and damage to them is therefore of significantly less consequence.
4.7 The Committee received expert advice that in clinical settings where difficult intubations may be encountered but multiple-use fibre optic endoscopes are not available, a delay in accessing a fibre optic endoscope may have important clinical consequences including brain injury or death. The Committee noted that no published evidence or clinical studies had been submitted to support this.
4.8 The Committee considered that using the Ambu aScope2 in the clinical settings described in 4.7 could lead to an improvement in clinical outcomes but it noted that no evidence had been submitted that overall costs would be reduced.
4.9 The Committee noted that no evidence was presented to support the claim that there would be a decrease in costs associated with a reduction in the incidence of cross-infection.
4.10 The Committee acknowledged the possibility that using the Ambu aScope2 would reduce the time and resources spent on cleaning and repair of multiple-use fibre optic endoscopes, but limited evidence was submitted to support this claim.