NICE supports NHS use of two innovative new devices


Vision ALD and Ambu aScope2 effective for detecting problems in pregnancy and keeping problem airways open

The National Institute for Health and Care Excellence (NICE) has published two new pieces of Medical Technology Guidance recognising the effectiveness of an airway support device and an innovation designed to assess pregnancy complications.

Following consultation on the technologies, the organisation is supporting the use of Ambu aScope2 and the Vision Amniotic Leak Detector (Vision ALD) within the NHS.

The Vision ALD, manufactured by Sutherland Health Group, is a diagnostic panty liner that can be attached to underwear. The device is issued by a midwife or other healthcare professional and is then worn by the woman for up to 12 hours, before the liner is then placed in a drying unit.

The indicator strip in the liner changes colour depending on the pH of the fluid causing the wetness, and whether ammonia, which is present in urine, is detected. If the indicator strip is yellow after drying, then the leak is unlikely to be amniotic fluid and a speculum examination can be avoided. If the indicator strip is blue-green after drying, this indicates the wetness is likely to be amniotic fluid or infection, which can then be confirmed by a speculum examination and a vaginal swab.

The estimated cost saving compared to current methods of testing is believed to be up to £24 per woman. In addition, the device benefits women by avoiding a potentially-unnecessary speculum examination and associated risk of infection, a reduction in time spent in hospital, and incidental detection of possible vaginal infection.

Commenting on the guidance, Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “This new guidance on use of the Vision ALD is good news both for pregnant women who experience unexplained vaginal wetness and for the NHS. The evidence considered shows that the device can reliably distinguish whether unexplained vaginal wetness in pregnancy is due to amniotic fluid leaking, or if it’s due to urine which is less of a concern. The guidance recommends that midwives and other healthcare professionals provide the Vision ALD to pregnant women experiencing this complication. This avoids the need for the woman to have an unnecessary speculum examination which is invasive and often uncomfortable.”

This guidance can help clinical units fill a current gap in provision, and make sure that this effective device is available at the point of need in an emergency

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

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 fibre optic endoscope that does not need calibration. There is also a reduced risk of cross-infection from contaminated multiple-use fibre optic endoscopes; and improved safety for patients with tracheostomies.

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Describing the device as an ‘important step forward for patient safety’, Professor Longson, said: “We are pleased to publish this new guidance on use of the Ambu aScope2 to help where emergency action is unexpectedly needed to keep a patient’s airway open. There are an estimated 22,000 instances each year in the UK where there are unexpected difficulties with endotracheal intubation in patients. In some cases, this can result in patients being brain-damaged or dying because unexpected problems with keeping the airway open has left the patient starved of oxygen. This guidance can help clinical units fill a current gap in provision, and make sure that this effective device is available at the point of need in an emergency.”