4.1 The sponsor claimed that use of the Vision Amniotic Leak Detector (ALD) would reduce time spent in hospital and associated staff time and bed use.
4.2 The Committee considered the setting in which the Vision ALD would be used. The Committee concluded that the most likely benefit would arise from using the Vision ALD in community health services to avoid unnecessary referrals to secondary care, such as an antenatal day unit or maternity triage service, releasing resources and clinical time in these departments. The Committee heard advice from clinical experts confirming that use of the Vision ALD by a midwife based in a GP practice, or by a community midwife visiting the woman's home, would be the most likely scenarios for use of the device in the community.
4.3 The Committee also noted that women contacting an antenatal day unit or maternity triage service by telephone, with concerns over unexplained wetness, could be advised to contact a community or primary care-based midwife to be given the Vision ALD, potentially avoiding unnecessary visits to secondary care services.
4.4 The Committee heard expert clinical advice that such a change in practice, aimed at reducing referrals to secondary care through the use of the Vision ALD, was realisable and was likely to be acceptable to clinicians involved in the current care pathway.
4.5 The Committee was advised by a clinical expert that the Vision ALD could be issued by a healthcare worker to women presenting at a GP practice with unexplained wetness. The Vision ALD could be worn by the woman while sitting in the waiting room and the results read by a midwife or GP.
4.6 The Committee heard clinical expert advice that a further possible scenario was self-administration of the Vision ALD by women in their own homes, and noted that this was outside the scope of the evaluation.