NICE medical technologies guidance addresses specific technologies notified to NICE by sponsors. The 'case for adoption' is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
1.1 The case for adopting the Vision Amniotic Leak Detector (ALD), when issued by a midwife or other healthcare worker, is supported by the evidence. The available evidence suggests that the device can reliably exclude amniotic fluid leak as a cause of vaginal wetness in pregnancy, avoiding the need for a speculum examination and its associated discomforts. Using the device in the community could prevent unnecessary referrals to secondary care antenatal day units or maternity triage services for speculum examinations, releasing clinical time.
1.2 The Vision ALD should be considered for use in pregnant women with unexplained vaginal wetness.
1.3 Based on cost modelling, using the Vision ALD is estimated to be cost saving in scenarios considered to be clinically likely, by avoiding the need for referral to an antenatal day unit. When issued by a midwife or other healthcare worker in a primary care setting, cost savings per woman of up to £24.01 (for prelabour rupture of membranes; PROM) and £18.25 (for preterm prelabour rupture of membranes; PPROM) could be achieved. When issued by a community midwife in a woman's home, Vision ALD is associated with an estimated cost saving of up to £21.01 per woman for PROM and £15.25 per woman for PPROM.