Regulatory Focus™ > News Articles > Amniotic Fluid Leak Detector Cleared by NICE

Amniotic Fluid Leak Detector Cleared by NICE

Posted 18 July 2013 | By Louise Zornoza 

The UK's National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of the Vision Amniotic Leak Detector (Vision ALD) during pregnancy to confirm that the fetal membrane had ruptured, reducing the potential for infection. 

The device permits the timely assessment of unexplained vaginal wetness during pregnancy as being caused by leaking amniotic fluid rather than urine. This avoids the need for woman to have unnecessary speculum examinations which are invasive and often uncomfortable.

It's estimated that in the UK each year, between 64,000 and 170,000 pregnant women experience a rupture of membranes prior to labor. Using the device in the community could prevent unnecessary referrals to secondary care antenatal day units or maternity triage services for speculum examinations - this will free up clinical time and resources and is estimated to save the NHS up to £24 per woman compared to standard management.


NICE Guidance on Vision ALD

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