Low Dose Accuracy in Neonatology

ENFit™ can lead to inaccurate dosage

As written in the ISO 80369-3, “Laboratory testing shows a mid-tolerance [ENFit™] connector pair in a female to male orientation displaces a mean average of 0.148ml (min 0.089ml and max 0.179ml with an n = 32) of fluid. “
This volume displacement is particularly unacceptable for oral medications administrated in low doses to neonatal patients.

Overdosing risk for ENFit, theoritical measurement and laboratory testing

 

A drawing-up device can’t eliminate the ENFit™ overdosing risk

If we assume the drawing-up protocol is correctly followed, the tension surface effect and/or the viscosity of the medication can still lead to a variation in the dose delivered (up to 0.148ml).
The volume displacement risk can’t be eliminated

The French Society of Neonatology (SFN) recommends a dedicated safety enteral system for neonates

In their newsletter of March 2016, the SFN warns French Neonatologists about the dose inaccuracy risk of ENFit™ and recommends a neonatal enteral feeding system with the following features:

Safe

  • Incompatible with Luer and other small-bore connectors used in other applications (e.g. IV)
  • Allowing a reliable connection between components without leakage or cracking

Accurate

  • Having an internal dead space less than 0.1ml
  • Generating a volume displacement during connection less than 0.05ml

Size adapted to preterm infants

  • Incorporating the smallest possible connectors
  • Incorporating the lowest possible weight connectors

Download the SFN Newsletter (in French)

Download the summary (in English)