Low Dose Accuracy in Neonatology

“Concerns have been raised about the possible risks of delivering inaccurate doses of medicines [with ENFit™] in certain clinical practices across high risk subpopulations (e.g. neonatal patients)”

Extract of ISO 80369-3:2016 - Annex A

Concerns about drug administration with a dose less than 2 ml

Delivering the right dose to a neonate is critically important. Underdosing can result in a lack of efficacy, and overdosing can result in adverse effects.

The Children’s Hospital of Philadelphia shared data showing that more than 80 different oral medications are administrated in volumes less than 2ml and 1,250 of these doses are prepared every day, representing 48% of their daily administrated oral doses. (1)    



As “laboratory testing shows a mid-tolerance [ENFit™] connector pair in a female to male orientation displaces a mean average of 0.148 ml […] of fluid “, neonatal specialists raised important concerns about the possibility of ENFit™ syringes being inaccurate for low dose administrations.

Extract of ISO 80369-3:2016 - Annex A

  • (1) Update on implementation of the new ENFit™ enteral connectors – ISMP newsletter – June 30, 2015