The ISO 20695 committee refused to include the LDT syringe in the normative requirements
In September 2017, the first draft of the International Standard was disapproved. One of the main reasons is that the "Low Dose Tip" (LDT) syringe had been integrated into ISO 20695, although its ability to reliably increase dose accuracy is not ensured.
National Coalition for Infant Health (NCfIH) warns about the use of the ENFit system in Neonatology.
As part of the introduction of ENFit on the market, the NCfIH organisation pointed out significant risks associated with the use of the ENFit connector or the Low Dose Tip syringe. In a letter to The Joint Commission, it expressed its concerns about the use of this system on premature newborns, for whom dosage must be of the highest accuracy.
The “Low Dose Tip” syringe can lead to dose inaccuracy
The new syringe design, called Low Dose Tip (LDT) syringe, doesn’t fully address concerns about dose accuracy in neonates. Laboratory testing showed inconclusive results.
ISO 80369-3 is now published !
A new ISO Standard to provide safety in enteral feeding therapy
In July 2016, the International Organisation for Standardisation published the ISO 80369-3, which creates a standardised safety enteral feeding connector. This new connection, named ENFit™, prevents the likelihood of tubing misconnections by its specific design. But while tubing misconnections are addressed, new risks are introduced for the tiny patients.