Safety Alert: Is ENFit safe for Small Children & Neonates?

Following a number of incidents where enteral drugs were delivered via intravenous devices the UK introduced the reverse luer lock system in order to prevent practitioners accidentally connecting drugs prepared in oral/enteral syringes to intravenous connectors.

More recently a global initiative was launched through the ISO 80369-3 standard. This introduced a new design of connection, ENFit, that is incompatible with both IV and current reverse Luer devices. Unfortunately there are a number of aspects of the design and operation of the ENFit devices that open to question their suitability for use in our small patients:

The ISO standard is designed & CE marked for enteral use ONLY: That is for delivery of drugs through indwelling enteral devices. The standard does not encompass oral use and devices made to this standard are not CE marked for oral use.

If Luer or ENFit devices are used for oral use, additional steps are required to ensure the correct dose is delivered at small volumes. The risk of this causing a problem is generally felt to be clinically insignificant. However there is a further risk of incorrect over-delivery of medication with ENFit low dose syringes, irrespective of delivery route (see Vygon link on resources page). Specific steps & practices may be introduced to mitigate against this, but can only be enforced through strict adherence to a prescribed procedure. When protocol violations occur, small patients may be exposed to both the previously known risk, plus the additional new additive risk of an overdose. Consideration needs to be given to the significance of this additive effect.

In addition to the above, some of the small dose oral syringes have ‘wings’ added around the hub. These do not form part of the ISO standard but have been perceived by some centres to pose a risk of tissue damage if used to deliver oral medications to children. It is understood that the manufacturers are looking to revise this, but that an improved design is not yet available.

An alternative proposed solution is to introduce other ‘oral’ syringes, alongside the ENFit devices to mitigate against the above issue. This introduces further complexity to the process of administering medications via the GI tract increasing the opportunity for further errors and protocol violations.

There are a growing number of paediatric & neonatal clinicians who are concerned that the design of this product has not taken sufficient account of the needs of their patient population. This is especially true when operation is considered, through the lens of human factors in the clinical environment.

A number of resources of information regarding these devices has been collated here. Please email MiST here if you have any further information that could be usefully added to this resource.

The MiST collaboration recommends that a full & detailed risk analysis is undertaken BEFORE the introduction of ENFit devices in any organisation.

Please note: With regard to ongoing supplies, Birmingham Children’s Hospital has been advised by the manufacturer, Medicina, that they will continue to supply exiting reverse luer lock devices until issues with small volume syringes have been resolved.