I hear this all the time from concerned clinicians at NICUs all over the U.S., and it’s a really valid concern. The design of the new ENFit™ enteral syringes—where male/female tips are switched and must be locking—was done to make enteral feeding practices safer, easier, and most importantly, to avoid potentially deadly misconnections. But unforeseen consequences of the male/female switch had an impact directly on NICU practice because the dead space in the female syringe became larger with the new design. The larger dead space means a possibility of under- or overdosing the patient. If more medication is left in the tip, the patient is under-dosed, and if that medication in the tip is flushed into the patient, it’s an overdose. Testing shows that the over/under dosing can be as much as 30% in medications 2 mL and under—and that’s the majority of medications in the NICU.
So what should we do?
Well, the Global Enteral Device Supplier Association (GEDSA), which is the regulating agency that oversees the ENFit design and implementation, has help coming. This help is in the form of a GEDSA low dose syringe. The low dose syringe will actually have dose accuracy better than what we currently have with PO syringes. It will have a +/- 10% accuracy for doses up to 0.2 mL. The design of the tip provides the accuracy clinicians are looking for. This is not a complete answer to the issue just yet because 1) it is not available, and 2) what about those doses under 0.2 mL?
The answer to “it is not available” does have a light at the end of the tunnel. The master file to approve the low dose syringe was previously filed with the FDA, and manufacturers have already begun receiving 510(k) clearance.
The doses under 0.2 mL need more evaluation and discussion, but are also solvable. The GEDSA testing for accuracy was only for doses to 0.2 mL, so it’s just not been tested. Those 0.2 mL doses, while certainly seen in the NICU environment, are still only a small number of doses. So when such a small dose needs to be given, ISMP recommends using PO syringes for accuracy. Discussions need to be had between clinicians and pharmacy at each individual hospital as to how to give that small PO dose: by mouth, via a gravity or pump feeding, but it can be done.
I suggest that clinicians start talking to each other, especially between the pharmacy and NICU/Pediatrics units as to how this ENFit transition will be implemented. Sign up for updates on the GEDSA.org website. Talk to vendors that supply enteral products to the NICU and ask questions about their plans for designs and transitions.
The ENFit low dose syringe designs are coming soon, and it’s forcing us to look at how we administer neonatal enteral products. The designs are safer and more accurate, and with some planning and discussion, should be easy to implement.