What is ENFit^® and How is Pharmacy Impacted?

What is ENFit? Review and Timelines

The Global Enteral Device Supplier Association (GEDSA) published a plan for member suppliers to begin phasing out legacy products beginning in July 2021 to make the move to the standardized enteral feeding design of ENFit. ENFit is recommended by the International Organization of Standardization (ISO-80369) to reduce enteral feeding connection errors and increase patient safety. The main features of the ENFit design include a unique locking system and reversal of the male and female connections.

These design changes present challenges in the neonatal/pediatric populations (see alternative solution here). The feeding tube hub that now features the male connection has a moat area that is prone to accumulating medication and milk buildup. Current clinical practice with legacy enteral products requires modification to prevent the overflow that results in said buildup. This not only includes nurses providing direct care at the patient bedside, but also the pharmacy teams preparing medications in the pharmacy.

ENFit in the Pharmacy

ENFit was not designed for medications or the pharmacy. Current practice within the pharmacy remains safe and accurate. The Institute for Safe Medication Practices (ISMP)-recommended oral medication syringes are engineered incompatible with IV Luers and they provide accuracy to the industry standard of +/-10%  fluid transfer. These oral syringes not only provide accurate dosing, they are also easily introduced to the oral cavity of an infant for oral dosing versus the large tip of the ENFit design which features external threading that poses potential risk for injury of the oral mucosa.  With a safe and accurate solution already established in pharmacy, why change!? The good news is: YOU DON’T HAVE TO!

Challenges with ENFit in the Pharmacy

Of course, with any new product, research to confirm that application in the clinical space will result in intended outcomes with its use is necessary. Pharmacy researchers at the University of Florida College of Pharmacy did just that. They looked at the performance of the ENFit female Low Dose Tip (LDT) syringes (0.5mL, 1mL, 3mL) and standard ENFit tip syringes (6mL, 12mL). Their primary research objective was to evaluate the frequency of dosing variance exceeding 10% of the intended dose between legacy and the female LDT syringes. What they found was “the incidence of dosing variance exceeding 10%, and absolute variance were significantly greater for 0.5 and 1ml LDT syringes compared to legacy.”

Additionally, their research raised additional concerns with ENFit LDT syringes for the enteral/oral route, demonstrating high dosing inaccuracies for both oral and enteral delivery.

Preparation Changes

A change to ENFit in the pharmacy also means a change to practice. What is currently a slip action of filling oral syringes would become a twisting motion with each step in the process. Additional ENFit connectors and accessories will need to be added to the pharmacy supply to facilitate drawing up liquid medications with the ENFit system. This not only complicates the process, but is also adds additional cost to an already strained hospital budget.

Medela's Solution

Medela has a patented unique solution called the Low Dose Dual Cap, which allows the pharmacy to remain unchanged in regards to both products and process. They will continue to utilize the ISMP-recommended oral medication syringes to prepare and dispense liquid medications to all units. Autonomy is given to the nurse administering the medication to determine the route in which it will be administered. If the route is to the oral cavity, nothing changes from the current delivery process, which is the majority of the time. If the route is to be administered via an enteral device (ENFit), the nurse would utilize the Low Dose Dual Cap to connect the pharmacy syringe to the enteral device to safely and accurately deliver the dose. Even with the smallest of doses, the low dose technology allows for accurate fluid transfer and ensures accuracy with every dose. The Dual Cap, just like it sounds, has two unique ends. The one end is compatible with oral pharmacy syringes, which are engineered incompatible with IV Leurs, and ENFit on the other end – resulting in a safe house wide solution.

To summarize, this solution offers no changes in pharmacy, who will continue using ISMP-recommended oral syringes to prepare and deliver medications. The majority of the time, oral pharmacy-prepared syringes are administered to the oral cavity and less often connected to an enteral device. During those times a connection to an ENFit device is necessary, the Medela Low Dose Dual Cap allows for the safe connection and administration of medications in all patient populations while maintaining industry standard accuracy levels.

Contact your local Medela Sales Representative to discuss our options further or reach out to our award-winning Medela Customer Excellence Team to get the conversation started!