Medication Delivery with an ENFit Transition and Focus on Pediatrics

Much has been written about medication delivery with ENFit in the neonatal space with regards to cleaning the hubs and accuracy of medication delivery. Pediatrics also has many of these same issues and some additional concerns to address when using ENFit and undergoing an ENFit transition.

Some background on ENFit and how it came to be: 

• ENFit is an enteral design from GEDSA.
• ISO, or the International Organization of Standards, made recommendations several years ago to prevent misconnections by having tubing designs that will not allow unlike lines to fit together.
• GEDSA is an organization of vendors that got together to design the new ENFit tubing based on the ISO recommendations above.
• All this began because misconnections were still happening in the enteral space, despite designs to make enteral products incompatible with IV or other lines. ISO recognized this and the call went out to make changes. GEDSA made the ENFit design of the 1) male/female connections being switched and 2) a locking system, to address the ISO call for improvements and safety.

Medication Delivery Considerations Before Your ENFit Transition

GEDSA, the organization of vendors, looked at designs to best address the issue of misconnections. The solution they came up with - male/female switch and locking system - definitely addressed the overall concerns. But, the design was not perfect for the neonatal or pediatric space.  This is mostly because the hub on the syringe was now female, meaning a much larger dead space (think what that means for medications), the NG tube tip was now male, and the locking system gave that male tip a big moat around it. What does a moat do? It collects and holds liquids. Administering so many feedings in NICU and in pediatrics via the tube means potential milk and medication collection in the NG tube moat. That means difficulty in cleaning the NG tube hub and, to some extent, potential accuracy issues with medications.

The pictures below shows the new design and some of the issues that it brings:

The first photo (above) is the female hub on a syringe.

The second photo (above) is the low dose (1ml) tip syringe - note the large tip, moat, and large threads on the sides.

The third photo (above) is the ENFit syringe overflowing with milk.

The fourth and fifth photos (above) show the moat surrounding the NG tube hub.

Accuracy

Accuracy issues with ENFit may occur with both neonatal and pediatric patients. They need to be understood and evaluated for best clinical practice. Two studies published from the University of Florida addressed many of the issues surrounding ENFit and medication administration:

• Dosing Inaccuracy with Enteral Use of ENFit^® Low Dose Tip Syringes: The Risk Beyond Oral Adapters
• Female Low Dose Tip Syringes-Increased Complexity of Use May Compromise Dosing Accuracy in Paediatric Patients

Highlights of the above research:

• The studies talking about accuracy concerns were with small doses of medications and the least accurate were the 1ml (low dose syringe) and smaller.
• Neonatal and Pediatric patients were the most likely to be negatively impacted.
• Oral slip-tip syringes were the most accurate of those tested.
• Dosing accuracy could be compromised when using a different adapter for dispensing than administering or when using adapters for only dispensing.
• When using oral adapters, inconsistent volumes were delivered – resulting in higher rates of a dose when compared to oral syringe delivery. (see more on this below)
• They also found that medication can accumulate in the “moat” area on the low dose syringe.

Cleaning

Cleaning becomes an issue because of the “moat-like” area around the now-male tip NG tube hub. Many cleaning products are on the market – ENFit cleaning brushes, Q-tips, toothbrushes, gauze pads and more. Medela teaches a “clean connection” technique to avoid overfilling and spilling into the “moat” area, but it means some technique changes for the nurse and we all understand that old habits die hard.

A study was recently published in 2020 out of Children’s Mercy in MO (Lyman et al) that was a randomized controlled trial assessing the effectiveness of two cleaning practices for ENFit connectors. They looked at a 17-step process versus a 9-step process – and yes, this is a lot of steps to take to clean something that is accessed multiple times a day! The overall conclusion was that neither regimen was significantly effective and it addressed the complexity of keeping the global ENFit hub clean. In the 17-step process, only 30.7% were clean. In the 9-step process, only 13.1% were clean. They used a toothbrush and a more expensive ENFit cleaning brush, but no difference was found in effective cleaning.

The results validate the concerns around keeping the ENFit connector clean, as well as the need for a diligent cleaning protocol whether residue is visible or not visible. A clean connection technique and preventing the build-up of milk would be optimal but, again, it means nursing needs to change with a practice technique. See the full RCT study.

Adapters

Adapters have been introduced for PO medication delivery to avoid the low dose (1ml) syringe issues of the large, moat-like cap with sharp threads going into a neonate or pediatric patient’s mouth. Adapters like the one below from Medela, called the Dose Cap, can be used and are sometimes popular in pediatrics where giving medications to a young child can be more challenging than with a neonate.

Adapters initially look to be a good solution, but when you look at the tip of the adapter it is much longer – meaning more dead space. More dead space means less accuracy and this cap is only accurate to the ISO standard of plus or minus 10% at 0.7ml, not the ISO standard of plus or minus 10% at 0.2ml. What this means is that only meds that are 0.7ml and above are accurately given within that 10% +/-range and under 0.7ml is not guaranteed. Also, vendors of these adapters do not recommend any volume for flushing because none have been done to determine that the medication is flushed through the dead space. Hospitals need to decide what to flush with and how much to clear the hub. One more consideration from a practical clinical view is that it would be very difficult to give a medication to a young child and try to come back with a flush for a second administration.

Solutions can be in place to make this product work, such as education on how and when to use the product and stressing that it should only be used for medications 0.7ml and above. But, that is a very limited range for medications – only meds 0.7, 0.8, 0.9 and 1ml can be given with this product in the ISO +/-10% accuracy range. How will you be sure it is used appropriately by all staff? Flushing can be determined by the hospital but, again, it will take some time and consideration from clinicians, pharmacists, and management to decide what to do.

Another solution that Medela offers to the Neonatal and Pediatric population is that Medela will continue offering both ENFit and the TwistLok (Legacy) line. The TwistLok line offers a complete safety system while avoiding some of the pitfalls of the ENFit design when it comes to cleaning, medication accuracy and Pharmacy changes. Medela has other product solutions, such as the Dual Cap, that will allow the Adult Units to move to ENFit, give medications with oral tipped syringes, and have no impact to an ENFit transition.

Proactively Understanding Your ENFit Transition

In conclusion, it’s best to understand how ENFit is going to impact your clinical area and remember that both your neonatal and pediatric departments have issues to address. However, issues related to medication administration, accuracy, and cleaning with ENFit can be addressed and solutions can be found. The first step is clearly understanding what they are in order to address them.