ENFit Syringes and Their Impact to New Standards in the NICU
Kim Flanagan, MSN, CRNP / July 2017
The goal of implementing the new ENFit system is simple: improve patient safety. The implementation itself however, may not always be that simple.
But as clinicians and hospitals navigate the challenging waters of change, perhaps it may be beneficial to keep the big picture in mind. To keep the daily struggles in check and maintain our perspective.
So, let’s look at the history of where and why these new standards came to be and what impact they may have for patient safety today.
One of the earliest medical misconnections documented in the literature was from 1972 when milk was inadvertently administered thru an IV. In 1996 the Joint Commission created a Sentinel Event Policy to assist healthcare facilities in taking steps to improve safety.
That same year, the Association for the Advancement of Medical Instrumentation (AAMI) implemented a standard to make enteral connectors incompatible with IV Luer-lock connectors. However, because it was a voluntary step, manufacturers never developed the alternative designs. And once they did they were not mandated, thus were never universally adopted.
Ten years later in 2006, Sentinel Event Issue 36 was released. The Joint Commission acknowledged the risks which could lead to patient safety issues, such as look-alike multi-purpose tubing, which continued to be a problem despite best efforts.
The Joint Commission has urged manufactures to implement design change for products that make them unique to their function. An example of this would be enteral feeding tubes and syringes that can no longer be used for anything other than enteral feeding by nature of their design. This is what we know as ENFit.
The design inherent in ENFit is called force function. Enteral feeding equipment will be the first of many product design changes that will finally be brought into the market. More importantly, the same design will be shared by multiple manufactures with the goal of not only national but global standardization.
As a result, hospitals will receive many benefits such as not having to change tubes when patients are transported from institution to institution. Future areas planned for change include: connectors for flow of gases, limb cuffs, urological access, neuraxial access.
But as we know from history, voluntary adoption of these products led to limited use. Finally, one state has no longer made this a voluntary option. In July 2016, the adoption of the force function design for enteral feeding became a legal requirement for all hospitals in the state of California, thus putting into effect what ASPEN and The Joint Commission has long recommended: the physical inability for a nurse to connect enteral feeding into intravenous line (or any connection other than enteral) regardless of how busy she is or how complex the clinical environment.
The effort to create a product design that allows a physical impediment to prevent a medical misconnection has been in the works for over 10 years. Researchers agree that human factors are the most frequent cause contributing to medical errors. Having products and equipment that have force function inherent in their design only brings us closer to our common goal: a culture of safety.
Minimizing risk in the NICU
What does all this mean for the Neonatal ICU? According to the National Association of Neonatal Nurses’ position statement on Medication Safety, medication administration is at increased risk for adversity related to three factors: “vulnerable nature of NICU patients, the complexity of the medications used, and the challenges of the NICU environment”. Examples of this include small size, non-verbal status, weight and physical immaturity. 
Not only are these patients at greater risk for experiencing a medication error but, because of their fragile condition, they are more likely to have a worse outcome as a result. The high acuity setting with its low lighting and array of tubing leaves a fatigued and over worked nurse at greater risk for harming a patient.
An example of the risk associated with the NICU population is the luer-lock or luer-slip fit syringes which are able to fit into both IV connectors and enteral tubing. In addition, feeding and medications are often infused on similar (if not the same) syringe pumps. Similar to the adult world, efforts have been made to allay these risks. Yet the incidence of medication errors are reported to be as high as 57% and occur eight times as often than in the adult population. Clearly, additional interventions such as ENFit are needed to improve patient safety.
Mistakes happen with frightening frequency in the United States. In the NICU our patients and clinicians are at even higher risk of an adverse event. Many of our medical institutions, government and regulatory agencies have worked very hard and continue to discuss and implement strategies to decrease the risk factor that contribute to these devastating outcomes.
Patient safety is a complex, multidisciplinary effort with no “one fix” solution. We have come a long way in making improvements in the area of medication safety. But we are now at the next stage where standards in devices and equipment are changing for the better. And new products are contributing solutions to decrease these horrific events.
As hard and costly as change can be, we as care providers and administrators are ethically obligated to analyze this next layer of protection from misconnection errors. If not only for our patients, but also for the people on the front lines of patient care who treat them every day.
What do you think of these new standards in enteral feeding? Will they make an impact in your effort to create a culture of safety in your hospital or NICU?
 Guenter, P.A., et al.: Enteral Feeding Misconnections: A Consortium Position Statement. He Joint Commission Journal on Quality and Patient Safety 34: 285-92, May 2008.
 American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI): Enteral Feeding Set Adapters and Connectors. Arlington, VA: ANSI/AAMI, 1996.
 Stavroudis, T. A., Miller, M. R., & Lehmann, C. U. (2008). Medication errors in
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 National Association of Neonatal Nurses. Medication Safety in the Neonatal Intensive Care Unit: Position Statement #3060. NANN Board of Directors. June 2014.
 Kozer E, Scolnik D, Keays T, Shi K, Luk T, Koren G. Large errors in the dosing of medications for children. N Engl J Med 2002; 346: 117
 Gray JE, Goldmann DA. Medication errors in the neonatal intensive care unit: special patients, unique issues. Arch Dis Child Fetal Neonatal Ed 2004; 89: 472–473.
 Sharek, P. J., Horbar, J. D., Mason, W., Bisarya, H., Thurm, C. ., Suresh, G.,Classen, D. (2006). Adverse events in the neonatal intensive care unit: Development, testing, and findings of a NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics, 118(4), 1332–1340
 Kugelman, A., Inbar-Sanado, E., Shinwell, E. S., Makhoul, I. R., Leshem, M.,Zangen, S., Bader, D. (2008). Iatrogenesis in neonatal intensive care units: Observational and interventional, prospective, multicenter study. Pediatrics, 122(3), 550–555.
About the Author
Kim Flanagan, MSN, CRNP, has worked as a NICU nurse and Neonatal Nurse Practitioner for 20 years. She currently serves as the Clinical NICU Specialist for Medela, LLC. In this role, she works with NICUs across the country to maximize their use of human milk in the neonatal population to improve patient outcomes, patient safety and best practices.