History of Safe Enteral Feeding: Where Did It All Begin?

Safe Enteral Feeding Progress and Timeline

Healthcare facilities across the country are evaluating their current practice for enteral feeding and modifying it accordingly to improve the practice and safety of enteral feeding. Because of this, I thought it might be beneficial to take a look at how far we have come with improving practice and safety for enteral practice and products. Inadvertent enteral feeding misconnections between enteral feeding systems and non-enteral feeding products, such as in intravascular line, have been reported over the past 50 years.  

Patients receiving both parenteral and enteral nutrition are at risk for receiving feeds (medications) through the wrong route. The administration of feeds intended for oral or enteral delivery intravenously or vice versa has been identified as a safety risk. When this happens, these unintended wrong-route deliveries can cause serious patient harm, including death. And, simultaneously, they can also cause secondary traumatic stress to the clinician that makes the error.  

One of the first case alerts was published in 1972 by Lancet, referencing that breast milk intended for an enteral feeding was delivered intravenously. Seven years later, in 1979, the earliest agency alert for enteral feeding products and incompatibility with intravenous lines was reported. Subsequently, in 1983, additional case reports were published, suggesting one of the ways to improve and provide safer enteral feeding practice was developing incompatible enteral and intravenous tubing connectors.

Over the next 20 years following these early publications and case reports, numerous medication and enteral feeding societies started publishing reports to alert hospitals and clinicians of the dangers related to misconnection. Here is a brief history highlighting a few of these reports and the corresponding recommendations:

• 1996 – AAMI “Standard passes specific guidelines” for feeding sets and adapters, recommend that adapters and connectors used in the enteral system be incompatible with female Luer-lock rigid connectors.
• 1996 – ISMP Medication Safety Alert, published described cases of inadvertent intravenous (IV) administration of liquid substances meant for administration via feeding tubes. Safe practice recommendations included labeling the distal ends of tubes and catheters to identify tubes, special labels which depict the word "ORAL" in giant upper case text, and use of oral syringes incompatible with luer-lock catheters and tubing.
• 2004 – ISMP published a medication self-assessment for hospitals (2nd version), designed to proactively identify opportunities for reducing patient harm when prescribing, storing, preparing, dispensing, and administering medications.
• 2005 – AAMI re-released their Standard with specific guidelines for feeding tubes and adapters being incompatible, along with FDA and ISMP support while voluntarily echoing these safety warnings.
• 2000-2006 – USP Reviews reported 24 incidents involving enteral feeding, other solutions, or medication intended for the feeding tube that were inadvertently delivered via the wrong route. The majority of the cases involved the use of IV syringe to the IV system, resulting in the wrong route error.
• 2006 – Joint Commission (then JCAHO) urged product manufactures to implement “design incompatibility” enteral systems to prevent misconnections.
• 2008 - The Joint Commission Position Statement Journal on Quality and Patient Safety provided a detailed explanation of the risk and recommendations to improve.
• 2009 – ASPEN, Enteral Nutrition Practice Recommendations, provided a detailed recommendation for an enteral feeding pump.

The recommendation called for vendor changes with enteral devices, syringe color coding, and design changes to include “ENTERAL only” markings on the syringe to the proximal and distal enteral system tubing connections – all to reduce the risk of patient harm. These changes provided some reduction in harm; however, misconnections continued. Still, there was a need to minimize patient risk of wrong route administration. The recommendation that followed was for enteral products to have a unique connector design.

Around this time, enteral feeding practice started to move away from using I.V. fluid tubing for enteral feeding. I remember where I worked when the transition was implemented. It was in 2010, while I was working at a large NICU in Central Florida, and we had formed a feeding committee to evaluate and develop a new feeding protocol. As you know, all practice improvement starts with reviewing the most recent evidence on the topic. Since this was shortly after the 2008 Position Statement in their Journal on Quality and Patient Safety (Guenter, 2008) was published, we thought it was important to review these practice recommendations. Not long after reviewing these recommendations (two years is the average time, as it takes a while before it is implemented in practice), we adopted the practice improvement and transitioned to an enteral-only system. We designated pumps as enteral only, which meant they were not for use with I.V. fluids or medication.

In 2014, The Joint Commission released a Sentinel Event Alert #53, with the goal of improving enteral feeding safety further and to notify healthcare facilities that misconnections continue to occur and cause significant patient injury. They introduced the NEW ISO tubing connector standards and encouraged facilities to put plans in place to reduce the risk of misconnections. In this alert, they also introduced the “new” ISO tubing connector standard (ANSI/AAMI/ISO 80369-1) for small bore connectors with the goal of making enteral feeding safer for all patients. The ISO-80369-3 is the international standard that addresses enteral connectors.

What About ENFit Integration?

An industry group came together to collaborate with the Internal Organization for Standardization (ISO) and develop ISO 80369 standards for small bore connectors. The Global Enteral Device Supplier Association (GEDSA) is the organization that was developed in the U.S. to help the medical device industry transition to the new global design standards for enteral feeding connectors. This standard specifies the exact shape, size, physical properties, functional performance, and physical characteristics of enteral connectors.

The new ENFit connector reverses the traditional orientation of the tubing connection. In fact, the ENFit design has not been without challenges, especially for the smallest (neonatal and pediatric) patients. The ENFit design reverse locking connection has a deeper hub and threads located on the feeding tube side, which creates a well for milk to accumulate. The tip of the ENFit syringe can be a challenge with medication and can cause inaccuracy; careful attention must be made to how medication prepared and its route of delivery.

The most recent regulatory communication regarding ENFit was issued on October 12, 2021 from the Food and Drug Administration. The FDA’s released communication recognizes the challenges with ENFit low dose tip syringes. However, they continue to recommend a safety system that reduces the risk of misconnections while not limiting this system to the use of enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1, ENFit^® (80369-3). They do recommend using enteral device systems that are designed to reduce the risk of misconnections.

In all, there have been more than 60 references of enteral misconnections and it is strongly believed that the reporting of enteral misconnections may greatly underrepresent the number of actual cases. This is because these inadvertent events can be reported as either medication errors or enteral misconnections, which makes the actual number of occurrences difficult to track. To date, many hospitals are in the process of reviewing their current enteral systems and feeding practices. For neonatal and pediatric units considering the use of ENFit, it is important to note the FDA has advised that the enteral system does not have to be ENFit specifically. Instead, it should be a system designed to reduce the possibility of a misconnection.

References

1. Guenter P, et al: Enteral feeding misconnections: a consortium position statement. The Joint Commission Journal of Quality and Patient Safety, May 2008
2. Bankhead, R, et al: Enteral Nutrition Practice Recommendations. American Society for Parenteral and Enteral Nutrition.  JPEN J Parenter Enteral Nutr OnlineFirst, published on January 26, 2009
3. The Joint Commission: Tubing misconnections – a persistent and potentially deadly occurrence, Sentinel Event Alert #36, April 3, 2006. (accessed Nov 22, 2021)
4. ISMP Medication Safety Self Assessment^® for Hospitals. April 2011. Medication Safety Self Assessment ^® for Hospitals | Institute For Safe Medication Practices (ismp.org) (accessed Dec 17, 2021).
5. The Joint Commission: Managing risk during transition to new ISO tubing connector standards, Sentinel Even Alert #53,  August 20, 2014. (accessed Dec 17, 2021)
6. Global Enteral Device Supplier Association (GEDSA),  https://gedsa.com
7. Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P; ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. doi: 10.1177/0148607116673053. Epub 2016 Nov 5. PMID: 27815525.
8. Federal Drug Administration. Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication. October 12, 2021. Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication | FDA