Do I Have to Go ENFit This Year?

If you’re like me, you may be questioning what changes are coming this year as it relates to enteral feeding connections and ENFit^®.  Despite the lack of movement in previous years, the time is now to take control of your enteral feeding plans.  In short, ENFit standardization is not mandated at this time, however it is recommended by many regulating bodies, including the Joint Commission and FDA.  The goal of ISO (International Organization for Standardization) is to provide safety syringes to prevent misconnections, and ENFit is not the only solution. The impact of ENFit can create significant impact in the NICU, but also areas including pediatrics, pharmacy, and supply chain.  Impacts to consider include practice changes for clinicians and technicians, medication accuracy, cleaning protocols, and infection prevention.  What will this look like for your unit, and what approach will have the least impact and best clinical outcomes for your patients?

The Global Enteral Device Supplier Association (GEDSA) is a supplier association that was formed to support international standards for medical device tubing connections. They have re-established their timeline for recommendations of the ENFit connector conversions and have published the revised timeline for beginning this year, 2021.  The recommended phase out begins July 1, 2021 where “legacy feeding and cross-application adaptors will no longer be manufactured,” then, come January 1, 2022, “transition sets and adaptors sold separately from other devices will no longer be manufactured.” (GEDSA, 2020).

“GEDSA members are committed to providing a continued supply of the enteral products that are currently being utilized in healthcare systems worldwide. GEDSA remains committed to ENFit, supports its use and acknowledges that it is the [standardized] ISO [80369-3] compliant option used globally in these times where the potential for a misconnection is exceptionally high.” (GEDSA, 2020)

ISO Standards Related to Enteral Feeding

ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements (ISO, 2018)

Part 1 provides the general guidelines and aim of the initiative. The design of connectors must mitigate risks of misconnection to the other connectors of the different applications.  By creating a unique international standard, risk of misconnections leading to patient harm or death can be avoided.

Criteria (Boulatta et al., 2016):

• Not be connectable to others in the series
• Be made of rigid or semi-rigid material
• Pass a misconnection test
• Not be connectable with Luer or needle-less connector ports

ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications (ISO, 2019)

Part 3 is dedicated to enteral applications. It describes all the dimensions, shape and functional requirements of the new proposed enteral standard connector, also known as ENFit.  Main feature of this design include a unique locking system with the male and female connections switched from that of traditional legacy designs.

Where is Your Unit in This Process?

What type of products are you using now? Have you started thinking about what direction you would like to move? Some NICUs have moved to some sort of safety system, which may not be ENFit. The design limitations of ENFit remind us of the complexity of this problem and that sometimes there is not only one solution to the problem. Medela offers a variety of enteral feeding solutions, including ENFit and also TwistLok, which is a safety locking system and is incompatible with any other systems! Take a minute to review the two side by side at the above link.

Logistics of Conversion to ENFit

A transition from legacy feeding supplies to the standardized ENFit connection entails consideration to be taken throughout the health system. As previously mentioned, the impact spans outside of the NICU, reaching pediatrics, pharmacy, and supply chain. Clinical practice changes are necessary to adopt in order to maintain cleanliness of feeding tubes, drawing up medications at the bedside, medication accuracy, and additional accessory pieces needed in the pharmacy with a standardized structure – to name a few. Because the NICU population experiences a greater impact with these changes, attention to patient safety with clinical practice change is necessary. Unlike the adult population, the NICU and pediatric population have special considerations that should be taken into account.

What are the Organization Recommendations?

There are multiple regulating bodies who now recommend and support the efforts put forth by GEDSA including: Joint Commission, ASPEN, ECRI, ISMP, AAMI, ASHRM, AVA, and the FDA.  I have provided a few of these recommendations for reference:

• Joint Commission
  The Joint Commission is a supporting organization of GEDSA.  They support the design standards put forth by GEDSA but do not endorse specific manufacturers, products, or devices nor mandate their use. They encourage the specific device selection and use of these products be left to the discretion of the clinicians (FDA, 2018).
• ASPEN
  The American Society for Parenteral and Enteral Nutrition (ASPEN) is a supporting organization of GEDSA.  Practice recommendations include utilizing enteral devices (tubes, syringes, administration and extension sets) with enteral connectors that comply with ISO standard 80369-3 (Boullata et al., 2016).
• FDA
  The U.S. Food and Drug Administration (FDA) is a supporting organization of GEDSA.  “The U.S. Food and Drug Administration is concerned by continued reports of misconnections with enteral devices. To reduce the risk of misconnections and patient injury, the FDA recommends hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections.” (FDA, 2018).

Supply vs Demand and Where to Go From Here

The goal is for customers and vendors to work together as a team during any transition. While the customer relies on product, vendors rely on strong communication regarding timelines and usage to guarantee manufacturing volumes can remain available to meet the demand. Messaging has begun going out from many manufacturers in an effort to stimulate these conversations. If you have ever experienced a backorder situation, you know the headaches that come along with it. By working together alongside our team of specialists, we can guide you and your team through the changes while minimizing the stress inflicted on staff and your patients and their families. Regardless of your path forward, it is critical that you work closely with your sales representative to establish a comprehensive plan that will ensure adequate supplies on your shelves and integration success!

I recognize this a lot of information and may seem like a great undertaking. However, whatever decision you make, Medela is here to support you through it. A transition to ENFit is not the only option you can choose because, as I mentioned, it is not mandated at this time. Medela TwistLok is a safety system that is incompatible with other systems, making it a safe and practical alternative that provides safety and security with a unique locking system – without the added challenges of cleaning, medication accuracy, and practice change. With our unique Dual Cap solution, necessary changes are limited, especially in the pharmacy! You have the power of decision in this case, and the time to consider what decision is best for your unit and hospital is NOW. What choice will you make?

Additional Neonatal Perspectives Blogs that Remain Relevant to This Topic

• What is GEDSA to the Neonatal Clinician?
• Cleaning ENFit Connector in the NICU: What You Need to Know
• The ENFit Enteral Connector Transition: Ready When You Are
• What ENFit Means for NICU and Pharmacy
• ENFit Syringes and Their Impact to New Standards in the NICU
• ENFit Low Dose and Medication Administration

References

Boullata, J. I. (2016). ASPEN Safe Practices for Enteral Nutrition Therapy. Journal of Parenteral and Enteral Nutrition. DOI: 10.1177/0148607116673053

Global Enteral Device Supplier Association (GEDSA). REVISED ENFit^® Connector Conversion Schedule: U.S. and Canada Legacy Connector Production Phase Out Dates. Updated September 2020. Accessed March 30, 2021. stayconnected.org/200914-revised-enfit-connector-conversion-schedule-u-s-production-phase-out-dates/

ISO. (2018). ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General Recommendations. Retrieved from iso.org/standard/64419.html

ISO. (2019). ISO 80369-3:2016/AMD 1:2019 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1. Retrieved from iso.org/standard/74038.html

U.S. Food & Drug Administration (FDA). (2018). Medical Device Connectors. Retrieved from fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors