Across the country, medical tubing connector changes are sweeping the healthcare landscape. The first connectors to be impacted by the latest standards relate to small bore connectors, including enteral feeding. Nowhere else is this change so impactful as in the neonatal intensive care unit, where a small error can lead to drastic consequences, as neonatal professionals well know. As healthcare facilities prepare to make improved safety changes to their enteral connectors, there are a few considerations to be placed at the forefront: Why ENFit? Why now?
The ENFit connector for enteral feeding applications has reached near celebrity status in the medical community over the last twelve months. As a potential solution to enteral device misconnection, it has gotten a lot of press. But how, and why, did it come about?
Connector safety standards came into the spotlight in April of 1996 with The Joint Commission’s “Sentinel Event Alert, Issue 36.” The Sentinel Alert identified tubing misconnections as a “persistent and potentially deadly occurrence.”1 Misconnections between tubing applications could and had resulted in death. Unfortunately it continued to remain a dangerous problem despite The Joint Commission’s stance on the issue.
One of the known misconnection casualties occurred in 2006 when an expectant mother and her unborn baby did not survive an incorrectly connected feeding tube. It had delivered enteral fluid to the mother’s bloodstream.
Opening with that same story, The New York Times published an article in August of 2010 titled “U.S. Inaction Lets Look-Alike Tubes Kill Patients.”2 After introducing readers to the young mother in the above misconnection event, the article went on to disclose that a 2006 survey revealed that 16% of hospitals had experienced a feeding tube mix-up.
For years healthcare professionals were in a tenuous position of consistently identifying correct connectors for patients under difficult circumstances. Visual identification could be difficult due to darkened rooms, and the sheer number of connectors made it difficult to identify matching connectors. To top it off, many of the device connectors would fit to each other despite differing applications. The Joint Commission had recognized misconnections as downright dangerous several years earlier, and this new attention brought to light something new: the connectors themselves were the problem – and the solution.
The ENFit enteral connector was designed by GEDSA (Global Enteral Device Supplier Association) in response to The Joint Commission Sentinel Alert, Issue 36, and AAMI (Association for the Advancement of Medical Instrumentation) guidelines. AAMI had worked closely with ISO (International Organization for Standardization) to establish specific enteral connector guidelines which would address the continuing problem of “one size fits all” connectors. The dimensions and reversed male to female connector specifications would make it impossible to connect to devices designed for other routes, such as IV delivery, thus eliminating the risk of misconnection within the connector itself.
In response, The Joint Commission released “Sentinel Event Alert, Issue 53: Managing Risk During Transition to New ISO Tubing Connector Standards” in August of 2014. It was clear that healthcare facilities undertaking the enteral connector transition would be facing many integration hurdles. The Joint Commission released this sentinel event alert with recommendations for clinical professionals and recommendations for the entire facility.3
Enteral device manufacturers began the process of offering the ENFit connector in 2015, as per the GEDSA plan. Several have made the connectors available, including Medela, while others continue to integrate the product into their portfolios. By 2016 the ENFit connector will be widespread and available across the country from most enteral feeding product manufacturers.
Neonatal intensive care units may be wondering why they should make a change in the short term. NICUs have steadily improved safety efforts over the last 20 years and units may feel they have a reliable system in place that is working well. There are, however, a few considerations that may impact this view.
Being the Decision-Maker for Your Unit
Neonatal intensive care represents a small portion of enteral device usage in the hospital. For that reason, purchasing departments may feel inclined to take on the reins in the ENFit connector venture and make a product decision for the entire hospital. While there is nothing wrong with looking to standardize, oftentimes the NICU may feel that the specialized needs of their unique patient population were not addressed. Stepping in early allows a unit to state preferences for neonatal products made specifically for their patients, and to provide clarity as to why they are necessary. This is especially valuable when considering that other influencers within the hospital may have designs to implement ENFit connectors as soon as possible.
“The hospital often makes decisions based on past relationships, pricing and other indicators that may not be best suited to the needs of the neonatal unit,” explains Sandy Beauman, MSN, RNC-NIC. “For instance, having a particularly small feeding tube, a specific length of extension tubing, and smaller syringes are all important to the NICU but not to other units. These things may not be considered if the decision-making process is left to purchasing or a Value Analysis Team without strong neonatal representation.”
Neonatal professionals are the best representatives for their patients. By speaking up early and often the odds can improve to gain access to tools needed for elevating neonatal patient care and outcomes. This is especially true when it comes to the new ENFit connectors.
Adoption Process and Timing
The Joint Commission’s Managing Risk During Transition to the New ISO Tubing Connector Standards explains that adoption of a new product such as the ENFit connector is more time-intensive than it may first seem. Implementing a sweeping change for patient safety requires both individual and team education efforts, internal protocol changes and the integration of new products into stock. Each unit should consider the time required for their institution to have a proper dialogue for NICU enteral needs.
Depending on the hospital, a six to nine month time period may be needed for internal teams to perform the following:
- Examining current standards and protocol
- Internal communications
- Vendor review
- Product trials
- Committee review and approval
- Acquiring new product
- Integrating new product
- Education for all NICU staff members
As this process requires much coordination and attention, NICUs will benefit from getting started well before the product adoption is expected to be complete.
Anticipating Product Integration Issues
The ENFit connector at first seems simple: a reversed male and female configuration, a slightly larger size, and a locking mechanism. After introduction, however, it does take time to get used to actual handling and usage. This is especially true if nurses are more familiar with slip tip connectors. Nursing professionals who will be working with ENFit connectors will need plenty of hands-on time to fully adopt it into their routine. A unit will need to anticipate the needs of their nurses and allow them time to adjust.
Another potential adoption issue impacts the healthcare facility pharmacy. The ENFit connector was designed specifically for enteral feeding and not medication delivery. This will impact pharmacy methods. For example, in a standard syringe, dead space in the tip fills when pulling milk (or medication) from a bottle. The dead space remains full when milk is delivered, thus delivering only the measured dose of milk. The ENFit syringe tip is different, due to the female configuration. This results in a fractional dead space difference when filling and delivering, and may impact the dosage by a very small percentage. This becomes a concern when low dose medication is loaded into an ENFit syringe. There will be instances when pharmacy will fill an ENFit syringe with medication to be delivered through an enteral feeding medication port. A solution for the dead space dosage must be in place, with pharmacy staff trained and ready for the new protocol. One example of a solution for this is the Medela medication cap and the dual cap, which allow pharmacy professionals to maintain filling practices despite the connector change.
The Institute for Safe Medication Practices (ISMP) focused on this medication delivery concern with the recent ISMP Medication Safety Alerts4,5 posted in April and July of this year, which documented a thorough explanation of medication delivery practices when using ENFit connectors. In addition to delving into the medication delivery methods, the ISMP also highlighted two additional areas of concern to pharmacy professionals: Operational issues involved in predetermining delivery route in the pharmacy, and the time and repetitive motion issues involved with high volume turnaround. For more information, visit ismp.org.
The state of California created bill AB 1867 some years ago. This bill was directed at enforcing safer small-bore connections in the healthcare setting. Bill AB 1867 “prohibits the use of intravenous, epidural or enteral feeding devices with connectors that fit into connection ports other than the type for which they were intended.”6
The bill was an ambitious one. It called for all healthcare facilities in the state to follow a new, legally enacted safety standard within a specific time frame. However, California lawmakers took into account the timeline that was needed to accomplish such a large-scale endeavor – the deadline was extended a few times in order for facilities to adopt new connectors. At most recent, the deadline will be July 1, 2016 for California healthcare facilities to comply with this new standard.
Healthcare facilities not in the state of California may still find themselves impacted by the state’s progressiveness, as other states may adopt similar laws.
Are You Ready?
Healthcare facilities will adopt the new connectors on their own timeline in accordance with capability, budget and training. For some it will be a rush to implement, while for others it will be a gradual and steady adoption. Either way, now is a good time to get started. Use this basic check list to help:
- Establish a timeline for product adoption
- Identify hospital resources and decision makers
- Know the facility change management process
- Position the NICU as a voice on the VAT committee for ENFit
- Follow Sentinel Event Alert 53 recommendations
- Review ENFit vendors for product, versatility and education offerings
- Evaluate staff to identify knowledge leaders for training
The ENFit connector itself may be a clean, simplistic design, but adoption of an entirely new safety-based enteral feeding connector process appears to be just a bit more complex. Understanding “why ENFit” and “why now” can help a unit prepare and plan for a successful transition into the new age of the safety enteral connector.
Medela Neonatal Solutions offers products for collection, storage and delivery of human milk to at-risk infants. Included in Medela Neonatal Solutions are ENFit syringes, feeding tubes, extension sets, milk warming and the Medela Enteral Feeding Pump, as well as pharmacy options in the form of a dual cap and medication cap. Speak with your local sales consultant for more information or email to EFinfo@medela.com
- The Joint Commission. (2006, April) Tubing misconnections—a persistent and potentially deadly occurrence. Sentinel Event Alert, Issue 36. Retrieved from jointcommission.org
- Harris, G. (2010, August 20). S. Inaction Lets Look-Alike Tubes Kill Patients. The New York Times. Retrieved from www.nytimes.com
- The Joint Commission. (2006, April) Managing risk during transition to new ISO tubing connector standards. Sentinel Event Alert, Issue 53. Retrieved from jointcommission.org
- Institution for Safe Medication Practices. (2015, July) Update on implementation of the new ENFit enteral connectors. Acute Care ISMP Safety Alert. Retrieved from www.ismp.org
- Institution for Safe Medication Practices. (2015, April) ENFit enteral devices are on their way…Important safety considerations for hospitals. Acute Care ISMP Safety Alert. Retrieved from ismp.org
- Health facilities: Equipment Standards, Cal. Assemb. AB 1867, Chapter 194 (2012). Retrieved from www.leginfo.ca.gov