Rise of the ENFit Enteral Connector
Evi Dewhurst / April 2015
Enteral connectors have undergone quite the facelift in the last 12 months. Many people have wondered, do all these changes really make a difference? The answer to that question is yes. The surprising thing is why it took so long.
While the last twelve months may seem the most significant to enteral connector standards progression, the journey actually began nearly twenty years ago.
Take a look back in time with us as we retrace those fateful steps leading to the rise of the ENFit enteral connector.
The changes you are witnessing today were birthed back in 1996 with the Joint Commission’s Sentinel Event Policy. The Joint Commission recognized risks which could lead to patient safety issues, such as look-alike multi-purpose tubing, which continued to be a problem despite best efforts.
Their Sentinel Event Policy was their effort to “partner with healthcare organizations that have experienced a serious patient safety event to protect the patient, improve systems, and prevent further harm.” They defined a sentinel event as a Patient Safety Event that 1) reaches the patient and 2) results in any of the following:1
- Permanent harm
- Severe temporary harm and intervention required to sustain life
The Join Commission named these events “sentinel” because they “signal the need for immediate investigation and response.”1
The Joint Commission released a Sentinel Event Alert, Issue 36: Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. This particular sentinel alert focused specifically on tubing and catheter misconnections.
In this alert, the Joint Commission explained that there had been nine cases involving tubing misconnections reported to the Sentinel Event Database. Unfortunately, eight of those had resulted in death while the ninth resulted in permanent loss of function. Seven adults and two infants were involved.
Luer connectors were involved with many of these misconnection cases. At that time, there were no initiatives to take action with this specific issue. The Joint Commission called for action in this alert, referring to an issue of ECRI’s Health Devices journal: “A well-designed device should prevent misconnections and should prompt the user to take the correct action.”2
The following steps were initially recommended:
- Labeling all tubes and catheters
- Color-coding tubes and catheters
The Joint Commission then added the following recommendations to this list:2
– Do not purchase non-intravenous equipment that is equipped with connectors that can physically mate with a female luer IV line connector.
– Conduct acceptance testing (for performance, safety and usability) and, as appropriate, risk assessment (e.g., failure mode and effect analysis) on new tubing and catheter purchases to identify the potential for misconnections and take appropriate preventive measures.
– Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion.
– Recheck connections and trace all patient tubes and catheters to their sources upon the patient’s arrival to a new setting or service as part of the hand-off process. Standardize this “line reconciliation” process.
– Route tubes and catheters having different purposes in different, standardized directions (e.g., IV lines routed toward the head; enteric lines toward the feet). This is especially important in the care of neonates.
– Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions.
– For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the – Never use a standard luer syringe for oral medications or enteric feedings.
– Emphasize the risk of tubing misconnections in orientation and training curricula.
– Identify and manage conditions and practices that may contribute to health care worker fatigue, and take appropriate action.
Finally, the Joint Commission called upon the manufacturers of such tubing, and asked them to implement “design incompatibility” as appropriate in an effort to further reduce misconnection issues.
The state of California enacted bill number AB 1867, which addressed the enteral connector issue head on.
This bill was an ambitious one. It called for all healthcare facilities in the state to follow this safety standard. However, the law also took into account the timeline needed to accomplish such a large-scale endeavor, and extended the deadline a few times in order for facilities to adopt new connectors. At most recent, the final date is January 1, 2016 for California healthcare facilities as outlined in the law to comply with this new standard.
The American Society for Parenteral and Enteral Nutrition (ASPEN) published their Enteral Nutrition Practice Recommendations.
These recommendations were:4
1. Review currently used systems to assess practices that include the potential for misconnection, including nonstandard, rigged work-arounds (luer adapters, etc.).
2. Train nonclinical staff and visitors not to reconnect lines but to seek clinical assistance instead. Only clinicians or users knowledgeable about the use of the device should make a reconnection, and should do so under proper lighting.
3. Do not modify or adapt IV or feeding devices because doing so may compromise the safety features incorporated into their design.
4. When making a reconnection, practitioners should routinely trace lines back to their origins and then ensure that they are secure. Route tubes and catheters that have different purposes in unique and standardized directions (eg, IV lines should be routed toward the patient’s head, and enteric lines should be routed toward the feet).
5. When arriving at a new setting or as part of a hand-off process, staff should recheck connections and trace all tubes.
6. Label or color-code feeding tubes and connectors, and educate staff about the labeling or color-coding process in the institution’s enteral feeding system.
7. Identify and confirm the EN label, because a 3-in-1 PN admixture can appear similar to an EN formulation bag. Label the bags with large, bold statements such as “WARNING! For Enteral Use Only—NOT for IV Use.”
8. Avoid buying enteral equipment that can mate with female luer connectors. Evaluate the need for and reduce the purchases of adapters and connectors that can be modified to make enteral feeding sets compatible with female luer connectors.
9. Purchase an adequate number of enteral pumps so that IV pumps are not used for enteral delivery for adult patients. When syringe pumps are used in neonatal ICUs for human milk or other feedings, they should be clearly distinct from syringe pumps used for IV or other medical purposes. Ideally, they should be a different model, color, or as different in appearance from IV pumps as possible. The enteral feeding pumps should be clearly labeled as enteral feeding pumps.
10. Ensure that hospital purchasing policies mandate buying only enteral feeding sets that are compliant with American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) which effectively excludes any that are compatible with female luer connectors. These devices must also be clearly labeled (eg, “Not for IV Use”).
11. Avoid buying pre-filled enteral feeding containers, except for those with design technology labeled non-IV compatible. In all cases, ensure that the enteral administration set is packaged with the enteral feeding bag or container before it is sent to the patient care unit. (The set should be secured to the bag, perhaps with a rubber band, or preattached sets should be requested from the manufacturer). In either case, the objective is to prevent bags or containers from being spiked with IV administration sets.
12. Purchase and use oral syringes instead of luerlock syringes to draw up and deliver medications into the enteral feeding system. Include pharmacy department recommendations to ensure the correct syringe type, along with dispensing and proper labeling protocols. Other syringes that may be used include large catheter tip syringes that cannot fit into IV systems.
The International Organization for Standardization (ISO) released ISO 80369-1:2010, small bore connectors for liquids and gases in healthcare applications. It specified the intent for general requirements for small-bore connectors which were “used in medical devices or accessories intended for use with a patient.”5
While some manufacturers had made changes in an effort to prevent small bore connector misconnections, issues with safety had never been completely resolved across international borders. ISO decided to set the standard with 80369-1 specifically for the following applications:5
- Breathing systems and gases
- Enteral and gastric
- Urethral and urinary
- Limb cuff inflation
- Neuraxial devices
- Intravascular or hypodermic
- Not compatible with others in series
- Rigid or semi-rigid
- Misconnection test with other devices
The things most closely examined in 80369-1were “inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6% Luer connectors, and all other non-Luer (6%) connectors that will be developed under future parts of this series of standards.”5
Clearly the tide took a turn for an identifiable outcome from here. Today, the FDA recognizes 80369-1 general requirements, and also recognizes Association for the Advancement of Medical Instrumentation (AAMI) recommendations.
The Global Enteral Device Manufacturer Organization (GEDSA) was formed. GEDSA is a nonprofit trade association formed to help introduce enteral feeding ISO standards and enhance patient safety.
Members of GEDSA were and continue to be comprised of manufacturers, distributors and suppliers of enteral nutrition devices worldwide. As a unified team intent on devising a connector to meet the rigorous and recommended safety standards, they identified eight safety issues with the use of universal luer designs:
- Low lighting
- Multiple lines
- Multiple devices
- Time pressure
- Lack of tactile feedback
- Unintended use of tubes
- Moving patient setting
Determined to unearth a solution, these companies worked for a common goal. Together, they created a solution for the enteral connector issues, and brought it from concept to reality: the ENFit connector.
The ENFit connector meets the standards outlined in ISO/DIS 80639-3 (see 2015), which are dimensions for SIZE and SHAPE. ISO 80639 did not apply standards to color. ENFit was released in 2014 and became available to the members of GEDSA to utilize within their own product portfolio within a specific release timeline (Q2 2015, syringes / Q3 2015, extension sets and feeding tubes).6
The ENFit connector has a unique enteral-specific design that:6
- Does not allow connectivity with many other connectors for any other clinical use
- Provides a locking feature that signals the appropriate connection and stays in place
- Has a female connector end for any administration sets and syringes that fit into a male patient-access feeding tube port
The Association for the Advancement of Medical Instrumentation, or AAMI, presented “Small-Bore Connectors – New Standards and Designs” at their 2014 Conference & Expo. Their intent was to explain why new small bore standards were needed, to describe the features of new connector standards, and to outline implementation and transition timing with enteral connectors as their example.
In this presentation, they stated three design changes to call for:7
- Product manufacturers are urged to implement “incompatibility by design” features (as recommended by Joint Commission)
- Mechanical incompatibility when inappropriate connections are attempted
- The entire line of connections must be unique to prevent mistakes in connection
AAMI also explained why it took so long for these changes to finally come around: Risk, adoption, validation and conversation. They recognized that the answer to these connectors would not be an easy one, and would take proper time investment to enact in the safest way with the strongest end result.
AAMI was a pivotal partner in assisting ISO to establish the 80369-3 standards (see 2015).8
The Joint Commission released Sentinel Event Alert 53: Managing Risk During Transition to New ISO Tubing Connector Standards in 2014.
With the newest standards out, the Joint Commission recognized that many issues could arise from transitioning to new connectors. Busy units with rotating shifts of nurses would need specific steps to outline practical measures for safety.
In preparation for the new ISO connector standards, they outlined:9
- Assess and manage: Enact an interdisciplinary task force to assess and manage existing issues and to focus on areas of highest risk
- Aware: Learn about the upcoming ISO standards and share information
- Prepare: Assess and adapt existing systems, begin a dialogue with suppliers
- Adopt: Manage the transition period
They recommend effective processes and procedures as:9
- Trace tubing or catheter from patient to point of origin
- Route tubes and catheters having different purposes in different directions
- Tubing should be labeled
- Ensure implementation of safe practices for high-alert medications
- Use tubing and related equipment only as they are intended to be used
- Take inventory and store carefully
In addition to all these, the Joint Commission called for appropriate education and training, effective communication, leadership, and a culture of safety.
ISO released ISO/DIS 80369-3.2: Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications.
80369-3 is a continuation of the 80369-1 requirements. ISO is making specific requirements for enteral connectors related to SIZE and SHAPE.
The ENFit connector meets these requirements.
80369-3 does not specify requirements for connectors which are used for:10
- Medical devices under gastric suction only
- Medical devices used only orally
- Pressurizing and depressurizing inflation cuffs used to hold invasive medical devices in place
- Skin level gastronomy medical devices
- Accessing enteral feeding reservoirs
At last, the rise of the ENFit enteral connector has arrived at the present day. Institutions are busy preparing for change, assessing and managing risk, and communicating with manufacturers and distributors. The Joint Commission, AAMI, ASPEN and more have all contributed to advancing the safety of small-bore connectors, as have organizations like GEDSA who have stepped up to assist in finding a solution.
ENFit is a trademark of Global Device Supplier Association, Inc., used with their permission