In 2006, a premature infant nearly died due to a mix-up of feeding and IV lines. That same year an expectant mother and her unborn baby did not survive after a bag of ready to hang enteral feeding was delivered via her PICC line. And by 2011, there were 116 documented cases of these type of misconnections.¹
Today this count is much higher, and the numbers are likely minimized because of under-reporting. Would it surprise you to know that one of the earliest documented misconnections happened in 1972 when breast milk was inadvertently connected to an IV?²
This video shows family members impacted by tubing misconnections. It only takes one mistake to impact a nurse and family for a lifetime.
A tubing misconnection is defined as an inadvertent connection between an enteral feeding system and a non-enteral system such as an intravascular catheter, tracheostomy, or medical gas tubing.² ENFit enteral connectors were designed by the Global Enteral Device Supplier Association (GEDSA) to mitigate such errors. StayConnected is GEDSA’s global initiative to help reduce the risk of medical device tubing misconnections with the overall goal of improving patient safety.³ We know that the risk for tubing misconnections is high and has been for years.
Transitioning to ENFit
Cook Children’s Medical Center in Fort Worth, Texas, recently became one of the many hospitals in the U.S. to transition to ENFit. They began with their neonatal intensive care unit, one of the largest all-private NICUs in the country, with the capacity to care for 106 of the tiniest and most fragile patients.
“For more than 100 years, patient safety has been the number one priority at Cook Children’s,” said Rachal Baxter, a NICU nurse manager at the freestanding pediatric health care system. “As other hospitals converted to ENFit, we realized there was a growing patient population with ENFit hubs on their G-tubes, etc. We felt converting to ENFit would help us better care for our current and future patients.”
After the NICU transition, Cook Children’s converted to ENFit house-wide.
“The transition process was quite a feat. It took input and contributions from a team of people, including directors, nurse managers, bedside nurses. Even our milk bank technicians, pharmacists, and supply chain personnel had a role in making the conversion a success,” Baxter said. “It’s now been six months since the transition, and things are running smoothly.”
Enteral connectors: The old way
In 1996, the Association for the Advancement of Medical Instrumentation (AAMI) brought together a group of experts to discuss the safety sets and connectors for enteral devices.² An alternative connection that would not connect to any other device was proposed, but never developed. Following the release of the AAMI standard, some manufacturers embraced the “Christmas tree” step connector, which, by a British standards document, was considered an alternate design. This connector stretched the opening of the feeding tube, causing connectors to slip from the tube, unlike a luer connector which required a twisting motion. These inadvertent disconnections allowed more opportunity for a line to be misconnected, because clinicians who reconnected the line did not always remember to trace the line back to its origin. That type of slip tip connector could also connect to lines other than enteral tubes, including trachs and some luer locks.
When a misconnection happens, there are three sets of victims: the patient, the family, and the nurse. No nurse seeks to intentionally harm a patient. It happens, unfortunately, because of issues like dim lighting, clinician fatigue, distraction, and tubing that is compatible between unlike systems (for example, luer lock or Christmas tree connectors).⁴
In 2014, The Joint Commission (TJC) issued a Sentinel Event Alert on Medications. From this, they announced the International Organization of Standardization’s (ISO) development of connection standards across six areas of healthcare, including enteral. The ISO, along with the FDA, developed ISO 80369-3, the ENFit connection that reverses the female/male orientation on enteral connections.⁴ʾ⁵
Global and U.S change
An Executive Brief put out by the ECRI Institute in 2018 listed the Top 10 Health Technology Hazards. The Top 10 Hazards included “Slow Adoption of Safer Enteral Feeding Connectors Leaves Patients at Risk.”⁶ The transition to ENFit is a global initiative.
In places like the Netherlands, New Zealand, and Austria, it is estimated that the transition is more than 50% complete. The UK is more than 80% complete. The conversion in Germany, France, Belgium, Spain, and Italy is well underway.
The transition to ENFit in the U.S. and Canada is moving at a much slower pace.⁴ California law “prohibits the use of an intravenous or enteral feeding connection that would fit into a connection port other than the type for which it was intended,” but the hesitation in the U.S. continues to be largely in part due to concern about production. With that said, this fear of transition can be minimized by talking with the great number of hospitals who have already successfully converted to ENFit.
Change is never easy, but we can incorporate and learn from institutions that have already moved forward with their ENFit transition.
Some are still hesitant to move forward with an ENFit conversion, and can benefit from small steps forward. A TwistLok enteral connector looks similar to a luer lock, but the diameter is different and makes it nearly impossible to connect with anything other than an enteral line. Some hospitals felt it was a good first step toward the transition to ENFit. Staff can become accustomed to a locking system prior to converting to the ENFit design.
Ultimately, every clinician’s highest priority is patient safety, and forward progress to improve their safety is critical to everyone involved.
Learn more about the Medela ENFit enteral feeding system for your hospital.
- The Joint Commission. (2014). Managing risk during transition to new ISO tubing connector standards. Sentinel Event Alert, Issue 53. Retrieved from jointcommission.org
- Guenter, P., et al. Enteral Feeding Misconnections: A Consortium Position Statement. Joint Commission Journal on Quality and Patient Safety. 2008;34(5):285-292.
- ECRI Institute. Implementing the ENFit initiative for preventing enteral tubing misconnections. Health Devices 2017 Mar 29.
- Shastay, A., Smetzer, J., Cohen, M., Jenkins, R., & Litman, R. Update on implementation of the new ENFit enteral connectors. ISMP Nurse Advise ERR. 2015;13(8):1-4.
- ECRI Institute. Executive Brief: Top 10 Health Technology Hazards for 2018.