Feeding Tube Misconnections -- A Safety Concern

Not every patient who has cancer needs an enteral feeding tube, but for those who do, it is a crucial part of their care.

Patients diagnosed with head and neck cancer who received combined radiation and chemotherapy frequently require a feeding tube, for example. As many as 200,000 patients annualy use this form of treatment.¹ Therefore, oncology nurses need to be aware of changes in care for patients with feeding tubes.

Concerns around tubing misconnections have appeared in the nursing literature for many years. If a nurse inadvertently connects an enteral device to another type of tube such as intravenous line or tracheal tube, it can cause the patient harm.

In 2006, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a sentinel event alert to raise awareness about an unexpected occurrence that could cause a patient harm not related to their illness. The JCAHO warned the healthcare industry to pay close attention to how catheters and tubing connected to a patient. JCAHO stated that reports had been made to them, the Food and Drug Administration (FDA), United States Pharmacopeia, the Institute for Safe Medication Practices and ECRI indicating that misconnections occurred frequently and had actually caused patient deaths.²

The sentinel event alert recommended that clinicians:

• do not purchase tubing that can be connected into IV tubing that was not made for IV tubing
• assess other products to decrease risk of misconnection
• trace the tubing from point of origin prior to connecting anything
• thoroughly assess tubing origin with each new patient arriving in a unit
• encourage patients and family to ask for assistance before disconnecting or reconnecting tubing
• remind nursing staff often of the risks of misconnections²

Tube misconnections posed such a serious risk to patients that California passed a law mandating all enteral products be designed to be enteral specific. It took quite some time for manufacturers to agree to this mandate. The idea was to make sure a luer lock connection could not be connected to a feeding tube connection. In 2007, manufacturers came together from around the world to develop a connector that would decrease the risk of misconnecting two unrelated systems. Requirements stated the connector parts:

• Cannot connect to luer lock or needleless ports
• Cannot connect with other devices in a series
• Must be tested and pass misconnection, risk analysis, and usability/human factor testing
• Must be semi rigid or rigid

The new design is a “reversed” orientation where the connection system is female-to-male.³ It is known as a small-bore connector series, and the designs are approved by the International Organization of Standardization (ISO) under ISO 80369.⁴ The FDA finally approved the new enteral product in 2015.⁵

The final product, ENFit, is unique and specific for enteral products only. The product intentionally does not fit together with other connectors to prevent accidents from happening. There are several companies supplying the ENFit product, which are purple in color to differentiate them from other tubing-related products. ENFit products and supplies are making their way into the market. However, it has been a slow process in some areas.

California Assembly Bill 444, mandated that hospitals and other health care facilities in state could not use a connector that fits into another type of device that was not meant for that use. California was the only state to introduce this mandate, and it is optional in the rest of the United States. The FDA worked alongside of ISO to develop the new standard and issued a guide to manufacturers encouraging them to adopt this new product.

An organization called the Global Enteral Device Supplies Association (GEDSA) was established to help introduce international standards in medical device tubing connectors. GEDSA, ECRI Institute and other agencies strongly recommended each healthcare facility transition to the new product even though it was not mandated. The United Kingdom has already been working on this health concern for quite some time. Many other countries began the change in 2017 and the push is on for it to be complete by 2018.³

Several obstacles have been identified as to why the transition to use ENFit has been lagging, with the chief barrier being availability of the products. The fact that it is not mandated in the US is causing delays as well. More education is needed, and the safety benefit needs to be clearly communicated to medical staff and institutions. According to GEDSA, Europe’s adoption is thought to be at 90% where Canada and North America are at less than 30%. Australia and New Zealand are estimated to have an adoption percentage of 50%.³

Nurses who are not using ENFit should share information about it with their hospital administrators.

More education for nurses, staff, and patients is important as the transition takes place to ENFit products.

For additional information, visit the GEDSA's "Stay Connected" website.⁶

References

• PEG Tube Feeding Overview. The Oral Cancer Foundation website. oralcancerfoundation.org/nutrition/peg-tube-feeding-overview/. Accessed July 24, 2018.
• The Joint Commission. Tubing misconnections-A persistent and potential deadly occurrence. Sentinel Event Alert. 2006;1-3.
• Implementing the ENFit Initiative for Preventing Enteral Tubing Misconnections. ERCI Institute website. www.ecri.org/components/HDJournal/Pages/ENFit-for-Preventing-Enteral-Tubing-Misconnections.aspx. Published 2017. Accessed August 3, 2018.
• International Organization for Standardization (ISO). ISO 80369-3:2016 (en) Small-bore connectors for liquids and gases in healthcare applications. www.iso.org/obp/ui/#iso.std:iso:80369:-3:ed-1:v1:en. Published 2016. Accessed August 3, 2018.
• Colburn J, USFDA. Medical Device Tubing [Mis} Connections [PowerPoint slides]. stayconnected.org/wp-content/uploads/2017/02/FDA-ENFit-Summit-Jan-2017.pdf. Published 2017. Accessed July 30, 2018.
• The Global Enteral Devise Supplier Association. ENFit® Advocacy Meeting [PowerPoint slides]. stayconnected.org/wp-content/uploads/2017/08/ENFit-Advocacy-Meeting-uploadv2.pdf. Published 2017. Accessed July 30, 2018.