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Transitioning to New Enteral Connectors
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Manpreet Mundi, MD, on behalf of the Oley Board of Trustees


 Caregiver Leslie M. demonstrates making a

blenderized tube feeding at the 2015 ENFit Summit.

By now, many of you have heard about the transition to new enteral connectors. You may even be using the new ENFit® tubes or supplies. As this is a big change with potential for confusion, we wanted to use this opportunity to summarize the background behind the transition, the results of the studies that have been done so far regarding ENFit connectors, and also how Oley will continue to support the home enteral nutrition community as we undergo this transition.

Background

Since 1972, when Dr. Wallace first reported about a patient who received 100 mL of cow’s milk intravenously instead of enterally, misconnections have been an ongoing issue, especially in the inpatient setting. These misconnections have led to multiple safety reports by organizations such as the Joint Commission. The universally compatible Luer lock connection used by feeding tubes (and other systems, such as IV access) has been noted as a common contributing element.

The state of California passed a law (HB 1867) mandating that   enteral nutrition supplies only fit a connection port for which they are intended. A single connector that works across systems (such as the Luer lock) is no longer considered acceptable. This has led to the development of standards for all major catheters/tubing by the International Organization of Standards (ISO). These standards will be implemented gradually.

Enteral nutrition tubes and supplies fall under the small-bore connector ISO 80369-3 standard. In an effort to facilitate the transition to connectors compatible with this ISO standard, many major enteral device and tubing manufacturers joined the Global Enteral Device Supplier Association (GEDSA), formed in 2013. ENFit connectors have been designed to fit the specifications outlined in the ISO 80369-3 standard, and are being manufactured by GEDSA members and others. It is possible that other connectors that fit the specifications outlined in this ISO standard may also be developed.

The timeline for making a transition to ISO-compatible connectors has continued to change based on the availability of adequate ENFit supplies and resolution of an issue with low-volume drug dosing using ENFit syringes. Additionally, groups such as the Oley Foundation and the Home Enteral Nutrition (HEN) Program at Mayo Clinic have brought up the need for testing to ensure that the new connectors will work well for the needs of outpatients who typically do not use a pump and instead may feed by gravity or syringe. It has also become apparent that blenderized tube feeding (BTF) use is increasing in popularity, with surveys of Oley members indicating that as many as 89.6% of pediatric patients and 65.9% of adults are using BTF on a routine basis (Epp, L., Lammert, L., Vallumsetla, N., Hurt, R. T. and Mundi, M. S. [2017], Use of Blenderized Tube Feeding in Adult and Pediatric Home Enteral Nutrition Patients. Nutrition in Clinical Practice, 32: 201–205. doi:10.1177/0884533616662992).

Studies Comparing ENFit to Legacy Tubes
In response to the concerns about whether ENFit would serve the needs of the home enteral nutrition (HEN) community, Oley organized a meeting in Atlanta in December 2015. One of the outcomes of this meeting was a collaboration between the Food and Drug Administration (FDA), GEDSA, and Mayo Clinic HEN program to formally test commercially available ENFit tubes under parameters more fitting for outpatient use. In order to minimize bias, no funding was obtained from GEDSA or any manufacturer for this testing. Manufacturers only supplied the tubes and some of the formula to be used and all testing was performed on a volunteer basis. Oley also helped provide formula for the testing and input from the patient perspective on the study design.

The goal of testing was to assess whether, as a whole, ENFit tubes led to any changes in gravity or syringe feeding compared to the tubes used currently—called “legacy” tubes to distinguish them from the new ENFit tubes. The goal was not to compare one tube to another but to get a sense of the overall impact the ENFit connector may have. Thus, the data analysis was done by combining the results for all available ENFit tubes and comparing them to the results for all legacy tubes.

The first study was performed simulating gravity flow in a laboratory setting. This was done by filling a 60-mL syringe with various formulas and recording the time it took the syringe to empty. This study found that as an aggregate, there was no significant difference in time between the ENFit and legacy tubes for low-profile, 18 French (Fr), and 20 Fr tubes. The ENFit 14 Fr tubes had a lower flow rate compared to legacy tubes largely due to one ENFit tube that seemed to perform poorly in this test. It was also noted that with some formulas, the 24 Fr ENFit tubes had lower flow rate compared to legacy.

The next set of tests was performed to evaluate the amount of force necessary to compress a syringe filled with various formulas and BTF in order to simulate syringe feeding. Again, various formulas, including Jevity, Nourish, Real Food Blends, and a Mayo Clinic recipe, were used for this testing. Out of all of the tests performed, only two results were significantly different between the ENFit and legacy tubes: the 20 Fr legacy tubes required higher pressure to compress the syringe filled with Jevity than the same size ENFit tubes; and the 14 Fr ENFit tubes required higher pressure compared to the 14 Fr legacy tubes when the syringe was filled with the blend from a Mayo Clinic BTF recipe. Additional analysis was done and showed that other factors—such as the formula used, the blender used, the time of blending and tube size—mattered more than whether the tube was ENFit or legacy when it came to syringe compression force.

Oley Foundation’s Role
Despite the studies performed so far, it is difficult to state the true impact of the transition to ENFit. The studies discussed above have shown that a large number of variables (formula versus BTF, tube manufacturer, tube size, blender used, time of blending, BTF recipe, etc.) may impact how enteral nutrition is provided. As an example, going from a legacy tube from one manufacturer to an ENFit tube of another manufacturer may actually improve flow rate, depending on the formula and tube size, even if the combined flow rate of ENFit tubes of a certain Fr size was slower than legacy tubes of the same size. The opposite can also be seen; even though there was no difference between the ENFit and legacy tubes for a particular result, there can still be a difference felt by the consumer depending on the type of tube, formula used, and method of administration (e.g., pump, gravity, syringe).

Due to this, we, the Oley Foundation, remain committed to supporting the entire home enteral nutrition community, whether you have or plan to transition to ENFit or you plan on continuing to use your legacy tubes. We will do this in a number of ways. We will continue to work with manufacturers to discuss the issues raised by Oley members and the results of trials in an effort to encourage improved tube design so your needs can be met.

We will also continue to hold consumer conferences and provide the latest information available, as well as additional resources to provide needed support. We will continue to partner with the Mayo Clinic, FDA, and other organizations to foster increased understanding of the needs of the HEN community and also improve outcomes through research. Please watch the newsletter and continue to visit our website for up-to-date information regarding this transition.



LifelineLetter, November/December 2017

more Calendar

5/11/2019
Oley Regional Conference - Santa Monica, California

6/21/2019 » 6/24/2019
2019 Oley/UI Health Combined Conference

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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