Synthesis of research on ENFit gastrostomy tubes with potential implications for US patients using these devices

Abstract

Misconnections between enteral devices and other medical devices have been associated with patient death and serious injuries. To minimize such misconnections, the design of connectors on enteral devices has been standardized. The most common adaptation of the standardized enteral connector is called ENFit. Gastrostomy tubes (G-tubes), which may or may not possess the ENFit connector, are increasingly used to deliver commercial and blenderized diets in home settings to enteral device users. To investigate and compare the performance of G-tubes with and without ENFit connectors, research investigations have recently been performed. However, synthesis of such investigations and quantitative discussion of the consequences of transitioning to ENFit-based G-tube devices has not yet occurred. Here we review the research findings from these studies, with data on patient practices from a Mayo Clinic survey, to estimate the impact on tube feeders in home settings of transitioning to ENFit-based G-tube devices. Extrapolating the findings from these studies to US enteral G-tube patients, 1.5%-8.6% of adult patients and 0.2%-1.9% of pediatric patients may experience perceptible slowing in their gravity feeds if using ENFit-based G-tube devices. About 2.5%-8.6% of adult patients and 0.5%-5.5% of pediatric patients (or their caregivers) may need to push with perceptibly more force for syringe push-based feeding using ENFit-based G-tube devices. Lastly, the article offers suggestions for patients and device manufacturers. [Correction added on 2 May 2022, after first online publication: In the preceding sentence, the percentage of adult patients was revised from 2.5%-8.6% to 1.5%-8.6%.].

Keywords: ENFit; blenderized diets; enteral nutrition; gastrostromy tube; misconnections.

FIGURE 1

Graphics show three different misconnections of various medical devices with enteral devices (adapted from https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections). These examples are not all inclusive

FIGURE 2

The timeline of seminal events or studies on ENFit connectors and devices. The inset is a graphical representation of the ENFit connector adapted with permission from the GEDSA webpage. ASPEN, American Society for Parenteral and Enteral Nutrition; ECRI, Emergency Care Research Institute; FDA, US Food and Drug Administration; GEDSA, Global Enteral Device Supplier Association; ISO, International Organization for Standardization; JC, Joint Commission. https://stayconnected.org/wp-content/uploads/2016/10/GEDSAStayconnected-Checklist-1-page.pdf

FIGURE 3

Flow diagram for identifying relevant articles that discuss enteral device performance in the context of the transition to ENFit. ISO, International Organization for Standardization

FIGURE 4

(A) A commonly used legacy syringe transitioning to an ENFit-based syringe. The plungers for the syringes have not been shown. (B) A bolus legacy extension set for low-profile G-tubes transitioning to the ENFit-based connection set. Note the short length of the connector section. Also, the low-profile G-tubes themselves remain unaffected by the transition. (C) A percutaneous endoscopic gastrostomy tube with long or short transition sections transitioning to ENFit-based devices with a relatively long transition section (figure adapted from Guha et al, 2020). G-tube, gastrostomy tube

FIGURE 5

(A) Flow rate data from FDA and Mayo Clinic for Isosource 1.5 at 18 Fr. (B) Flow rate data from FDA data with Peptamen AF at two device sizes across legacy and ENFit devices. (C) Force data from FDA with two blenderized diets at two device sizes across legacy and ENFit devices. L1–L4, E1, and E2 were standard G-tubes and L5 and E3 were low-profile G-tubes. E, ENFit device; FDA, US Food and Drug Administration; Fr, French; G-tube, gastrostomy tube; L, legacy device