Feasibility of International Proposed Standardized Enteral Connector for Semi-Solid Formula Feeding

Abstract

Background/Aims: The current study was undertaken to assess if the semi-solid formulas could be used with a new ENFit connector with similar force to current percutaneous endoscopic gastrostomy (PEG) tubes. Methods: Experiment 1: We measured the applied pressure (force) needed to compress the syringe containing 7 viscous semi-solid formulas with a 20 Fr PEG tube and low-profile tube through the ENFit connector or the current connector. Experiment 2: This experiment was conducted to evaluate the compression force through 2 connectors in 3 infusion velocity, 7 PEG tube types with 2 semi-solid formulas. Results: Experiment 1: The force needed to compress the syringe through the ENFit connector was higher in 3 semi-solid formulas with a 20 Fr low-profile tube; otherwise, there were no significant differences. Experiment 2: Each formula required a higher force in the ENFit connector in 6 settings out of 21. Conclusions: The ENFit connector will likely not show any remarkable change in the force to administer the semi-solid formula. However, a higher force was required under some conditions in the prototype ENFit connector. Further investigation of sensory test is needed to confirm the feasibility of the ENFit connector for using the semi-solid formulas.

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

“…Concerns have been raised by some stakeholders about the performance of the ENFit‐based G‐tube devices in delivering HEN 6 . HEN has been increasingly used because it reduces the time spent in a hospital 10 . HEN users have raised concerns that the new G‐tube devices will result in increased time of feeding, increased likelihood of clogging, difficulty in pushing diets because of a higher resistance to flow, cleaning problems, and the potential for drug dosing inaccuracy because of ENFit's smaller inner diameter and direction of flow 4,13 .…”

“…Low‐profile G‐tube devices are also considered to have a lower likelihood of dislodgement compared with standard G‐tubes. The Japanese Pharmaceuticals and Medical Device Agency also conducted a similar force study, 10 although their testing was performed on ENFit prototypes rather than finished devices. They used seven different commercial semisolid formulas and studied push rates of 0.83, 1.66, and 2.5 ml/s.…”

“…Figure 2 shows the timeline of the introduction of the ISO standard along with salient events and research in the last decade pertaining to the ISO standard. To reduce enteral misconnections, it is expected that nearly 500,000 feeding tube users in the US will be transitioning to the new feeding tubes with the ISO 80369‐3 connectors 9,10 . Although the ISO 80369‐3 standard stipulates an enteral small‐bore connector (internal) diameter of 2.9 mm, the standard does not specify all dimensions of a finished gastrostomy tube (G‐tube) device (eg, the length of the connector outside the physical connection) nor the direction of male‐female connections.…”

“…To reduce enteral misconnections, it is expected that nearly 500,000 feeding tube users in the US will be transitioning to the new feeding tubes with the ISO 80369-3 connectors. 9,10 Although the ISO 80369-3 standard stipulates an enteral small-bore connector (internal) diameter of 2.9 mm, the standard does not specify all dimensions of a finished gastrostomy tube (G-tube) device (eg, the length of the connector outside the physical connection) nor the direction of male-female connections. ENFit, the most common adaptation of the ISO 80369-3 standard, has received considerable attention from stakeholders, including patients, primary caregivers, healthcare delivery organizations, patient advocates, and manufacturers.…”