AAMI News November 2015

Spotlight on Standards: Small-Bore Connector Committee Addresses ENFit Concerns

EnFit low-dose syringeWith the transition to the new ENFit connector underway, AAMI and the Global Enteral Device Supplier Association (GEDSA) have spent the past few months addressing design concerns, namely issues related to the dosing accuracy of ENFit syringes and worries from patients who tube feed with a blenderized diet.

ENFit is GEDSA’s trademarked name for the connectors found in the new design standard for enteral feeding sets and syringes to connect to feeding tubes—ISO 80369-3—which is part of the 80369 standard series being developed to reduce tubing misconnections.

Improving Dose Accuracy

ENFit syringes have a reverse orientation from the syringes typically used in the enteral setting, with female tips that fit around male connectors. In recent months, this has presented an engineering challenge because the dead space volume in the female-tip syringe can be displaced when engaged with the ENFIT male connector, causing a greater variance in dosing than the male-tip syringes used today. For doses of 2 mL or less, this can cause more than a 10% overdose of medication, which is problematic, especially in the neonatal setting.

After these concerns were raised at a forum convened at the Children’s Hospital of Philadelphia by the Institute for Safe Medication Practices and numerous other organizations, a number of solutions were presented. Taking into account the hospital and home environment, as well as healthcare professionals’ preferences, the committee decided to move forward with the development of a new ENFit low-dose syringe that extends the fluid lumen to form a male-oriented tip within the female ENFit connector, allowing it to function similarly to oral syringes.

ENFit low-dose syringes are currently in production and are expected to be available in early 2016.

Accommodating a Blenderized Diet

Patients and caregivers are fearful that the proposed size of the opening, or bore, of the ENFit connector will reduce liquid flow and cause clogging when used with a blenderized diet. A blenderized diet, as the name suggests, consists of food blended to a consistency that can pass through a feeding tube.

On Oct. 14, AAMI and GEDSA brought together members of ISO/TC 210/JWG4, the international group authoring the 80369 series of standards; industry representatives; nonprofit and advocacy organizations; and patients to address these concerns.

“Getting feedback from patients is critical to the development process. User feedback allows manufacturers to understand first-hand how their products are used, carefully assess patient needs, and determine the best ways to ensure an optimal user experience. This input will fuel design concepts for future medical devices to better serve select patient populations and drive continuous improvement, while striving to maintain compliance with the standard,” said Tom Hancock, executive director of GEDSA.

During the open meeting, Don McMichael of Halyard Health presented results from his company’s product testing. During these tests, McMichael compared ENFit with the current systems, including a skin-level tube, PEG tube, G-tube, and GJ-tube. He found that the gravity flow rates were similar between the old and new systems.

At the conclusion of the meeting, McMichael performed a live side-by-side gravity feeding demonstration using formula that illustrated no difference in flow rates between the current connectors and ENFit.

Next Steps

The final draft international standard ballot is expected to open on Dec. 3. However, the committee acknowledged the need to continue to provide an open forum for discussion. The committee will be reaching out to patient advocacy partners to determine the best ways to engage concerned patients.

If you have any questions about the committee or the 80369 standard, please contact Colleen Elliott at celliott@aami.org.