AAMI News August 2016

Spotlight on Standards: Enteral Connector Standard Nears U.S. Finish Line

Colleen ElliottColleen Elliott is a director of standards at AAMI. Her main areas of focus are anesthetic and respiratory equipment and connectors for healthcare applications.

A standard that deals with connectors for feeding tubes and other enteral applications has been recognized by the Food and Drug Administration (FDA), an important step in drawing attention to a sweeping and complex effort to address the patient safety issue of tubing misconnections.

The international version of the standard, ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications was published on July 1, and the American National Standards Institute (ANSI) is expected to approve an identical U.S. version by late summer.

80369-3 is part of a larger series that intends to prevent medical device tubing from unintentionally being attached to another device that performs a completely different function by making the design of each connector specific to its application.

The Global Enteral Device Supplier Association (GEDSA) is leading the “Stay Connected” initiative to facilitate implementation of the new enteral connectors. GEDSA comprises manufacturers, distributors, and suppliers of enteral nutrition devices worldwide.

Throughout the development of the standard, ISO/TC 210/JWG4 and GEDSA faced a number of challenges, including the need to improve dosing accuracy and assess the effect of the change on blenderized diets.

Based on specifications in 80369-3, syringes have a reverse orientation from the syringes typically used in the enteral setting, with “female” tips that fit around “male” connectors. The dead space volume in the female-tip syringe can be displaced when engaged with the male connector. 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.

To address these concerns raised by clinicians, manufacturers created a low-dose tip syringe that recently received 510(k) clearance from the FDA. This low-dose tip design will be incorporated into the draft of ISO 20695, Enteral feeding catheters and enteral giving sets for single use and their connectors, a new standard being developed by two working groups that focus on catheters.

The other issue the group faced was raised by patients who tube feed at home using blenderized diets. A blenderized diet is pretty much what it sounds like: food that has been blended into a liquid and can be passed into the body through a catheter. They were worried that the smaller diameter of the new connector would negatively affect flow rate and would clog due to the viscosity and presence of particulate in blenderized diets.

This resulted in a desire by manufacturers and clinicians to better define parameters around blenderized diets and understand how they can be managed safely and effectively with 80369-3 connectors. The Mayo Clinic has started researching blenderized diets, with the FDA and GEDSA as observers. Manufacturers are not doing the actual testing but are providing input and supporting the test centers with products that utilize both the old and new connectors.

Based on these efforts, an amendment to 80369-3 has been proposed that would make minor dimensional changes to the connector to allow for the incorporation of the low-dose tip syringe design and provide more consistent flow for blenderized diets. This and another new work item proposal that would allow for the use of 80369-3 connectors with indwelling rectal medical devices with the capability of delivering fluids and medications into the rectum are being balloted to the member countries of ISO/TC 210.

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

Other Published Standards in the 80369 Series

Part 1:  General requirements
Part 5:  Connectors for limb cuff inflation applications
Part 6:  Connectors for neuraxial applications
Part 20: Common test methods

Upcoming Additions

Part 7: Connectors for intravascular or hypodermic applications
Approval and publication are anticipated later this year.

Part 2: Connectors for breathing systems and driving gases applications
Approval and publication anticipated in 2017.