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Small Bore Connectors June 2014 Update

International standards are currently in development for:

  • 80369-7 “Luer” connectors: IV and hypodermic applications
  • 80369-3 “Enfit” connectors: enteral applications (e.g., feedings)
  • 80369-6 connectors: neuraxial applications
  • 80369-2 connectors: breathing and driving gas applications
  • 80369-5 connectors: limb-cuff inflation systems

The January 2016 California deadline applies to IV applications, enteral feeding, and epidural uses. The first three of the above standards are relevant to this deadline.

The Luer connector standards will tighten current specifications, so that fewer connector problems (e.g., leaking junctions) will be encountered in IV applications. Otherwise, the Luer standard has not significantly changed, and end-users should not notice any differences.

Enfit connectors are progressing as expected, and first products using these connectors (feeding sets) will be available late 2014. This will be followed by Enfit syringes, and ultimately Enfit feeding tubes. “Transitional connectors” will also be available during the changeover: these connectors will allow connections between the new administration sets and syringes to legacy feeding tubes. The phased approach will ensure that everyone has the new sets and syringes prior to the new feeding tubes appearing in the market, so that the feeding tubes should be fully supported as soon as they appear on the scene.

Neuraxial connectors are expected to come out the second half of 2015. Recent ergonomic testing identified potential cross-connections with certain non-neuraxial small-bore connectors when users applied high forces to the connectors. While the cross-connections were low-risk (connecting a proximal neuraxial connector—the male connector—to another type of proximal connector, so that the patient is not receiving the medication at all), the cross-connections needed to be addressed. Cognizant of the California deadline, the ISO committee is making changes to the standards that can rapidly be adopted and retested. Retesting should take place over the next several months, and it still appears that the connectors will be on the market in time to meet the California deadline.

CHPSO remains heavily engaged in the process and is meeting periodically with neuraxial device manufacturers to facilitate a smooth and timely transition to the new, safer, connectors.

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