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
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.