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Small Bore Connectors
February 2015 Update

International standards are currently in development for:

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

The January 2016 California deadline applies to IV applications, enteral feeding and epidural uses. The -3, -6 and -7 standards are relevant to this deadline. CHPSO is a US clinical representative on the ISO committee workgroups and is heavily involved in industry and distributor planning for the roll-out of these new safer connectors.

IV Connectors

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.

Enteral Connectors

ENFit connectors are appearing in the marketplace now. First to arrive are feeding sets. For 2015, these new sets have both the new ENFit connector and a “transition connector” that allows connection to a legacy enteral adapter. Consequently, the new sets can be used in current patients without difficulty. In Q2 2015, the ENFit syringes will arrive. These syringes fit the upcoming ENFit feeding tubes, but can be used with traditional feeding tubes by using the transition connector supplied with the feeding sets. In Q3 2015, ENFit feeding tubes will come on the market.

The introduction is phased to allow providers time to use up legacy supplies and to accumulate adequate stock of the new supplies prior to introduction of the new feeding tubes. All facilities should have adequate supplies of the ENFit feeding sets and syringes by the beginning of Q3 2015 to avoid interruptions in care should a patient with an ENFit feeding tube arrive at the facility. To meet the California deadline, facilities should fully transition to the new ENFit connector: feeding set, syringes and feeding tubes, by the end of 2015.

Transition checklists for the ENFit connector are available for pharmacists, nurses and other clinicians, and facilities.

Epidural Connectors

In 2014, end-user testing of the new epidural connector unexpectedly showed a risk of cross-connection with IV sets under certain extreme conditions. A solution to markedly reduce this risk was quickly found and tested, but created temporary uncertainty regarding the final design and a delay in manufacturer tooling for the -7 connector. Advamed, in its required annual report to the California legislature, has requested a delay in enactment of the epidural requirement. This delay would be less than one year and would allow time to better coordinate rollout of product, as product availability may be spotty by the current 1/1/2016 deadline. Unlike feeding tubes, epidural catheters rarely reside in a patient for longer than several days, so a phased introduction is not needed. At the time of the changeover, kits will be redesigned to have the appropriate connectors on the supplied items, such as syringes and filters. Hospitals will have to ensure that other supplies commonly used during neuraxial procedures are also in stock.

Opportunity to Participate and Further Education

CHPSO will be working with clinicians to provide guidance to suppliers and manufacturers on steps to a smooth epidural connector rollout. We are now forming a workgroup to develop the guidance, and invite interested clinicians to contact us at info@chpso.org if interested in participating.

CHPSO will also be holding a webinar on March 24, open to all, to further discuss the new connectors and steps needed for a safe and efficient transition to the new devices. The webinar will cost $99 per line. Included is one nursing CE credit per purchased line. Additional CE credits are available at $49 per person. Click here for online registration.

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