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UPDATE: New ENFit connectors available in Q1 2015. See revised timeline for details.

stay-connected

Reducing the Risk of Medical Device Tubing Misconnections

A new global design standard for tubing connectors will improve patient safety by reducing the incidence of medical device tubing misconnections.

This international effort needs your help.

 Get ready for the first clinical application—enteral devices.

 Explore the timeline below for rollout dates and details.

Make sure you’re ready

Filter by:

Enteral

Neuraxial

Where to Find Us

GROUP 1 US, Canada, Puerto Rico

i

GROUP 2 EMEA + ANZ

GROUP 3 United Kingdom, Ireland

GROUP 2

Europe, Middle East, Africa, Australia, New Zealand

The UK and Ireland will transition seperately from the rest of Europe

All dates are projected estimates and subject to change due to timing of product-specific regulatory review and supplier discretion. Consult your supplier representative for product-specific availability, indications, contraindications, precautions, and warnings.

2011

  • Completion and adoption of foundational standard ISO 80369-1 that sets general requirements for safer connectors
    An international group of clinicians, manufacturers, and regulators, such as the FDA, in collaboration with the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization of Standardization developed ISO 80369-1. This standard establishes requirements for small-bore connectors for liquids and gases, making it difficult, if not impossible, for unrelated delivery systems to be connected.
    Learn about the history of the initiative

2012

  • Introduction of new nutrition end small-bore connectors
    New nutrition ports and administration set connectors were introduced to reduce the risk of misconnections. These connectors will be recognized in the new design standards.
    Learn about the devices affected by the initiative

2013

  • Formation of the Global Enteral Device Supplier Association to develop, validate, and help introduce new connectors
    A group of manufacturers, suppliers, and distributors from across the globe formed the Global Enteral Device Supplier Association, a nonprofit trade association.
    Learn about GEDSA

2014

  • The Stay Connected initiative for using safer connectors is launched and the Awareness phase of the ENFit enteral connector transition begins
    Partnering with experts from leading industry organizations, GEDSA begins execution of Stay Connected, a three-phase communications program to ensure the broader healthcare community becomes aware of, prepares for, and adopts the new connectors —ENFit— into clinical practice to improve patient safety.
    Meet the organizations behind Stay Connected

2014

2015

  • Awareness campaign for the new neuraxial connector transition begins

 

2015

  • Q1
  • GROUP 1 Transition sets available in US, Canada, Puerto Rico
    Administration tubing sets will have a new female ENFit connector and a limited-use ENFit Transition Connector to facilitate compatibility between the new and the ENFit system existing port. Learn more about the transition to the new ENFit connector

 

2015

  • Q2
  • GROUP 1 Enteral-specific syringes available in US, Canada, Puerto Rico
    The new ENFit connector requires the new enteral-specific syringe that can be used for med, flush, and bolus feeding. The Luer-tipped syringe will not work with the new ENFit connector system. See all enteral devices affected by the initiative

 

2015

  • Q3
  • GROUP 1 New enteral feeding tubes with the ENFit connector available in US, Canada, Puerto Rico
    The final step of the transition will be the proliferation of the new ENFit male connector port. After the new ENFit male connectors are in place and have been fully adopted in the market, the transition adapters may not be needed. Plan ahead for the transition

2015

  • GROUP 2 Transition sets and syringes available in Europe, Middle East, Africa, Australia, New Zealand
     

    Administration sets will have the new ENFit female connector and the limited-use transition connector to facilitate compatibility between the new ENFit system and the original stepped/funnel port or proprietary ports like ENLock.

    The new connector requires the new enteral syringe that can be used for medicine, flush, and bolus feeding. The Luer-tipped syringe will not work the new ENFit connector system.
    Learn more about the transition to the new connector

 

2015

  • Sept.
  • GROUP 3 Transition sets, enteral-specific syringes, and new enteral feeding tubes with ENFit connector available in United Kingdom and Ireland
  • GROUP 3 Patient-access end transition set available in United Kingdom and Ireland
    Administration sets will have the new ENFit female connector and the limited-use ENFit Transition Connector to facilitate compatibility between the new ENFit system and the existing port.
  • Enteral-specific syringes available in United Kingdom and Ireland
    The new connector requires the new enteral-specific syringe that can be used for medicine, flush, and bolus feeding. The reverse Luer-tipped syringe will not fit the new ENFit male connector tube.
  • New enteral feeding tubes with ENFit Connector available in United Kingdom and Ireland
    The final step of the transition will be the proliferation of the new ENFit male connector port.

2016

  • Q1
  • GROUP 2 New enteral feeding tubes with ISO standard connector available in Europe, Middle East, Africa, Australia, New Zealand
    The final step of the transition will be the proliferation of the new ENFit male connector port. After the new ENFit male connectors are in place and have been fully adopted in the market, the transition adapters may not be needed.

2016

  • GROUP 1 US transition to new ISO standard connector complete. California mandate takes effect
    Effective Jan. 1, 2016, a California law (HB 1867) will prohibit general acute care, acute psychiatric, and special hospitals from using an epidural, intravenous or enteral feeding connector that fits into a connection port other than the type for which it was intended.

2016

  • Q2
  • GROUP 3 With new ENFit male connectors in place, all transition connectors will be removed from the market in United Kingdom and Ireland
    The final step of the transition will be the proliferation of the new ENFit male connector port. After the new ENFit male connectors are in place and have been fully adopted in the market, the transition adapters may not be needed.

2017

  • GROUP 2 Group 2 transition to new ISO standard connector complete

Unite. Connect. Deliver.

At GEDSA, the Global Enteral Device Supplier Association, we believe together we are stronger. Members of GEDSA—a nonprofit trade association of manufacturers, distributors, and suppliers—joined forces to help introduce international standards in medical tubing connectors.

Learn more about GEDSA
charter-pill

Charter Members
as of December 10, 2014

associate-pill

Associate Members
as of December 10, 2014