• To reduce the risk of wrong route delivery of fluids and gases (tubing misconnections) there is an ongoing effort led by the International Organization for Standardization, ISO 80369, to address small-bore connectors for healthcare applications. The ISO 80369-3 standard for enteral applications has been approved and published to enable manufacturers to adopt a safer connector design which will be used on medical devices providing a safer enteral feeding system.

  • GEDSA fully supports the recent letter on "The Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury" issued by the FDA on September 7, 2018 (https://tinyurl.com/FDA-80369-3) and applauds the FDA for its release. GEDSA expects this letter to serve as the catalyst for accelerated U.S. market adoption of safer compliant connectors, as defined by the Int er na tional St andards Organization (ISO) 80369-3, commonly known by the federally registered trademarked name ENFit®. GEDSA and its supporting organizations urge manufacturers, distributors/suppliers and health care providers to actively participate in the adoption of new ENFit® connectors as called for in the FDA's letter.

  • GEDSA Position Statement in support of ISO 80369-3 (ENFit enteral connector)There is an ongoing effort led by the International Organization for Standardization (ISO) to address small-bore connectors for healthcare applications in an effort to prevent wrong route delivery of fluids and gases (tubing misconnections).

  • ENFit ® Supply and Demand for the U.SDear Manufacturers, Patients, Caregivers, Healthcare and Supply Chain Professionals, The Global Enteral Device Supplier Association (GEDSA) previously announced that member manufacturers will phase out legacy feeding devices and transition adaptors starting July 1st, 2020.

  • Dear Manufacturers, Patients, Caregivers, Healthcare and Supply Chain Professionals, The Global Enteral Device Supplier Association (GEDSA) previously announced that member manufacturers will phase out legacy feeding devices and transition adaptors starting July 1st, 2020.

  • ENFit ® Supply and Demand for the U.SDear Manufacturers, Patients, Caregivers, Healthcare and Supply Chain Professionals, The Global Enteral Device Supplier Association (GEDSA) previously announced that member manufacturers will phase out legacy feeding devices and transition adaptors starting July 1st, 2020.

  • As you may be aware, on September 14th, 2020, the Global Enteral Device Supplier Association (GEDSA) released a revised conversion schedule indicating that member manufacturers will phase out legacy enteral feeding products and transition adapters. This transition will meet ISO standard 80369-3, commonly referred to as ENFit®.

  • As you may be aware, in September 2020, the Global Enteral Device Supplier Association (GEDSA) released a revised conversion schedule indicating that member manufacturers will phase out legacy enteral feeding products and transition adapters. This transition will meet ISO standard 80369-3, commonly referred to as ENFit®

  • ECRI UPDATE Navigating the Transition to ENFit Enteral Connectors

  • (EPSG)* StatementISO 80369-3: IMPORTANT UPDATE – ENFit ImplementationIssuedFebruary2016As part of a carefully planned 2–stage process, ENFit implementation commenced in September 2015throughout the UK. ENFit is the global enteral feeding device connector design that complies with the newInternational Standard (ISO 80369-3).