In July of 2020, the Global Enteral Device Suppliers Association (GEDSA) announced the REVISED ENFit®Connector Conversion Schedule: U.S. and Legacy Connector Production Phase Out Dates

Published 3/29/2017 Executive SummaryNumerous reports describe the risks from misconnections of enteral feeding tubing (such as tubes being connected to catheters or to non-enteral tubing), sometimes with fatal outcomes. In response, there is a growing movement toward using a connector design called ENFit.

April 26, 2021 ‐ PSQHNebraska Medicine’s ENFit Conversion Designed to Improve Patient SafetyBy Stacie Ethington, MSN, RN-BCBackgroundAdverse outcomes caused by enteral tubing misconnections are well documented in The Joint Commission’s Sentinel Event Alertfrom August 2014 that states “Tubing misconnections continue to cause severe patient injury and death.” To address the issue, in fall 2020 Nebraska Medicine converted legacy enteral tubes and disposables to be compatible with the ISO 80369-3 standard, also known as ENFit®, that is designed to prevent misconnections and disconnections.

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.