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) to address small bore connectors for healthcare applications.
Earlier this year, GEDSA manufacturers submitted letters with their manufacturing plans for conversion to ENFit. Those statements were consolidated into one unified document linked here. Recently, Cardinal Health and MOOG submitted updates to confirm that they were adhering to their schedules and are on track as originally communicated.
May 25th, 2021
Dear Valued Customer,
On September 14th, 2020, the Global Enteral Device Supplier Association (GEDSA) announced 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®.
GEDSA is a 501(c)(6) federal tax exempt Non-Profit Trade Association incorporated in the State of Ohio, USA. GEDSA’s mission is to promote initiatives surrounding safe and optimal delivery of enteral feeding and connectivity. It is GEDSA’s policy and the responsibility of every GEDSA member to comply in all respects with federal, state and international antitrust laws. Any discussion is strictly prohibited for the purpose of raising, lowering, or stabilizing prices; regulating production; allocating markets; encouraging boycotts; fostering unfair trade practices; or assisting monopolization at any GEDSA function. Any questions regarding the meaning or applicability of this policy, as well as any concerns regarding activities or discussions at GEDSA functions, should be promptly brought to the attention of GEDSA’s executive director, officers, and/or legal counsel.
All material provided in this email is intended for informational purposes only and should not be used to replace regulatory or company-specific documents, nor should it replace the advice of a qualified professional. This information is based on the draft ISO 80369 standard; does not imply or suggest any regulatory clearance of any specific product and may not be predictive of clinical outcomes. Images provided do not imply endorsement of any specific product. All products and product designs are the responsibility of each specific legal manufacturer, distributor or supplier. Products with these design features may be pending regulatory clearance or may not be available in a specific geography. Consult your supplier representative for product-specific availability, indications, contraindications, precautions, and warnings.