02/22/2020
The Global Enteral Device Supplier Association (GEDSA) announced today that member manufacturers will phase out legacy feeding devices and transition adaptors starting July 1st, 2020 in order to comply with guidance from the U.S. Food and Drug Administration (FDA)1, Joint Commission2 and Centers for Medicare & Medicaid Services3 (CMS) to reduce medical tubing misconnections and improve patient safety. GEDSA members will monitor the transition through robust post market surveillance, following FDA guidance, and are prepared to adjust supply and product needs accordingly.
The ISO 80369 series is a family of small-bore connectors created by the International Organization for Standardization (ISO) to maximize patient safety by reducing the risk of medical tubing misconnections. ISO 80369-3, commonly known as ENFit, is approaching a 100 percent adoption rate throughout Europe with the Middle East, Australia and New Zealand following behind. Europe has been using ENFit connectors for over two years without a single known reported adverse event.