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ENFit ® Connector Conversion Schedule for the U.S.
COLUMBUS, Ohio, July 18, 2019 /PRNewswire/ -- 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. Along with North America, GEDSA actively supports advancing adoption throughout Latin America and Asia to improve patient safety worldwide and comply with regulatory guidance in each country.
Important Dates for the U.S. Device and Adaptor Conversion to ISO 80369-3 Safety Standards:
GEDSA member manufacturers have aligned to only produce ISO 80369-3 compliant devices with ENFit connectors according to the following deadlines:
July 1st, 2020
Legacy feeding tubes and cross-application adaptors
January 1st, 2021
Transition sets and adaptors sold separately
1 The U.S. Food and Drug Administration. (2018, September 7). The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury. Retrieved from https://www.fda.gov/media/115846/download
2 The Joint Commission Online. (2018 September 12). Quality and safety. Retrieved from https://www.jointcommission.org/assets/1/23/JC_Online_Sept_12.pdf
3 The Centers for Medicare & Medicaid Services. (2018, October 4). Enteral Device Connectors that Reduce Patient Injury. Retrieved from https://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2018-10-04-eNews.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending#_Toc526322347
4 Legacy devices consist of enteral device connectors that are not ISO 80369-3 compliant
The Global Enteral Device Supplier Association (GEDSA) is a 501(c)6 nonprofit trade association formed to help introduce international safety standards for healthcare tubing connectors. Comprised of manufacturers, distributors, and suppliers of enteral nutrition devices worldwide, GEDSA facilitates information flow about the three-phase initiative, which is designed to increase patient safety and optimal delivery of enteral feeding by reducing the risk of tubing misconnections.
ENFit® is a federally registered trademark of GEDSA in multiple jurisdictions throughout the world.
Current GEDSA Members:
A. Hopf GmbH
Q Medical Devices
GEDSA Supporting Organizations:
SOURCE Global Enteral Device Supplier Association