Enteral Device Product Discontinuation Update
GEDSA Members and Affiliates Share ENFit® Transition Support & Product Shift Timelines to Increase Patient Safety
March 16, 2022 08:00 AM Eastern Daylight Time
POWELL, Ohio–(BUSINESS WIRE)–Recently the Global Enteral Device Supplier Association (GEDSA) members and affiliates in the enteral feeding device market have released new communications that reiterate their support for the ENFit® conversion schedule and provide critical updates to company timelines for North American production phase out of legacy enteral connectors.
GEDSA has compiled these individual communications and product timelines into a unified message from suppliers supporting the transition to ENFit®-only connectors. Key timelines and statements come from North American suppliers including Cardinal Health, Moog Medical, GBUK, IMI and others.
The switch to the ISO 80369-3 compliant ENFit® connectors will improve patient safety by reducing the risks of potentially fatal medical device misconnections and minimize unintentional disconnections, which can lead to loss of prescribed nutrition. Given global supply challenges, the ability to consolidate to one universal technology should mitigate supply chain interruptions for enteral small-bore connectors.
This harmonization to the standardized ENFit connectors increases the robustness of the supply chain and of course the main objective of increasing patient safety is also furthered. For patients whose tubes have not been switched to ENFit, a select supply of stand-alone transition adaptors will be available until no longer warranted.
This patient safety initiative is supported by clinicians, regulatory agencies, patient safety organizations, Group Purchasing Organizations (GPOs), Durable Medical Equipment providers (DMEs), manufacturers and suppliers. GEDSA thanks all their members and affiliates for their continued support to increase patient safety worldwide.
To see a full list of GEDSA members and supporting organizations visit www.stayconnected.org.
GEDSA Unified ENFit Conversion Message
REVISED ENFit® Connector Conversion Schedule: U.S. and Canada Legacy Connector Production Phase Out Dates
The Joint Commission: Phase out dates coming up for ISO standard on legacy feeding devices, adaptors
Statement by the ISMP/ECRI Institute
FDA Statement: The FDA Encourages Use of Enteral Device Connectors That Reduce Risk of Misconnection and Patient Injury
Centers for Medicare & Medicaid Services: Luer Misconnection Adverse Events
The Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association formed to establish a voice for addressing issues that face enteral device manufacturers, suppliers, and distributors, and to help introduce international patient safety standards for healthcare tubing connectors. For More Information, Visit StayConnected.org.
Natalie Bigler, GEDSA