The FDA Encourages the Use of Enteral Device Connectors

UCM619782.pdf

The FDA Encourages the Use of Enteral Device Connectors

The U.S. Food and Drug Administration (FDA) is concerned by continued reports of misconnections with enteral devices. To reduce the risk of misconnections and patient injury, the FDA recommends hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that meet the 80369-3 standards, many of which are identified by the tradename ENFit.  Today the FDA is providing recommendations (https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM619782.pdf)  to support the transition to enteral devices with 80369-3 compliant connectors.