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Use Enteral Device Connectors that Reduce Risk of Misconnection
Patient Safety Alert

Misconnections between enteral devices and other devices (e.g., IV), while rare, can have catastrophic consequences. In recognition of this, California has a law prohibiting hospitals and skilled nursing facilities from using enteral feeding connectors that would fit into other types of connectors (e.g., intravenous), unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care. CHPSO participated in the successful industry effort to develop international standards for the design and testing of safer connectors for uses such as intrathecal, intravenous and enteral administration.

Today, the FDA issued a letter encouraging the use of enteral device connectors that reduce risk of misconnection and patient injury. In that letter, the FDA recommends that providers use enteral devices with connectors that meet the ISO standards for small bore connectors (typically ISO 80369-3 for enteral connectors). Many of these 80369-3 connectors are identified as “ENFit connectors.” The FDA’s recommendations:

Health care professionals:

  • Use enteral devices that meet the ISO standards and are intended to reduce the risk of misconnection.
  • Check the labeling or check with the distributor or manufacturer to determine whether your connectors meet the ISO standards.
  • Organize a plan for your organization to implement the use of these new devices.
  • Do not modify or adapt devices since that may defeat their safety system.
  • Minimize the use of transition adapters (a device component that forms an intermediary connection between two incompatible medical devices).
  • Do not use cross-application connectors.
  • Trace all lines back to their origin when reconnecting devices.
  • Route tubes and catheters that have different purposes in unique and standardized directions, to avoid accidental misconnections.

Hospital purchasing departments and distributors:

  • Purchase enteral devices that comply with the new ISO 80369-1 or ISO 80369-3 series standards to reduce the risk of misconnection.
  • Ensure that an adequate inventory of the new devices is available to purchasers.

CHPSO has tools and materials available to aid in the transition, as does GEDSA. Contact CHPSO at info@chpso.org with any questions.