STANDARDIZATION OF SMALL-BORE CONNECTORS TO AVOID WRONG-ROUTE ERRORS

To support the use of medication administration device connectors and fittings that are designed to prevent misconnections and wrong-route errors; further,

To encourage healthcare organizations to prepare for safe transition to use of medication delivery device connectors and adapters that meet International Organization for Standardization standards; further,

To identify and promote the implementation of best practices for preventing wrong-route errors.

Rationale

Interconnectivity among drug delivery devices and their fittings is a significant and preventable cause of serious or fatal wrong-route errors. Connector and tubing design unique to the route of administration that cannot be linked to a device used for a different route is the strongest type of control for these errors. While some solutions have been advanced to minimize misconnections and improve patient safety, such as the availability of NRFit for neuraxial administration and ENFit for enteral administration, standards and best practices are still needed. Previously, an international joint working group composed of the International Organization for Standardization (ISO), Association for the Advancement of Medical Instrumentation (AAMI), Food and Drug Administration (FDA), manufacturers, clinicians, and other regulators developed ISO connector standards that were voluntary and intended to facilitate global standardization of medical devices. Subsequently, the first ISO standard for enteral device connectors (ANSI/AAMI/ISO 80369-1) was adopted industrywide. Also in response, the Joint Commission published Sentinel Event Alert #53, Managing risk and transition during transition to new ISO tubing connector standards. The provided alert suggested actions from the 2014 Get Connected campaign provided by the Global Enteral Device Supplier Association (GEDSA) as well as updates to the recommendations from the 2006 Sentinel Event Alert #36 on tubing misconnections. Since then, the FDA and other organizations have continued advancing standards for connector designs until they become universally adopted in healthcare facilities.

Until this happens, healthcare workers are encouraged to reference StayConnected.org, maintained by GEDSA, and to follow these recommendations from the FDA to prevent device misconnections: Assess equipment, Communicate, and Trace.