ISO 80369 Compliant Connectors Help to Reduce Route of Administration Errors

^{By Merissa Andersen, PharmD, MPH}

The Institute for Safe Medication Practices (ISMP) has reported on numerous wrong route errors, the most devasting being when intravenous (IV) vinCRIStine is inadvertently administered via the intrathecal route. An error such as this can lead to paralysis, autonomic dysfunction, then respiratory failure, coma, and eventually death. ISMP has written about several other types of errors including those where patients were given oral medications by the IV route when they are prepared/dispensed in a parenteral syringe that connects to vascular access lines. Fatalities have occurred when the contents of liquid filled capsules, such as nimodipine, were withdrawn with a parenteral syringe for oral administration via a nasogastric tube then inadvertently given IV. It is imperative to implement system level automations that design out hazards through automation and remove potential for human error (known as forcing functions) to prevent potentially fatal wrong route errors. 

To help address inadvertent wrong routes errors due to device misconnections, the International Organization for Standardization (ISO) has developed new engineering standards (ISO 80369) to specify the design of small-bore connectors. These connectors have been created with a unique design for each clinical application, thus creating a forcing function that ensures the small-bore connectors and tubing for each specific route will not fit into the connections for another clinical applications (e.g. neuraxial, IV, enteral). 

The first implementation of ISO 80369 compliant connectors was introduced in 2016 with the Global Enteral Device Supplier Association (GEDSA) ENFit device, designed specifically for enteral administration. The special design ensures that these devices will not connect to vascular access lines. Had this technology been present in cases described above, the errors where oral medication was given IV may have been prevented, since the ENFit syringe would not have fit a vascular access line (e.g. IV line). The ENFit syringe has been highly adopted in California due to a state mandate, but nationwide adoption of this technology is only about 25%. Many organizations like ISMP, GEDSA, ECRI, The Joint Commission, and the American Society for Parenteral and Enteral Nutrition (ASPEN) are strongly recommending widespread implementation of ENFit, the only ISO-compliant option for enteral administration. Another ISO 80369 compliant connector has been introduced for neuraxial (or epidural) use. This new connection, which has been named NRFit, is incompatible with the popular Luer system. Again, this design acts as a forcing function to prevent an erroneous administration via the neuraxial route.

Although the adoption of ISO 80369 small-bore connectors is not mandated in most states, it is strongly recommended by many regulatory and accrediting bodies. ISMP’s 2020-2021 Target Medication Safety Best Practices for Hospitals recommends that all oral liquid medications that are not commercially available in unit dose packaging are dispensed by the pharmacy in an oral syringe or an enteral syringe that meets the International Organization for Standardization (ISO) 80369 standard, such as ENFit (Best Practice #4).