Standards Development

Scope

This Technical Report specifies a recommended colour allocation for tubing devices and syringes that incorporate SMALL-BORE CONNECTORS, for each of the applications specified in ISO 80369-1.

Purpose

ISO/TC210/JWG4 has developed the ISO 80369 series of Small-bore connectors for liquids and gases in healthcare applications. This is a patient safety initiative to reduce the risk of gas or liquids administration via an unintended route. The new connectors are an alternative to the Luer connector, for use in different clinical applications, and will not connect with each other.

However, as several look very similar to the Luer connector a very determined person, with strength, could possibly force a connection between devices with connectors for different applications.

Despite human factors research supporting the use of colour in clinical decision making there is no standard for the allocation of colour for clinical applications. Some manufacturers have already chosen a colour for devices for an application, but as there is no standard there exists risk that various manufacturers may choose different colours for the same application, or different manufacturers may use the same color for devices intended for different applications. The first situation is confusing. The second scenario increases the risk of an unintended connection as a strong, determined person may keep trying to make the cross connection. If each application was assigned a colour, then the determined person is less likely to keep trying to make the cross connection.

There is already a precedent for colour allocation for connectors as it is used for identification of medical gas pipeline terminals and cylinders. The interface dimensions of the gas-specific connectors are dimensionally different to prevent connection to the incorrect gas and the colour coding is an additional aid or prompt.

Allocation of a colour for each small-bore application, similar to the system used for medical gas pipeline terminals and cylinders, is a secondary cue to aid identification of the intended application of the devices and would enhance patient safety.

The use of the colour for a particular application, will prevent different manufacturers choosing the colour themselves which will reduce the risk of the same colour being chosen for devices used for different applications, different colours being chosen for the same application and, the risk of a forced connection between devices for different applications.