Distinguishability and identifiability of products with small bore connectors according to ISO DIS 80369 series: risk analysis and summative evaluation

The ISO 80369-series replace Luer-connectors in five application areas to fight misconnections. Although the standard avoids the mechanical problem of misconnections, the design of products and packages remains arbitrary. So, packages and products with same functions but different connectors could have similar designs and hence could be mixed-up. To ascertain whether standardization is needed for marking non-distinguishable products and packages, a risk management and usability engineering process were carried out, partly. The ensuing risk analysis created nine unacceptable risks relating to non-distinguishable packages and lookalike-products. Based on this, risk control (standardization) is needed for lookalikes with the following proposed measures: colour allocation and haptic textures for products, colour allocation and symbols for packages. Furthermore, three scenarios were planned for summative evaluation. An additional consideration of the efficiency of proposed combinations of measures and products relying on measures would be helpful.