Usability Assessment of an Innovative Device in Infusion Therapy: A Mix-Method Approach Study

Background: Flushing a venous access device is an important procedure to maintain their patency and prevent malfunctioning and complications. An innovative double-chamber syringe was developed, allowing for the assessment of catheter patency, drug delivery and final flush. This study aims to assess the usability of this new device, considering three development stages (concept, semi-functional prototype, functional prototype). Methods: An iterative methodology based on a mix-method design (qualitative and quantitative) enabled the assessment of the devices' usability by their primary end-users. A usability questionnaire was developed and applied, along with focus groups and individual interviews to nurses. Results: The usability questionnaire integrated 42 items focused on four dimensions (usefulness; ease of use; ease of learning; satisfaction and intention to use). The initial psychometric findings indicate a good internal consistency and the conceptual relevance of the items. The scores seem to be sensitive to the usability evaluation of the medical devices in different stages of product development (with lower values on functional prototype evaluation), and related to nurses' perceptions about functional and ergonomic characteristics. Conclusions: Quantitative and qualitative data provided a comprehensive overview of the double-chamber syringes' usability from the nurses' point of view, informing us of features that must be addressed.