An extended protocol for usability validation of medical devices: Research design and reference model

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a...

Combining situated Cognitive Engineering with a novel testing method in a case study comparing two infusion pump interfaces

We validated the usability of a new infusion pump interface designed with a situated Cognitive Engineering approach by comparing it to a reference interface using a novel testing method employing repeated measurements and process measures, in addition to traditional outcome measures. The sample consisted of 25 nurses who performed eight critical...

Network measures for characterising team adaptation processes

The aim of this study was to advance the conceptualisation of team adaptation by applying social network analysis (SNA) measures in a field study of a paediatric cardiac surgical team adapting to changes in task complexity and ongoing dynamic complexity. Forty surgical procedures were observed by trained human factors researchers, and...

With how many users should you test a medical infusion pump? Sampling strategies for usability tests on high-risk systems

Usability testing is recognized as an effective means to improve the usability of medical devices and prevent harm for patients and users. Effectiveness of problem discovery in usability testing strongly depends on size and representativeness of the sample. We introduce the late control strategy, which is to continuously monitor effectiveness of...