Evaluation criteria for mobile X-ray devices – a novel benchmark based on literature review and lead user interviews in trauma surgery and orthopaedics

Objectives: The study aims on evaluation criteria applicable for the development process of new mobile 3D X-ray imaging devices, based on existent knowledge from literature and user expertise. Methods: For this purpose, a structured literature review was performed to outline limitations and opportunities of established systems on the market. Additionally, medical professionals from various medical fields were interviewed, following a structured interview protocol, to identify critical evaluation aspects from a user perspective. Results: The study identified a total of 52 evaluation criteria, which were categorized into the following domains: clinical application and manageability, image quality, radiation dose and risk of infection. The analysis of user needs, subsequent summarization, and rating of these needs will serve as a new benchmark for the evaluation of both existing and new devices. This will provide guidance to procurement, medical experts, and manufacturers. Conclusions: While the structured evaluation of mobile X-ray devices is possible, consultation of the users regarding their weighting of varying needs will remain an important aspect of the process. The evaluation items can serve as a starting point for this analysis.