Usability testing of instructions for use in cleaning, disinfection and sterilization of ultrasound probes

Abstract

Infection Prevention and Control (IPC) represents an area of big interest in healthcare. In this context, 'reprocessing' means a cleaning, disinfection or sterilisation process carried out on a used device in order to allow its safe reuse. A typical IPC responsibility assignments matrix includes healthcare facilities, manufacturers of reprocessing agents and equipment, and manufacturers of medical devices. This project aims to analyze and validate the Instructions for Use (IFUs) for reprocessing of ultrasound (US) probes, from the point of view of the usability, in accordance with IEC 62366-1:2015+AMD1:2020 and IEC TR 62366-2:2016.US probes enable a wide range of applications, with the level of infection risk based on the Spaulding Classification, going from noncritical and semi-critical (intact skin and mucous membrane contacts respectively), to critical (intraoperative). In addition to the diverse clinical procedures, the risk of contamination depends also on the variability in the healthcare environment and user knowledge and expertise.Safe reprocessing of an US probe requires that its IFUs, considered as part of the user interface, are clear, legible, and complete. For this reason, to ensure their correct execution and workflow, a usability testing for the reprocessing IFUs is performed. According to the IEC 62366 standards, such test consists of two steps: formative and summative evaluations. The overall aim of the first step is to explore if the instructions are recognizable, understandable and operable by the user and to identify worst-case scenarios and critical tasks which will be further investigated during the second step by a user group, including lay and professional users with different profiles and needs. For the purpose of this project, the usability testing has confirmed a powerful tool to verify that our reprocessing IFUs for aUS probe can be easily and effectively used. The preliminary analysis and the following interviews of diverse users operating in different environments, have provided evidence that such IFUs enable the user to perform a proper and reliable reprocessing for a safe reuse of the probe.