Improving the usability of medical devices is a crucial issue in ensuring patient safety. According to the ISO 9241-11:2018, usability is defined as “the extent to which a system, product, or service can be used by specific users to achieve specific goals effectively, efficiently, and satisfactorily within a specific context of use” [1]. In other words, it is important to design user interfaces of medical devices that enable healthcare providers to provide the intended medical treatment efficiently and without error. Indeed, there have been reports of medical incidents thought to have resulted from poor usability. For example, operational errors, such as entering an incorrect speed or time into intravenous smart pumps, are considered major causes of medication errors [2, 3, 4, 5]. Problems in usability can cause errors in medical practice, even among experienced doctors [6]. The Association for the Advancement of Medical Instrumentation (AAMI)/Food and Drug Administration (FDA) infusion device summit conducted in 2010 called for a reduction in errors by improving usability and user-interface development [7], and an increasing number of studies have been focusing on the safety of infusion devices [8]. To improve the work systems of healthcare providers effectively, it is desirable to apply human factors/ergonomics (HFE) methods [9]. The US national academies [10] and the World Health Organization (WHO) [11] have recommended that patient safety can be ensured by promoting the application of HFE methods in healthcare.
Human-centered design (HCD) is often applied as an ergonomic approach to usability. HCD is an approach to interactive system development that specifically focuses on making systems usable [1]. HCD mainly comprises the following four activities: understanding and specifying the context of use, specifying user requirements, producing design solutions, and evaluating the design [12]. In HCD, specifying the user requirements is essential, and it is necessary to determine user dissatisfaction with devices that are difficult to use. Communication between medical device designers and users to identify user problems affects the safety of medical devices [13]. Therefore, usability evaluation conducted by incumbent healthcare providers is crucial for determining issues specific to the health care domain [14].
Among healthcare providers, clinical engineers (CEs) are medical device specialists. In Japan, CEs are not only responsible for cardiopulmonary, respiratory, and dialysis care but also for a wide range of diseases, treatments, and medical equipment as well as the management of the entire medical facility’s safety [15]. Identifying user dissatisfaction is an important process in assessing usability, and the expectations for CEs involved with medical devices on a daily basis are significantly high. However, although CEs often evaluate the performance of medical devices with regard to patient care and safety related to electricity, gas, and electromagnetic waves, they rarely evaluate the usability of device interfaces. One possible reason behind this attribute is the lack of education on usability. Because CEs are essential in ensuring patient safety, it is necessary to ensure that they understand the concept of system safety based on HCD and HFE in their training schools [16, 17]. However, in training schools, there are few examples of usability education that focuses on all healthcare providers, and not just on CEs.
In this study, we conducted usability evaluation training for students enrolled at a CE training school. In addition, we verified the effectiveness of our training program by analyzing the results of the students’ usability evaluation. We also conducted text mining on the students’ comments regarding their impressions about the training program.