Abstract
BACKGROUND: Suboptimal design of infusion pumps may lead to usage errors, thereby compromising patient safety. Usability evaluation enables medical device design teams to identify and rectify design-related usability issues in a timely manner. Nevertheless, existing research on infusion pump usability continues to exhibit limitations in aspects such as task design. OBJECTIVE: The study aimed to evaluate the usability of an infusion pump (SLGO SP-200 [SLGO Medical Technology Co, Ltd]) through simulation-based testing with nurses in a usability laboratory designed to simulate an intensive care unit. METHODS: A total of 12 registered nurses with experience in using infusion pumps participated in this study. Nurses were asked to perform 12 operational tasks using the infusion pump. The participants were also asked to perform 7 knowledge tasks, where they were required to find relevant information in the user manual. Participants' behavioral measures (task completion time, frequency of manual query, frequency of asking for assistance from researchers, frequencies of operation difficulties, near-misses, and failures), perceptions (perceived ease of use, perceived concentration level required, perceived likelihood of making programming errors, perceived mental workload, satisfaction, and use intention) were collected to evaluate the usability and identify interface design deficiencies of the pump. RESULTS: The study found that the participants were generally able to complete the tasks. All operational tasks were completed within 3 minutes, and all knowledge tasks were completed within 2 minutes. Our study identified 79 difficult operations, 9 near-miss operations, and 36 operation failures. The causes of the above problems were analyzed. Participants generally found the infusion pump to be user-friendly, requiring a medium level of attention resources, and reported low levels of mental workload and likelihood of making programming errors. CONCLUSIONS: The study results can provide a basis for the design of infusion pumps, help practitioners define the risks of use and the key content of training, and provide an important reference for the design of usability evaluation schemes for medical devices.