How medical device instructions for use engage users

Instructions for use (IFUs) often are used as risk control measures for medical devices with the potential to expose users or others to use-related hazards and hazardous situations that are not entirely mitigated by device design. In the authors’ extensive experience observing representative users interact with medical devices in simulated-use studies, individuals’ engagement with medical device IFUs varies widely. This variance raises questions regarding how various user groups use IFUs and the factors that make an IFU stronger or weaker for its intended users, uses, and use environments. An online survey was conducted to examine (1) first-time use of medical device IFUs, (2) how first-time use strategies vary across typical user groups for medical devices (e.g., patients, lay caregivers, and healthcare professionals), and (3) which design elements promote initial engagement with IFUs. The results showed that IFUs are used in a variety of ways, including as preparation before use, as guides during use, and as troubleshooting resources during use, as well as that IFUs are not used at all. Overall, the user groups tested responded similarly across all of the survey questions. Bullet point organization, figures, and logical flow were reported to be the most engaging design elements. Small font size and poor organization and flow were reported to be the least engaging design elements. IFU designers can use various usability testing methods to assess their assumptions regarding how a product’s users will use the IFU and to make the IFU more engaging. © Copyright AAMI 2020.