Testing Portable Medical Device Instructions: Comparing Experts and Non-Experts

Abstract

Point-of-care testing devices providing medically relevant information are increasingly used by members of the public without any formal medical knowledge. As a result, these devices may be used in extremely different contexts of use by users with different knowledge bases, whether that was the original designers’ intent or not. In this study, we first conducted out-of-the-box testing of a device for non-invasive blood hemoglobin measurement, for its potential for use by individuals with no healthcare-specific training. To do so, we photographed each step, condensing these into five higher-order categories, which we considered potential generic instructions for any point-of-care testing device. We then had individuals with no specific healthcare training test use of the device. We asked two groups of participants, one with Human Factors experience in healthcare and another with no Human Factors or healthcare specific training, to use the device and to list the steps they followed when using the device, keeping in mind if another individual was to follow the same steps to successfully use the device. The results from our study demonstrated that all users were able successfully complete the primary user task (i.e., to measure their hemoglobin) and to develop defined steps of device use. The latter were compared with a set of generic instructions developed by the study team. Our generic instructions may provide a standardized and generally applicable approach to using point-of-care testing devices.