Optimizing usability and signal capture: a proactive risk assessment for the implementation of a wireless vital sign monitoring system

Abstract

Wearable vital sign monitors are a promising step towards optimal patient surveillance, providing continuous data to allow for early detection and treatment of patient deterioration. However, as wearable monitors become more widely adopted in healthcare, there is a corresponding need to carefully design the implementation of these tools to promote their integration into clinical workflows and defend against potential misuse and patient harm. Prior to the roll-out of these monitors, our multidisciplinary team of clinicians, clinical engineers, information technologists and research investigators conducted a modified Healthcare Failure Mode and Effect Analysis (HFMEA), a proactive evaluation of potential problems which could be encountered in the use of a wireless vital signs monitoring system. This evaluation was accomplished by focussing on the identification of procedures and actions that would be required during the devices' regular usage, as well as the implementation of the system as a comprehensive process. Using this method, the team identified challenges that would arise throughout the lifecycle of the device and developed recommendations to address them. This proactive risk assessment can guide the implementation of wearable patient monitors, optimising the use of innovative health information technology.

Keywords: Wearable vital sign monitors; clinical workflow; health information technology; healthcare failure mode and effect analysis; medical device.