Output Medical’s Formative Usability Study took place at Jump Trading Simulation & Education Center on Monday, May 15th though Tuesday, May 16th. The study was designed for the purposes of testing the usability of Output Medical’s HydroLink device. The HydroLink system is a Class II, 510(k) exempt medical device that is designed to automate urine output measurement in the ICU. The device is registered and cleared with the FDA; this study had no involvement with any FDA processing. Over the course of the study, 12 Intensive Care Unit (ICU) and Critical Care Unit (CCU) nurses participated.
The study was conducted in one-on-one simulated use sessions with all 12 particpants. The study duration was approximately 60 minutes per participant. With each participant, the HydroLink device was evaluated through simulated use. Prior to performing and tasks or simulated use, all nurse participants received an in-service training from the moderator.
The usability of the device was evaluated based upon ease of learning and ease of use once the participant was educated on how to use the device and subsequently given the opportunity to install and use the device. The usability began with a cognitive walk-through followed by a simulated hands-on interactive set up of the device. During the simulated set up, the participant was encouraged to think aloud and verbalize his or her thought process. However, if the participant struggled with simulated tasks, (e.g. struggles for thirty seconds), the moderator provided assistance. All verbalization, requests for help, and additional actions by the participant were documented by the moderator, a third-party observer, and participant feedback was formalized in a survey following the simulated use trial.
Overall, the simulation proved that the product is quite simple to use, scoring very well on the Likert scale. The main concerns the nurses had with the device were sterility, device location, and alert duration. These concerns will all be taken into consideration when the HydroLink device is updated for clinical use. Many of the tasks involved in device setup were only foreign to the nurse due to it being the first time seeing the device. Most nurses mentioned that if they had more experience with the device, the tasks would be quite simple.
The Output Medical team gained excellent feedback and resounding positive notes on the device. The electronic health record integration was a major highlight, as this functionality has the ability to drastically improve nursing efficiency as hospitals aim to get away from manual charting. The final takeaway was that the HydroLink device is not difficult for nurses to learn and would be a welcome addition to the ICU environment.