Validation and Clinical Evaluation of a Digital Wound Management Checklist

Abstract

The research objective was to explore how a medical device software called the Wound Navigator affects the clinical decision-making process, and to analyse the usability of the Wound Navigator in clinical settings. Another objective was to gain knowhow and produce suggestions on how to execute validation activities and gain insights to complement clinical evaluation of a medical device at Helsinki University Hospital IT Management.

The research was conducted as case study research. The data collection was executed in two parts. First part represented the validation activities in the medical device product development process, and it was conducted as an end-user testing. The end-users tested the Wound Navigator with fictional patient cases. In addition to testing, testers were interviewed regarding the usability of the Wound Navigator and overall experiences regarding digital checklists. The entire end-user testing was observed when possible, and any findings relating to the use of Wound Navigator were noted. The second part of data collection complemented the clinical evaluation in the medical device product development process. Expert statements were collected from wound management professionals to evaluate the clinical accuracy and usefulness of the Wound Navigator.

The structural approach in the Wound Navigator was viewed to support the clinical decision-making process. Majority of testers reported that the procedure recommendations were clear and concise. Overall, the feedback of the usability of the Wound Navigator was positive, and some development recommendations were collected. The expert statements agreed that the flowcharts of the Wound Navigator were clinically accurate.

Based on the findings, it was concluded that there is an unmet need for digital checklists, especially as literature has shown that use of checklists can decrease adverse effects in health care. The importance of end-user involvement in the development was highlighted in order to develop timesaving, usable and truly beneficial tools. The findings of this research could be implemented to practice when developing new medical device software.