Addressing the Need for a Specialized Disconnection Device in Catheter Connection Management: A Case Study of User-Centered Medical Device Innovation

Background/Objectives: Improvements in catheter connection design intended to increase safety have resulted in connections that are difficult to release manually. No medical device exists to safely disconnect catheter connections. Nurses and other users have developed workarounds including use of hemostats, tourniquets, and wrenches. These workarounds are not always successful for performing this task and can break catheters and catheter connections. This study aimed to evaluate a disconnection device to safely disconnect catheter connections. Methods: This is a mixed-methods study using a user-centered design approach with triangulation of quantitative and qualitative data mapped to Valdez’s sociotechnical framework. Nurses (N = 139) from units across two academic medical centers encompassing diverse patient populations engaged in usability testing and surveys. Data about users’ past catheter disconnection experiences and usability of the specialized disconnection device were collected and analyzed. Triangulation of quantitative data and qualitative themes was mapped using Valdez’s socio-technical framework to complement and strengthen the final design generated for nurses’ user requirements. Results: Ninety-five percent of nurses reported previous difficulty with disconnecting luer connections; 93% of those reporting difficulty improvised with readily available medical devices or products to better grip the connected parts. Over 85% of nurses reported positive experiences using the specialized disconnection device; others suggested design improvements for better performance. Conclusions: The nurses who tested the developed disconnection device reported high acceptability, accessibility, ease of use, and improved task performance. Moreover, as workarounds develop at points of practice where no systematic solution exists, aiming product development activities at these points help close gaps in achieving and maintaining patient safety. This study was not registered.