Context-Driven Design of a Laparoscopic Instrument Cleaner for Use in Rural Low-Resource Hospitals

Laparoscopic surgery offers significant benefits to patients in low-resource settings compared to open surgery such as faster recovery, less pain, and lower infection rate. However, there exist significant barriers to the safe introduction of laparoscopy such as high costs and limited availability of trained staff. Low- and middle-income country (LMIC) hospitals suffer from higher post-surgical infection which might be due to the limited facilities for the sterile reprocessing of laparoscopic instruments. To design a solution to this issue, a detailed understanding of local settings was needed. Therefore, this research applied a context-driven design approach, based on the Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide. Over several design phases, the need for a reprocessing device was established. An analysis of the sterile reprocessing of laparoscopic instruments led to a list of context-specific design requirements. These were translated to a final conceptual design of a laparoscopic instrument cleaner using a waterfall design method. Finally, a usability study of the loading system of the device was conducted with nurses in four Indian hospitals. A root-cause analysis of the usability study showed that the device was not intuitive enough to use for Indian nurses. A redesign of the loading system was made to improve its ease of use. The design process used in this study can be used as an example for designers wanting to address the critical issue of context-specific medical devices worldwide, or more specifically, the sterile supply of surgical instruments in resource-constrained environments.