Usability evaluation of a process optimized integrated workstation based on the IEEE 11073 SDC standard

Several studies have identified that the Operating Room (OR) is costly to maintain, but also the most profit generating department. The 2019 approved ISO IEEE 11073 SDC family defines a manufacturer independent communication standard, which creates open interoperability in the OR and clinic for the first time. Using SDC, medical device data can be collected and used for display on a central cockpit, documentation purposes during an ongoing operation and also be streamed outside the OR. The goal of this research was to analyze and evaluate how medical device data and context information (current workflow step, location, patient, operator) could be used inside and outside the OR (e.g., maintenance and reparation) to improve clinical processes and benefit patient care. We also analyzed if the availability of such information might affect the efficiency and safety of patient care. A process analysis has been performed with clinical staff from the Uniklinik RWTH Aachen. The planning procedure of the OR management has been discussed and clinical use cases have been discussed with nurses, surgeons and anesthesiologists. Potential improvements using interoperable device data have been developed and corresponding interactive functional models have been implemented and discussed with the user groups. After several iterations, these concepts were implemented as part of surgical, anesthesia and OR management workstations. A formative usability evaluation (using the Thinking Aloud technique and questionnaires) has been carried out with a small user group (n=9) to check whether interoperable device data and context information improved the usability and safety of the clinical processes. Inside the demonstrator OR at the Chair of Medical Engineering (RWTH Aachen University) surgeons and anesthesiologists tested and evaluated different interfaces for OR procedures. During the formative evaluation, interfaces inside a remote SDC workstation were tested for: OR-Light, OR-Table, Video-Switch, High Frequency Cutting device and a navigation interface in combination with a standalone tracking system and a universal foot switch. The results were very promising and showed that most interfaces had a high degree of usability. Potential for improvement has been identified in the handling, comprehensibility and discernibility of the navigation system. In a second part, the developed processes for OR-optimization were discussed and evaluated. The clinical staff (n=9) reported that they need to gather information from various sources and systems during surgery (Ø 4.63 out of 5 on a Likert scale) and that repeated recordings of redundant information into multiple protocols is also required. They supported the access, availability and integration of device context information inside clinical processes. All clinical users agreed that utilizing automatic documentation through interoperable medical devices can save valuable time (Ø 4,85 of 5). A concept, in which workflow step specific device settings were suggested, was met with approval but also with criticism. The users saw benefits for time saving and standardization purposes, but also drawbacks for possible dependency and less independent thinking. The statement “The collected data helps to build up a database, on which OR-management can make more efficient decisions” was also met with approval (Ø 4,88 of 5). Interoperable medical devices (using ISO IEE 11073 SDC) can be used to create a useful data base and to support time and resource savings and helps to conduct efficient decisions inside and outside the OR. User interfaces were displayed and evaluated in combination with process supporting data. Workflow specific suggestions for device property changes were declared as helpful, although concerns have been expressed (see above). We showed that interoperable SDC medical device data and context information can be used to improve and support clinical processes.