Integration of a surgical robotic arm to the connected operating room via ISO IEEE 11073 SDC

PURPOSE: Since 2019, intraoperative networking with ISO IEEE 11073 SDC has, for the first time, enabled standardized multi-vendor data exchange between medical devices. For seamless plug-and-play integration of devices without previous configuration, further specifications for device profiles (“device specializations”) on top of the existing core standards must be developed. These generic interfaces are then incorporated into the standardization process. METHODS: An existing classification scheme of robotic assistance functions is being adopted and used as a baseline to derive functional requirements for a universal interface for modular robot arms. Additionally, the robot system requires machine-machine interfaces (MMI) to a surgical navigation system and a surgical planning software in order to carry out its function. Further technical requirements are derived from these MMI. The functional and technical requirements motivate the design of an SDC-compatible device profile. The device profile is then assessed for feasibility. RESULTS: We present a new modeling of a device profile for surgical robotic arms intended for neurosurgery and orthopedic surgery. The modeling in SDC succeeds for the most part. However, some details of the proposed model cannot yet be realized within the framework of the existing SDC standards. Some aspects can already be realized, but could be better supported in the future by the nomenclature system. These improvements are being presented as well. CONCLUSION: The proposed device profile presents a first step toward a uniform technical description model for modular surgical robot systems. The current SDC core standards lack some functionality to fully support the proposed device profile. These could be defined in future work and then included in standardization efforts.