Focus group SOPs in modular digital ORs of the future

 

Chairs:Patrick Meere, MD, PhD, New York, USA and Armin Janß, PhD, Aachen, Germany

 
Background and Motivation
Standard Operating Procedures (SOP) in medicine are of major importance for quality assurance on an expert level. However, the establishment of SOPs has to be based on clinical evidences and on a broad clinical consensus supported by modern computer integrated technologies enabling closed loop control of the clinical pathways from diagnosis to therapy planning, computer assisted surgery and rehabilitation. Open and secure digital networks in the OR and clinic provide the necessary flexibility and interconnectivity for data exchange and an optimal adaptation of SOPs to the specific needs of each individual patient in a given clinical context.
 
Since 2019 the international acceptance of the open communication standard family IEEE 11073 SDC, initiated by the international OR.NET initiative (www.ornet.org) , enables manufacturer-independent medical device interconnection in the OR and therefore provides new potential for the standardization of the intraoperative workflow while maintaining flexibility for its context and patient specific adaptation. The approach towards open integrated ORs provides new flexibility for data exchange and visualization, automatic documentation, surgical monitoring, and AI assistance as well as remote- and in-the-loop-control of smart device functions and parameters. Moreover, it opens the door towards more cost-efficient solutions based on modular technical system design replacing monolithic vendor specific solutions.
 
However,for an open interconnection of medical devices and IT-systems, the definition of SOPs gets even more important as risk management and usability engineering of open modular digital ORs essentially rely on the definition of standardized processes, device profiles and application scenarios. Therefore, the OR.NET initiative is cooperating with international societies in different clinical disciplines (intensive care, endoscopic surgery, neurosurgery,…).
Objectives
  • Standardized SOPs in orthopedic surgery (including clinical workflows and pathways, generic technical profiles for devices and system configurations as well as generic risk management and usability engineering guidelines)
  • Development of  standardized generic multimodal user interfaces for sterile and unsterile OR personnel
  • Elaboration of standardized workflows and extended SOPs with regard to specific use cases for the usage of modular systems in CAOS
  • Evaluation of effects regarding SDC integration on conventional operating techniques as well as process steps for robotics and planning
  • Communication and transfer to other disciplines and medical professional societies
  • Establish the information and result exchange with the working group “Clinical Users and Operators” of the OR.NET initiative (www.ornet.org – aiming at the international dissemination and application of the SDC standard since 2016)
  • CAOS International will be pioneering SOPs in the modular digital OR of the future and will be the reference partner organization of the international OR.NET initiative for the field of Orthopaedics and Traumatology and for industry looking forward towards an application of the IEEE 11073 SDC in orthopaedic surgery
 
These objectives can only be achieved based on the cooperation of a interdisciplinary focus group of clinicians and engineers.

Figure: ORNET Showcase Integrated Surgical Workstation based on standard device communication (IEEE 11073 SDC) on DMEA fair and conference 2019, Berlin, Germany

 

Activities

  • Online meetings regarding the “Introduction in IEEE 11073 SDC based open integrated digital ORs" and "Why SOPs for open integrated ORs?” will be announced soon.