[Evaluation of an integrated OR based on open standards in Cochlea Implant surgery].

Background: Digitalization in surgery makes it necessary to develop modern surgical concepts. New approaches to system networking with integration and open standardized communication of all medical devices are being pursued.

Methods: At the University Hospital Leipzig, a demonstration of the integrated OR was carried out together with the Innovation Center for Computer Assisted Surgery (ICCAS) using the example of a cochlea implantation.

GATOR: connecting integrated operating room solutions based on the IEEE 11073 SDC and ORiN standards.

Purpose: Medical device interoperability in operating rooms (OR) provides advantages for both, patients and physicians. Several approaches were made to provide standards for successful device integration. However, with high heterogeneity of standards in the market, device vendors may reject these approaches.

Extending BPMN 2.0 for intraoperative workflow modeling with IEEE 11073 SDC for description and orchestration of interoperable, networked medical devices.

Purpose: Surgical workflow management in integrated operating rooms (ORs) enables the implementation of novel computer-aided surgical assistance and new applications in process automation, situation awareness, and decision support. The context-sensitive configuration and orchestration of interoperable, networked medical devices is a prerequisite for an effective reduction in the surgeons' workload, by providing the right service and right information at the right time. The information about the surgical situation must be described as surgical process models and distributed to the medical devices and IT systems in the OR.

Enabling artificial intelligence in high acuity medical environments.

Acute patient treatment can heavily profit from AI-based assistive and decision support systems, in terms of improved patient outcome as well as increased efficiency. Yet, only very few applications have been reported because of the limited accessibility of device data due to the lack of adoption of open standards, and the complexity of regulatory/approval requirements for AI-based systems. The fragmentation of data, still being stored in isolated silos, results in limited accessibility for AI in healthcare and machine learning is complicated by the loss of semantics in data conversions.

The intelligent OR: design and validation of a context-aware surgical working environment.

Purpose: Interoperability of medical devices based on standards starts to establish in the operating room (OR). Devices share their data and control functionalities. Yet, the OR technology rarely implements cooperative, intelligent behavior, especially in terms of active cooperation with the OR team.

From SOMDA to application - integration strategies in the OR.NET demonstration sites.

The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices.

The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions.

Mechanism for safe remote activation of networked surgical and PoC devices using dynamic assignable controls.

The number of devices within an operating room (OR) increases continuously as well as the complexity of the complete system. One key enabler to handle the complexity is an interoperable and vendor independent system of networked medical devices. To build up such an interoperable system we use the proposed IEEE 11073 SDC standards (IEEE P11073-10207, -20701, -20702) for networked point-of-care (PoC) and surgical devices.

Video-based detection of device interaction in the operating room.

The establishment of modern workflow management technologies requires the integration of dated devices. The extraction of the essential device data and usage time spans is a central requirement for an integrated OR environment. Therefore, methods are required that extract such information from the output provided by older generation devices, namely video signals.

Requirements for the structured recording of surgical device data in the digital operating room.

Purpose: Due to the increasing complexity of the surgical working environment, increasingly technical solutions must be found to help relieve the surgeon. This objective is supported by a structured storage concept for all relevant device data.

Methods: In this work, we present a concept and prototype development of a storage system to address intraoperative medical data.