Max Rockstroh

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC

PurposeClinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders.MethodThe demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff.ResultsIn the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms.ConclusionThe implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.

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

Abstract 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. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

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

Abstract 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. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

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. One of the major problems within the OR is that typically every device has its own control unit. This leads to unsatisfying situations like a high number of foot switches that causes operating errors or the problem that the physician cannot reach the control unit of the device where parameters have to be changed or an activation should be triggered. Dynamically assignable controls will solve these problems. This paper describes mechanisms that allow a safe remote activation of safety critical device functionalities based on a potentially unsafe off-the-shelf network with problems like connection loss and jitter. The proposed systems is based on a periodic reactivation of the device functionality and the additional use safety related information that is included into the activate operation command. The main advantage is that all described mechanisms make use of the self-description capability provided by the IEEE 11073 SDC. This enables a real interoperability and plug-and-play functionality because both the medical device and the control client do not need any a priori knowledge about each other.

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

PurposeInteroperability 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. Technical context-awareness will be an essential feature of the next generation of medical devices to address the increasing demands to clinicians in information seeking, decision making, and human–machine interaction in complex surgical working environments.MethodsThe paper describes the technical validation of an intelligent surgical working environment for endoscopic ear–nose–throat surgery. We briefly summarize the design of our framework for context-aware system’s behavior in integrated OR and present example realizations of novel assistance functionalities. In a study on patient phantoms, twenty-four procedures were implemented in the proposed intelligent surgical working environment based on recordings of real interventions. Subsequently, the whole processing pipeline for context-awareness from workflow recognition to the final system’s behavior is analyzed.ResultsRule-based behavior that considers multiple perspectives on the procedure can partially compensate recognition errors. A considerable robustness could be achieved with a reasonable quality of the recognition. Overall, reliable reactive as well as proactive behavior of the surgical working environment can be implemented in the proposed environment.ConclusionsThe obtained validation results indicate the suitability of the overall approach. The setup is a reliable starting point for a subsequent evaluation of the proposed context-aware assistance. The major challenge for future work will be to implement the complex approach in a cross-vendor setting.

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

Abstract 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. We developed a four-level approach for video-based device information extraction. Usually, video streams contain all relevant patient data and device usage information. We propose an approach consisting of defining regions of interest, grabbing video signals, analyzing the signals and storing the data in a centralized and structured location. The analysis considers textual information and graphical visualization. A prototype of the analysis approach was implemented and applied to a neurosurgical case. An evaluation study was conducted to measure the performance of the approach on video recordings of real interventions. Three medical devices were considered: intraoperative ultrasound, neuro-navigation and microscope. Overall, recognition rates for device usage higher than 95% were obtained. The approach is not limited to a single surgical discipline and does not require modification of medical devices. Furthermore, the analysis of microscopic video streams expands the detectable aspects of the surgical workflow beyond the recognition of device usage.

A Method for the Context-Aware Assignment of Medical Device Functions to Input Devices in Integrated Operating Rooms

Operating rooms will emerge to integrated systems with a consistent, cooperative behavior. Recent developments towards context-awareness for medical devices aim to keep system’s complexity manageable for the staff. In that context, we propose a modeling approach for the realization of a dynamic assignment of device functions to remote input devices. In the present experiments, we focused on the surgeon’s human-machine interactions. The results of the preliminary technical validation indicate that the proposed approach has the potential to increase the surgeon’s direct control with a reasonable set of already established input devices. The context-aware assignment of functions will ease the complexity where automation is not applicable due to induced risks. Thus, it contributes to the implementation of context-aware systems’ behavior for a intelligent surgical working environment.

Context-aware medical technologies - relief or burden for clinical users?

Abstract The open, cross-vendor interoperability of medical devices is an enabling technology for the implementation of context-aware biomedical systems in daily clinical routine. The surgical working environment is both a valuable field of application and a particular challenge. A design of context-aware medical technologies that shows intelligent behaviour and ensures safe operation is demanding; thus implementations are yet limited to prototypes and specific surgical use cases. Many open research questions need to be addressed to empower context-aware medical systems to be a relief and not a burden for the clinical user.

Context-awareness for control consoles in integrated operating rooms

Abstract In surgery, the possibilities of fully automatic assistance are limited. A valuable automated assistance can be implemented by realizing context-aware behaviour of control consoles in integrated operating rooms (ORs). We developed an intraoperative pipeline for surgical context interpretation and an integrated console. Based on that, we propose a method for the context-aware ranking of configuration profiles, which facilitate the handling of devices during endoscopic interventions. The method is evaluated with twenty-four simulated endoscopic ear-nosethroat (ENT) workflows. The results indicate that a continuous automatic ranking based on the surgical situation, can significantly reduce manual user interaction while the surgeon’s control is preserved.

A service for monitoring the quality of intraoperative cone beam CT images

Abstract In recent years, operating rooms (ORs) have transformed into integrated operating rooms, where devices are able to communicate, exchange data, or even steer and control each other. However, image data processing is commonly done by dedicated workstations for specific clinical use-cases. In this paper, we propose a concept for a dynamic service component for image data processing on the example of automatic image quality assessment (AQUA) of intraoperative cone beam computed tomography (CBCT) images. The service is build using the Open Surgical Communication Protocol (OSCP) and the standard for Digital Imaging and Communications in Medicine (DICOM). We have validated the proposed concept in an integrated demonstrator OR.