[Evaluation of an integrated OR based on open standards in Cochlea Implant surgery]. / Evaluation eines integrierten OP-Saals auf Basis offener Standards in der Cochlea-Implantat-Chirurgie.

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. The preoperative management, technical preparation, surgical procedure and postoperative documentation by a total of n = 30 study participants (2 expert groups) were evaluated. In addition to the collection of objective parameters, qualitative questionnaires and quantitative, interval-scaled questions were used. RESULTS: Preoperatively, the digital presentation of the patient's clinical data was considered as helpful by both groups (group 1: median = 5, group 2: median = 4). This also applies to the personalized OR settings, the intraoperative display options and the dynamic, surgeon-centered visualization (median = 4). Similar positive conclusions were drawn for postoperative documentation and postoperative follow-up (median = 4). A significant difference in the final evaluation of the integrated surgical concept between the two expert groups could not be determined (p > 0.05). CONCLUSIONS: The positive study results show that the theoretical idea of system networking based on open standards can be successfully implemented in practice using the example of a cochlea implantation. Thus, the intelligent "operating room of the future" no longer seems to be a fictitious idea, but a realistic image of modern surgical medicine.

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. We outline a reference model that addresses the requirements of innovative AI-based research systems as well as the clinical reality. The integration of networked medical devices and Clinical Repositories based on open standards, such as IEEE 11073 SDC and HL7 FHIR, will foster novel assistance and decision support. The reference model will make point-of-care device data available for AI-based approaches. Semantic interoperability between Clinical and Research Repositories will allow correlating patient data, device data, and the patient outcome. Thus, complete workflows in high acuity environments can be analysed. Open semantic interoperability will enable the improvement of patient outcome and the increase of efficiency on a large scale and across clinical applications.

Data Exchange Between Ambulance and Trauma Center: Interview Study About the Needs of Emergency Trauma Room Staff.

BACKGROUND: In emergency trauma room, adequate preparation of all resources prior to the patient's arrival is essential to ensure optimal continuation of the treatment. Therefore, a good transfer of information between pre-hospital and hospital is very important, for example through networking technologies. OBJECTIVES: The aim is to identify what pre-hospital information is needed to ensure that all necessary resources in the ETR are optimally prepared for the incoming trauma patient. METHODS: A qualitative, semi structured interview was conducted with physicians of ETR team at four trauma centers. RESULTS: Physicians mentioned similar requests for pre-hospital information. The workflow in ETRs differed in alerting of team members and transferring of pre-notification information. CONCLUSION: Clinical needs for pre-hospital information for future development of support systems in the networking of accident site and hospital could be identified.

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. Available modeling languages are not capable of describing surgical processes for this application. METHODS: In this work, the BPMNSIX modeling language for intraoperative processes is technically enhanced and implemented for workflow build-time and run-time. Therefore, particular attention is given to the integration of the recently published IEEE 11073 SDC standard family for a service-oriented architecture of networked medical devices. In addition, interaction patterns for context-aware configuration and device orchestration were presented. RESULTS: The identified interaction patterns were implemented in BPMNSIX for an ophthalmologic use case. Therefore, the examples of the process-driven incorporation and control of device services could be demonstrated. CONCLUSION: The modeling of surgical procedures with BPMNSIX allows the implementation of context-sensitive surgical assistance functionalities and enables flexibility in terms of the orchestration of dynamically changing device ensembles and integration of unknown devices in the surgical workflow management.

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. The aim of this work is therefore to provide a proof of concept for the connection of two promising integration solutions OR.NET and SCOT to increase vendor interest. METHODS: The connection of devices between both domains is targeted by implementing an application to map device capabilities between the IEEE 11073 SDC and ORiN standards. Potential properties of the respective architectures are defined. The connection was evaluated by latency measurements in a demonstrator setup utilizing an OR light as an exemplary device. RESULTS: The latency measurements resulted in a similar transmission speed of the GATOR (53.0 ms) and direct SDC-to-SDC (38.0 ms) communication. Direct proprietary ORiN-to-ORiN communication was faster in any case (8.0 ms). CONCLUSION: A connection between both standards was successfully achieved via the GATOR application. The results show comparable magnitudes of the communication between the standards compared to the direct standard-internal communication.

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. 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. METHODS: The 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. RESULTS: Rule-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. CONCLUSIONS: The 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.

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. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

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. 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.

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.

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. 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.

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.

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. The requirements of such a system are described, and solutions for data transfer, processing, and storage are presented. In a subsequent study, a prototype based on the presented concept is tested for correct and complete data transmission and storage and for the ability to record a complete neurosurgical intervention with low processing latencies. In the final section, several applications for the presented data recorder are shown. RESULTS: The developed system based on the presented concept is able to store the generated data correctly, completely, and quickly enough even if much more data than expected are sent during a surgical intervention. CONCLUSIONS: The Surgical Data Recorder supports automatic recognition of the interventional situation by providing a centralized data storage and access interface to the OR communication bus. In the future, further data acquisition technologies should be integrated. Therefore, additional interfaces must be developed. The data generated by these devices and technologies should also be stored in or referenced by the Surgical Data Recorder to support the analysis of the OR situation.