Service-Oriented Medical Device Connectivity: Particular Standards for Endoscopic Surgery.

To translate recent advances in medical device interoperability research into clinical practice, standards are being developed that specify precise requirements towards the network representation of particular medical devices connecting through ISO/IEEE 11073 SDC. The present contribution supplements this protocol standard with specific models for endoscopic camera systems, light sources, insufflators, and pumps. Through industry consensus, these new standards provide modular means to describe the devices' capabilities and modes of interaction in a service-oriented medical device communication architecture. This enables seamless data exchange and the potential for new assistive systems to support the caregiver.

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.

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.

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.

OR.NET RT: how service-oriented medical device architecture meets real-time communication.

Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).

Software design and implementation concepts for an interoperable medical communication framework.

The new IEEE 11073 service-oriented device connectivity (SDC) standard proposals for networked point-of-care and surgical devices constitutes the basis for improved interoperability due to its independence of vendors. To accelerate the distribution of the standard a reference implementation is indispensable. However, the implementation of such a framework has to overcome several non-trivial challenges. First, the high level of complexity of the underlying standard must be reflected in the software design. An efficient implementation has to consider the limited resources of the underlying hardware. Moreover, the frameworks purpose of realizing a distributed system demands a high degree of reliability of the framework itself and its internal mechanisms. Additionally, a framework must provide an easy-to-use and fail-safe application programming interface (API). In this work, we address these challenges by discussing suitable software engineering principles and practical coding guidelines. A descriptive model is developed that identifies key strategies. General feasibility is shown by outlining environments in which our implementation has been utilized.

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.

New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.