Martin Kasparick

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. Todays 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 patients 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.

Medical DPWS: New IEEE 11073 standard for safe and interoperable medical device communication

The number of devices in an operation room (OR) and the complexity of the components and the overall system increases continuously. Todays vendor-dependent integrated ORs are expensive and not able to handle this complexity because they can only form isolated solutions. Thus a device communication for medical devices among each other and to medical information systems has to be based on open and vendor-independent standards. In this paper we will present new standards for networked Point-of-Care medical devices that will be part of the IEEE 11073 family of standards. A service-oriented device communication is defined by means of an architecture definition, a transport specification called Medical Devices Profile for Web Services (MDPWS), and a Domain Information & Service Model. The new system will make the complexity of a comprehensive OR integration manageable and thereby improve patients safety. The focus of this paper is on MDPWS that enables a device communication for medical requirements and safety issues, like safe data transmission that will typically be used for safe remote control (dual channel and safety context), data streaming, and compact transmission. The suitability of the concept has been shown by a demonstrator with over 20 real world OR devices from more than 10 vendors.

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.

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

Abstract 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).

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.

Software design and implementation concepts for an interoperable medical communication framework

Abstract 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.

Extending the IEEE 11073-1010X nomenclature for the modelling of surgical devices

The current lack of medical device interoperability can only be overcome by the usage of structural and semantic standards. Therefore, a modern service-oriented architecture for systems of networked medical devices has been developed within the IEEE 11073 series. Its application to new domains such as surgery also demands an extension of the IEEE 11073-1010X Nomenclature, which was initially designed for only a limited set of device types. We thus propose new terms for surgical devices and component interactions, options for the (limited) post-coordination of terms, and term mapping to SNOMED CT and LOINC. In addition, we discuss the development of device specialisation standards.

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.

Point-of-care medical devices and systems interoperability: A mapping of ICE and FHIR

Medical devices at the point-of-care can be interconnected through standardised communication protocols to build an Integrated Clinical Environment (ICE), but in order to interoperate with clinical information systems, different data exchange standards need to be conformed to. The emerging HL7 Fast Healthcare Interoperability Resources (FHIR) framework appeals to developers and clinicians alike and is a promising candidate to modernise this domain. Novel IEEE 11073 standard proposals that specify a service-oriented architecture of networked medical devices are one example for an ICE architecture. They are based on expressing a devices capabilities and state in a machine-readable way in order to be safely accessed and manipulated by other participants in the networked device system. In this work, the domain information and service model of this ICE architecture was mapped to FHIR resources that were constrained and extended to support the modelling of this device architecture. Through the definition of a FHIR profile, the data structures were aligned, effectively allowing for the transformation of medical device observation data from ICE to FHIR representation without the need for any proprietary interface. The implementation of this transformation, e. g. as a gateway, bridges the structural interoperability gap between two contemporary communication architectures for medical devices and clinical information systems and thus lays the foundation for semantic interoperability that can be achieved through the combined use with controlled vocabularies. The consequent availability of device data enables secondary usage such as large-scale data analytics. Future sub-profiles for specific device types further simplify the transformation.