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An approach to integrate distributed systems of medical devices in high acuity environments
Abstract
This paper presents a comprehensive solution to build a distributed system of medical devices in high acuity environments. It is based on the concept of a Service Oriented Medical Device Architecture. It uses the Devices Profile for Web Services as a transport layer protocol and enhances it to the Medical Devices Profile forWeb Service (MDPWS) to meet medical requirements. By applying the ISO/IEEE 11073 Domain Information Model, device data can be semantically described and exchanged by means of a generic service interface. Data model and service interface are subsumed under the Basic Integrated Clinical Environment Specification (BICEPS). MDPWS and BICEPS are implemented as part of the publically available openSDC stack. Performance measurements and a real world setup prove that openSDC is feasible to be deployed in distributed systems of medical devices. © David Gregorczyk, Stefan Fischer, Timm Busshaus, Stefan Schlichting, and Stephan Pöhlsen.
... Modern implementations of the MDCF can be configured to use either a purpose-built message-bus provided by MIDAS or the Data Distribution Service (DDS) [19,22]. Some commercial MAP implementations (e.g., Docbox) use DDS, while others (e.g., Dräger) use a purpose-built web-service framework [23]. ...
... Since it is unnecessary (or possibly even inappropriate) to have commands sent from a logic module to a specific device broadcast widely, point-to-point communication is, in these cases, preferable to pub-sub. While it is possible to have per-device topics (a strategy employed by, e.g., the MDCF); one advantage of Dräger's web-service architecture is the explicit inclusion of point-to-point (discussed in their work as request-response) style connections for private communications and device control [23]. ...
... Note that as device components themselves are not instantiated (since they are physical objects) they are not listed here. 3. Channels: A list of the connections between the components, consisting of the publishing and subscribing port names and component descriptions (lines [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29]. Information that is unknowable at compile-time, such as channel names and the names of specific devices, is represented by the string $PLACEHOLDER$ and is replaced as the app is launched. ...
Medical devices have traditionally been designed, built, and certified for use as monolithic units. A new vision of "Medical Application Platforms" (MAPs) is emerging that would enable compositional medical systems to be instantiated at the point of care from a collection of trusted components. This work details efforts to create a development environment for applications that run on these MAPs.
The first contribution of this effort is a language and code generator that can be used to model and implement MAP applications. The language is a subset of the Architecture, Analysis and Design Language (AADL) that has been tailored to the platform-based environment of MAPs. Accompanying the language is software tooling that provides automated code generation targeting an existing MAP implementation.
The second contribution is a new hazard analysis process called the Systematic Analysis of Faults and Errors (SAFE). SAFE is a modified version of the previously-existing System Theoretic Process Analysis (STPA), that has been made more rigorous, partially compositional, and easier. SAFE is not a replacement for STPA, however, rather it more effectively analyzes the hardware- and software-based elements of a full safety-critical system. SAFE has both manual and tool-assisted formats; the latter consists of AADL annotations that are designed to be used with the language subset from the first contribution. An automated report generator has also been implemented to accelerate the hazard analysis process.
Third, this work examines how, independent of its place in the system hierarchy or the precise configuration of its environment, a component may contribute to the safety (or lack thereof) of an entire system. Based on this, we propose a reference model which generalizes notions of harm and the role of components in their environment so that they can be applied to components either in isolation or as part of a complete system. Connections between these formalisms and existing approaches for system composition and fault propagation are also established.
This dissertation presents these contributions along with a review of relevant literature, evaluation of the SAFE process, and concludes with discussion of potential future work.
... Projects as [1], [6], [16], and [17] focus on providing a reference architecture to support interoperability between medical devices and applications. The importance of connectivity is also targeted by [18]. Medical devices connectivity and interoperability is central for designing ICEenabled applications where it would be possible for devices of different suppliers to connect and exchange data without human intervention preserving the required safety. ...
... In the aforementioned study, a modular system architecture is pro-posed based on distributed intelligence and decentralized control, for online configuration of manufacturing robots, which can be well-extended to medical ones. In [96], a methodology is introduced for constructing a distributed system of medical devices, in service-oriented settings. The DPWS is utilized as the protocol for the transport layer, which is modified to obtain the Medical DPWS (MDPWS), in order to abide by the medical requirements. ...
Among numerous applications of medical robotics, this paper concentrates on the design, optimal use and maintenance of the related technologies in the context of healthcare, rehabilitation and assistive robotics, and provides a comprehensive review of the latest advancements in the foregoing field of science and technology, while extensively dealing with the possible applications of participatory and opportunistic mobile sensing in the aforementioned domains. The main motivation for the latter choice is the variety of such applications in the settings having partial contributions to functionalities such as artery, radiosurgery, neurosurgery and vascular intervention. From a broad perspective, the aforementioned applications can be realized via various strategies and devices benefiting from detachable drives, intelligent robots, human-centric sensing and computing, miniature and micro-robots. Throughout the paper tens of subjects, including sensor-fusion, kinematic, dynamic and 3D tissue models are discussed based on the existing literature on the state-of-the-art technologies. In addition, from a managerial perspective, topics such as safety monitoring, security, privacy and evolutionary optimization of the operational efficiency are reviewed.
... Recently, a number of contributions on designing eHealth systems has appeared such as [25] that introduces an IoT healthcare assisted leaving design or [26] that provides a process oriented design; Ref. [27] that describes the real-time transmissions for telehealth applications; Ref. [28] that discusses security aspects on eHealth; Ref. [29] that provides a framework for integration of medical systems and distributed technology; in [30], a component model is described that allows developing medical systems for ICE-compliant applications. However, none of these contributions focuses on provisioning the ICE standard with reconfiguration and on line service composition facilities. ...
Medical and eHealth systems are progressively realized in the context of standardized architectures that support safety and ease the integration of the heterogeneous (and often proprietary) medical devices and sensors. The Integrated Clinical Environment (ICE) architecture appeared recently with the goal of becoming a common framework for defining the structure of the medical applications as concerns the safe integration of medical devices and sensors. ICE is simply a high level architecture that defines the functional blocks that should be part of a medical system to support interoperability. As a result, the underlying communication backbone is broadly undefined as concerns the enabling software technology (including the middleware) and associated algorithms that meet the ICE requirements of the flexible integration of medical devices and services. Supporting the on line composition of services in a medical system is also not part of ICE; however, supporting this behavior would enable flexible orchestration of functions (e.g., addition and/or removal of services and medical equipment) on the fly. iLandis one of the few software technologies that supports on line service composition and reconfiguration, ensuring time-bounded transitions across different service orchestrations; it supports the design, deployment and on line reconfiguration of applications, which this paper applies to service-based eHealth domains. This paper designs the integration between ICE architecture and iLand middleware to enhance the capabilities of ICE with on line service composition and the time-bounded reconfiguration of medical systems based on distributed services. A prototype implementation of a service-based eHealth system for the remote monitoring of patients is described; it validates the enhanced capacity of ICE to support dynamic reconfiguration of the application services. Results show that the temporal cost of the on line reconfiguration of the eHealth application is bounded, achieving a low overhead resulting from the addition of ICE compliance.
... sensing data) into higher level contexts (e.g. business operations or knowledge extraction), new types of services are made possible; these are expected to be vital for future end-user as well as enterprise deployments, in a number of industry domains. The use and benefits of DPWS have already been studied extensively by researchers in the context of various fields, such as railway systems [6], industrial automation [7], eHealth [8], smart cities [9] and smart homes [10]. ...
Interconnected computing systems, in various forms, will soon permeate our lives, realizing the Internet of Things (IoT) and allowing us to enjoy novel, enhanced services that promise to improve our everyday life. Nevertheless, this new reality introduces significant challenges in terms of performance, scaling, usability and interoperability. Leveraging the benefits of Service Oriented Architectures (SOAs) can help alleviate many of the issues that developers, implementers and end-users alike have to face in the context of the IoT. This work presents Node.DPWS, a novel implementation of the Devices Profile for Web Services (DPWS) based on the Node.js platform. As such, Node.DPWS is the first DPWS library being made available to Node.js developers and can be used to deploy lightweight, efficient and scalable Web Services over heterogeneous nodes, including devices with limited resources. A performance evaluation on typical embedded devices validates the benefits of Node.DPWS compared to alternative DPWS toolkits.
The concept of an Integrated Clinical Environment can be implemented by a fully connected operation room containing devices from different manufacturers. An exchange architecture and protocol for this kind of environment is defined by the IEEE 11073 Service-oriented Device Connectivity family of standards. Therein, a Domain Information and Service Model is bound to the Medical Devices Communication Profile for Web Services, which is the specification for the information exchange technology. It is employed as the communication layer in the software library SDCLib/J that implements an Integrated Clinical Environment. In order to demonstrate that the functionality of SDCLib/J is independent of the underlying transport technology, its communication layer was replaced with an implementation of the Data Distribution Service. Therefore, its publish-subscribe pattern needed to be redesigned and transformed so that it matches the library’s request-response principle.
As medical devices become increasingly complex and the amount of intraoperative information produced in the operating room becomes harder to monitor by hospital staff, the demand for an open communication standard allowing the exchange of data between medical devices, equipment and computer systems is in the rise. Above technical issues, regulatory preconditions pose major challenges: European guidelines oblige medical device manufacturers to specify a list of permissible equipment for each product along with the documentation of its intended use. Operating networks of medical devices beyond their intended use necessitates documented risk management activities. The aim of this article is the development of a methodology that facilitates the detection of risks arising from the dynamic composition of medical device networks. To this end, we describe a novel machine-readable description method, allowing automated threat detection of networks composed of so-described medical devices and equipment. We evaluate our approach in a novel interconnected medical device setup and discuss possible limitations of the strategy.
Healthcare processes are frequently fragmented and often badly supported with IT. Inter- and intra-organizational communication and media frictions complicate the continuous provision of information according to the principle of information logistics. Based on extensive literature review, we present the vision of seamless healthcare with horizontally and vertically integrated healthcare processes enabled by seamless IT support. Its implementation requires the establishment of a communication infrastructure and the deployment of adequate standards in healthcare. There are already comprehensive approaches for dealing with integrating heterogeneous information systems. However, they lack a common communication infrastructure and do not support proactivity and flexibility which are dominant characteristics in healthcare. We propose a software agent-based approach for realizing the vision of seamless healthcare. We present a corresponding implementation for integrating heterogeneous information systems in the context of the German Health Telematics Infrastructure. Based on the concept and the implementation, we show that the modular approach is capable of supporting a wide range of different applications. We furthermore outline which facets of an agent-based solution could be implemented in an operative real-world environment. In closing we derive implications for IT decision makers in healthcare and show directions for future approaches for reducing information logistics related shortcomings in healthcare.
This Reference Model for Service Oriented Architecture is an abstract framework for understanding significant entities and relationships between them within a service-oriented environment, and for the development of consistent standards or specifications supporting that environment. It is based on unifying concepts of SOA and may be used by architects developing specific service oriented architectures or in training and explaining SOA.
A reference model is not directly tied to any standards, technologies or other concrete implementation details. It does seek to provide a common semantics that can be used unambiguously across and between different implementations. The relationship between the Reference Model and particular architectures, technologies and other aspects of SOA is illustrated in Figure 1.
While service-orientation may be a popular concept found in a broad variety of applications, this reference model focuses on the field of software architecture. The concepts and relationships described may apply to other "service" environments; however, this specification makes no attempt to completely account for use outside of the software domain.
As we know, interoperability is an almost nonexistent feature of medical devices. This paper defines interoperability; discusses why the lack of medical device interoperability is a problem, and the scope of the problem. Possible reasons for the lack of medical device interoperability are explored. Numerous benefits to medical device interoperability are outlined and possible risks of maintaining the status quo are predicted.
Leveraging existing and emerging standards from both the embedded-device and IT domains within a Service-Oriented Device Architecture (SODA) has been proposed to eliminate the complexity and cost associated with integrating devices into highly distributed enterprise systems. SODA is an adaptation of a service-oriented architecture (SOA) which integrates business systems through a set of services that can be reused and combined to address changing business priorities. The SODA approach to designing and building distributed software is to integrate a wide range of physical devices into distributed IT enterprise systems. SODA, at the simplest level allows programmers to deal with sensors and actuators just as business services are used in enterprise SOAs. SODA focuses on the boundary layer between the physical and digital realms and aims to provide higher-level abstractions of the physical realms. Its also aims to insulate enterprise system developers from the standards device interfaces.
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