Biomedical Engineering / Biomedizinische Technik

Published by De Gruyter

Volume 63 Issue 1 - Special Issue: OR.NET – Secure Dynamic Networks in Operating Room and Clinic

Issue of Biomedical Engineering / Biomedizinische Technik

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Contents
Journal Overview

Publicly Available February 8, 2018

Frontmatter

Page range: i-iii

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Editorial

February 8, 2018

OR.NET – secure dynamic networks in the operating room and clinic

Frank Golatowski, Armin Janss, Martin Leucker, Thomas Neumuth

Page range: 1-3

Special Issue Articles

December 29, 2017

Why OR.NET? Requirements and perspectives from a medical user’s, clinical operator’s and device manufacturer’s points of view

Michael Czaplik, Verena Voigt, Hannes Kenngott, Hans Clusmann, Rüdiger Hoffmann, Armin Will, further members of the Medical Board, BMBF Research Project “OR.NET – Secure Dynamic Networking in the Operating Room and Clinic”

Page range: 5-10

Abstract

In the past decades, modern medicine has been undergoing a change in the direction of digitalisation and automation. Not only the integration of new digital technologies, but also the interconnection of all components can simplify clinical processes and allow progress and development of new innovations. The integration and interconnection of medical devices with each other and with information technology (IT) systems was addressed within the framework of the Federal Ministry of Education and Research (BMBF)-funded lighthouse project OR.NET (“Secure dynamic networking in the operating room and clinic”.) (OR.net-Forschungskonsortium (OR.net Research Syndicate.) OR.net – Sichere dynamische Vernetzung in Operationssaal und Klinik [Online]. Available: www.ornet.org. [last accessed 22 March 2017]). In this project the standards and concepts for interdisciplinary networking in the operating room (OR) were developed. In this paper, the diverse advantages of the OR.NET concept are presented and explained by the OR.NET “Medical Board”. This board represents the forum of clinical users and includes clinicians and experts from various specialties. Furthermore, the opinion from the viewpoint of operators is presented. In a concluding comment of the “Operator Board”, clinical user needs are aligned with technical requirements.

January 18, 2018

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability

Martin Kasparick, Malte Schmitz, Björn Andersen, Max Rockstroh, Stefan Franke, Stefan Schlichting, Frank Golatowski, Dirk Timmermann

Page range: 11-30

Abstract

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.

November 18, 2017

Development concepts of a Smart Cyber Operating Theater (SCOT) using ORiN technology

Jun Okamoto, Ken Masamune, Hiroshi Iseki, Yoshihiro Muragaki

Page range: 31-37

Abstract

Currently, networking has not progressed in the treatment room. Almost every medical device in the treatment room operates as a stand-alone device. In this project, we aim to develop a networked operating room called “Smart Cyber Operating Theater (SCOT)”. Medical devices are connected using Open Resource interface for the Network (ORiN) technology. In this paper, we describe the concept of the SCOT project. SCOT is integrated using the communication interface ORiN, which was originally developed for industry. One feature of ORiN is that the system can be constructed flexibly. ORiN creates abstracts of the same type of devices and increases the robustness of the system for device exchange. By using ORiN technology, we are developing new applications, such as decision-making navigation or a precision guided treatment system.

July 22, 2017

OpenICE medical device interoperability platform overview and requirement analysis

David Arney, Jeffrey Plourde, Julian M. Goldman

Page range: 39-47

Abstract

We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

November 14, 2017

Software design and implementation concepts for an interoperable medical communication framework

Andreas Besting, Sebastian Bürger, Martin Kasparick, Benjamin Strathen, Frank Portheine

Page range: 49-56

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.

December 22, 2017

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

Björn Andersen, Martin Kasparick, Hannes Ulrich, Stefan Franke, Jan Schlamelcher, Max Rockstroh, Josef Ingenerf

Page range: 57-68

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.

February 3, 2018

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

Max Rockstroh, Stefan Franke, Raluca Dees, Angela Merzweiler, Gerd Schneider, Max Dingler, Christian Dietz, Jonas Pfeifer, Franziska Kühn, Malte Schmitz, Alexander Mildner, Armin Janß, Jasmin Dell’Anna Pudlik, Marcus Köny, Björn Andersen, Björn Bergh, Thomas Neumuth

Page range: 69-80

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.

October 31, 2017

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

Jonas H. Pfeiffer, Martin Kasparick, Benjamin Strathen, Christian Dietz, Max E. Dingler, Tim C. Lueth, Dirk Timmermann, Klaus Radermacher, Frank Golatowski

Page range: 81-93

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).

August 25, 2017

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard

Armin Janß, Johannes Thorn, Malte Schmitz, Alexander Mildner, Jasmin Dell’Anna-Pudlik, Martin Leucker, Klaus Radermacher

Page range: 95-103

Abstract

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012–2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.

About this journal

Objective
Biomedical Engineering / Biomedizinische Technik (BMT) is a high-quality forum for the exchange of knowledge in the fields of biomedical engineering, medical information technology and biotechnology/bioengineering. As an established journal with a tradition of more than 60 years, BMT addresses engineers, natural scientists, and clinicians working in research, industry, or clinical practice. All articles are peer-reviewed. All manuscripts must be submitted in English.

Topics

diagnostic imaging
image processing
biosignal processing
modelling and simulation
biomechanics
information and communication in medicine
telemedicine and e-health
surgery
minimum invasive interventions
endoscopy and image-guided therapy
diagnostic and therapeutic instrumentation
clinical engineering
micro- and nanosystems in medicine
active implants
biosensors
neuro-engineering
neural systems
rehabilitation and prosthetics
biomaterials
cellular and tissue engineering
artificial organs
biomedical engineering for audiology, ophthalmology, emergency and dental medicine
general subjects (e.g., education and training, health technology assessment)
special topics (e.g., linking proteomics and genomics with biomedical engineering, emergency medicine)

Article formats
Reviews, Research Articles, Short Communications