Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Merhof, Dorit

Biomedical Engineering / Biomedizinische Technik

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering and the German Society of Biomaterials

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Habibović, Pamela / Haueisen, Jens / Jahnen-Dechent, Wilhelm / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenarz, Thomas / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /


IMPACT FACTOR 2018: 1.007
5-year IMPACT FACTOR: 1.390

CiteScore 2018: 1.24

SCImago Journal Rank (SJR) 2018: 0.282
Source Normalized Impact per Paper (SNIP) 2018: 0.831

Online
ISSN
1862-278X
See all formats and pricing
More options …
Volume 63, Issue 1

Issues

Volume 57 (2012)

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

Martin KasparickORCID iD: http://orcid.org/0000-0003-0577-8463 / Malte Schmitz
  • Institute for Software Engineering and Programming Languages, University of Lübeck, 23562 Lübeck, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Björn AndersenORCID iD: http://orcid.org/0000-0003-4547-7438 / Max Rockstroh
  • Innovation Center Computer Assisted Surgery (ICCAS), University of Leipzig, 04103 Leipzig, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Stefan Franke
  • Innovation Center Computer Assisted Surgery (ICCAS), University of Leipzig, 04103 Leipzig, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Stefan Schlichting / Frank GolatowskiORCID iD: https://orcid.org/0000-0003-0848-7784 / Dirk TimmermannORCID iD: https://orcid.org/0000-0001-9267-9695
Published Online: 2018-01-18 | DOI: https://doi.org/10.1515/bmt-2017-0020

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.

Keywords: computer-assisted surgery; digital operating room; IEEE 11073 SDC; integrated operating room; medical device interoperability; open medical device communication standards; OR.NET; safety and security of medical devices; service-oriented medical device architecture (SOMDA)

References

  • [1]

    Andersen B, Kasparick M, Golatowski F, Ingenerf J. Extending the IEEE 11073-1010X nomenclature for the modelling of surgical devices. In: 2016 IEEE-EMBS International Conference on Biomedical and Health Informatics (BHI), Las Vegas, NV, USA, Feb 2016: 244–247 [Online]. Available: dx.doi.org/10.1109/BHI.2016.7455880.Google Scholar

  • [2]

    Andersen B, Kasparick M, Ulrich H, et al. Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices. Biomed Eng-Biomed Tech 2018; 63: 57–68.Google Scholar

  • [3]

    ASTM International (American Society for Testing and Materials). ASTM F2761-09(2013), Medical Devices and Medical Systems – essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) – part 1: general requirements and conceptual model. West Conshohocken, PA.Google Scholar

  • [4]

    Benzko J, Krause L, Janß A, et al. Modular user interface design for integrated surgical workplaces. Biomed Eng/Biomed Tech 2016; 61: 183–197.Google Scholar

  • [5]

    Christian CK, Gustafson ML, Roth EM, et al. A prospective study of patient safety in the operating room. Surgery 2006; 139: 159–173.PubMedCrossrefGoogle Scholar

  • [6]

    Cleary K, Kinsella A, Mun SK. OR 2020 workshop report: operating room of the future. Int Congr Ser 2005; 1281: 832–838.CrossrefGoogle Scholar

  • [7]

    de Deugd S, Carroll R, Kelly KE, Millett B, Ricker J. SODA: Service Oriented Device Architecture. Pervas Comput IEEE 2006; 5: 94–96.CrossrefGoogle Scholar

  • [8]

    Dell’Anna J, Janß A, Clusmann H, Radermacher K. A configurable footswitch unit for the open networked neurosurgical OR – development, evaluation and future perspectives. i-com 2016; 15: 227.Google Scholar

  • [9]

    Dell’Anna J, Janß A, Zeissig E-M, Ganser K, Radermacher K, Clusmann H. Development of new concepts for safe and usable human-machine-interfaces in the open networked neurosurgical OR. In: 67th Annual Meeting of the German Society of Neurosurgery (DGNC), Frankfurt am Main, 2016 [Online]. Available: http://dx.doi.org/10.3205/16dgnc357.

  • [10]

    DOOP-Projekt (Dienst-orientierte OP-Integration). 16.01.2017. [Online]. Available: http://www.doop-projekt.de/.

  • [11]

    Erl T. Service-oriented architecture: concepts, technology, and design. Upper Saddle River, NJ, USA: Prentice Hall PTR 2005.Google Scholar

  • [12]

    Erl T. SOA – principles of service design. Upper Saddle River, NJ, USA: Prentice Hall PTR 2007.Google Scholar

  • [13]

    Gessat M, Bohn S, Vorunganti A, Franke S, Burgert O. TiCoLi: an open software infrastructure for device integration in the digital OR. Int J Comput Assist Radiol Surg 2011; 6: 284.Google Scholar

  • [14]

    Guédon A, Wauben L, Overvelde M, et al. Safety status system for operating room devices. Technol Health Care 2014; 22: 795–803.PubMedGoogle Scholar

  • [15]

    Healthcare Information and Management Systems Society (HIMSS). HIMSS Dictionary of Healthcare Information Technology Terms, Acronyms and Organizations, Third Edition. 2013, p. 75.Google Scholar

  • [16]

    Health Level Seven International (HL7). HL7 FHIR [Online]. Available: www.hl7.org/fhir/.

  • [17]

    Hu Y-Y, Arriaga AF, Roth EM, et al. Protecting patients from an unsafe system: the etiology & recovery of intra-operative deviations in care. Ann Surg 2012; 256: 203–210.CrossrefGoogle Scholar

  • [18]

    Ibach B, Benzko J, Radermacher K. OR-integration based on SOA – automatic detection of new Service Providers using DPWS. In: Lemke HU, editor. Int J Comput Assist Radiol Surg, vol. 1, CARS. Geneva (Switzerland): Springer, 2010: 195–196.Google Scholar

  • [19]

    iData Research. US Market for Video, High-Tech and Integrated & Hybrid Operating Theatre Equipment. Tech. Rep. 2016. [Online]. Available: http://www.idataresearch.com/product/us-video-high-tech-and-integrated-operating-theatre-equipment-market-2016-forecasted-to-2022-medsuite/.

  • [20]

    IEEE Standards Association. ISO/IEEE Health Informatics – point-of-care medical device communication – part 10101: nomenclature. ISO/IEEE 11073-10101:2004(E), 2004, pp. 1–492.Google Scholar

  • [21]

    IEEE Standards Association. Standard for ISO/IEEE Health Informatics – Point-of-care medical device communication – part 10201: domain information model. ISO/IEEE 11073-10201:2004(E), 2005, pp. 1–183.Google Scholar

  • [22]

    IEEE Standards Association. IEEE 11073-10207-2017 – IEEE Approved Draft Standard for Domain Information & Service Model for Service-Oriented Point-of-Care Medical Device Communication. 2017. [Online]. Available: https://standards.ieee.org/findstds/standard/11073-10207-2017.html.

  • [23]

    IEEE Standards Association. IEEE Project P11073-20701 – Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding [Online]. Available: http://standards.ieee.org/develop/project/11073-20701.html.

  • [24]

    IEEE Standards Association. Health informatics–point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services. In: IEEE Std 11073-20702-2016, 2016, pp. 1–49.Google Scholar

  • [25]

    Janß A, Plogmann S, Radermacher K. Human-centered risk management for medical devices – new methods and tools. Biomed Eng/Biomed Tech 2016; 61: 165–181.Google Scholar

  • [26]

    Janß A, Thorn J, Schmitz M, et al. Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard. Biomed Eng-Biomed Tech 2018; 63: 95–103.Google Scholar

  • [27]

    Kasparick M, Andersen B. Offene Standards im vernetzten Operationssaal. Elektron Praxis 2016; 14: 62–64.Google Scholar

  • [28]

    Kasparick M, Golatowski F, Timmermann D. Cyber-physische Systeme im OP-Saal – Ein Machbarkeitsnachweis. In: INFORMATIK 2014 Big Data – Komplexität meistern 44. Jahrestagung der Gesellschaft für Informatik e.V. (GI), Stuttgart, Germany, Sep 2014: 1203–1214.Google Scholar

  • [29]

    Kasparick M, Rockstroh M, Schlichting S, Golatowski F, Timmermann D. Mechanism for safe remote activation of networked surgical and PoC devices using dynamic assignable controls. In: 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, Orlando, FL, USA, Aug 2016: 2390–2394. [Online]. Available: http://ieeexplore.ieee.org/document/7591211/.

  • [30]

    Kasparick M, Schlichting S, Golatowski F, Timmermann D. New IEEE 11073 standards for interoperable, networked point-of-care Medical Devices. In: Engineering in Medicine and Biology Society (EMBC), 2015 37th Annual International Conference of the IEEE, Milan, Italy, Aug 2015, pp. 1721–1724.Google Scholar

  • [31]

    Kasparick M, Schlichting S, Golatowski F, Timmermann D. Medical DPWS: new IEEE 11073 standard for safe and interoperable medical device communication. In: Standards for Communications and Networking (CSCN), 2015 IEEE Conference on, Tokyo, Japan, Oct 2015, pp. 212–217.Google Scholar

  • [32]

    Kasparick M, Schmitz M, Golatowski F, Timmermann D. Dynamic remote control through service orchestration of point-of-care and surgical devices based on IEEE 11073 SDC. In: 2016 IEEE Healthcare Innovation Point-Of-Care Technologies Conference (HI-POCT). Cancun: IEEE, Nov 2016: 121–125. [Online]. Available: http://ieeexplore.ieee.org/document/7797712/.

  • [33]

    Knipp P, Janß A. Regulatory approval route and strategy for open networked medical devices. In: 49. Jahrestagung der Deutschen Gesellschaft für Biomedizinische Technik (DGBMT), BMT 2015, Lübeck, 2015.Google Scholar

  • [34]

    Koeny M, Benzko J, Czaplik M, et al. The smart operating room: smartOR. In: Memon QA, editor. Distributed networks – intelligence, security, and applications. Boca Raton, FL, USA: CRC Press – Taylor & Francis Group 2013: 291–315.Google Scholar

  • [35]

    Lemke HU, Vannier MW. The operating room and the need for an IT infrastructure and standards. Int J Comput Assist Radiol Surg 2006; 1: 117–121.CrossrefGoogle Scholar

  • [36]

    Lesh K, Weininger S, Goldman JM, Wilson B, Himes G. Medical device interoperability-assessing the environment. In: 2007 joint workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007). IEEE, Jun 2007: 3–12. Available: http://dx.doi.org/10.1109/HCMDSS-MDPnP.2007.22; http://ieeexplore.ieee.org/document/4438159/.

  • [37]

    Mauro C, Sunyaev A, Leimeister JM, Krcmar H. Standardized device services – a design pattern for service oriented integration of medical devices. In: 2010 43rd Hawaii international conference on system sciences, Honolulu, HI, USA, Jan 2010, pp. 1–10.Google Scholar

  • [38]

    MD PnP Program. Medical Device “Plug-and-Play” Interoperability Program. 2015-03-14. [Online]. Available: www.mdpnp.org/.

  • [39]

    MD PnP Program. OpenICE [Online]. Available: www.openice.info.

  • [40]

    Melzer I. Service-orientierte Architekturen mit Web Services: Konzepte – Standards – Praxis, 4th ed. Heidelberg, Germany: Springer Spektrum Akademischer Verlag, 2010.Google Scholar

  • [41]

    National Committee on Vital and Health Statistics (NCVHS). Report on Uniform Data Standards for Patient Medical Record Information. 2000, pp. 21–22.Google Scholar

  • [42]

    OASIS. UDDI Version 3.0.2 – OASIS Technical Specification. 2004 [Online]. Available: https://www.oasis-open.org/committees/uddi-spec/doc/spec/v3/uddi-v3.0.2-20041019.htm.

  • [43]

    OASIS. Reference model for Service Oriented Architecture 1.0 – OASIS Standard. 2006 [Online]. Available: http://docs.oasis-open.org/soa-rm/v1.0/.

  • [44]

    OASIS. Devices Profile for Web Services Version 1.1 - OASIS Standard. 2009 [Online]. Available: http://docs.oasis-open.org/ws-dd/dpws/1.1/os/wsdd-dpws-1.1-spec-os.html.

  • [45]

    OASIS. Web Services Dynamic Discovery (WS-Discovery) Version 1.1. 2009 [Online]. Available: http://docs.oasis-open.org/ws-dd/discovery/1.1/os/wsdd-discovery-1.1-spec-os.html.

  • [46]

    Object Management Group. Data Distribution Service (DDS) Specification [Online]. Available: http://www.omg.org/spec/#DDS.

  • [47]

    Okamoto J, Masamune K, Iseki H, Muragaki Y. Development of a next-generation operating room “Smart Cyber Operating Theater (SCOT)” – development concept and project summay. In: Proceedings of CARS 2015: International Conference and Exhibition on Computer Assisted Radiology and Surgery, Barcelona, Spain, 2015: 156–158.Google Scholar

  • [48]

    “OR.NET – Flagship project funded by the German Federal Ministry of Education and Research,” www.ornet.org (retrieved May 20th, 2016).

  • [49]

    Pfeiffer JH, Dingler ME, Dietz C, Lueth TC. Requirements and architecture design for open real-time communication in the operating room. In: 2015 IEEE International Conference on Robotics and Biomimetics (ROBIO). IEEE, Zhuhai, China, Dec 2015: 458–463 [Online]. Available: http://ieeexplore.ieee.org/document/7418810/.

  • [50]

    Pfeiffer JH, Kasparick M, Strathen B, et al. OR.NET RT: how service-oriented medical device architecture meets real-time communication. Biomed Eng-Biomed Tech 2018; 63: 81–93.Google Scholar

  • [51]

    Rockstroh M, Franke S, Dees R, et al. From SOMDA to application – integration strategies in the OR.NET demonstration sites. Biomed Eng-Biomed Tech 2018; 63: 69–80.Google Scholar

  • [52]

    Rockstroh M, Franke S, Hofer M, et al. OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC. Int J Comput Assist Radiol Surg 2017; 12: 1461–1469.CrossrefGoogle Scholar

  • [53]

    Schlamelcher J, Onken M, Eichelberg M, Hein A. Dynamic DICOM configuration in a Service-Oriented Medical Device Architecture. In: 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Milan, Italy, Aug 2015: 1717–1720.Google Scholar

  • [54]

    Schlichting S, Pöhlsen S. An architecture for distributed systems of medical devices in high acuity environments – a proposal for standards adoption. In: HL7, 2014. 11073/HL7 Standards Week, San Antonio, Texas, USA, 2014 [Online]. Available: www.hl7.org/documentcenter/public/wg/healthcaredevices/20140116 An architecture for distributed systems of medical devices in high-acuity environments.pdf.

  • [55]

    “sourceforge: OpenSDC facilitates development of distributed systems of medical devices.” [Online]. Available: https://sourceforge.net/projects/opensdc/.

  • [56]

    SurgiTAIX AG. Open Surgical Communication Library (OSCLib) [Online]. Available: https://github.com/surgitaix/osclib.

  • [57]

    SurgiTAIX AG. “Software for the Integrated Clinical Environment (SoftICE)” [Online]. Available: https://bitbucket.org/surgitaix/softice.

  • [58]

    TeKoMed – Technologische Kompatibilität in der Medizintechnik durch serviceorientierte Architekturen. 2017-01-17 [Online]. Available: http://kosse-sh.de/projekte/tekomed/.

  • [59]

    W3C Working Group Note. Web Services Glossary. 2004 [Online]. Available: http://www.w3.org/TR/2004/NOTE-ws-gloss-20040211/.

  • [60]

    Weerakkody RA, Cheshire NJ, Riga C, et al. Surgical technology and operating-room safety failures: a systematic review of quantitative studies. BMJ Qual Saf 2013; 22: 710–718.PubMedCrossrefGoogle Scholar

  • [61]

    Will A, Pahontu R, Bergh B. Vernetzte Medizintechnik im Krankenhaus: Vernetzung von Medizingeräten und weiteren IT-Komponenten. KU Gesundheitsmanagement 2015: 54–56.Google Scholar

  • [62]

    World Wide Web Consortium (W3C). Web Services Description Language (WSDL) 1.1 – W3C Note. 2001 [Online]. Available: http://www.w3.org/TR/2001/NOTE-wsdl-20010315.

  • [63]

    World Wide Web Consortium (W3C). SOAP Version 1.2 Part 1: messaging framework (Second Edition) – W3C recommendation. 2007 [Online]. Available: http://www.w3.org/TR/2007/REC-soap12-part1-20070427/.

  • [64]

    World Wide Web Consortium (W3C). Web Services Policy (WS-Policy) 1.5 – Framework – W3C Recommendation. 2007 [Online]. Available: http://www.w3.org/TR/2007/REC-ws-policy-20070904/.

  • [65]

    World Wide Web Consortium (W3C). Web Services Description Language (WSDL) Version 2.0 part 1: core language – W3C recommendation. 2007 [Online]. Available: https://www.w3.org/TR/2007/REC-wsdl20-20070626/.

  • [66]

    World Wide Web Consortium (W3C). Efficient XML Interchange (EXI) Format 1.0 (Second Edition) – W3C Recommendation. 2014 [Online]. Available: http://www.w3.org/TR/2014/REC-exi-20140211/.

  • [67]

    Wubben I, van Manen JG, van den Akker BJ, Vaartjes SR, van Harten WH. Equipment-related incidents in the operating room: an analysis of occurrence, underlying causes and consequences for the clinical process. BMJ Qual Saf 2010; 19: e64.CrossrefGoogle Scholar

About the article

Received: 2017-02-19

Accepted: 2017-10-12

Published Online: 2018-01-18

Published in Print: 2018-02-23


Research funding: This work has been partially funded by the German Federal Ministry of Education and Research (BMBF) as part of the OR.NET project. Grand numbers: 16KT1235, 16KT1236, 16KT1238, 16KT1239.


Citation Information: Biomedical Engineering / Biomedizinische Technik, Volume 63, Issue 1, Pages 11–30, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2017-0020.

Export Citation

©2018 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Johann Berger, Max Rockstroh, Erik Schreiber, Yukishige Yoshida, Jun Okamoto, Ken Masamune, Yoshihiro Muragaki, and Thomas Neumuth
International Journal of Computer Assisted Radiology and Surgery, 2019
[2]
Juliane Neumann, Stefan Franke, Max Rockstroh, Martin Kasparick, and Thomas Neumuth
International Journal of Computer Assisted Radiology and Surgery, 2019, Volume 14, Number 8, Page 1403
[3]
Marian Ohligs, Carina Pereira, Verena Voigt, Marcus Koeny, Armin Janß, Rolf Rossaint, and Michael Czaplik
JMIR Human Factors, 2019, Volume 6, Number 2, Page e12553
[4]
Martin Kasparick, Björn Andersen, Stefan Franke, Max Rockstroh, Frank Golatowski, Dirk Timmermann, Josef Ingenerf, and Thomas Neumuth
Minimally Invasive Therapy & Allied Technologies, 2019, Volume 28, Number 2, Page 120
[5]
Kendall Burdick, Madison Courtney, Mark Wallace, Sarah Baum Miller, and Joseph Schlesinger
Multimodal Technologies and Interaction, 2019, Volume 3, Number 1, Page 2
[6]
Jun Okamoto, Ken Masamune, Hiroshi Iseki, and Yoshihiro Muragaki
Journal of Japan Society of Computer Aided Surgery, 2018, Volume 20, Number 3, Page 129

Comments (0)

Please log in or register to comment.
Log in