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

Max Rockstroh 1 , Stefan Franke 1 , Raluca Dees 2 , Angela Merzweiler 2 , Gerd Schneider 2 , Max Dingler 3 , Christian Dietz 3 , Jonas Pfeifer 3 , Franziska Kühn 4 , Malte Schmitz 5 , Alexander Mildner 6 , Armin Janß 7 , Jasmin Dell’Anna Pudlik 7 , Marcus Köny 8 , Björn Andersenhttp://orcid.org/0000-0003-4547-7438 9 , Björn Bergh 2 ,  and Thomas Neumuth 1
  • 1 Universität Leipzig, Innovation Center Computer Assisted Surgery, Semmelweisstr. 14, D-04103 Leipzig, Germany
  • 2 Department of Medical Information Systems, Heidelberg University Hospital, 69115 Heidelberg, Germany
  • 3 Institute of Institute of Micro Technology and Medical Device Technology, Technical University of Munich, 85748 Garching bei München, Germany
  • 4 Institute for Telematics, University of Lübeck, 23562 Lübeck, Germany
  • 5 Institute for Software Engineering and Programming Languages, University of Lübeck, 23562 Lübeck, Germany
  • 6 UniTransferKlinik Lübeck, 23562 Lübeck, Germany
  • 7 Chair of Medical Engineering in the Helmholtz-Institute at the RWTH Aachen University, Pauwelsstr. 20, 52074 Aachen, Germany
  • 8 University Hospital RWTH Aachen, Department of Anaesthesiology, Pauwelsstrasse 30, D-52074 Aachen, Germany
  • 9 Institute of Medical Informatics, University of Lübeck, 23562 Lübeck, Germany
Max Rockstroh
  • Corresponding author
  • Universität Leipzig, Innovation Center Computer Assisted Surgery, Semmelweisstr. 14, D-04103 Leipzig, Germany
  • Email
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Stefan Franke
  • Universität Leipzig, Innovation Center Computer Assisted Surgery, Semmelweisstr. 14, D-04103 Leipzig, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Raluca Dees
  • Department of Medical Information Systems, Heidelberg University Hospital, 69115 Heidelberg, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Angela Merzweiler
  • Department of Medical Information Systems, Heidelberg University Hospital, 69115 Heidelberg, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Gerd Schneider
  • Department of Medical Information Systems, Heidelberg University Hospital, 69115 Heidelberg, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Max Dingler
  • Institute of Institute of Micro Technology and Medical Device Technology, Technical University of Munich, 85748 Garching bei München, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Christian Dietz
  • Institute of Institute of Micro Technology and Medical Device Technology, Technical University of Munich, 85748 Garching bei München, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Jonas Pfeifer
  • Institute of Institute of Micro Technology and Medical Device Technology, Technical University of Munich, 85748 Garching bei München, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Franziska Kühn, Malte Schmitz
  • Institute for Software Engineering and Programming Languages, University of Lübeck, 23562 Lübeck, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Alexander Mildner, Armin Janß
  • Chair of Medical Engineering in the Helmholtz-Institute at the RWTH Aachen University, Pauwelsstr. 20, 52074 Aachen, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Jasmin Dell’Anna Pudlik
  • Chair of Medical Engineering in the Helmholtz-Institute at the RWTH Aachen University, Pauwelsstr. 20, 52074 Aachen, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Marcus Köny
  • University Hospital RWTH Aachen, Department of Anaesthesiology, Pauwelsstrasse 30, D-52074 Aachen, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
, Björn AndersenORCID iD: http://orcid.org/0000-0003-4547-7438, Björn Bergh
  • Department of Medical Information Systems, Heidelberg University Hospital, 69115 Heidelberg, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar
and Thomas Neumuth
  • Universität Leipzig, Innovation Center Computer Assisted Surgery, Semmelweisstr. 14, D-04103 Leipzig, Germany
  • Search for other articles:
  • degruyter.comGoogle Scholar

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.

  • [1]

    Andersen B, Ulrich H, Kock A-K, Wrage J-H, Ingenerf J. Semantic interoperability in the OR.NET project on networking of medical devices and information systems – A requirements analysis. In 2014 IEEE-EMBS International Conference on Biomedical and Health Informatics (BHI), Valencia, Spain, 2014: 428–431.

  • [2]

    Andersen B, Ulrich H, Rehmann D, Kock A-K, Wrage J-H, Ingenerf J. Reporting Device Observations for semantic interoperability of surgical devices and clinical information systems. In Proceedings of the 37th IEEE Engineering in Medicine and Biology Society (EMBC), Milano, Italy, 2015: 1725–1728.

  • [3]

    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.

  • [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.

  • [5]

    Blaar M, Janß A, Dell’Anna J, Höllig A, Radermacher K, Clusmann H. Bottlenecks and needs in human-human and human-machine interaction – a view from and into the neurosurgical OR. Biomed Eng/Biomed Tech 2016; 61: 135–146.

  • [6]

    Decker N, Kuhn F, Thoma D. Runtime verification of web services for interconnected medical devices, presented at the IEEE 25th International Symposium on Software Reliability Engineering (ISSRE 2014), Naples, Italy, 2014: 235–244.

  • [7]

    Dell’Anna J, Janß A, Clusmann H, Radermacher K. A Configurable footswitch unit for the open networked neurosurgical OR – 8development, evaluation and future perspectives. i-com 2016; 15: 227–247.

  • [8]

    Dietz C, Lueddemann T, Dingler M, Lüth T. Automated risk detection for medical device networks with hard real time requirements. In Proceedings of the IEEE/SICE International Symposium on System Integration (SII 2016), Sapporo (Japan), 2016: 471–476.

  • [9]

    Dingler M, Dietz C, Pfeiffer J, Lueddemann T, Luth T. A framework for automatic testing of medical device compatibility. In Proceedings of 13th International Conference on Telecommunications (ConTEL), Graz, Austria, 2015: 1–8.

  • [10]

    Dingler M, Pfeiffer J, Lüddemann T, Dietz C, Lüth TC. Open real time communication of medical devices in the operating room. Medical Technology in Bavaria – Profiles, Portraits, Perspectives 2016; 2016: 40–43.

  • [11]

    Dingler M, Dietz C, Lüth T. Verification of on-demand medical device networks. CDBME 2017; 3: 445–448.

  • [12]

    Franke S, Neumuth T. Rule-based medical device adaptation for the digital operating room. In Proceedings of 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Milano, 2015: 1733–1736.

  • [13]

    Franke S, Rockstroh M, Schreiber E, Neumann J, Neumuth T. Context-aware medical assistance systems in integrated surgical environments. In 28th Conference of the international Society for Medical Innovation and 1Technology (SMIT), Delft, Netherlands, 2016.

  • [14]

    Janß A, Benzko J, Merz P, Dell’Anna J, Radermacher K. Development of medical device UI-profiles for reliable and safe human-machine-interaction in the integrated operating room of the future. In Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, Krakow, 2014: 1855–1860.

  • [15]

    KARL STORZ GmbH & Co. KG. OR1 – KARL STORZ Endoskope. 14-Jan-2016.

  • [16]

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

  • [17]

    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. Conf Proc IEEE Eng Med Biol Soc 2016; 2016: 2390–2394.

    • PubMed
    • Export Citation
  • [18]

    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 IEEE-NIH 2016 Special Topics Conference on Healthcare Innovations and Point-of-Care Technologies, Cancun, Mexico, 2016.

  • [19]

    Kasparick M, Schmitz M, Andersen B, et al. OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability. Biomed Eng-Biomed Tech 2018; 63: 11–30.

  • [20]

    Krieg SM, Sabih J, Bulubasova L, et al. Preoperative motor mapping by navigated transcranial magnetic brain stimulation improves outcome for motor eloquent lesions. Neuro-Oncol 2014; 16: 1274–1282.

    • Crossref
    • PubMed
    • Export Citation
  • [21]

    Kühn F, Leucker M. OR.NET: safe interconnection of medical devices. In: Gibbons J, MacCaull W, editors. Foundations of health information engineering and systems, vol. 8315. Berlin, Heidelberg: Springer Berlin Heidelberg 2014: 188–198.

    • Crossref
    • Export Citation
  • [22]

    Lüth TC, Lüddemann T, Pfeiffer JH, Dingler ME, Dietz C. OR.NET, Abschlussbericht 2016, Lehrstuhl MIMED. Technische Universität München, Lehrstuhl für Mikrotechnik und Medizingerätetechnik, 2016. Available at: https://doi.org/10.2314/GBV:873806719

  • [23]

    Olympus Europa SE & Co. KG. Olympus – Systems Integration. 14-Jan-2016.

  • [24]

    Pfeiffer JH, Dingler ME, Dietz C, Lueth TC. Requirements and architecture design for open real-time communication in the operating room. In Proceedings of IEEE International Conference on Robotics and Biomimetics (ROBIO 2015), Zhuhai, China, 2015: 458–463.

  • [25]

    Pfeiffer J, Borbáth Á, Dietz C, Lueth TC. A new module that combines two tracking cameras to expand the workspace of surgical navigation systems. In Proceedings of the International Symposium on System Integration (SII 2016), Sapporo (Japan), 2016: 477–482.

  • [26]

    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.

  • [27]

    Rockstroh M, Franke S, Neumuth T. A workflow-driven surgical information source management. In International Journal Computer Assisted Radiology and Surgery, Heidelberg, 2013; 8: 189–191.

  • [28]

    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.

    • Crossref
    • PubMed
    • Export Citation
  • [29]

    Schlamelcher J, Onken M, Eichelberg M, Hein A. Dynamic DICOM configuration in a service-oriented medical device architecture. In Conf Proc of the Engineering in Medicine and Biology Society (EMBC), Milano, Italy, 2015: 1717–1720.

  • [30]

    Strauss G, Koulechov K, Hofer M, et al. The navigation-controlled drill in temporal bone surgery: a feasibility study. Laryngoscope 2007; 117: 434–441.

    • Crossref
    • PubMed
    • Export Citation
  • [31]

    Vitting A, Janß A, Strathen B, Strake M, Radermacher K. Further development and evaluation of a universal foot switch for diverse medical disciplines within the framework of an open integration concept for the operation theatre of the future. In: Duffy V, Lightner N, editors. Advances in human factors and ergonomics in healthcare and medical devices, vol. 590. Cham: Springer International Publishing 2018: 438–449.

    • Crossref
    • Export Citation
  • [32]

    Zeißig E-M, Janß A, Dell’Anna-Pudlik J, Ziefle M, Radermacher K. Development and experimental evaluation of an alarm concept for an integrated surgical workstation. Biomed Eng/Biomed Tech 2016; 61: 199–209.

Purchase article
Get instant unlimited access to the article.
$42.00
Log in
Already have access? Please log in.


or
Log in with your institution

Journal + Issues

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. BMT addresses engineers, natural scientists, and clinicians working in research, industry, or clinical practice. All articles are peer-reviewed.

 

Search