OR.NET - Secure Dynamic Networking in the Operating Room and Clinic
Funding
The OR.NET project is funded by the German Federal Ministery of Education and Research.
(Project term: 9/2012-8/2015)
Backgound
The increasing number of computer-based devices and instruments currently leads to the need to integrate systems and software solutions in a holistic IT infrastructure of an operating room or a clinic. The wide variety of devices and with this associated information can be integrated in the framework of this association through a dynamic networking and convergence of new and innovative features. Thereby, also innovative approaches for future developments are presented. Based on in previous projects developed approaches to modular and dynamic networking of medical devices in the operating room and based on the paradigm of service-oriented architecture (SOA), the aim of the project is the development of certifiable, dynamic, multi-vendor networking opportunities for existing and future devices and software solutions in the medical environment. For this, the existing approaches in terms of plug and play networking are developed further with regard to the aspects of eligibility and risk management and are implemented technical and generic parallel to the project commercial medical products of the SME project partner.
Goals
The goal of the project is to develop, evaluate and convert basic concepts for safe dynamic linking of components in the operating room and clinic into standardization activities in pre-competitive research and development of medical technology. Especially the automatic and dynamic linking of computerized medical devices in the OR with each other and the interaction of these devices with medically approved software is a particular challenge for the information and communications technology (ICT) application in the medical environment. A proving of such concepts by the manufacturers and operators as well as the standardization will give a boost to new methods and applications of information and communication technologies in the operating room of the future..
Against this background, the aim of the project OR.NET is the balancing of the interests of the manufacturer according to defined and stable boundary conditions on the one hand, and the demand of the operator for dynamically internetworkable, safe and efficiently operable medical devices on the other side. The components divide into three groups: Medical equipment, medical software and medical information systems. Integrated functions are characterized by the fact that information processing is not only done by humans, but their components are involved in case of need in terms of networked embedded systems for information processing architectures. This affects not only distributed software solutions but also active controllable surgical instruments and interfaces of the person-machine interaction.
From the medical perspective, already two networked devices offer interesting, but unfortunately also intervention depending risky - functional variants. In case of lacking performance of an individual component, the resulting risks are also depending on the intervention. Accordingly, the issue of responsibility has to be treated legally.
Moreover, project aims are the development of operating models for the efficient operation of safe and effective medical devices operating networks in the clinic. All is in the context of realizing a ubiquitous computing acquisition and processing with the goal of efficient and safe treatment of patients.
Project Coordination
Prof. Dr. med. Björn Bergh (Spokesman)
Direktor - Zentrum für Informations- und Medizintechnik (ZIM)
Universitätsklinikum Heidelberg
Speyerer Str. 4
69115 Heidelberg
Phone: +49 6221-56-22000
Fax: +49 6221-56-22004
Prof. Dr.-Ing. K. Radermacher (Project Coordinator)
RWTH Aachen University
Pauwelsstraße 20
D-52074 Aachen
Phone: +49-241-80-23873
Fax: +49-241-80-22870
Consortium
In OR.NET, providers of integrated operating rooms, manufacturers of medical devices such as medical equipment and medical components as well (IT) service providers and software vendors work together. They are supported by numerous research institutes and hospitals. Of the clinical partners both clinics and hospital IT departments and equipment operators will be involved in the project. To make the project results Germany-wide and beyond that, the project OR.NET is actively involved in the standardization and normalization and is supported by the appropriate committees and regulatory bodies.
The following partners drive the project OR.NET active forward, while being supported by other associate partners:
Providers of Integrated Operating Room Systems:
- Karl Storz GmbH & Co. KG
- Richard Wolf GmbH
Manufacturers of Medical Devices and Components:
- SurgiTAIX AG
- Inomed Medizintechnik GmbH, Research and Development
- Localite GmbH
- KLS Martin Group
- Möller-Wedel GmbH ImageNET (R&D)
- Ziehm Imaging GmbH
- Söring GmbH
(IT) Service Providers:
- UTK – UniTransferKlinik GmbH
- Synagon GmbH
- MedPlan Engineering GmbH
- MT2IT GmbH & Co. KG
Software and IT-Solutions for Networking:
- MEDNOVO Medical Software Solutions GmbH
- how to organize
- Conworx Technology GmbH
- VISUS Technology Transfer GmbH/ R & D
Research Institutes:
- Fraunhofer-Institut MEVIS
- Fraunhofer-Institut FOKUS
- Technische Universität München, Lehrstuhl für Mikrotechnik und Medizingerätetechnik
- ITM – Institut für Telematik, Universität zu Lübeck
- ISP -Institut für Softwaretechnik und Programmiersprachen, Universität zu Lübeck
- ICCAS – Innovation Center Comupter Assisted Surgery, Universität Leipzig
- MedIT – Lehrstuhl für Medizinische Informationstechnik, RWTH Aachen
- mediTEC – Lehrstuhl für Medizintechnik, RWTH Aachen
- OFFIS – Institut für Informatik e.V. / FuE-Bereich Gesundheit
- Institut für Angewandte Mikroelektronik und Datentechnik, Universität Rostock
- Institut für Medizinische Informatik, Universität zu Lübeck
- Universitätsklinikum RWTH Aachen, Integrierte Teleanästhesiologie
- Technische Universität München, Lehrstuhl für Automatisierung und Informationssysteme
- Technische Universität München, Institut für Informatik, Robotics and Embedded Systems
- Technische Universität München, MITI, Minimal-invasive Interdisziplinäre Therapeutische Intervention
- Universität Augsburg, FMPR, Forschungsstelle für Medizinprodukterecht
Hospitals and Clinics:
- Uniklinik Tübingen, Universitätsklinik für Urologie
- Uniklinik Tübingen, Universitätsklinik für Radiologie
- Uniklinik Tübingen, Universitäts-Frauenklinik
- Klinikum Rostock Anästhesie, Klinik für Anästhesiologie und Intensivmedizin
- Uniklinik Schleswig-Holstein, Klinik für Chirurgie
- Uniklinik Leipzig, Klinik für Herzchirurgie
- Uniklinik der RWTH Aachen, Klinik für Anästhesiologie
- Uniklinik der RWTH Aachen, Orthopädische Klinik
- Uniklinik der RWTH Aachen, Neurochirurgie
- Uniklinikum Heidelberg, Fachklinken für Chirurgie, Urologie und Orthopädie
Clinc IT Departments and Operators:
- Uniklinikum Heidelberg, Zentrum für Informations- und Medizintechnik
- Rhön-Kliniken AG
- Uniklinik Schleswig-Holstein, IT-Planung und -Strategie
Standardization and Authorization:
- Verband der Elektrotechnik Elektronik Informationstechnik
- Deutsches Institut für Normung e. V./ Normenausschuss Medizin (NAMed)
- IHE Deutschland e. V. c/o Bundesverband Gesundheits-IT e. V. (bvitg e. V.)
- qcmed GmbH Quality Consulting Medical
Publications
- A. Janß, S. Schlichting & K. Radermacher: Operating Room and Clinic 4.0: The OR.NET Approach. In: W. Frenz (ed.): Handbook Industry 4.0: Law, Technology, Society, Springer Berlin Heidelberg, 2022, pp. 857-878 [DOI: 10.1007/978-3-662-64448-5_45]
- F. Beger, A. Janß, M. Kasparick, S. Bürger & H. Clusmann: Gerätevernetzung im OP 4.0 wird Standard. In meditronic-journal - Fachzeitschrift für Medizin-Technik, Vol. 5, pp. 6–10, Beam-Verlag, Marburg, Deutschland, November 2018
- P. Krumholz, A. Janß & K. Radermacher: Designkonzept zur einhändigen OP-Tisch Bedienung via Touch. mt medizintechnik, 2018, 138(6), pp. 20-23
- P. Krumholz, A. Janß & K. Radermacher: Usability Evaluation of a One-Handed Touchbased OR-Table Control. Current Directions in Biomedical Engineering, 2018, 4(1), pp. 157-160
- J. Heibeyn, B. Strathen, A. Janß, M. Geiger, D. Wieschebrock, H. Clusmann & K. Radermacher: Integration of a gesture control system within the open interconnection of medical devices in the OR. Proceedings, Abstract, Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2018), 2018
- A. Janß, J. Thorn, M. Schmitz, A. Mildner, J. Dell'Anna-Pudlik, M. Leucker & K. Radermacher: Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard. Biomed Tech (Berl), 2018, 63(1), pp. 95-103
- M. Rockstroh, S. Franke, R. Dees, A. Merzweiler, G. Schneider, M. Dingler, C. Dietz, J. Pfeifer, F. Kühn, M. Schmitz, A. Mildner, A. Janß, J. Dell'Anna Pudlik, M. Köny, B. Andersen, B. Bergh & T. Neumuth: From SOMDA to application - integration strategies in the OR.NET demonstration sites. Biomed Tech (Berl), 2018, 63(1), pp. 69-80
- B. Andersen, M. Kasparick, A. Janß, M. Rockstroh, S. Franke , F. Golatowski, K. Radermacher, T. Neumuth & J. Ingenerf: Unterstützung des Chirurgen durch vernetzte Medizingeräte & Computer-assistierte Chirurgie. In: Einhäupl K.M. (ed.), Medizin 4.0 – Zur Zukunft der Medizin in der digitalisierten Welt, Berlin, Germany, Hanns Martin Schleyer-Stiftung, 88, 159-172, 2017
- F. Beger, A. Janß, M. Kasparick & A. Besting: Der Operationssaal OP 4.0 - Für mehr Sicherheit und Effizienz durch offene Vernetzung in Operationssälen und Kliniken der Zukunft. In meditronic-journal - Fachzeitschrift für Medizin-Technik, Vol. 4, pp. 20-24, beam-Verlag, Marburg, Deutschland, November 2017
- A. Janss, A. Vitting, B. Strathen, M. Strake & K. Radermacher: Intraoperative Workflow Optimization by Using a Universal Foot Switch for Open Integrated OR Systems in Orthopaedic Surgery. In: K. Radermacher & F. Rodriguez Y Baena (ed.): CAOS2017. EPiC Series in Health Sciences, 1, 2017, pp. 248-253
- A. Vitting, A. Janß, B. Strathen, M. Strake & K. Radermacher: 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: V. Duffy & N. Lightner (ed.): Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, online, 2017, pp. 438-449
- M. Vossel, B. Strathen, M. Kasparick, M. Müller, K. Radermacher, M. de La Fuente & A. Janß: Integration of Robotic Applications in Open and Safe Medical Device IT Networks Using IEEE 11073 SDC. In: K. Radermacher & F. Rodriguez Y Baena (ed.): CAOS2017. EPiC Series in Health Sciences, 1, 2017, pp. 254-257
- B. Andersen, B. Bergh, A. Besting, J. Dehm, J. Dell'Anna-Pudlik, M. Dingler, S. Ermeling, S. Franke, A. Janß, K. Radermacher, M. Kasparick, F. Kühn, A. Merzweiler, R. Pahontu, M. Rockstroh, M. Röser, M. Schmitz & A. Zimolong: OR.NET - Secure and dynamic networking in operating room and hospital (Update 2016) In Booklet OR.NET - Secure and dynamic networking in operating room and hospital (Update 2016), Aachen, Deutschland, April 2016
- J. Benzko, L. Krause, A. Janß, B. Marschollek, P. Merz, J. Dell’Anna & K. Radermacher: Modular User Interface Design for Integrated Surgical Workplaces. Biomedizinische Technik, 2016, 61(2), pp. 183-197
- M. Blaar, A. Janß, J. Dell'Anna, A. Höllig, K. Radermacher & H. Clusmann: Bottlenecks and needs in human-human and human-machine interaction - a view from and into the neurosurgical OR. Biomedizinische Technik, 2016, 61(2), pp. 135-146
- J. Dell'Anna, A. Janß, H. Clusmann & K. Radermacher: A Configurable Footswitch Unit for the Open Networked Neurosurgical OR – Development, Evaluation and Future Perspectives. i-com, 2016, 15(3), pp. 227-247
- E.-M. Zeißig, A. Janß, J. Dell'Anna-Pudlik, M. Ziefle & K. Radermacher: Development and experimental evaluation of an alarm concept for an integrated surgical workstation. Biomedizinische Technik / Biomedical Engineering, 2016, 61(2), pp. 199–209
- A. Janß, P. Merz, J. Dell’Anna, M. Strake & K. Radermacher: Application of Medical Device User Interface Profiles for Human-Risk Analysis of Open Integrated OR Systems. Proceedings of the 49th DGBMT Annual Conference, 60(1), 2015, pp. 300
- A. Mildner, A. Janß, J. Dell’Anna, P. Merz, M. Leucker & K. Radermacher: Device- and service profiles for integrated or systems based on open standards. Current Directions in Biomedical Engineering, 2015, 1(1), pp. 538–542
- A. Mildner, A. Janß, J. Dell’Anna, P. Merz, M. Leucker & K. Radermacher: Development of Device- and Service-Profiles for a Safe and Secure Interconnection of Medical Devices in the Integrated Open OR. In: F. Seehusen (ed.): Proceedings of the Risk Assessment and Risk Driven Testing, Third International Workshop, RISK 2015, 9488, 2015, pp. 65-74
- J. Dell'Anna, A. Janß, M. Blaar, A. Höllig, H. Clusmann & K. Radermacher: Analysis of User-Induced Risks in the Neurosurgical OR. Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, 2014, pp. 352-358
- A. Janß, M. de la Fuente, A. Ladenburger, M. Strake & K. Radermacher: Risk Analysis and Usability Evaluation of the Zero-Dose-C-Arm-Navigation (ZDCAN) System for Application in Lumbar Interventions. Proceedings Computer Assisted Orthopaedic Surgery, 2014
- J. Benzko, A. Janß & K. Radermacher: Bewertung und Gestaltung der Mensch-Maschine-Schnittstellen in integrierten OP-Systemen. In: S. Leonhardt, D. Abel & K. Radermacher (ed.): Automatisierungsverfahren für die Medizin, 17(286), 2012, pp. 29-30
- A. Janß, J. Benzko & K. Radermacher: Evaluation and Design of Human-Machine-Interfaces in Integrated Operating Theatres. Proceedings of the 44th Annual Nordic Ergonomic Society Conference, 2012
- A. Janß, W. Lauer, F. Chuembou Pekam & K. Radermacher: Using New Model-Based Techniques for the User Interface Design of Medical Devices and Systems. In Roecker, C., Ziefle, M. (eds.): Human Centered Design of E-Health Technologies: Concepts, Methods and Applications. Hershey, P.A.; IGI Global, 2011, pp. 234-251
- W. Lauer, A. Janß, B. Ibach & K. Radermacher: Man-Machine-Interaction in Complex Intraoperative Orthopedic Work Systems. In: V.G. Duffy (ed.): Advances in Human Factors and Ergonomics in Healthcare, 2010, pp. 825-833
- A. Janß, W. Lauer & K. Radermacher: Usability Evaluation Of A Non-Active Remote Pointing Device For Computer-assisted Orthopaedic Surgery. In: B. Davies, L. Joskowicz & S. Murphy (ed.): Proceedings of the 9th Annual Meeting of CAOS International, 9, 2009, pp. 529-532
- A. Janß, W. Lauer & K. Radermacher: Performance Evaluation of a Multi-Purpose Input Device for Computer-Assisted Surgery. In: O. Dössel & W.C. Schlegel (ed.): IFMBE Proceedings of 11th International World Congress on Medical Physics and Biomedical Engineering, 25/V, 2009, pp. 183-185
- A. Janß, W. Lauer & K. Radermacher: Using Cognitive Task Analysis for UI Design in Surgical Work Systems. Proceedings of the 14th European Conference on Cognitive Ergonomics, 2008
- A. Janß, W. Lauer & K. Radermacher: Model-Based Usability Assessment of Interactive Applications in Surgical Work Systems. Proceedings of the 40th Annual Nordic Ergonomic Society Conference, 2008
- W. Lauer, A. Kanert, A. Janß & K. Radermacher: Analyse humaninduzierter Risiken bei der Optimierung des Workflows in chirurgischen Arbeitssystemen. In: H. Wörn & U. Spetzger (ed.): Tagungsband 6. Jahrestagung der Deutschen Gesellschaft für Computergestützte Chirurgie, 2007, pp. 317-320