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Development of Device-and Service-Profiles for a Safe and Secure Interconnection of Medical Devices in the Integrated Open OR

  • Alexander Mildner
  • Armin Janß
  • Jasmin Dell’Anna-Pudlik
  • Paul Merz
  • Martin Leucker
  • Klaus Radermacher
Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 9488)

Abstract

Today’s integrated OR systems are closed and proprietary, so that the interconnection of components from third-party vendors is only possible with high time and cost effort. An integrated operating theatre with open interfaces, giving clinical operators the opportunity to choose individual medical devices from different manufacturers, would be advantageous for both hospital operators and small and medium-sized manufacturers of medical devices. Actual standards and concepts regarding technical feasibility and accreditation process do not cope with the requirements for modular integration based on an open standard. Therefore, strategies as well as device-and service-profiles to enable a procedure for risk management and certification capability are in the focus of the BMBF-funded OR.NET-project. The use of standardized device-and service-profiles shall allow the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.

Keywords

Accreditation strategies Medical device integration Dynamic interconnection Open standards Interoperability OR.net project Risk management Usability engineering Device-and service-profiles 

References

  1. 1.
    Birkle, M., Benzko, J., Shevchenko, N.: Das Projekt OR.NET - Sichere dynamische Vernetzung in OP und Klinik. Deutsche Zeitschrift für klinische Forschung, Innovation und. Praxis 11(12), 41–45 (2012)Google Scholar
  2. 2.
    Kuehn, F., Leucker, M., Mildner, A.: OR.NET - approaches for risk analysis and measures of dynamically interconnected medical devices. In: 5th Workshop on Medical Cyber-Physical Systems: OASIcs, vol. 36, pp. 133–136. Schloss Dagstuhl-Leibniz-Zentrum fuer Informatik (2014)Google Scholar
  3. 3.
    DIN EN 80001–1:2011-11, VDE 0756-1:2011-11: Application of risk management for IT-networks incorporating medical devices - Part 1: roles, responsibilities and activities (IEC 80001-1:2010), German version EN 80001-1:2011 (2011)Google Scholar
  4. 4.
    DIN EN 60601–1:2013-12, VDE 0750-1:2013-12: Medical electrical equipment - Part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012), German version EN 60601-1:2006 + Cor.:2010 + A1:2013 (2013)Google Scholar
  5. 5.
    DIN EN ISO 14971: Medical devices - application of risk management to medical devices (ISO 14971:2007, Corrected version 2007–10-01), German version EN ISO 14971:2012 (2012)Google Scholar
  6. 6.
    Benzko, J., Janß, A., Dell’Anna, J., Radermacher, K.: Man-machine interfaces in the operating room. In: Proceedings of the 48th DGBMT Annual Conference, vol. 59, p. 430 (2014)Google Scholar
  7. 7.
    Janß, A., Benzko, J., Merz, P., Dell’Anna, J., Strake, M., 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, pp. 1855–1860 (2014)Google Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Alexander Mildner
    • 1
    • 3
  • Armin Janß
    • 2
  • Jasmin Dell’Anna-Pudlik
    • 2
  • Paul Merz
    • 2
  • Martin Leucker
    • 3
  • Klaus Radermacher
    • 2
  1. 1.UniTransferKlinik LübeckLübeckGermany
  2. 2.Chair of Medical Engineering, Helmholtz-Institute for Biomedical EngineeringRWTH Aachen UniversityAachenGermany
  3. 3.Institute for Software Engineering and Programming LanguagesUniversity of LübeckLübeckGermany

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