Approval strategies


The working group „Approval strategies“ is emerged from the OR.NET subproject “Approval ability” and discusses results with Notified bodies and presents actual approaches e.g. in the Notified Body Recommendation Group.

The main focus of the working group is on the development of methods and tools for manufacturer and clinical operators for the modular approval process of open integrated medical devices in the OR, based on the IEEE 11073 communication standard.

Mission of the working group

The open, dynamic integration of medical devices with various hardware and software components (from different manufacturers) represents a completely new situation as well as an important legal issue regarding the accreditation process. The risk management according to DIN EN ISO 14971 and especially the risk analysis (technical and MMI-centered) as well as the methodology of validating software components have to be solved. The task is to find a technically feasible and legally unambiguous modular overall architecture, which on the one hand permits the accreditation as a medical device for manufacturers and on the other hand provides procedures and tools for the support of risk management for operators.

Goals of the working group

The aim of this working group is to consider the problems of the modular approval of subsystems with open interfaces as components of an integrated OR. In the framework of the risk management process as part of the conformity assessment, manufacturers and operators must be enabled to integrate the risk analyzes of the individual components into an overall risk assessment. Therefore, tools and standards have to be developed to support the new approval process of modular device systems. Particularly in the case of human risk assessment, the combination of single interface solutions within e.g. a surgical workstation and the Human-Machine-Interaction with a newly and modular combined system may create additional human risks.

Publications

  • A. Janß, S. Plogmann & K. Radermacher: Human-centered risk management for medical devices – new methods and tools. Biomedical Engineering / Biomedizinische Technik, 2016, 61(2), pp. 165–181
  • 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
  • J. Dell’Anna, A. Janß, E.-M. Zeißig, K. Ganser, K. Radermacher & H. Clusmann: Development of new concepts for safe and usable human-machine-interfaces in the open networked neurosurgical OR. 67. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), 1. Joint Meeting mit der Koreanischen Gesellschaft für Neurochirurgie (KNS), 2016
  • 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
  • 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, 2015, 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, 2015, 61(2), pp. 135-146
  • H. Clusmann, M. Blaar, J. Dell’Anna, A. Janß, A. Höllig & K. Radermacher: A critical view into the neurosurgical OR: bottlenecks and perspectives in human-human and human-machine interaction. Proceedings of The European Association of Neurosurgical Societies – EANS 2015, Annual Meeting “Technical advances in Neurosurgery”, 2015
  • H. Clusmann, A. Janß, J. Dell’Anna & K. Radermacher: Improvement of Human-Machine-Interaction and Workflow in the OR by central surgical workstations in an Open-Network approach. Proceedings of The European Association of Neurosurgical Societies – EANS 2015, Annual Meeting “Technical advances in Neurosurgery”, 2015
  • 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
  • P. Knipp & A. Janß: Regulatory Approval Route and Strategy for Open Networked Medical Devices. 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: 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
  • 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
  • K. Radermacher & A. Janß: Usability engineering approach towards secure open networks in the integrated operating room of the future. Proc. IUPESM 2015 WORLD CONGRESS ON MEDICAL PHYSICS & BIOMEDICAL ENGINEERING, 2015, pp. 421
  • J. Benzko, A. Janß, J. Dell’Anna & K. Radermacher: Man-Machine Interfaces in the Operating Room. Proceedings of the 48th DGBMT Annual Conference, 59(1), 2014, pp. 430
  • 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, J. Benzko, P. Merz, J. Dell’Anna, M. Strake & K. Radermacher: Development of Medical Device UI-Profiles for Reliable and Safe Human-Machine-Interaction in the Integrated Operating Room of the Future. Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, 2014, pp. 1855-1860
  • A. Janß & K. Radermacher: Usability First – Modellbasierter Ansatz zur nutzungsorientierten Risikoanalyse von Medizinprodukten. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz. Themenschwerpunkt: Sicherheit von Medizinprodukten – Neueste Entwicklungen, 2014, 57(12), pp. 1384-1392

The next public presentation of the results will take place on the conhIT2017 between 25th and 27th of April in Berlin. The group “Approval strategies” is working intensively within the framework of the EFRE project ZiMT (Certified Integrated Medical Technology, duration: 01.07.2016-30.06.2019).

Figure 1: Presentation of the approval strategies for the Notified Body from VDE
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