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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 / Lenarz, Thomas / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /

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Volume 61, Issue 2

Issues

Volume 57 (2012)

Human-centered risk management for medical devices – new methods and tools

Armin Janß
  • Corresponding author
  • Helmholtz-Institute f. BME of the RWTH Aachen University, Chair of Medical Engineering, Aachen, Germany
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Simon Plogmann
  • Helmholtz-Institute f. BME of the RWTH Aachen University, Chair of Medical Engineering, Aachen, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Klaus Radermacher
  • Helmholtz-Institute f. BME of the RWTH Aachen University, Chair of Medical Engineering, Aachen, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2016-03-17 | DOI: https://doi.org/10.1515/bmt-2014-0124

Abstract

Studies regarding adverse events with technical devices in the medical context showed, that in most of the cases non-usable interfaces are the cause for use deficiencies and therefore a potential harm for the patient and third parties. This is partially due to the lack of suitable methods for interlinking usability engineering and human-centered risk management. Especially regarding the early identification of human-induced errors and the systematic control of these failures, medical device manufacturers and in particular the developers have to be supported in order to guarantee reliable design and error-tolerant human-machine interfaces (HMI). In this context, we developed the HiFEM methodology and a corresponding software tool (mAIXuse) for model-based human risk analysis. Based on a two-fold approach, HiFEM provides a task-type-sensitive modeling structure with integrated temporal relations in order to represent and analyze the use process in a detailed way. The approach can be used from early developmental stages up to the validation process. Results of a comparative study with the HiFEM method and a classical process-failure mode and effect analysis (FMEA) depict, that the new modeling and analysis technique clearly outperforms the FMEA. Besides, we implemented a new method for systematic human risk control (mAIXcontrol). Accessing information from the method’s knowledge base enables the operator to detect the most suitable countermeasures for a respective risk. Forty-one approved generic countermeasure principles have been indexed as a resulting combination of root causes and failures in a matrix. The methodology has been tested in comparison to a conventional approach as well. Evaluation of the matrix and the reassessment of the risk priority numbers by a blind expert demonstrate a substantial benefit of the new mAIXcontrol method.

Keywords: human-machine interaction; human-risk analysis; human-risk control; human errors; human error taxonomy; human factors; medical devices; model-based usability evaluation

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About the article

Corresponding author: Armin Janß, Helmholtz-Institute f. BME of the RWTH Aachen University, Chair of Medical Engineering, Aachen, Germany


Received: 2014-10-12

Accepted: 2016-01-25

Published Online: 2016-03-17

Published in Print: 2016-04-01


Citation Information: Biomedical Engineering / Biomedizinische Technik, Volume 61, Issue 2, Pages 165–181, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2014-0124.

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