The Effect of New Standards on the Global Movement Toward Usable Medical Devices

  • Torsten Gruchmann
  • Anfried Borgert
Part of the Lecture Notes in Computer Science book series (LNCS, volume 4799)


Ergonomics and usability do not only pertain to computer work places. More and more they are becoming an important factor in the process of ensuring safety, efficacy, and a return on investment. Especially in the medical field, the increasing life expectancy requires among other things continually new methods of therapy and diagnosis. Triggered by competition and higher functionality of the devices medical products becomes more and more complex. The growing density of achievements in the public health care system such as DRG’s, as well as the larger number of various medical devices imply for physicians and nursing staff a heavy burden that can deteriorate therapy quality and safety. The rapidly changing user requirements have a high pressure also on products’ development. The critical questions refer equally to an efficient development combined with reduced expenses for development time and costs, as to an optimized use of the products by the customer with reduced process costs and an increased user satisfaction and safety for the welfare of patients and users. In order to guarantee the safe use of medical devices, a usability engineering process (UEP) should be integrated into a medical device development program. This article describes challenges and possible solutions for medical devices’ manufacturers seeking to do so.


Human Factors Usability EN 60601-1-6:2004 Use Error Safety Medical Product Development ROI 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Wiklund, M.E.: Return on Investment in Human Factors. MD&DI Magazine , 48 (August 2005)Google Scholar
  2. 2.
    Institute of Medicine; To Err Is Human: Building a safer Health System. National Academic Press, Washingdon Dc (2000)Google Scholar
  3. 3.
    Carstensen, P.: Human factors and patient safety: FDA role and experience. In: Human Factors, Ergonomics and Patient Safety for Medical Devices; Association for the Advancement of Medical Instrumentation (2005)Google Scholar
  4. 4.
    FDA (Food and Drug Administration), Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, U.S. Department of Health and Human Services, Washington DC (2000)Google Scholar
  5. 5.
    Holzinger, A., Geierhofer, R., Errath, M.: Semantic Information in Medical Information Systems - from Data and Information to Knowledge: Facing Information Overload. In: Proc. of I-MEDIA 2007 and I-SEMANTICS 2007, pp. 323–330 (2007)Google Scholar
  6. 6.
    EN 60601-1-6:2004, Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability; International Electro technical Commission (2005)Google Scholar
  7. 7.
    Holzinger, A.: Usability Engineering for Software Developers. Communications of the ACM 48(1), 71–74 (2005)CrossRefGoogle Scholar
  8. 8.
    Holzinger, A.: Application of Rapid Prototyping to the User Interface Development for a Virtual Medical Campus. IEEE Software 21(1), 92–99 (2004)CrossRefGoogle Scholar
  9. 9.
    Memmel, T., Reiterer, H., Holzinger, A.: Agile Methods and Visual Specification in Software Development: a chance to ensure Universal Access. In: Coping with Diversity in Universal Access, Research and Development Methods in Universal Access. LNCS, vol. 4554, pp. 453–462. Springer, Heidelberg (2007)CrossRefGoogle Scholar
  10. 10.
    Holzinger, A., Sammer, P., Hofmann-Wellenhof, R.: Mobile Computing in Medicine: Designing Mobile Questionnaires for Elderly and Partially Sighted People. In: Miesenberger, K., Klaus, J., Zagler, W., Karshmer, A.I. (eds.) ICCHP 2006. LNCS, vol. 4061, pp. 732–739. Springer, Heidelberg (2006)CrossRefGoogle Scholar
  11. 11.
    Hoelscher, U., Liu, L., Gruchmann, T., Pantiskas, C.: Cross-National and Cross-Cultural Design of Medical Devices; AAMI HE75 (2006)Google Scholar
  12. 12.
    Wiklund, M.E., Gruchmann, T., Barnes, S.: Developing User Requirements for Global Products; MD&DI Magazine (Medical Device & Diagnostics Industry Magazine) (April 2006)Google Scholar
  13. 13.
    Gruchmann, T.: The Usability of a Usability Standard. In: 1st EQUID Workshop, Berlin (2007)Google Scholar
  14. 14.
    Gruchmann, T.: Usability Specification; Gemeinsame Jahrestagung der deutschen, österreichischen und schweizerischen Gesellschaften für Biomedizinische Technik 2006 (2006)Google Scholar
  15. 15.
    Nielsen, J.: Usability Engineering. Academic Press, London (1993)zbMATHGoogle Scholar
  16. 16.
    Gruchmann, T.: The Impact of Usability on Patient Safety. BI&T (AAMI, Biomedical Instrumentation & Technology) 39(6) (2005)Google Scholar
  17. 17.
    Gruchmann, T., Hoelscher, U., Liu, L.: Umsetzung von Usability Standards bei der Entwicklung medizinischer Produkte; Useware 2004, VDI-Bericht 1837, VDI-Verlag, pp.175–184 ( 2004)Google Scholar
  18. 18.
    Hoelscher, U., Gruchmann, T., Liu, L.: Usability of Medical Devices; International Encyclopedia of Ergonomics and Human Factors, 2nd edn. pp. 1717–1722. CRC Press/Taylor & Francis Ltd, Abington (2005)Google Scholar
  19. 19.
    Winters, J.M., Story, M.F.: Medical Instrumentation: Accessibility and Usability Considerations. CRC Press/Taylor & Francis Ltd, Abington (2007)Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2007

Authors and Affiliations

  • Torsten Gruchmann
    • 1
  • Anfried Borgert
    • 1
  1. 1.Use-Lab GmbH, Buergerkamp 3, D-48565 SteinfurtGermany

Personalised recommendations