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Designing safer medical device user interfaces

Gerrit Niezen
June 02, 2014
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Designing safer medical device user interfaces

Presented at the first User Experience in Life Science workshop held at FinnMedi in Tampere, Finland. Download the PDF version for clickable links.

Gerrit Niezen

June 02, 2014
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Transcript

  1. 3/5 entered incorrect data ! 5/5 pushed “Start” button to

    power on ! 3/5 chose mg/h instead of mL ! 3/5 were confused that arrow button is also decimal point button ! 2/5 who had confusion with programming had no negative comments (qualitatively) about the design
  2. MODELLING USING FEEDBACK LOOPS Photo Credits: DiverDave (Wikimedia Commons), Phil

    King (Flickr: pkingDesign), Marcin Wichary (Flickr: mwichary), comedy_nose (Flickr)
  3. 3/5 entered incorrect data ! 5/5 pushed “Start” button to

    power on ! 3/5 chose mg/h instead of mL ! 2/5 who had confusion with programming had no negative comments (qualitatively) about the design
  4. Adhering to standards US: FCC, UL, FDA
 EU: CE marking


    More than 20 directives, for example 
 low voltage or lifts Notified bodies needed for some 
 conformity assessments
  5. Standards Medical devices - Application of usability engineering to medical

    devices ISO/IEC 62366:2007 Process standard ANSI/AAMI HE75:2009 Design principles standard Human Factors Engineering - Design of medical devices Other standards for electrical compliance, risk management, alarm systems, graphical symbols and labelling
  6. 3/5 entered incorrect data ! 5/5 pushed “Start” button to

    power on ! 3/5 chose mg/h instead of mL ! 2/5 who had confusion with programming had no negative comments (qualitatively) about the design
  7. 3/5 entered incorrect data ! 5/5 pushed “Start” button to

    power on ! 3/5 chose mg/h instead of mL ! 2/5 who had confusion with programming had no negative comments (qualitatively) about the design
  8. HOSPIRA SYMBIQ INFUSION PUMP 2007 Medical Device Excellence Award HFES

    2006 User-centered Product Design Award “… users possibly experiencing a delayed response and/or the screen registering a different value from the value selected by the user.” – FDA recall notice
  9. User centred design (UCD) was primarily developed to improve user

    experience (UX), not for designing out "never events"
  10. Generic Infusion Pump (GIP) project making medical devices safer uses

    verification methods to 
 improve software safety reference specification for PCA pump software
  11. Medical devices and HCI Full-day tutorial Sunday 26 October 2014

    Aalto University’s School of Arts, Design and Architecture NordiCHI’14, 26-30 October 2014 Marina Congress Center, Helsinki
  12. Images are used under the Creative Commons license: Joe Pemberton,

    Marcin Wichary, Tim Gee, redspotted, Walt Stoneburner, Phil King, Timo Noko and Adafruit Industries from Flickr DiverDave, Chris 73 and Daniel Zanetti from Wikimedia Commons Henry Rider from the Noun Project ! Fluorouracil label image used with permission from Harold Thimbleby