Gerrit Niezen Postdoctoral researcher Swansea University, Wales, United Kingdom

Designing safer medical device user interfaces

! @gendor

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

ENTERING DATA

SERIAL DIGIT ENTRY

INDEPENDENT DIGIT ENTRY

INCREMENTAL NUMBER ENTRY

MODELLING USING FEEDBACK LOOPS

Photo Credits: DiverDave (Wikimedia Commons), Phil King (Flickr: pkingDesign), Marcin Wichary (Flickr: mwichary), comedy_nose (Flickr)

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

Adhering to standards

US: FCC, UL, FDA

EU: CE markingMore than 20 directives, for example

low voltage or lifts

Notified bodies needed for some conformity assessments

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

http://www.chi-med.ac.uk/researchers/industrypublications.php

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

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

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

User centred design (UCD) was primarily developed to improve user experience (UX), not for designing out "never events"

Generic Infusion Pump (GIP) project

making medical devices safer

uses verification methods to improve software safety

reference specification for PCA pump software

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

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