human factors in medical device design.pdf
TRANSCRIPT
HUMAN FACTORS IN
MEDICAL DEVICE DESIGN
Michael Sheedy
SIMULATION AS A TOOL
Disclosure
Human Factors Engineering Definition
“application of knowledge about human behaviour, abilities, limitations, and
other characteristics related to the design of tools, devices, systems, tasks,
jobs, and environments to achieve adequate USABILITY” [ISO 62366:2007]
Also known as Usability Engineering
Human Factors in Design
Procedures
Physical Barriers
Information
Decisions
Poor Protocols
Faulty Equipment
Missing Information
Inadequate Supervision
Patient
Harmed
Human Factors and
Design Medical Devices
Purchasing Advice
Use Medical Devices
Simulation
Exploring the possiblities
“Being forced to confront the prospect of failure head-on – to study it, dissect it, tear apart all its components and consequences – really works.”
Human Factors Considerations
Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
Draft Guidance for Industry and Food and Drug Administration Staff.
Identify Users
Engage all Stakeholders
Staff
Patients
Public
Involve them early on in design
User characteristics (e.g., functional capabilities, attitudes and behaviours)
that could impact the safe and effective use of the device
Ways in which users might use the device that could cause harm
USERS
NHS. (2010). Lessons from high hazard industries for healthcare. National Reporting and Learning Service Full Report.
Every User is Different
Elephant Path
USE ENVIRONMENT
CDHB Cardboard Hospital
Hardware Components
Switches, buttons and knobs
Information
Indicators, displays and alarms
Size
Labelling
User Manuals
DEVICE / INTERFACE
Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
Draft Guidance for Industry and Food and Drug Administration Staff.
Information Perception
Where it goes wrong
Systems Approach
1. Cafazzo, J. A., & Olivier, S. (2012). Human Factors in Patient Safety: From Discovery to Design: The Evolution of Human Factors in Healthcare.
Healthcare Quarterly, 15 (1).
2. Dekker, S. (2011). Patient Safety: A Human Factors Approach. CRC Press.
“Tapestry of Strategies”
Substitution Myth
Technology removes error?
Creates new human work
1
2
Iterative Formative Evaluations
Evaluation using Simulation
Availability of the situation
Accessibility
Analysis
Heuristic Analysis
Failure Mode & Effects Analysis(FMEA)
Human Factors for Health Technology Safety: Evaluating & Improving the use of Health Technology in the Real World. Cassano-Piche, A. et. al.
Function and Task Analysis
Food and Drug Administration. (2011). Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
Draft Guidance for Industry and Food and Drug Administration Staff.
Equipment Procurement
Pre-purchase evaluation
Identify Human Factors Problems
Tailor training to correct
Pat Baird, “Incident Data: Filling the Gaps, Identifying the Value, and Prioritizing Needed Information.” Presentation at the AAMI/FDA Infusion Device Summit, Oct. 6, 2010.
Why is it important?
Tracey-Jane Havill-Nelson
http://www.stuff.co.nz/national/health/10418956/IV-line-kills-woman-in-Christchurch
“IV line kills woman in Christchurch”
Central Venous Access Device
CVAD Changes
Images: Dr Hamish Gray
Recap
Users
Environment
Device/Interface
Reduce the risk of harm - Increased Patient Safety
“Making it easy to do the right thing.”
[Bromiley 2010]
Simulation is useful in all parts of the process
Acknowledgements
Shona McMillan
Dr Maggie Meeks
Chris Beasley
Dr Hamish Gray