FDA
Human Factors
of Medical Devices
Ensuring a safe,
user friendly
device-user interface
Medical Errors in U.S.
each Year Result In:
• Up to 98,000 deaths
• 5th leading case of death: exceeds
auto accidents, breast cancer and
AIDS
• $29 Billion added cost
FDA Medical Device
Incident Reports:
• 100,000 reports per year
• More than 1/3 involve use error
• Tip of the Iceberg
FDA Recall Study
• 44% of medical device recalls
due to design problems.
• Use error often linked to design.
More user friendly
Design
• Operations - don’t exceed user
capabilities
• Information - Sufficient, legible and
intelligible
• Procedures - logical and intuitive
• Operations - consistent with
conventions
• Dangerous error - designed out
• Conditions of use - considered and
addressed
Key safety concepts in design
•
•
•
•
•
•
•
make things visible
simplify the operation
avoid reliance on memory
avoid reliance on vigilance
use natural mappings
use forcing functions
make it easy to reverse an error
FDA’s authority
• Quality Systems Regulation/ CGMP
- Design Controls (1996)
Design Controls
• Regulatory Language:
– “… design requirements …
intended use … needs of the
user and patient.”
– “… testing production units
under actual or simulated use
conditions.”
– “… conduct risk analysis.”
Design Controls
• Preamble Language:
– “… conduct appropriate human
factors studies, analyses, and
tests …”
– “… human interface includes
both the hardware and software
characteristics…”
Design Controls - Human
Factors Engineering (HFE)
Process
• HFE applied from concept stage to
final design
• Early Involvement of typical users
is critical
• The process is iterative
Human Factors Engineering Process
Concept
Design
Phase
Input
Perform * Develop
Studies &
RequireAnalyses
ments
Design
Output
Develop
Specs.
Verification
Test Output
Against
Input
Validation
Test Against
Patient &
User
Needs
HF Elements
Literature
Safety
Drawings
Analyses
Complaints
Environment
Mockups
Observation
Users
Performance
Computer
Prototypes
Expert
Evaluation
Interviews
Rapid
Prototyping
*Design and Development Planning Important Here
Production
Units
Full Usability
Test
Risk Assessment
Human Factors Engineering Summary of Methodology
• Study the user population and use
conditions
• Analyze function, tasks, and
hazards
• Incorporate findings in
requirements
Human Factors Engineering Summary of Methodology
• Test and analyze prototypes
against requirements
• Test production models in
simulated environment
• Conduct a risk assessment
HFE Standards
• ANSI/AAMI HE74:2001 Human
factors design process for medical
devices
• IEC 60601-1-6, Ed1, Usability
ANSI/AAMI HE74:2001
• Overview of the HFE process
• Planning the HFE process
• HFE process: a systems approach
• Methods and techniques
• Risk & cost benefit analysis
ANSI/AAMI HE74:2001
• Need for user input
• Scaling the HFE work
• Documenting the HFE activities
• Design evaluation: verification &
validation
ANSI/AAMI HE74:2001
• Relevant FDA regulations
• Practical tips
• Bibliography
- General HFE references
- Human error
- Human computer interface
- Usability testing
FDA Web Site
• http://www.
fda.gov/cdrh/humanfactors.html
fda.gov/cdrh/usererror.html