FDA Human Factors of Medical Devices

1
FDA Human Factorsof Medical Devices

• Ensuring a safe,
• user friendly
• device-user interface

2
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

3
FDA Medical Device Incident Reports

• 100,000 reports per year
• More than 1/3 involve use error
• Tip of the Iceberg

4
FDA Recall Study

• 44 of medical device recalls due to design
  problems.
• Use error often linked to design.

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More user friendly Design

• Operations - dont 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

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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

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FDAs authority

• Quality Systems Regulation/ CGMP - Design
  Controls (1996)

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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.

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Design Controls

• Preamble Language
• conduct appropriate human factors studies,
  analyses, and tests
• human interface includes both the hardware and
  software characteristics

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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

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Human Factors Engineering Process
Concept Phase
Design Input
Design Output
Verification
Validation

HF Elements
Analyses Expert Evaluation Rapid Prototyping
Literature Complaints Observation Interviews
Safety Environment Users Performance
Drawings Mockups Computer Prototypes
Production Units Full Usability Test Risk
Assessment
Design and Development Planning Important Here
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Human Factors Engineering - Summary of Methodology

• Study the user population and use conditions
• Analyze function, tasks, and hazards
• Incorporate findings in requirements

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Human Factors Engineering - Summary of Methodology

• Test and analyze prototypes against requirements
• Test production models in simulated environment
• Conduct a risk assessment

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HFE Standards

• ANSI/AAMI HE742001 Human factors design process
  for medical devices
• IEC 60601-1-6, Ed1, Usability

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ANSI/AAMI HE742001

• Overview of the HFE process
• Planning the HFE process
• HFE process a systems approach
• Methods and techniques
• Risk cost benefit analysis

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ANSI/AAMI HE742001

• Need for user input
• Scaling the HFE work
• Documenting the HFE activities
• Design evaluation verification validation

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ANSI/AAMI HE742001

• Relevant FDA regulations
• Practical tips
• Bibliography - General HFE references -
  Human error - Human computer interface -
  Usability testing

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FDA Web Site

• http//www.
• fda.gov/cdrh/humanfactors.html
• fda.gov/cdrh/usererror.html