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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.

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Fda human factors of medical devices l.jpg

FDA Human Factorsof Medical Devices

Ensuring a safe,

user friendly

device-user interface


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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


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FDA Medical Device Incident Reports:

  • 100,000 reports per year

  • More than 1/3 involve use error

  • Tip of the Iceberg


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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 - 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


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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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FDA’s 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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Perform

Studies &

Analyses

Develop

Require-

ments

Develop

Specs.

Test Output

Against

Input

Test Against

Patient &

User

Needs

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 HE74:2001 Human factors design process for medical devices

  • IEC 60601-1-6, Ed1, Usability


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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


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ANSI/AAMI HE74:2001

  • Need for user input

  • Scaling the HFE work

  • Documenting the HFE activities

  • Design evaluation: verification & validation


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ANSI/AAMI HE74:2001

  • 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