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FDA Human Factors of Medical Devices Ensuring a safe, user friendly device-user interface Ensuring a safe, user friendly device-user interface.

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Presentation on theme: "FDA Human Factors of Medical Devices Ensuring a safe, user friendly device-user interface Ensuring a safe, user friendly device-user interface."— Presentation transcript:

1 FDA Human Factors of Medical Devices Ensuring a safe, user friendly device-user interface 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 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 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. 44% of medical device recalls due to design problems. Use error often linked to design.

5 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 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

6 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 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

7 FDAs authority Quality Systems Regulation/ CGMP - Design Controls (1996)

8 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. Regulatory Language: –… design requirements … intended use … needs of the user and patient. –… testing production units under actual or simulated use conditions. –… conduct risk analysis.

9 Design Controls Preamble Language: –… conduct appropriate human factors studies, analyses, and tests … –… human interface includes both the hardware and software characteristics… Preamble Language: –… conduct appropriate human factors studies, analyses, and tests … –… human interface includes both the hardware and software characteristics…

10 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 HFE applied from concept stage to final design Early Involvement of typical users is critical The process is iterative

11 Perform Studies & Analyses Develop Require- ments Develop Specs. Test Output Against Input Test Against Patient & User Needs Concept Phase Design Input Design Output VerificationValidation HF Elements 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 Human Factors Engineering Process Analyses Expert Evaluation Rapid Prototyping

12 Human Factors Engineering - Summary of Methodology Study the user population and use conditions Analyze function, tasks, and hazards Incorporate findings in requirements Study the user population and use conditions Analyze function, tasks, and hazards Incorporate findings in requirements

13 Test and analyze prototypes against requirements Test production models in simulated environment Conduct a risk assessment Test and analyze prototypes against requirements Test production models in simulated environment Conduct a risk assessment Human Factors Engineering - Summary of Methodology

14 HFE Standards ANSI/AAMI HE74:2001 Human factors design process for medical devices IEC , Ed1, Usability ANSI/AAMI HE74:2001 Human factors design process for medical devices IEC , Ed1, Usability

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

16 ANSI/AAMI HE74:2001 Need for user input Scaling the HFE work Documenting the HFE activities Design evaluation: verification & validation Need for user input Scaling the HFE work Documenting the HFE activities Design evaluation: verification & validation

17 ANSI/AAMI HE74:2001 Relevant FDA regulations Practical tips Bibliography - General HFE references - Human error - Human computer interface - Usability testing Relevant FDA regulations Practical tips Bibliography - General HFE references - Human error - Human computer interface - Usability testing

18 FDA Web Site fda.gov/cdrh/humanfactors.html fda.gov/cdrh/usererror.html fda.gov/cdrh/humanfactors.html fda.gov/cdrh/usererror.html


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