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.

5. 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

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

7. FDA’s 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.”

9. Design Controls • 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

11. 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

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

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

14. HFE Standards • ANSI/AAMI HE74:2001 Human factors design process for medical devices • IEC 60601-1-6, 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

16. ANSI/AAMI HE74:2001 • 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

18. FDA Web Site • http://www. fda.gov/cdrh/humanfactors.html fda.gov/cdrh/usererror.html