FDA’s Human Factors Program for Medical Devices医疗器械FDA的人文因素计划.pptVIP

FDA Human Factorsof 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 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 assessmen