FDA Human Factors of Medical Devices Ensuring a safe, user friendly device-user interface I will be speaking to you today about some of the opportunities and problems Plug-N-Play present us in dealing with dangerous use error and patient safety. I will tell what FDA is doing to try to see that medical devices more user friendly and safer. We see real promise in the Plug-N-Play scheme and we also see some possible problems. But the promise looks like it may far out weigh the problems.

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 An Institute of Medicine report cites studies that show that as many as 98,000 people die every year from medical error. That’s equivalent to an overloaded jumbo jet falling out of the sky every other day of the year. In addition, thousands more are injured. Medical errors attributable to device use is not the major cause. Non-the-less, we have every reason to believe it’s a significant contributor.

FDA Medical Device Incident Reports: 100,000 reports per year More than 1/3 involve use error Tip of the Iceberg FDA receives about 100,000 medical device incident reports every year. More than than 1/3 of these reports can be attributed primarily to use error. This is a small fraction of all the incidents that actually occur. Really only a few percent of the total.

FDA Recall Study 44% of medical device recalls due to design problems. Use error often linked to design. An internal FDA study some years ago showed that 44% of medical device recalls were the result of design problems and more than 1/3 involved the device-user interface (device, it’s labeling or instructions for use).

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 Here’s some advice to help avoid these mistakes?

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) The FDA Quality Systems Regulation is the basis for FDA authority to require proper attention to the design of the device user interface. FDA wants to make sure manufacturers know how to achieve good design and this authority provides us a means for educating slow learners. Nothing like the threat of a little jail time to get their attention.

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.” The Design Control provisions of the FDA regulation require manufacturers to address the user's needs and those needs certainly include a safe user interface. Design validation calls for testing under actual or simulated use conditions and for a risk analysis to be carried out.

Design Controls Preamble Language: “… conduct appropriate human factors studies, analyses, and tests …” “… human interface includes both the hardware and software characteristics…” The preamble to the FDA regulation speaks, in some detail, to the need for human factors studies, analysis and tests. Preambles to FDA regulations have legal standing and are used to clarify and provide the rationale for the regulation.

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 Incorporating HFE into the design process is the only way to reliably ensure that the needs of the user are adequately addressed in the final product.

Human Factors Engineering Process Concept Phase Design Input Design Output Verification Validation Perform Studies & Analyses Develop Require- ments Specs. Test Output Against Input Test Against Patient & User Needs * HF Elements Analyses Expert Evaluation Rapid Prototyping Literature Complaints Observation Interviews HFE is conducted throughout the design process from beginning to end. It's also a process that must be fully integrated into the overall design activities. HFE starts early, involves typical users, is iterative just like the rest of the design process. Safety Environment Users Performance Drawings Mockups Computer Prototypes Production Units Full Usability Test Risk Assessment *Design and Development Planning Important Here

Human Factors Engineering - Summary of Methodology Study the user population and use conditions Analyze function, tasks, and hazards Incorporate findings in requirements To summarize the HFE methodology. All this information has been provided to manufacturers via our FDA website and in a number of voluntary consensus standards that FDA has recognized.

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

HFE Standards ANSI/AAMI HE74:2001 Human factors design process for medical devices IEC 60601-1-6, Ed1, Usability Here is one of those voluntary consensus standards that FDA has recognized to give guidance to manufacturers. We highly recommend it. FDA staff worked closely with the AAMI HFE Committee and medical device manufacturers to write this standard. A survey of manufacturers was carried out to determine what information they needed and what question they wanted answered. It’s a user friendly guidance document designed for the HFE novice as well as the HFE experts. It served as the basis for the new IEC 60601-1-6, Collateral Standard: Usability which is currently being balloted as an FDIS.

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 This is an overview of contents of that standard.

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

ANSI/AAMI HE74:2001 Relevant FDA regulations Practical tips Bibliography - General HFE references - Human error - Human computer interface - Usability testing More useful content. That is – useful according to the feed back from manufacturers.

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