1. 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.

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
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.

3. 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.

4. 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).

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
Here’s some advice to help avoid these mistakes?

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)
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.

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.”
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.

9. 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.

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
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.

11. 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

12. 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.

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

14. HFE Standards
ANSI/AAMI HE74:2001 Human factors design process for medical devices
IEC , 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 , Collateral Standard: Usability which is currently being balloted as an FDIS.

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
This is an overview of contents of that standard.

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

17. 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.

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