FDA Takes Human Factors Seriously—You Should Too
It is hard to come up with anyone who has had more influence on the acceptance of human factors engineering by the medical device industry than Peter Carstensen, who recently retired as CDRH’s human factors team leader. He not only helped CDRH’s reviewers assess human factors issues for products seeking approval, but he constantly preached to industry about the value of human factors engineering, and how it correlates with patient safety.
Anyone involved with medical device design should be aware of who Carstensen is and what he thinks; he remains involved with industry as a consultant. Luckily, you can find some of his thoughts in the October issue of MD&DI.
Despite Carstensen’s retirement, FDA continues to take human factors issues very seriously. It expects to see a comprehensive human factors program fully integrated into your design process. What it does not want to see, Carstensen says, is “a very superficial job which fails to addresses FDA’s main concern, namely use error that threatens patient safety.” Too often, he laments, device firms conduct usability tests solely for marketing purposes, gauging things like user satisfaction and speed as opposed to safety. That may fly in some sectors, but not in the medical device industry.
The most important aspect of a proper human factors engineering program, he says, is “identifying risks and assessing them and finding ways to mitigate or eliminate them, starting at the earliest stages and continuously refining that risk assessment as the design evolves.”
Why? Because, he says, “There is nothing more expensive than to learn near the end that you have a problem.” That should turn your senior management on to the value of human factors.
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