In November AAMI is presenting three online seminars on Human Factors Approaches to Ensuring Safe Medical Devices. The seminars are offered over three days and cover topics including FDA validation usability testing, designing error resistant devices, and identifying human-factors related hazards. Instructors include Michael Wiklund (Wiklund Research & Design) and Ron Kaye of the FDA.
Meanhwhile MDDI (pictured) continues Preaching the Value of Human Factors, with an interview with Peter Carstensen, formerly the FDA's #1 human factors guru. Carstensen talks about the pros and cons of human factors application in the current medical device industry, and discusses the (still) forthcoming AAMI HE75 guidelines:
"HE75 is a very comprehensive handbook describing almost everything a designer needs to know. It’s a one-stop shopping text with most all the information a designer would need to design a good user interface and validate it. But it still requires intelligent interpretation. It’s like someone could write a detailed text on how to perform brain surgery, but careful study and practice will be needed to pull it off. HE75 is a very good start but it’s not a substitute for expertise in the field. There is an even more comprehensive text based on HE75 which should be published before the end of the year. It’s around 700 pages and will sell for the remarkably cheap price of around $125."
