Ansi/aami He75 2009 Edition

GeneralThis recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error.The presumed users of this document are human factors and usability specialists, software developers, industrial, biomedical, mechanical, and electrical engineers, and other development personnel.

• He75 Standard

No notes for slide. I’m sure everyone here is familiar with the impact of poor us. Therac disaster a combination of software and usability problems. Lead to sweeping changes in software safety testing.

He75 Standard

Usability not addressed until recently. James Carstensen 1990 FDA presentation: 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). Were earlier guidances and processes – FDA Do it by design, 1990, HE-74 (now an annex in 62366), 60601-1-6 (now deprecated to refer to 62366). Age and disease state can affect vision, memory, tactile sensitivity, etc.

Emotional state – high stress greatly increases chance of use error. Keypad layout is only par. Simulated use – bring in beds, other equipment, use dummies, pipe in sounds to simulate other equipment. Using of device designed for trained clinician by patient in home care environment.