Do It By Design: An Introduction to Human Factors in Medical Devices

摘要

The FDA has just published the primer, 'Do It By Design: An Introduction to HumanFactors in Medical Devices.' This is a guidance document (about 50 pages) for manufacturers, and it also contains information useful to health facilities, including some advice specifically for healthcare practitioners. This first primer defines human factors issues by use of medical device examples and general human factors design rules. It then discusses human factors design tools and methodologies. Finally, it contains practical advice for the medical device industry and healthcare community.