AAMI is offering a new course this spring that will focus on a topic of growing interest in the medical device industry—the application of human factors to the development of instructional materials.
The 1.5-day course is scheduled for April 16-17, 2016, immediately following the 2016 International Symposium on Human Factors and Ergonomics in Health Care hosted by the Human Factors and Ergonomics Society (HFES). Both the symposium and course will take place in San Diego, CA.
Registration for the course, which is being developed in collaboration with HFES, is available only to attendees of the symposium until March 1, 2016. If space allows, registration will open to the public on March 2, 2016.
The course will focus on the design, development, and human factors testing of instructional materials for medical devices. It will provide information, a process, and methodology that are all consistent with federal guidelines, including those from the Food and Drug Administration (FDA), and industry standards and recommended practices, such as AAMI TIR49, which focuses on the design of training and instructional materials for medical devices used in nonclinical environments.
Topics to be covered in the course include:
- Relating instructional materials to the human factors engineering process for medical devices as implemented in design controls
- Relating the purpose of instructional materials to the FDA perspective
- Identifying where instructional materials fit into the effort to reduce use error
- Identifying the role of instructional materials in FDA submissions
- Analyzing the user—not just instructional materials—as a system component
- Designing instructional materials
The course will include lectures, as well as interactive in-class exercises. The scheduled trainers are Pat Patterson, Renee Bailey, and Melissa Lemke, all with Agilis Consulting Group, LLC, which specializes in human factors and the medical industry.
The course is aimed at human factors professionals responsible for fulfilling regulatory requirements, labeling, and packaging, as well as clinicians, engineers, and marketing personnel involved in developing user instructional materials.