Human Factors Engineering — Design of Medical Devices A Review of ANSI/AAMI HE75:2009
During the design and manufacturing process, manufacturers must consider human factors in order to make a safe and effective product. ANSI/AAMI HE75: 2009, Human factors engineering—Design of medical devices, provides comprehensive guidance to device manufacturers, clinical engineers, biomedical equipment technicians, regulators, and students on a significant number of specific human factors topics, including designing a high-quality user interface and conducting usability tests.
This webinar CD features the Human Factors Committee members who participated in the drafting of the standard and will review AAMI HE75’s content with specific samples of guidance.
PROGRAM
| Define human factors engineering and its relationship to designing safe, effective, and satisfying medical devices. | ||
| Describes the standard’s general purpose and development history. | ||
| Provides a clinician’s perspective on the need for medical devices that reflect good human factors engineering. | ||
| Discusses the consequence of poor human factors in medical device design. | ||
| Explains that using AAMI HE75 is an essential step toward meeting FDA's and other regulators’ expectations for human factors engineering. | ||
| Clarifies that good user interface design is not a “cookbook” exercise, but that the “encyclopedia” of guidance found in AAMI HE75 can be an excellent resource that compliments engineering judgment and creativity. | ||
| Presents illustrated cases of how particular user interfaces could be enhanced through the application of AAMI HE75’s guidance. | ||
| Provides a manufacturer’s perspective on the need to practice good human factors engineering to secure regulatory approvals, achieve commercial goals, and protect against recalls and lawsuits. | ||
| Discusses how to use AAMI HE75 in the course of a medical device development effort. |
SPEAKERS
- Michael Wiklund, Human factors consultant, President – Wiklund Research & Design, member of AAMI Human Factors Committee, co-editor of Handbook of Human Factors Engineering in Medical Device Design
- Matthew Weinger, Anesthesiologist, Professor of Anesthesiology, Biomedical Informatics, and Medical Education at Vanderbilt University, Co-Chair – AAMI Human Factors Committee, co-editor of Handbook of Human Factors Engineering in Medical Device Design
- Jonathan Kendler, Human factors consultant, Design Director – Wiklund Research & Design, coauthor of Usability Testing of Medical Devices
- Sara Waxberg, Manager of Human Factors, Baxter Healthcare, member of AAMI Human Factors Committee
WHO SHOULD PURCHASE
This program was designed for medical device professionals who are responsible for design and/or engineering, quality systems compliance, risk assessment, assurance, management, or anyone charged with the responsibility of human factors design integration.
WEBINAR CD
Includes pdf of handout materials and webinar recording on CD.
- $295 for webinar registrants
- $395 for non-registrants
WAYS TO ORDER
1. Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card
2. Fax – Select and download the order form and fax to 240-396-5781 .
3. Mail – Select and download the order form and mail with payment to:
HE75 CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.