Human Factors Approaches to Ensuring Safe Medical Devices
Design engineers, quality system managers, risk managers, and compliance officers have a responsibility to their employer, the clinician user, and the public to ensure that their medical device products are safe and effective. It is for this reason that medical device professionals must have a solid understanding of FDA regulations, possible hazards resulting from design flaws, and detailed steps to conduct and validate usability tests. To educate industry professionals on human factors concepts, AAMI offers this three-part webinar series on cd that provides participants with the opportunity to increase the safety and efficacy of their medical device products.
Don’t miss out on this training opportunity! Purchase one, two, or all three CD packages!
PROGRAM OBJECTIVES
1. Conducting a Validation Usability Test
- How the U.S. Food and Drug Administration’s (FDA’s) Quality System regulation, ANSI/AAMI HE74:2001—Human factors design process for medical devices and IEC 62366:2007—Medical devices—Application of usability engineering to medical devices call for medical device manufacturers to conduct usability tests in order to validate users’ needs.
- Why and how you should conduct a series of preliminary (i.e., formative) usability tests before validating usability tests in order to reduce the risk of product launch delays.
- How to choose an appropriate number of validation usability test participants based on multiple factors, including the degree of user population homogeneity.
- Why and how a validation usability test can identify problems with hardware and software user interfaces as well as identifying issues with product documentation, e.g., user instructions.
- How to select tasks that test participants will perform during a validation usability test.
- How to determine if a medical device has passed its validation usability test.
- How you can differentiate safety-related usability problems from those that may not affect user safety but could affect a medical device’s commercial success.
- How to effectively and accurately document a validation test for inclusion in a design history file.
2. Designing Error Resistant and Tolerant Medical Devices
- How medical device design flaws lead to human errors.
- How to help users identify and recover from inevitable use errors.
- Why it is important to address the needs of the “worst case user” when designing a user interface.
- How the thorough application of human factors design principles will make a medical device less prone to use error.
- Why performing several iterations of usability testing is an effective way to identify and resolve design flaws that might induce use errors.
- How to design a medical device that guides users through the error recovery process.
3. Identifying Human Factors-Related Hazards
- How flaws in medical device user interface design have led to patient injuries and deaths.
- How shortcomings in users’ knowledge, skill, training, and their work environments can increase the chance of an adverse event.
- How and why the FDA expects manufacturers to systematically identify and mitigate use-related hazards.
- How user research techniques, such as observations, interviews, and task analyses can identify potential use-related hazards and opportunities for dangerous use errors.
- How to estimate the likelihood and severity of an adverse event resulting from a use-related hazard.
- How methods of identifying engineering-related hazards can be adapted to identify use-related hazards.
SPEAKERS
- Peter Carstensen, Senior Analyst, Wiklund Research & Design, Inc
- Michael Wiklund, PE, CHFP, President, Wiklund Research & Design
- Ron Kaye, MS, Human Factors Specialist, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA)
- Jonathan Kendler, MS, Design Director, Wiklund Research & Design
- Rollin (Terry) J. Fairbanks, MD, MS, Assistant Professor of Emergency Medicine, University of Rochester Medical Center
- Jason M. Bush, PhD, Human Factors Scientist, Roche Diagnostics Corporation
CD FEES
WEBINAR CD - Includes handout material and CD. Receive a discount if you order all three programs!
If you purchase a CD for one, two or each program separately, you pay a fee per CD of:
$295 for webinar registrants
$395 for non-registrants-
If you purchase a CD for all three programs together, you pay a fee of:
$750 for webinar registrants
$1005 for non-registrants
Please note: Domestic and international shipping rates apply.
THREE WAYS TO PURCHASE
- Phone – 1-877-249-8226 / 240-646-7031 to order with credit card.
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
Human Factors Webinar CD
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
All orders must be prepaid and in U.S. Dollars.
QUESTIONS?
For questions about ordering the CD, please contact AAMI’s Publications at 1-877-249-8226 / 240-646-7031.