JOIN US! Join us for a review and discussion on the latest Human Factors Standard for the design of medical devices.
What: Design of Medical Devices - AAMI/ANSI HE75 Standard Review
When: Wednesday, July 21st: 6:30 – 9pm (food and beverage served and review to start at 7pm
55 Dupont Drive, Providence, RI 02907
Click for directions, Google Maps
IDSA Members: $15
HFES, AAMI Members: $25
For IDSA Members: Registration has been set up online. Please log into your IDSA account and go to “My IDSA” (found under the log in) and locate this event.
All others: Please Register online via this link or visit http://tinyurl.com/Design-of-Med-Dev-IDSA.
A copy of the HE75 standard will be given away as a door prize thanks to AAMI ($270 value).
The ANSI/AAMI HE75 Human Factors Standard overview is sponsored by the IDSA Medical Section with the IDSA Rhode Island Chapter, and hosted by Ximedica.
The review will be led by Steve Wilcox, Ph.D., the current Human Interaction Section Chair of the IDSA. Steve is on the AAMI Human Factors committee that developed the standard and is a contributing author to HE75 content. Steve will be joined by Michael Wiklund of Wiklund Research and Design.
What is the agenda?
Steve will present an overview of the Standard’s contents and intention for use, three examples of how it could be used, and mediate a discussion/Q&A session.
What is the AAMI/ANSI HE 75 standard?
The standard was developed by the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors committee in cooperation with the FDA; it supplants HE48, which was written in the mid 80s, to provide design guidelines for user interface development in medical devices.
It is essential for the medical device designer to be well versed in the many regulatory standards that apply to the healthcare industry in order to contribute as critical member of the device development team. This is especially true for the human factors standards since they pertain specifically to the user interaction element of the design.
Over the past decade or so the FDA has started really focusing on the fact that use error was the source of the majority of adverse events (nice word for really bad things regarding the patient). This focus translated into an emphasis on human factors and device ease-of-use (reference 21CFR820.30). It is recognized that the most effective way to mitigate use error is through the design of the device in the first place (as opposed to training or instruction for use).
Who should attend?
Medical Device Industry Professionals, Industrial Designers, Quality Engineers, Mechanical Engineers, Software Engineers, Human Factors Engineers.