What: Design of Medical Devices - AAMI/ANSI HE75 Standard Review

When: Wednesday, July 21^st:  6:30 – 9pm (food and beverage served with review to start at 7pm)

Where: Ximedica

55 Dupont Drive, Providence, RI 02907

Click for directions, Google Maps

IDSA Members: $15

HFES, AAMI Members: $25

Non-Members: $35

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.

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.

Thank you!  Free feel to contact me with any questions you may have.

Andrea Larocque

Marketing Manager

Ximedica

55 DuPont Drive

Providence, RI  02907

401-330-3163 Ext. 132

Fax  401-626-3356

www.ximedica.com

Read Ximedica’s blog, Living Innovation, at http://www.ximedica.com/living-innovation