Design of Medical Devices - AAMI/ANSI HE75 Standard Review
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: Thursday, May 20th - 6:30-9:00pm
Where: Daedalus Product Development
4923 Centre Ave.
Pittsburgh, PA 15213
412.687.7000
IDSA Members: $15
HFES, AAMI Members: $25
Non-Members: $35
PLEASE RSVP: online (preferred), by email to tfletcher@daed.com or by phone 412.687.7000
One copy of the HE75 standard will be given away as a door prize thanks to AAMI ($270 value).
SPONSORED BY: IDSA Medical Section and the Western PA IDSA Chapter
HOSTED BY: Daedalus Product Development
The review will be led by a contributor to the development of HE75, Sean Hägen of BlackHägen Design. Sean is on the AAMI Human Factors committee that authored the standard and is the current Medical Section Chair of the IDSA.
WHAT IS THE AGENDA?
An overview of the Standard’s contents and intention for use, a case study of how it could be used, and a 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 affective 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.
QUESTIONS, COMMENTS, OR CONCERNS?
Contact: Daedalus Product Development
4923 Centre Ave.
Pittsburgh, PA 15213
412.687.7000
What: Design of Medical Devices - AAMI/ANSI HE75 Standard Review
When: Thursday, May 20th - 6:30-9:00pm
Where: Daedalus Product Development
4923 Centre Ave.
Pittsburgh, PA 15213
412.687.7000
IDSA Members: $15
HFES, AAMI Members: $25
Non-Members: $35
PLEASE RSVP: online (preferred), by email to tfletcher@daed.com or by phone 412.687.7000
One copy of the HE75 standard will be given away as a door prize thanks to AAMI ($270 value).
SPONSORED BY: IDSA Medical Section and the Western PA IDSA Chapter
HOSTED BY: Daedalus Product Development
The review will be led by a contributor to the development of HE75, Sean Hägen of BlackHägen Design. Sean is on the AAMI Human Factors committee that authored the standard and is the current Medical Section Chair of the IDSA.
WHAT IS THE AGENDA?
An overview of the Standard’s contents and intention for use, a case study of how it could be used, and a 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 affective 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.
QUESTIONS, COMMENTS, OR CONCERNS?
Contact: Daedalus Product Development
4923 Centre Ave.
Pittsburgh, PA 15213
412.687.7000
posted by Western PA IDSA Chapter at
10:29 PM
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