Human Factors for Medical Devices
Written by: Cindy NolteWednesday, November 4th, 2009 | FDA Medical Device Regulations
I recently attended the “Human Factors for Medical Devices” course sponsored by the Association for the Advancement of Medical Instrumentation (AAMI). The three-day program provided an introduction to human factors, discussion of FDA regulatory requirements related to human factors, and the role of human factors in design controls. Among the faculty was Ronald Kaye, Human Factors Specialist in the Office of Device Evaluation (ODE) at FDA’s Center for Devices and Radiological Health (CDRH), as well as experts in the field of human factors engineering.
Human Factors Engineering in Medical Devices
Human factors engineering (HFE) plays an important role in creating safe, highly-usable, and innovative products. It will be more and more important for device manufactures to understand and address a number of HFE related issues, including; the development of user profiles that identify traits that may impact device design; the creation of use scenarios that define the interactions of the user with the device; and task analyses that prioritize tasks in consideration of their risk.
I was particularly interested to hear FDA officials speak about the agency’s plans to ensure that medical device manufacturers utilize HFE in device design and provide evidence in premarket submissions that user interfaces are tested to verify usability. FDA’s focus during the review of HFE documentation will be on data collected during formative and summative usability assessments to support the safe and effective use of the medical device.
Objective Data is Critical
A key takeaway from this training program was hearing the importance that FDA will place on objective evidence to demonstrate HFE principles in medical device premarket submissions. Manufactures will need to provide well-written and comprehensive usability validation reports that include a detailed explanation of the evaluation process and how it relates to device safety. FDA expects that usability validation reports will also include a thorough analysis of each failure and the residual risk remaining. The agency also cautions against leaving interpretation of the usability test results to the FDA reviewer. As more medical devices are required to incorporate HFE in principles in their design and development, a smooth review and rapid product clearance or approval will be dependent on well-written reports to demonstrate the proper application of HFE principles and thorough testing of the device in the use environment.
2 Comments to Human Factors for Medical Devices
I appreciate the summary of your experiences at the conference. I’ve been interested in HFE for sometime, even though I am not in a position to perform extensive use or research. Regardless, I am intrigued that the FDA will will look for HFE principles when considering submitted products.
Hey its an interesting post, its informative, thank you for the post.
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