To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts.
“‘Human factors’ is a buzzword in the industry because it’s essential. Regardless of what your device is, you need to make sure every person who uses it will be able to use it properly,” said Alex Butler, manager of medical device solutions at MasterControl (1).
HFE is No. 2 on a list of top five developments likely to affect the device industry this year, according to a new white paper, “Top 5 Medical Device Industry Trends in 2019.” Four medtech experts shared their insights and offered some advice in the white paper.
What is human factors engineering? Under the FDA’s definition, the term (also known as usability engineering) refers to the application of knowledge about human behavior, abilities, limitations and other characteristics to the design of medical devices to help enhance and ensure safe and effective use (2).
HFE is a practical concept based on the fact that medical device safety depends, in part, on correct use. A simple device like a crutch poses no complications for users, but an infusion pump or an artificial knee significantly raises the likelihood of risks when used incorrectly.
For example, an infusion pump that requires a dozen steps to activate is inherently complicated. What if the pump needs to be restarted every hour? Performing a dozen steps to restart a single device every hour could be risky because it’s likely that an overworked and stressed-out nurse would make an error.
If the manufacturer applied HFE during the pump’s design phase, it would have considered user conditions, such as nurses and caregivers working long hours under stressful circumstances. It might have found a way to simplify the process from 12 to just three steps.
Device manufacturers are required to apply HFE under 21 CFR Part 820, while FDA guidance documents encourage them to do so by providing standards and explaining the agency’s expectations.
Part 820 doesn’t use the term “human factors engineering,” but it does require design validation to “ensure that devices conform to user needs and intended uses and shall include testing of production units under actual or simulated use conditions” (3).
Two FDA guidance documents issued in 2016 reinforce the importance of HFE. The agency said it “considers human factors testing for medical devices as a part of a robust design control subsystem.” It recommended the inclusion of HFE data in premarket submissions for devices with risk analysis that shows incorrect use of the device could result in serious harm. An accompanying guidance specified the types of devices that should include human factors data in premarket submissions (4).
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The importance of human factors is highlighted in a recent warning letter sent by the FDA to a medical device company for failure to conduct a postmarket HFE study and testing. The FDA warned the company that without HFE, the failure of the device could cause infection and possibly serious adverse health consequences. It required the firm to conduct a human factor study with five participants enrolled per month during a six-month period, but the firm failed to conduct the HFE testing (5).
The warning letter imparts an underlying lesson: if the firm had integrated HFE during the design phase, it might have avoided postmarket violations. It behooves manufacturers to identify hazards related to user errors as part of their risk management strategy.
The FDA could not have explained the HFE principle better. The agency said in its 2016 guidance: “Many device manufacturers have found that the application of HFE/UE during the development of their products reduces the need for design modifications and costly updates after market introduction and offers competitive advantages. (6)” Indeed, applying HFE is both a matter of product safety and good business sense. Expect this message to be amplified now more than ever.
(1) Alex Butler, manager of medical device solutions at MasterControl, oversees development and continuous improvement initiatives for several MasterControl core products, including MasterControl Regulatory Excellence. He has an extensive background in medical device technology and innovation, with over eight years devoted to product development, strategic planning, quality assurance and process improvement. Prior to joining MasterControl, he served as a product development manager for Opal Orthodontics, where he was directly involved in the development, quality and compliance, risk management, registrations and launch of several Class II medical devices.
(2) From the FDA’s guidance document, “Applying Human Factors and Usability Engineering to Medical Devices.”
(3) 21 CFR Part 820.30, Design Controls.
(4) FDA guidance documents: “Applying Human Factors and Usability Engineering to Medical Devices” and “List of Highest Priority Devices for Human Factors Review,” released February 2016.
(5) FDA warning letter to Olympus Corporation, issued on March 9, 2018.
(6) FDA guidance document: “Applying Human Factors and Usability Engineering to Medical Devices.”
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.