Michael Wiklund works to ensure safe and usable medical devices through the application of human factors engineering. The president of the firm Wiklund Research & Design, Inc. also helped develop the standard, ANSI/AAMI HE75:2009, Human factors principles for medical device design, which will be released soon. In this issue of AAMI News, he discusses the challenges of human factors and why they are important for biomeds and manufacturers.

AAMI News: What are some of the inherent challenges in human factors?

Michael Wiklund: One challenge is that people’s perceptions and stated opinions do not always match their decisions and behaviors. For example, an individual might say she prefers a functionally lean and simple-to-use device, but then buys one packed with features that are hard to use because it holds greater emotional appeal.

AN: How should manufacturers think“outside the box” when it comes to preventing use-related hazards?

MW: Manufacturers must decide how broadly to address the potential for use error. A narrow approach will keep them focused on intended device uses and lead them to mitigate against the associated use errors. A broader approach will lead them to evaluate unintended uses (including off-label uses) and mitigate against a larger set of potential use errors. The broader approach is likely to pay off by lowering the potential for adverse events while the narrow approach could result in potentially preventable patient injuries and deaths.

Otherwise, I think manufacturers are well served to think “inside the box” when it comes to human factors and preventing use-related hazards. A mainstream approach to applying human factors in medical device development should serve them well.

AN: How can knowledge of human factors be helpful to clinical engineering?

MW: Knowledge of human factors can help them recognize medical devices with good versus poor user interfaces. Presuming their departments play a role in purchasing capital equipment, they can promote the purchase of safer and more user-friendly products. Knowledge of human factors also can help clinical engineers link use errors to user interface design flaws, rather than attribute them to human blunder.

AN: As technology continues to advance, how will the application of human factors engineering adapt?

MW: It seems like an ever-increasing number of medical devices have microprocessors at their core and communicate via a computerized display. Human factors engineering research, design, and testing efforts will focus increasingly on the user-computer interface as opposed to the design of ergonomically correct seating positions, logical control panel layouts, and comfortable handle grips. They will also help to create devices that protect against use errors.

AN: You worked to develop HE75. What is different about this standard?

MW: We — the members of the AAMI Human Factors Committee — conceived the standard based on a bit of user research. Years ago, we asked a sample of medical device designers what kind of human factors design standard they wanted. They told us that they wanted a comprehensive standard that would be a “one-stop” source of guidance. So that’s what we developed — a virtual encyclopedia of user interface design guidance to complement the design process-related guidance contained in ANSI/AAMI HE74:2001, Human factors design process for medical devices.

AAMI News: February 2010, Vol. 45, No. 2