Human Factors Standard Helps Firms Design Usability Into A Unique Device

Article preview from "The Silver Sheet"- May, 2010

Device manufacturers have a new industry standard to add to their compliance toolbox to help ensure that usability is adequately designed into products.

Human Factors Standard Helps Firms Design Usability Into A Unique Device

Article preview from "The Silver Sheet"- May, 2010

Device manufacturers have a new industry standard to add to their compliance toolbox to help ensure that usability is adequately designed into products.

HE75:2009, "Human Factors Engineering - Design of Medical Devices," draws on usability and psychological research to provide specific design recommendations for a variety of devices.

"What this [standard] is about is ensuring that devices are designed such that the users ... are not going to be confused, and they're not going to make small pivotal errors and have those errors manifested into injuries of users and patients," said Ron Kaye, FDA's human factors and device-use safety team leader.

"Devices have become much more complex, and the requirement of the operator [to understand] those devices is increasing in terms of its burden and complexity," Kaye said.

"And, of course, you have various levels of capability of the users of those devices, and there are small train wrecks that are going to happen if that isn't managed carefully," he said.

The new standard, 10 years in the making and released in early April, was developed by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI).

HE75 "emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error," the document states.

"We tried very hard in HE75 to give examples of how human factors applies to medical devices, as opposed to giving general human factors considerations," said Ed Israelski, human factors program manager at Abbott and co-chair of AAMI's human factors engineering committee.

HE75 is designed to be used in conjunction with other human factors standards, including IEC 62366:2007, "Medical Devices - Application of Usability Engineering to Medical Devices," and HE74:2001, "Human Factors Design Process for Medical Devices," as well as FDA's 2000 guidance, "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management."

"IEC 62366 and HE74 are process standards," Israelski said. "They tell you what human factors engineering criteria are. That's where you're going to learn about all of the important human factors usability engineering process steps that you should follow in your product design."

Meanwhile, the new HE75 standard "is about design principles. What makes for a good display? What makes for a good hand tool? What makes for a good workstation?" he said.

- Shawn M. Schmitt

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