Medical Device & Diagnostic Industry

Product Development _Insight
New Human Factors Standard
on the Horizon
The upcoming release of AAMI HE75 should be of great help to device
manufacturers.

Michael Wiklund

Wiklund Research & Design

Next year, AAMI is likely to release AAMI HE75:200X

—an encyclopedic document containing more than a thousand human factors guidelines for the design of safe, effective, and user-friendly medical devices.¹ The new document will tell you how to make a patient monitor’s digital readouts legible, what features enhance a portable CT scanner’s mobility, how to design alarms that draw attention in noisy environments, and myriad other ways to improve medical device safety, effectiveness, and usability.

The document promises to give user interface quality a boost just when the medical device industry needs as much guidance as possible to respond effectively to the requirements set forth by IEC 62366:2007, “Medical Devices— Application of Usability Engineering to Medical Devices.”² In a nutshell, the IEC standard calls for manufacturers to follow good human factors processes when designing a medical device, but does not provide detailed design guidance. That’s the forthcoming standard’s job.

AAMI’s Human Factors Engineering Committee, which includes a few dozen engineers, human factors specialists, and clinicians with a special interest in medical device safety and usability, spent the better part of the past decade creating the lengthy collection of design guidance—560 pages and counting. The document is currently undergoing editing in response to industry and commit-

tee member comments on a draft released for public comment in early 2007. It still could undergo another round of public comment and editing depending on the extent of the current round of edits, grammatical nitpicks notwithstanding. So, the exact release date remains uncertain.

AAMI’s Teresa Zuraski, senior vice president of standards policy and programs, says, “The draft standard will eventually be submitted to American National Standards Institute (ANSI) for approval as an American National Standard.” Just as ANSI/AAMI HE74: 2001’s influence has extended beyond the United States, the new standard should also affect medical device design worldwide. ³ Although human factors guidelines are available in many other forms, none focus so specifically on medical devices (see the sidebar, “Popular Sources of Human Factors Guidance,” on page 47 for a list of those publications). Rather, they tend to focus on military equipment, computer software programs intended for personal and business use, industrial equipment, and consumer electronics.

Development History

The new standard succeeds a portion of ANSI/AAMI HE48:1993, which combined design process guidance with applied design guidance. ⁴ In 1998, when ANSI/AAMI HE48:1993 became subject to recall after its fifth

year in circulation, the Human Factors Engineering (HFE) Committee determined that there was a need for more in-depth process and design guidance than that found in the aging document. Based on research involving potential users—hardware and software developers working within medical device manufacturing companies— the committee decided to produce an updated version in two parts: one outlining good human factors methods and a second presenting detailed design guidance. This strategy enabled the committee to quickly publish the process-oriented guide and put more time into the applied guidelines.