Medical Device & Diagnostic Industry

user interface design. Looking forward, there will be no excuse for illegible displays, confusing controls, and incoherent software menus. So, medical device manufacturers, prepare yourselves. Our industry is well past the point at which human factors may be regarded as newfangled. The rigorous application of human factors in medical device design is now conventional, and most likely starting in 2009, AAMI HE75:200X will help define the conventions.

Indeed, AAMI HE75’s release should cause more relief than pain. Israelski, who spends much of his time infusing human factors into development projects, believes, “HE75 will be a great help to manufacturers that do not have trained HF staff, as well as a good tool for those that do have onboard staff. The goal is that the standard provides a lot of guidance collected in one convenient place. HE75 will save developers time in searching out the HF literature for design guidance. Each of the 25 sections has extensive references for those who need to dig deeper into design guidance for particular areas such as alarms, displays, documentation, workstations, software, etc.” He adds, “It should help all manufacturers make better design decisions. But, it is not to be seen as a cookbook or a shortcut for doing the complete HF process during development.”

Electrotechnical Commission, 2007).

3. ANSI/AAMI HE74:2001, “Human Fac-

tors Design Process for Medical Devices”

(Arlington, VA: AAMI, 2001).

4. ANSI/AAMI HE48:1993, “Human Fac-

tors Engineering Guidelines and Preferred

Practices for the Design of Medical De-

vices” (Arlington, VA: AAMI, 1993).

5. IEC 60601-1-6, “Medical Electrical Equip-

ment—Part 1-6: General Requirements for

Safety—Collateral Standard: Usability”

(Geneva: International Electrotechnical

Commission, 2006).

6. MIL-STD-1472F, “Department of Defense

Design Criteria Standard—Human Engi-

neering” (Washington, DC: Department

of Defense, 1999).

7. Malcolm Gladwell, The Tipping Point:

How Little Things Can Make a Big Dif-

ference (New York: Little, 2001). ■

Disclaimer

AAMI has granted permission to the author to quote from AAMI’s draft standard, AAMI HE75:200X. This article represents the view of the author only and not the views of AAMI or the AAMI Human Factors Engineering Committee. Neither AAMI nor the committee has reviewed this article for completeness or accuracy. AAMI HE75:200X is currently in draft form and may change substantially in the future based on the committee’s review of ballot and public comments on the draft standard.