of industry comments on the draft
standard.
The list of potential standard users
goes on. Consumers, including clinicians and buyers involved in medical
device procurements, could draw upon
the standard to evaluate candidate devices, such as portable ventilators used
in ambulances. In such cases, they
would want to pay close attention to
the standard’s section on Environment
of Use, which states, “High-vibration
environments include ground and air
emergency transport vehicles, for example. For medical devices used in
these types of environments, consider
large display characters, minimize display clutter, and provide large enough
manual controls to counteract tracking and reach errors that can occur
above accelerations of 2.0 m/sec2.”
Effect on Industry
Undoubtedly, AAMI HE75:200X
will place greater pressure on medical
device manufacturers to conform to
good human factors practice because
it contains far more guidelines than
its predecessor. The section authors
adapted many guidelines from reference documents such as other AAMI,
ANSI, IEC, ISO, and military standards, as well as authoritative textbooks. However, to fill voids, they also
created new guidelines based on their
professional knowledge and experience. As such, readers will find guidance on topics never before addressed
in a medical-related design standard.
AAMI HE75:200X should accelerate several medical device design tasks,
including establishing user requirements, developing design solutions,
determining testing criteria, and writing final design specifications. Until
now, developers had to conduct a wide
and often frustrating search for human
factors guidelines that they could convert into requirements, criteria, and
specifications. Often, they took what
they could from the old AAMI standard (AAMI HE48-1993) and from
MIL-STD-1472, the venerable human
factors standard for military equipment. 6 Using the latter, medical device
designers often had to translate guidance intended to help weapon design
into something applicable to a diagnostic device, for example. Medical
device designers lucked out if their
new instrument, a surgical stapler for
example, incorporated a trigger. The
new standard promises to be a one-stop shop for such guidelines, although
it cites many other resources.
One challenge facing AAMI
HE75:200X readers is determining
which guidelines apply to their medical device—not a simple task given the
large number of guidelines. For example, an infusion pump manufacturer
might need to follow guidelines found
in the controls; visual displays; alarm
design; connectors and connections;
software user interface; and signs, symbols, and markings sections. But then,
other medical device standards, such as
IEC 60601-1, pose a similar challenge.
Richard Stein, a principal engineer
with St. Jude Medical and a member
of the AAMI HFE committee, expects
that “rank and file engineers will react
to the HE75 standard in various ways.
On the positive side, engineers who
value published and accepted guidance
will use the standard as a definitive
POPULAR SOURCES
OF HUMAN FACTORS
GUIDANCE
ANSI/HFES 100, “Human Factors
Engineering of Computer Workstations” (New York, American National Standards Institute, 2007).
ANSI/HFES 200, “Ergonomic Requirements for Software User Interfaces” (New York, ANSI, 2008).
Gavriel Salvendy, ed., Handbook
on Human Factors and Ergonomics
(Hoboken, NJ: Wiley, 2006).
Wesley Woodson et al., Human
Factors Design Handbook (New
York: McGraw-Hill, 1992).
MIL-S TD-1472F, “Department of
Defense Design Criteria Standard—
Human Engineering” (Washington,
DC: Department of Defense, 1999).
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