Page 188 - Safety Risk Management for Medical Devices

Risk Controls 167

When using information for safety as a Risk Control, consider the following:
To whom—To whom will you be communicating? A trained clinician? A home
user? Elderly? Youth? How well is it perceived and comprehended?
How—Will you be using words? Icons? What type of media (printed, digital
screen)? What location/timing of the information? What level of detail?
What—What are the hazardous conditions? What are the consequences of exposure
and what should be done to prevent Harm? In what priority should actions be taken?
Information for safety can be in many forms. For example: in user manuals, in
labeling that is attached to the medical device, in graphical user interfaces such as
screens, or even in the form of audio or tactile annunciations.
The primary intention should be avoidance of Hazardous Situations, either by pre-
vention of Hazards, or by prevention of exposure to Hazards. Secondarily, informa-
tion for safety should offer guidance on remedial actions if Harm has happened. The
priority of actions should be commensurate with the level of risk, and be properly
communicated to the users. Use of word such as: “Danger,” “Warning,” “Caution,”
“Alert,” and “Note” could indicate the priority of the information for safety.
The three guiding principles in the utilization of information for safety as Risk
Control are:

Inform Motivate Enable

According to Guide 51 [1] labeling should be:
• “conspicuous, legible, durable and understandable;
• worded in the official language(s) of the country/countries where the prod-
uct or System is intended to be used, unless one of the languages associated
with a particular technical field is more appropriate;
• concise and unambiguous.”
With respect to legibility, consider the user population. What visual acuity can be
expected? Under what lighting conditions will the user typically use the device? Use
AAMI HE75 [20] for guidance on font sizes for visual displays.
The labeling should be durable and not fade, rub off, smear, or separate from its
intended location during the expected life of the device.
Whether in audio or visual format, the information for safety should be under-
standable by the users. In today’s global economy, with so many languages and cultures
this is a challenging requirement. Even the choice of colors may convey one thing in
one culture, and another in a different culture. For example, in the American culture
the color yellow is usually an indication of a warning. But in the Japanese culture
yellow is an indication of sickness and ill health.
Translations are a sensitive and critical aspect of communication of information for
safety. In many companies the information for safety is drafted in a central language,