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About Human Factors
Leading to Medical Device Adverse Events
ADVERSE EVENTS involving medical
devices or equipment can lead to serious problems, including
incorrect or delayed diagnosis and treatment or patient injuries.
When errors involving medical devices recur repeatedly, people
typically blame the users instead of the real culprit, which is
often a poorly designed interface between the medical device and
the user. Human factors is the science that focuses on
understanding and supporting how people interact with technology.
In health care, the objective of
human factors is to improve human performance with medical
products, including medical devices, and to reduce the likelihood
of error or injury, thus improving patient and workplace safety.
There are three major areas for
evaluating medical-device-related adverse events from a human
factors perspective :
1. user characteristics, including
the person’s abilities and training and her expectations of the
device.
2. device design considerations,
which focus on the device-user interface, including instructions
for use.
3. the environment in which the
device is used, including the lighting, noise, distractions, and
time constraints.
(More details at :
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
TipsandArticlesonDeviceSafety/ucm070185.htm).
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