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This book is a practical guide for individuals responsible for
creating products that are safe, effective, usable, and satisfying
in the hands of the intended users. The contents are intended to
reduce the number of use errors involving medical devices that have
led to injuries and deaths. The book presents the strong connection
between user interface requirements and risk management for medical
devices and instructs readers how to develop specific requirements
that are sufficiently comprehensive and detailed to produce good
results - a user-friendly product that is likely to be used
correctly. The book's tutorial content is complemented by many
real-world examples of user interface requirements, including ones
pertaining to an inhaler, automated external defibrillator, medical
robot, and mobile app that a patient might use to manage her
diabetes. The book is intended for people representing a variety of
product development disciplines who have responsibility for
producing safe, effective, usable, and satisfying medical devices,
including those who are studying or working in human factors
engineering, psychology, mechanical engineering, biomedical
engineering, systems engineering, software programming, technical
writing, industrial design, graphic design, and regulatory affairs.
This book is a practical guide for individuals responsible for
creating products that are safe, effective, usable, and satisfying
in the hands of the intended users. The contents are intended to
reduce the number of use errors involving medical devices that have
led to injuries and deaths. The book presents the strong connection
between user interface requirements and risk management for medical
devices and instructs readers how to develop specific requirements
that are sufficiently comprehensive and detailed to produce good
results - a user-friendly product that is likely to be used
correctly. The book's tutorial content is complemented by many
real-world examples of user interface requirements, including ones
pertaining to an inhaler, automated external defibrillator, medical
robot, and mobile app that a patient might use to manage her
diabetes. The book is intended for people representing a variety of
product development disciplines who have responsibility for
producing safe, effective, usable, and satisfying medical devices,
including those who are studying or working in human factors
engineering, psychology, mechanical engineering, biomedical
engineering, systems engineering, software programming, technical
writing, industrial design, graphic design, and regulatory affairs.
How do you prevent a critical care nurse from accidentally
delivering a morphine overdose to an ill patient? Or ensure that
people don't insert their arm into a hydraulic mulcher? And what
about enabling trapped airline passengers to escape safely in an
emergency? Product designers and engineers face myriad such
questions every day. Failure to answer them correctly can result in
product designs that lead to injury or even death due to use error.
Historically, designers and engineers have searched for answers by
sifting through complicated safety standards or obscure industry
guidance documents. Designing for Safe Use is the first
comprehensive source of safety-focused design principles for
product developers working in any industry. Inside you'll find 100
principles that help ensure safe interactions with products as
varied as baby strollers, stepladders, chainsaws, automobiles,
apps, medication packaging, and even airliners. You'll discover how
protective features such as blade guards, roll bars, confirmation
screens, antimicrobial coatings, and functional groupings can
protect against a wide range of dangerous hazards, including sharp
edges that can lacerate, top-heavy items that can roll over and
crush, fumes that can poison, and small parts that can pose a
choking hazard. Special book features include: Concise, illustrated
descriptions of design principles Sample product designs that
illustrate the book's guidelines and exemplify best practices
Literature references for readers interested in learning more about
specific hazards and protective measures Statistics on the number
of injuries that have arisen in the past due to causes that might
be eliminated by applying the principles in the book Despite its
serious subject matter, the book's friendly tone, surprising
anecdotes, bold visuals, and occasional attempts at dry humor will
keep you interested in the art and science of making products
safer. Whether you read the book cover-to-cover or jump around, the
book's relatable and practical approach will help you learn a lot
about making products safe. Designing for Safe Use is a primer that
will spark in readers a strong appreciation for the need to design
safety into products. This reference is for designers, engineers,
and students who seek a broad knowledge of safe design solutions. .
How do you prevent a critical care nurse from accidentally
delivering a morphine overdose to an ill patient? Or ensure that
people don't insert their arm into a hydraulic mulcher? And what
about enabling trapped airline passengers to escape safely in an
emergency? Product designers and engineers face myriad such
questions every day. Failure to answer them correctly can result in
product designs that lead to injury or even death due to use error.
Historically, designers and engineers have searched for answers by
sifting through complicated safety standards or obscure industry
guidance documents. Designing for Safe Use is the first
comprehensive source of safety-focused design principles for
product developers working in any industry. Inside you'll find 100
principles that help ensure safe interactions with products as
varied as baby strollers, stepladders, chainsaws, automobiles,
apps, medication packaging, and even airliners. You'll discover how
protective features such as blade guards, roll bars, confirmation
screens, antimicrobial coatings, and functional groupings can
protect against a wide range of dangerous hazards, including sharp
edges that can lacerate, top-heavy items that can roll over and
crush, fumes that can poison, and small parts that can pose a
choking hazard. Special book features include: Concise, illustrated
descriptions of design principles Sample product designs that
illustrate the book's guidelines and exemplify best practices
Literature references for readers interested in learning more about
specific hazards and protective measures Statistics on the number
of injuries that have arisen in the past due to causes that might
be eliminated by applying the principles in the book Despite its
serious subject matter, the book's friendly tone, surprising
anecdotes, bold visuals, and occasional attempts at dry humor will
keep you interested in the art and science of making products
safer. Whether you read the book cover-to-cover or jump around, the
book's relatable and practical approach will help you learn a lot
about making products safe. Designing for Safe Use is a primer that
will spark in readers a strong appreciation for the need to design
safety into products. This reference is for designers, engineers,
and students who seek a broad knowledge of safe design solutions. .
Medical Device Use Error: Root Cause Analysis offers practical
guidance on how to methodically discover and explain the root cause
of a use error-a mistake-that occurs when someone uses a medical
device. Covering medical devices used in the home and those used in
clinical environments, the book presents informative case studies
about the use errors (mistakes) that people make when using a
medical device, the potential consequences, and design-based
preventions. Using clear illustrations and simple narrative
explanations, the text: Covers the fundamentals and language of
root cause analysis and regulators' expectations regarding the
thorough analysis of use errors Describes how to identify use
errors, interview users about use errors, and fix user interface
design flaws that could induce use errors Reinforces the
application of best practices in human factors engineering,
including conducting both formative and summative usability tests
Medical Device Use Error: Root Cause Analysis delineates a
systematic method of analyzing medical device use errors. The book
provides a valuable reference to human factors specialists, product
development professionals, and others committed to making medical
devices as safe and effective as possible.
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