Applied Human Factors in Medical Device Design PDF Download
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Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128161647
Category : Science
Languages : en
Pages : 371
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Book Description
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. - Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) - Explains technology development and the application of human factors throughout the development process - Covers FDA and MHRA regulations - Includes case examples with each method
Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128161647
Category : Science
Languages : en
Pages : 371
Get Book Here
Book Description
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. - Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) - Explains technology development and the application of human factors throughout the development process - Covers FDA and MHRA regulations - Includes case examples with each method
Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 472
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Book Description
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h
Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1351579150
Category : Business & Economics
Languages : en
Pages : 588
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Book Description
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. .
Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1040071023
Category : Medical
Languages : en
Pages : 233
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Book Description
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
Author: Michael E. Wiklund
Publisher:
ISBN: 9781570206894
Category : Human engineering
Languages : en
Pages : 218
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Book Description
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309212405
Category : Medical
Languages : en
Pages : 202
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Book Description
In the United States, health care devices, technologies, and practices are rapidly moving into the home. The factors driving this migration include the costs of health care, the growing numbers of older adults, the increasing prevalence of chronic conditions and diseases and improved survival rates for people with those conditions and diseases, and a wide range of technological innovations. The health care that results varies considerably in its safety, effectiveness, and efficiency, as well as in its quality and cost. Health Care Comes Home reviews the state of current knowledge and practice about many aspects of health care in residential settings and explores the short- and long-term effects of emerging trends and technologies. By evaluating existing systems, the book identifies design problems and imbalances between technological system demands and the capabilities of users. Health Care Comes Home recommends critical steps to improve health care in the home. The book's recommendations cover the regulation of health care technologies, proper training and preparation for people who provide in-home care, and how existing housing can be modified and new accessible housing can be better designed for residential health care. The book also identifies knowledge gaps in the field and how these can be addressed through research and development initiatives. Health Care Comes Home lays the foundation for the integration of human health factors with the design and implementation of home health care devices, technologies, and practices. The book describes ways in which the Agency for Healthcare Research and Quality (AHRQ), the U.S. Food and Drug Administration (FDA), and federal housing agencies can collaborate to improve the quality of health care at home. It is also a valuable resource for residential health care providers and caregivers.
Author: Russell J. Branaghan
Publisher: Springer Nature
ISBN: 3030644332
Category : Technology & Engineering
Languages : en
Pages : 395
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Book Description
This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.
Author: Guruprasad Madhavan
Publisher: Springer Science & Business Media
ISBN: 038776495X
Category : Technology & Engineering
Languages : en
Pages : 524
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Book Description
This indispensable guide provides a roadmap to the broad and varied career development opportunities in bioengineering, biotechnology, and related fields. Eminent practitioners lay out career paths related to academia, industry, government and regulatory affairs, healthcare, law, marketing, entrepreneurship, and more. Lifetimes of experience and wisdom are shared, including "war stories," strategies for success, and discussions of the authors’ personal views and motivations.
Author: Douglas A. Wiegmann
Publisher: Routledge
ISBN: 1351962353
Category : Technology & Engineering
Languages : en
Pages : 174
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Book Description
Human error is implicated in nearly all aviation accidents, yet most investigation and prevention programs are not designed around any theoretical framework of human error. Appropriate for all levels of expertise, the book provides the knowledge and tools required to conduct a human error analysis of accidents, regardless of operational setting (i.e. military, commercial, or general aviation). The book contains a complete description of the Human Factors Analysis and Classification System (HFACS), which incorporates James Reason's model of latent and active failures as a foundation. Widely disseminated among military and civilian organizations, HFACS encompasses all aspects of human error, including the conditions of operators and elements of supervisory and organizational failure. It attracts a very broad readership. Specifically, the book serves as the main textbook for a course in aviation accident investigation taught by one of the authors at the University of Illinois. This book will also be used in courses designed for military safety officers and flight surgeons in the U.S. Navy, Army and the Canadian Defense Force, who currently utilize the HFACS system during aviation accident investigations. Additionally, the book has been incorporated into the popular workshop on accident analysis and prevention provided by the authors at several professional conferences world-wide. The book is also targeted for students attending Embry-Riddle Aeronautical University which has satellite campuses throughout the world and offers a course in human factors accident investigation for many of its majors. In addition, the book will be incorporated into courses offered by Transportation Safety International and the Southern California Safety Institute. Finally, this book serves as an excellent reference guide for many safety professionals and investigators already in the field.
Author: Sidney Dekker
Publisher: Routledge
ISBN: 1351786032
Category : Social Science
Languages : en
Pages : 137
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Book Description
This title was first published in 2002: This field guide assesses two views of human error - the old view, in which human error becomes the cause of an incident or accident, or the new view, in which human error is merely a symptom of deeper trouble within the system. The two parts of this guide concentrate on each view, leading towards an appreciation of the new view, in which human error is the starting point of an investigation, rather than its conclusion. The second part of this guide focuses on the circumstances which unfold around people, which causes their assessments and actions to change accordingly. It shows how to "reverse engineer" human error, which, like any other componant, needs to be put back together in a mishap investigation.
