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

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

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

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.

Increased concern for patient safety has put the issue at the top of the agenda of practitioners, hospitals, and even governments. The risks to patients are many and diverse, and the complexity of the healthcare system that delivers them is huge. Yet the discourse is often oversimplified and underdeveloped. Written from a scientific, human factors