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Medical Device Use Error by Michael Wiklund,Andrea Dwyer,Erin Davis Pdf
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,Andrea M. Dwyer,Erin Davis Publisher : CRC Press Page : 0 pages File Size : 44,9 Mb Release : 2016-01-12 Category : Medical ISBN : 1498705790
Medical Device Use Error by Michael E. Wiklund,Andrea M. Dwyer,Erin Davis Pdf
Root Cause Analysis of Use Error delineates a systematic method of analyzing medical device use errors. The book is to the specific needs of people developing medical devices, people studying to serve this role, and the folks responsible for evaluating device use error (including the regulators).
This edited collection of articles addresses aspects of medical care in which human error is associated with unanticipated adverse outcomes. For the purposes of this book, human error encompasses mismanagement of medical care due to: * inadequacies or ambiguity in the design of a medical device or institutional setting for the delivery of medical care; * inappropriate responses to antagonistic environmental conditions such as crowding and excessive clutter in institutional settings, extremes in weather, or lack of power and water in a home or field setting; * cognitive errors of omission and commission precipitated by inadequate information and/or situational factors -- stress, fatigue, excessive cognitive workload. The first to address the subject of human error in medicine, this book considers the topic from a problem oriented, systems perspective; that is, human error is considered not as the source of the problem, but as a flag indicating that a problem exists. The focus is on the identification of the factors within the system in which an error occurs that contribute to the problem of human error. As those factors are identified, efforts to alleviate them can be instituted and reduce the likelihood of error in medical care. Human error occurs in all aspects of human activity and can have particularly grave consequences when it occurs in medicine. Nearly everyone at some point in life will be the recipient of medical care and has the possibility of experiencing the consequences of medical error. The consideration of human error in medicine is important because of the number of people that are affected, the problems incurred by such error, and the societal impact of such problems. The cost of those consequences to the individuals involved in medical error, both in the health care providers' concern and the patients' emotional and physical pain, the cost of care to alleviate the consequences of the error, and the cost to society in dollars and in lost personal contributions, mandates consideration of ways to reduce the likelihood of human error in medicine. The chapters were written by leaders in a variety of fields, including psychology, medicine, engineering, cognitive science, human factors, gerontology, and nursing. Their experience was gained through actual hands-on provision of medical care and/or research into factors contributing to error in such care. Because of the experience of the chapter authors, their systematic consideration of the issues in this book affords the reader an insightful, applied approach to human error in medicine -- an approach fortified by academic discipline.
Usability Testing of Medical Devices by Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic Pdf
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 by Mary Beth Privitera Pdf
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
National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Health Care Services,Committee on Diagnostic Error in Health Care
Author : National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Health Care Services,Committee on Diagnostic Error in Health Care Publisher : National Academies Press Page : 473 pages File Size : 51,8 Mb Release : 2015-12-29 Category : Medical ISBN : 9780309377720
Improving Diagnosis in Health Care by National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Health Care Services,Committee on Diagnostic Error in Health Care Pdf
Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.
Humanizing Healthcare – Human Factors for Medical Device Design by Russell J. Branaghan,Joseph S. O’Brian,Emily A. Hildebrand,L. Bryant Foster Pdf
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.
National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care Publisher : National Academies Press Page : 322 pages File Size : 46,6 Mb Release : 2010-11-14 Category : Medical ISBN : 9780309156295
The Role of Human Factors in Home Health Care by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care Pdf
The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Identifying, Understanding, and Communicating Medical Device Use Errors: Observations from an FDA Pilot Program by Anonim Pdf
The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe use; guide manufacturers to improve design, labeling, and training to address known risks; and guide users to make smart decisions about the acquisition and introduction of new technology. To identify the risks associated with medical devices, FDA has begun development of a device error reporting system, the Medical Product Surveillance Network (MedSun). The purpose of MedSun is to rapidly detect and understand previously unknown and serious problems, particularly close-call events. The heart of MedSun is its relationships with a relatively small, specifically trained and motivated group of workers who are focused on identifying device-related issues. This allows FDA to quickly react to the potential problems and identify the causes, contributing factors, and magnitude of a new risk. MedSun also serves as a virtual laboratory for problem research by focusing on certain devices, units, and users. This provides FDA with a better understanding of device problems, especially the human factors issues. This paper describes the development, implementation, and progress of the MedSun program.
Author : World Health Organization Publisher : World Health Organization Page : 147 pages File Size : 50,5 Mb Release : 2010 Category : Medical ISBN : 9789241564045
Designing for Safe Use by Michael Wiklund,Jonathan Kendler,Jon Tilliss,Cory Costantino,Kimmy Ansems,Valerie Ng,Ruben Post,Brenda van Geel,Rachel Aronchick,Alix Dorfman Pdf
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 Error and Patient Safety by George A. Peters,Barbara J. Peters Pdf
A difficult and recalcitrant phenomenon, medical error causes pervasive and expensive problems in terms of patient injury, ineffective treatment, and rising healthcare costs. Simple heightened awareness can help, but it requires organized, effective remedies and countermeasures that are reasonable, acceptable, and adaptable to see a truly significant drop in the intolerable rate of medical mistakes. Only with better understanding, knowledge, and directed techniques can there be rapid and marked improvement in medical error management discipline. Since medical error is situation specific and involves diverse variables in equipment, environment, and human performance, the correct choice of preventive and corrective techniques is critical. Providing a wealth of useful ideas, concepts, and techniques, Medical Error and Patient Safety: Human Factors in Medicine uses abroad perspective to present more than 500 remedies that can be applied and tailored to your unique circumstances. This detailed review of so many measures enables you to correctly identify needs and undertake appropriate actions to achieve a success that can be measured in avoided injuries, improved healthcare, and reduced cost. Thought provoking and useful, this book considers the potential for error and the possibility for improvement in every aspect of healthcare. After an introduction to general concepts and approaches, it examines vulnerabilities in medical services, including emergency services, healthcare facilities, and infection control. It covers risks in medical devices and product design; human factors such as fatigue and stress; management errors; errors in communication at all levels of the healthcare hierarchy; as well as mistakes in drug delivery including faulty labels and warnings. The authors also compare and contrast several analytical methods, their interpretation, and their translation into a plan of action.
Human Reliability And Error In Medical System by B S Dhillon Pdf
Human reliability and error have become a very important issue in health care, owing to the vast number of associated deaths each year. For example, according to the findings of the Institute of Medicine in 1999, around 100000 Americans die each year because of human error. This makes human error in health care the eighth leading cause of deaths in the US. Moreover, the total annual national cost of the medical errors is estimated at between $17 billion and $37.6 billion.There are very few books on this subject, and none of them covers it at a significant depth. The need for a book presenting the basics of human reliability, human factors and comprehensive information on error in medical systems is essential. This book meets that need.
Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors
Author : Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors Publisher : National Academies Press Page : 481 pages File Size : 43,9 Mb Release : 2007-01-11 Category : Medical ISBN : 9780309101479
Preventing Medication Errors by Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors Pdf
In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.
