Medical Device Use Error

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

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

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 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

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.

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.