Medical Device Use Error

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1498705804
Format: PDF
Download Now
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.

Medical Device Use Error

Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 9781498705790
Format: PDF, Docs
Download Now
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).

Usability Testing of Medical Devices Second Edition

Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Format: PDF, ePub, Docs
Download Now
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 have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Handbook of Human Factors in Medical Device Design

Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 9781420063516
Format: PDF, Mobi
Download Now
Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.

Handbook of Investigation and Effective CAPA Systems Second Edition

Author: José Rodríguez-Pérez
Publisher: ASQ Quality Press
ISBN: 0873899261
Format: PDF, ePub, Docs
Download Now
Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

Human Reliability and Error in Medical System

Author: Balbir S. Dhillon
Publisher: World Scientific
ISBN: 9812795235
Format: PDF
Download Now
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. Contents: Human Reliability and Error Mathematics; Human Factors Basics; Human Reliability and Error Basics; Methods for Performing Human Reliability and Error Analysis in Health Care System; Human Error in Medication; Human Error in Anesthesia; Human Error in Miscellaneous Health Care Areas and Health Care Human Error Cost; Human Factors in Medical Devices; Mathematical Models for Predicting Human Reliability and Error in Medical System; Health Care Human Error Reporting Systems and Data; Appendix: Bibliography: Literature on Human Reliability and Error in Health Care. Readership: Health care and safety professionals, administrators, students, human-factors/psychology specialists, biomedical engineers and health care researchers.

Medical Device Software Verification Validation and Compliance

Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Format: PDF, Docs
Download Now
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

Patient Safety

Author: Robert J. Latino
Publisher: CRC Press
ISBN: 9781420087284
Format: PDF, ePub, Docs
Download Now
Are you ready and willing to get to the root causes of problems? As Medicare, Medicaid, and major insurance companies increasingly deny payment for never events, it has become imperative that hospitals and doctors develop new ways to prevent these avoidable catastrophes from recurring. Proactive tools such as root cause analysis (RCA), basic failure mode and effects analysis (FMEA), and opportunity analysis (OA) are useful in preventing error, but in healthcare, such tools are often constrained by reticence to share information about mistakes and other problems inherent to the industry. ...well written and extremely applicable to health care. Every healthcare professional should have a copy. - Matthew C. Mireles, President / CEO, Community Medical Foundation for Patient Safety, Bellaire, Texas Patient Safety: The PROACT® Root Cause Analysis Approach addresses the proactive methodologies and organizational paradigms that must change in order to support and sustain such activities in the interest of patient safety. Written by reliability expert Robert J. Latino, this book provides a perspective on patient care from outside the health industry and culture. It teaches a proven approach that measures its effectiveness based on patient safety results, rather than compliance, and demonstrates the Return-On-Investment for using RCA to reduce and/or eliminate undesirable outcomes. Addressing the contribution of human error to physical consequences, Latino explores ways to identify conditions that are more prone to result in human error. It also uses FMEA to proactively identify unacceptable risks, and then uses the concepts of RCA to prevent risks from materializing. Are you ready to be tenacious in your approach and completely honest in your assessment? Root Cause Analysis requires courage and honesty. When properly applied RCA will point out the problems and lead you to solutions. Visit the author's website; find out if RCA is right for your organization Robert J. Latino has spent the past 10 years researching the differences in industrial culture versus the healthcare culture. In this book, he expertly makes the appropriate modifications to proven methodologies to successfully bridge the proactive technologies from industry to healthcare. Additional information, including an audio-visual presentation by the author, is available on the PROACT website at http://www.proactforhealthcare.com

To Err Is Human

Author: Committee on Quality of Health Care in America
Publisher: National Academies Press
ISBN: 0309068371
Format: PDF
Download Now
Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDS--three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequence--but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda--with state and local implications--for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors--which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health care--it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates--as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine

Medication Errors

Author: Michael Richard Cohen
Publisher: American Pharmacist Associa
ISBN: 1582120927
Format: PDF
Download Now
In the second, expanded edition of the acclaimedMedication Errors(1999), Michael R. Cohen brings together some 30 experts from pharmacy, medicine, nursing, and risk management to provide the best, most current thinking about medication errors. Their contributions make this the most comprehensive, authoritative examination in print of the causes of medication errors and strategies to prevent them.Medication Errorsprovides the health care communityacute care, long-term care, ambulatory care, the pharmaceutical industry, regulatory affairs, and academiawith practical guidance to make patients who take or receive medications safer.