Medical Device Use Error

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1498705804
Format: PDF, ePub, Docs
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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
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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
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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, ePub
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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.

Usability Testing of Medical Devices Second Edition

Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Format: PDF, ePub, Mobi
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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 Investigation and Effective CAPA Systems Second Edition

Author: José Rodríguez-Pérez
Publisher: ASQ Quality Press
ISBN: 0873899261
Format: PDF, Kindle
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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.

Patient Safety

Author: Robert J. Latino
Publisher: CRC Press
ISBN: 9781420087284
Format: PDF
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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

Human Reliability and Error in Medical System

Author: B S Dhillon
Publisher: World Scientific
ISBN: 9814486086
Format: PDF
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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 MathematicsHuman Factors BasicsHuman Reliability and Error BasicsMethods for Performing Human Reliability and Error Analysis in Health Care SystemHuman Error in MedicationHuman Error in AnesthesiaHuman Error in Miscellaneous Health Care Areas and Health Care Human Error CostHuman Factors in Medical DevicesMathematical Models for Predicting Human Reliability and Error in Medical SystemHealth Care Human Error Reporting Systems and DataAppendix: 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. Keywords:Healthcare;Medical System;Human Error;Human Reliability;Medical DevicesReviews:“The book is interesting and easy to read, with concrete data from major studies conducted over the last 20 years, and an extensive bibliography that makes it a very useful tool for a large audience of healthcare professionals. It is also recommended as a very good teaching aid in Biomedical Engineering graduate and post-graduate programs.”International Federation for Medical & Biological Engineering News

Patient Safety

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1439873860
Format: PDF, ePub
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With unintended harm during hospital care costing billions of dollars to the world economy, not to mention millions of deaths each year, it’s no wonder the issue is equally front and center in the minds of healthcare providers and the public. Although the issue has been tackled in journal articles and conference proceedings, there are very few books on the topic. And none consider how methods and techniques developed in the area of engineering can handle safety and human error-related problems. Until now. Written by an expert with vast know-how in engineering management, design, reliability, safety, and quality, Patient Safety: An Engineering Approach brings together the pertinent information scattered throughout books and journals, eliminating the need to consult many different and diverse sources to find what you need. B.S. Dhillon draws on his real-world experience to demonstrate how to handle patient safety-related problems using engineering techniques and backs this up with references for further reading at the end of each chapter. He sets the stage with introductory chapters on mathematical, patient safety, and human factors concepts essential to understanding materials presented in subsequent chapters. Dhillon’s clear, concise discussion of the topics presents the information in such a way that no previous knowledge is required to understand the contents, yet he does not present it at a merely rudimentary level. He brings a fresh approach and engineering perspective to the issues, giving you a new tool kit for performing patient safety-related analysis, designing better medical systems/devices, and handling patient safety-related problems from an engineering perspective.

Safe Medical Devices for Children

Author: Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher: National Academies Press
ISBN: 0309096316
Format: PDF, ePub, Docs
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Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.