Medical Device Use Error

Root Cause Analysis

Author: Michael Wiklund,Andrea Dwyer,Erin Davis

Publisher: CRC Press

ISBN: 1498705804

Category: Technology & Engineering

Page: 245

View: 6604

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

Root Cause Analysis

Author: Michael E. Wiklund,Andrea M. Dwyer,Erin Davis

Publisher: CRC Press

ISBN: 9781498705790

Category: Medical

Page: 224

View: 8910

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.,Jonathan Kendler,Allison Y. Strochlic

Publisher: CRC Press

ISBN: 1466595892

Category: Medical

Page: 455

View: 1215

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,Michael E. Wiklund,Daryle Jean Gardner-Bonneau

Publisher: CRC Press

ISBN: 9781420063516

Category: Technology & Engineering

Page: 844

View: 9629

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.,Jonathan Kendler,Allison Y. Strochlic

Publisher: CRC Press

ISBN: 1466595892

Category: Medical

Page: 455

View: 8527

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

Category: Business & Economics

Page: 234

View: 3642

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

The PROACT Root Cause Analysis Approach

Author: Robert J. Latino

Publisher: CRC Press

ISBN: 9781420087284

Category: Technology & Engineering

Page: 192

View: 3210

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

Category: Medical

Page: 232

View: 1477

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

Root Cause Analysis

Basic Tools and Techniques

Author: Denise Robitaille

Publisher: Paton Professional

ISBN: 1932828028

Category: Business & Economics

Page: 104

View: 8296


Patient Safety

Investigating and Reporting Serious Clinical Incidents

Author: Russell Kelsey

Publisher: CRC Press

ISBN: 1498781179

Category: Law

Page: 222

View: 4979

At a time of increasing regulatory scrutiny and medico-legal risk, managing serious clinical incidents within primary care has never been more important. Failure to manage appropriately can have serious consequences both for service organisations and for individuals involved. This is the first book to provide detailed guidance on how to conduct incident investigations in primary care. The concise guide explains how to recognise a serious clinical incident, how to conduct a root cause analysis investigation, and how and when duty of candour applies covers the technical aspects of serious incident recognition and report writing includes a wealth of practical advice and 'top tips', including how to manage the common pitfalls in writing reports offers practical advice as well as some new and innovative tools to help make the RCA process easier to follow explores the all-important human factors in clinical incidents in detail, with multiple examples and worked-through cases studies as well as in-depth sample reports and analysis. This book offers a master class for anyone performing RCA and aiming to demonstrate learning and service improvement in response to serious clinical incidents. It is essential reading for any clinical or governance leads in primary care, including GP practices, 'out-of-hours', urgent care centres, prison health and NHS 111. It also offers valuable insights to any clinician who is in training or working at the coal face who wishes to understand how serious clinical are investigated and managed.

Medication Errors

Author: Michael Richard Cohen

Publisher: American Pharmacist Associa

ISBN: 1582120927

Category: Medical

Page: 680

View: 4738

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.

Behind Human Error

Author: Dr Leila Johannesen,Dr Nadine Sarter,Dr Richard Cook,Professor Sidney Dekker,Professor David D Woods

Publisher: Ashgate Publishing, Ltd.

ISBN: 1409486389

Category: Technology & Engineering

Page: 292

View: 7641

Human error is so often cited as a cause of accidents. There is perception of a 'human error problem'. Solutions are thought to lie in changing the people or their role. The label 'human error', however, is prejudicial and hides more than it reveals about how a system malfunctions. This book takes you behind the label. It explains how human error results from social and psychological judgments by the system's stakeholders that focus only on one facet of a set of interacting contributors.

Patient Safety

An Engineering Approach

Author: B.S. Dhillon

Publisher: CRC Press

ISBN: 1439873860

Category: Technology & Engineering

Page: 234

View: 8089

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.

Medical Device Software Verification, Validation and Compliance

Author: David A. Vogel

Publisher: Artech House

ISBN: 1596934239

Category: Biomedical engineering

Page: 444

View: 8488

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."

Root Cause Analysis

The Core of Problem Solving and Corrective Action

Author: Duke Okes

Publisher: ASQ Quality Press

ISBN: 0873897641

Category: Business & Economics

Page: 200

View: 7061

This book provides detailed steps for how to solve problems, focusing heavily on the analytical process involved in finding the actual causes of problems. It does so using a large number of figures, diagrams, and tools useful for helping make our thinking visible. The primary focus is on solving repetitive problems, rather than performing investigations for major incidents/accidents. Most of the terminology used is everyday language and can be used for both workplace and personal applications. Many of the examples will involve situations with which the reader will likely be familiar. The focus of the book is not on statistics but instead on the logic of finding causes. It has sometimes been described in training workshops as “Six Sigma lite”…problem solving without the all the heavy statistics.

To Err Is Human:

Building a Safer Health System

Author: Committee on Quality of Health Care in America,Institute of Medicine

Publisher: National Academies Press

ISBN: 0309068371

Category: Medical

Page: 312

View: 1280

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

Patient Safety Workshop

Learning from Error

Author: World Health Organization

Publisher: N.A

ISBN: 9789241599023

Category: Medical

Page: 28

View: 2878

This booklet which includes a CD-ROM should enable any health-care worker to facilitate a workshop on patient safety. This workshop explores how multiple weaknesses present within the hospital system can lead to error. It aims to provide all health-care workers and managers with an insight into the underlying cause of such events. Although the workshop materials revolve around an error involving the inappropriate administration of vincristine, the underlying principles of why an error occurs are universal and the learning objectives can be applied in any error-related situation.

Patient Safety

Achieving a New Standard for Care

Author: Committee on Data Standards for Patient Safety,Board on Health Care Services,Institute of Medicine

Publisher: National Academies Press

ISBN: 0309529328

Category: Medical

Page: 501

View: 8540

Americans should be able to count on receiving health care that is safe. To achieve this, a new health care delivery system is needed — a system that both prevents errors from occurring, and learns from them when they do occur. The development of such a system requires a commitment by all stakeholders to a culture of safety and to the development of improved information systems for the delivery of health care. This national health information infrastructure is needed to provide immediate access to complete patient information and decision-support tools for clinicians and their patients. In addition, this infrastructure must capture patient safety information as a by-product of care and use this information to design even safer delivery systems. Health data standards are both a critical and time-sensitive building block of the national health information infrastructure. Building on the Institute of Medicine reports To Err Is Human and Crossing the Quality Chasm, Patient Safety puts forward a road map for the development and adoption of key health care data standards to support both information exchange and the reporting and analysis of patient safety data.

Biodesign

The Process of Innovating Medical Technologies

Author: Stefanos Zenios,Josh Makower,Paul Yock

Publisher: Cambridge University Press

ISBN: 0521517427

Category: Medical

Page: 742

View: 510

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Medication Safety

A Guide for Health Care Facilities

Author: Henri Richard Manasse,Kasey K. Thompson

Publisher: ASHP

ISBN: 1585280895

Category: Medical

Page: 380

View: 4955

Medication safety is the most challenging goal for pharmacy practice and patient safety professionals in all health care facilities.