Medical Device Use Error: Root Cause Analysis

Medical Device Use Error: Root Cause Analysis

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Medical Device Use Error: Root Cause Analysis

by Michael Wiklund, Andrea Dwyer, Erin Davis

Medical Device Use Error: Root Cause Analysis is a comprehensive guide that 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. Written by Michael Wiklund, Andrea Dwyer, and Erin Davis, this book covers both medical devices used in the home and those used in clinical environments. With informative case studies and design-based preventions, the authors provide valuable insights on how to improve the safety and effectiveness of medical devices. Whether you are a human factors specialist, a product development professional, or simply interested in understanding medical device errors, this book is a must-read resource.

The field of medical devices is constantly evolving with new technologies and advancements. However, safety concerns related to the use of these devices are still prevalent. Use errors can have serious consequences, ranging from minor inconveniences to life-threatening situations. It is essential for manufacturers and healthcare professionals to understand the root causes of these errors to address them effectively. This book offers a systematic method for analyzing medical device use errors and provides guidance on how to prevent them.

One of the key aspects of this book is its focus on root cause analysis. The authors explain the fundamentals and language of root cause analysis, as well as regulators’ expectations regarding the thorough analysis of use errors. They provide practical strategies for identifying use errors and conducting interviews with users to gather valuable insights. Additionally, the book emphasizes the importance of user interface design and how flaws in design can induce use errors. By understanding and addressing these design flaws, manufacturers can significantly reduce the occurrence of use errors.

The book also highlights the role of human factors engineering in preventing medical device errors. It covers best practices in conducting both formative and summative usability tests to ensure that medical devices are designed with the user in mind. By involving users throughout the design and development process, manufacturers can address potential use errors early on and make necessary improvements.

With clear illustrations and simple narrative explanations, Medical Device Use Error: Root Cause Analysis offers a comprehensive approach to understanding and preventing use errors in medical devices. The authors provide real-life case studies that demonstrate the potential consequences of use errors and the importance of design-based preventions. By learning from these case studies, readers can gain valuable insights and apply them to their own work.

This book is not only informative but also highly practical. It provides step-by-step guidance on how to conduct root cause analysis and implement preventive measures. The authors’ expertise in the field of human factors engineering and medical device development is evident throughout the book. Their insights and recommendations are backed by research and industry best practices.

Furthermore, Medical Device Use Error: Root Cause Analysis is written in a clear and engaging manner. The authors avoid excessive technical jargon, making the book accessible to a wide range of readers. Whether you are a seasoned professional or new to the field, you will find the content easy to understand and apply to your work.

In addition to its practicality, this book also serves as a valuable reference. It covers a wide range of topics related to medical device use errors, from root cause analysis to human factors engineering. The authors provide comprehensive references and resources for further exploration, making it easy for readers to dive deeper into specific topics of interest.

If you are passionate about improving the safety and effectiveness of medical devices, Medical Device Use Error: Root Cause Analysis is a must-read. It will equip you with the knowledge and tools necessary to identify and prevent use errors. By implementing the recommendations outlined in this book, you can contribute to the development of safer and more user-friendly medical devices.

Order your copy of Medical Device Use Error: Root Cause Analysis today and join the community of professionals dedicated to improving medical device safety. This book is an essential resource for anyone involved in the design, development, and regulation of medical devices. Don’t miss out on the opportunity to enhance your understanding and make a positive impact in the field!

Product Details

    • 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
  • 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

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