Medical Device Reliability and Associated Areas

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 9781420042238
Release Date: 2000-03-29
Genre: Technology & Engineering

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

Six Sigma for Medical Device Design

Author: Jose Justiniano
Publisher: CRC Press
ISBN: 9780203485743
Release Date: 2004-11-15
Genre: Technology & Engineering

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field. Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

Reliability Technology Human Error and Quality in Health Care

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420065599
Release Date: 2008-02-21
Genre: Technology & Engineering

The effective and interrelated functioning of system reliability technology, human factors, and quality play an important role in the appropriate, efficient, and cost-effective delivery of health care. Simply put, it can save you time, money, and more importantly, lives. Over the years a large number of journal and conference proceedings articles on these topics have been published, but there are only a small number of books written on each individual topic, and virtually none that brings the pieces together into a unified whole.

Reliable Design of Medical Devices Third Edition

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9781439894941
Release Date: 2016-04-19
Genre: Medical

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Applied Reliability and Quality

Author: Balbir S. Dhillon
Publisher: Springer Science & Business Media
ISBN: 9781846284984
Release Date: 2007-02-23
Genre: Technology & Engineering

Each industry, from robotics to health care, power generation to software, has its own tailored reliability and quality principles, methods, and procedures. This book brings these together so that reliability and quality professionals can more easily learn about each other's work, which may help them, directly or indirectly, to perform their tasks more effectively.

Design Reliability

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 1420050141
Release Date: 1999-06-18
Genre: Technology & Engineering

As engineering systems become more and more complex, industry has recognized the importance of system and product reliability and places ever increasing emphasis on it during the design phase. Despite its efforts, however, industry continues to lose billions of dollars each year because of unexpected system failures. Therefore, it becomes increasingly important for designers and engineers to have a solid grounding in reliability engineering and keep abreast of new developments and research results.

Safety and Reliability in Pediatrics An Issue of Pediatric Clinics E Book

Author: Brian Jacobs
Publisher: Elsevier Health Sciences
ISBN: 9781455747399
Release Date: 2012-11-14
Genre: Medical

The Guest Editors have assembled an international list of top experts to present the most current information to pediatricians about patient safety. The issue has a primarily clinical focus with a few articles addressing the business and practice of patient safety. Articles are devoted to the following topics: Developing performance standards and expectations for safety; The role of CPOE in patient safety; The role of smart infusion pumps on patient safety; Abstracted detection of adverse events in children; The role of effective communication (including handoffs) in patient safety; Reducing mortality resulting from adverse events; Optimizing standardization of case reviews (morbidity and mortality rounds) to promote patient safety; Impact of (resident) duty work hours on patient safety; Role of simulation in safety; The role of diagnostic errors in patient safety; The role of collaborative efforts to reduce hospital acquired conditions; Patient safety in ambulatory care; Role of FDA and pediatric safety; and Patient safety through the eyes of a parent.

Durability and Reliability of Medical Polymers

Author: Mike Jenkins
Publisher: Elsevier
ISBN: 9780857096517
Release Date: 2012-08-13
Genre: Technology & Engineering

Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers. Part one provides a review of the types and properties of bioresorbable medical polymers. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. Transport phenomena and the degradation of bioresorbable medical polymers are reviewed, before an exploration of synthetic bioresorbable polymers and their use in orthopaedic tissue regeneration. Part two goes on to explore the durability and reliability of non-bioresorbable medical polymers, and wear processes in polymer implants and ageing processes of biomedical polymers in the body are discussed in depth, before an investigation into manufacturing defects and the failure of synthetic polymeric medical devices. With its distinguished editors and international team of expert contributors, Durability and reliability of medical polymers is an essential tool for all materials scientists, researchers and engineers involved in the design, development and application of medical polymers, whilst also providing a helpful overview of the subject for biologists, chemist and clinicians. Comprehensively examines the performance of both bioresorbable and non-bioresorbable medical polymers Discusses the processing of bioresorbable and other polymers for medical applications, before reviewing the degradation of bioresorbable medical polymers Explores the durability and reliability of non-bioresorbable medical polymers and discusses wear processes in polymer implants and ageing processes of biomedical polymers in the body

Medical Devices

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241564045
Release Date: 2010
Genre: Medical

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Human Reliability and Error in Medical System

Author: Balbir S. Dhillon
Publisher: World Scientific
ISBN: 9789812795236
Release Date: 2003
Genre: Biomedical engineering

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.

Safety and Human Error in Engineering Systems

Author: B.S. Dhillon
Publisher: CRC Press
ISBN: 9781466506954
Release Date: 2012-07-05
Genre: Technology & Engineering

In an approach that combines coverage of safety and human error into a single volume, Safety and Human Error in Engineering Systems eliminates the need to consult many different and diverse sources for those who need information about both topics. The book begins with an introduction to aspects of safety and human error and a discussion of mathematical concepts that builds understanding of the material presented in subsequent chapters. The author describes the methods that can be used to perform safety and human error analysis in engineering systems and includes examples, along with their solutions, as well as problems to test reader comprehension. He presents a total of ten methods considered useful for performing safety and human error analysis in engineering systems. The book also covers safety and human error transportation systems, medical systems, and mining equipment as well as robots and software. Nowadays, engineering systems are an important element of the world economy as each year billions of dollars are spent to develop, manufacture, and operate various types of engineering systems around the globe. A rise in accidental deaths has put the spotlight on the role human error plays in the safety and failure of these systems. Written by an expert in various aspects of healthcare, engineering management, design, reliability, safety, and quality, this book provides tools and techniques for improving engineering systems with respect to human error and safety.