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Medical Device Reliability and Associated Areas by B.S. Dhillon Pdf
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,
Medical Device Reliability and Associated Areas by B.S. Dhillon Pdf
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.
Reliable Design of Medical Devices by Richard C. Fries Pdf
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
Biomaterials in the Design and Reliability of Medical Devices by Michael N. Helmus Pdf
This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.
Reliable Design of Medical Devices, Third Edition by Richard C. Fries Pdf
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.
Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Reliability and Maintenance of Medical Devices by Sharareh Taghipour Pdf
For decades, reliability engineering techniques have been successfully applied in many industries to improve the performance of equipment maintenance management. Numerous inspection and optimization models are developed and widely used to achieve maintenance excellence, i.e. the balance of performance, risk, resources and cost to reach to an optimal solution. However, the application of all these techniques and models to medical devices is new. Hospitals, due to possessing a large number of difference devices, can benefit significantly if the optimization techniques are used properly in the equipment management processes. Most research in the area of reliability engineering for medical equipment mainly considers the devices in their design or manufacturing stage and suggests some techniques to improve the reliability. To this point, best maintenance strategies for medical equipment in their operating context have not been considered.We aim to address this gap and propose methods to improve current maintenance strategies in the healthcare industry. More specifically, we first identify or propose the criteria which are important to assess the criticality of medical devices, and propose a model for the prioritization of medical equipment for maintenance decisions. The model is a novel application of multi-criteria decision making methodology to prioritize medical devices in a hospital according to their criticality. The devices with high level of criticality should be included in the hospital's maintenance management program.Then, we propose a method to statistically analyze maintenance data for complex medical devices with censoring and missing information. We present a classification of failure types and establish policies for analyzing data at different levels of the device. Moreover, a new method for trend analysis of censored failure data is proposed. A novel feature of this work is that it considers dependent failure histories which are censored by inspection intervals. Trend analysis of this type of data has not been discussed in the literature.Finally, we introduce some assumptions based on the results of the analysis, and develop several new models to find the optimal inspection interval for a system subject to hard and soft failures. Hard failures are instantaneously revealed and fixed. Soft failures are only rectified at inspections. They do not halt the system, although they reduce its performance or productivity. The models are constructed for two main cases with the assumption of periodic inspections, and periodic and opportunistic inspections, respectively. All numerical examples and case studies presented in the dissertation are adapted from the maintenance data received from a Canadian hospital.
Reliability Technology, Human Error, and Quality in Health Care by B.S. Dhillon Pdf
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.
Handbook of Medical Device Design by Richard C. Fries Pdf
First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf
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
Applied Reliability, Usability, and Quality for Engineers by B.S. Dhillon Pdf
Global competition is forcing reliability and other professionals to work closely during the product design and manufacturing phase. Because of this collaboration, reliability, usability, and quality principles are being applied across many diverse sectors of the economy. This book offers the principles, methods, and procedures for these areas in one resource. This book brings together the areas of reliability, usability, and quality for those working in diverse areas to allow them to be exposed to activities that can help them perform their tasks more effectively. This is the only book that covers these areas together in this manner and written in such a way that no previous knowledge is required to understand it. The sources of the material presented are included in the reference section at the end of each chapter along with examples and solutions to test reader comprehension. Applied Reliability, Usability, and Quality for Engineers is useful to design, manufacturing, and systems engineers, as well as manufacturing managers, reliability, usability and, quality specialists. It can also be helpful to graduate, senior undergraduate students, and instructors.
Reliable Design of Medical Devices by Richard C. Fries Pdf
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 D
Author : World Health Organization Publisher : World Health Organization Page : 147 pages File Size : 53,6 Mb Release : 2010 Category : Medical ISBN : 9789241564045
Applied Reliability for Engineers by B.S. Dhillon Pdf
Engineering systems and products are an important element of the world economy and each year billions of dollars are spent to develop, manufacture, operate, and maintain systems and products around the globe. Because of this, global competition is requiring reliability professionals to work closely with other departments involved in engineering development during the product design and manufacturing phase. Applied Reliability for Engineers is an attempt to meet the need for a single volume that addresses a wide range of applied reliability topics. The material is treated in such a manner that the reader will require no previous knowledge to understand the text. The sources of most of the information presented are given in a reference section at the end of each chapter. At appropriate places, the book contains examples along with their solutions. At the end of each chapter there are numerous problems to test reader comprehension. This volume is thus suitable for use as a textbook as well as for reference. Applied Reliability for Engineers is useful to design professionals, system engineers, reliability specialists, graduate and senior undergraduate students, researchers and instructors of reliability engineering, and engineers-at-large.
