Reliability And Maintenance Of Medical Devices

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Reliability and Maintenance of Medical Devices

Author : Sharareh Taghipour
Publisher : Unknown
Page : 668 pages
File Size : 54,9 Mb
Release : 2011
Category : Electronic
ISBN : 0494776536

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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.

Medical Device Reliability and Associated Areas

Author : B.S. Dhillon
Publisher : CRC Press
Page : 265 pages
File Size : 41,6 Mb
Release : 2000-03-29
Category : Business & Economics
ISBN : 9781420042238

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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,

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 51,6 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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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.

Medical Equipment Maintenance

Author : Binseng Wang
Publisher : Springer Nature
Page : 76 pages
File Size : 55,6 Mb
Release : 2022-05-31
Category : Technology & Engineering
ISBN : 9783031016554

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Medical Equipment Maintenance by Binseng Wang Pdf

In addition to being essential for safe and effective patient care, medical equipment also has significant impact on the income and, thus, vitality of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand all of the relevant factors. This book presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance against equivalent performance levels at similar organizations. The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge. Table of Contents: Introduction / Regulatory Framework / Core Functions of Medical Equipment Maintenance and Management / CE Department Management / Performance Management / Discussion and Conclusions

Medical Equipment Maintenance

Author : Binseng Wang
Publisher : Morgan & Claypool Publishers
Page : 88 pages
File Size : 47,9 Mb
Release : 2012
Category : Medical
ISBN : 9781627050562

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Medical Equipment Maintenance by Binseng Wang Pdf

Presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance.

Evidence-Based Maintenance of Medical Equipment

Author : Binseng Wang
Publisher : Unknown
Page : 206 pages
File Size : 48,6 Mb
Release : 2019-09-29
Category : Electronic
ISBN : 169600540X

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Evidence-Based Maintenance of Medical Equipment by Binseng Wang Pdf

Instead of blindly following manufacturers' maintenance recommendations, Clinical Engineering (CE), also known as Health Technology Management (HTM), professionals can use a method similar to Evidence-Based Medicine to keep medical equipment safe and reliable while using judiciously their limited resources. Evidence-Based Maintenance (EBM) analyzes the causes of equipment failures and uses these results to continually improve maintenance. EBM is particularly suited for those who want to take advantage of the Alternate Equipment Management (AEM) program allowed by the Centers for Medicare & Medicaid Services (CMS) because it allows comparison of different maintenance strategies and provides concrete evidence to prove the safety and effectiveness of the AEM program adopted.

Inspection of Medical Devices

Author : Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić
Publisher : Springer Nature
Page : 441 pages
File Size : 43,8 Mb
Release : 2023-12-28
Category : Technology & Engineering
ISBN : 9783031434440

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Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf

This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania

Author : Simona Vlad,Nicolae Marius Roman
Publisher : Springer
Page : 367 pages
File Size : 43,6 Mb
Release : 2017-03-15
Category : Technology & Engineering
ISBN : 9783319528755

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International Conference on Advancements of Medicine and Health Care through Technology; 12th - 15th October 2016, Cluj-Napoca, Romania by Simona Vlad,Nicolae Marius Roman Pdf

This volume presents the contributions of the fifth International Conference on Advancements of Medicine and Health Care through Technology (Meditech 2016), held in in Cluj-Napoka, Romania. The papers of this Proceedings volume present new developments in - Health Care Technology, - Medical Devices, Measurement and Instrumentation, - Medical Imaging, Image and Signal Processing, - Modeling and Simulation, - Molecular Bioengineering, - Biomechanics.

Reliability, Quality, and Safety for Engineers

Author : B.S. Dhillon
Publisher : CRC Press
Page : 238 pages
File Size : 49,7 Mb
Release : 2004-11-15
Category : Business & Economics
ISBN : 9780203006139

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Reliability, Quality, and Safety for Engineers by B.S. Dhillon Pdf

Due to global competition, safety regulations, and other factors, manufacturers are increasingly pressed to create products that are safe, highly reliable, and of high quality. Engineers and quality assurance professionals need a cross-disciplinary understanding of these topics in order to ensure high standards in the design and manufacturing proce

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
Page : 501 pages
File Size : 47,5 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439894941

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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

Biomaterials in the Design and Reliability of Medical Devices

Author : Michael N. Helmus
Publisher : Springer Science & Business Media
Page : 240 pages
File Size : 47,8 Mb
Release : 2003-01-31
Category : Technology & Engineering
ISBN : 0306476908

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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.

Quality, Reliability and Maintenance 2004

Author : G. J. McNulty
Publisher : John Wiley & Sons
Page : 360 pages
File Size : 40,6 Mb
Release : 2004-05-21
Category : Technology & Engineering
ISBN : 1860584403

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Quality, Reliability and Maintenance 2004 by G. J. McNulty Pdf

The papers included in this volume were presented at the 5th international conference on Quality, Reliability and Maintenance which took place at the University of Oxford in April 2004. They highlight the importance of the QRM disciplines and represent the latest developments, trends and progress, and are essential reference material for all reasearch academics, quality planners, maintenance executives and personnel who have the responsibility to implement the findings of quality audits and maintenance policy. Quality, Reliabilty, and Maintenance - be it in industry, commerce, education, or academia - influences and guides every contemporary aspect of our lives. This collection of papers includes topics such as: Quality Analysis Condition Monitoring Maintenance Management Computer Applications Education and Training Research Applications

Case Studies in Reliability and Maintenance

Author : Wallace R. Blischke,D. N. Prabhakar Murthy
Publisher : John Wiley & Sons
Page : 691 pages
File Size : 47,5 Mb
Release : 2003-03-27
Category : Mathematics
ISBN : 9780471458739

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Case Studies in Reliability and Maintenance by Wallace R. Blischke,D. N. Prabhakar Murthy Pdf

Introducing a groundbreaking companion book to a bestselling reliability text Reliability is one of the most important characteristics defining the quality of a product or system, both for the manufacturer and the purchaser. One achieves high reliability through careful monitoring of design, materials and other input, production, quality assurance efforts, ongoing maintenance, and a variety of related decisions and activities. All of these factors must be considered in determining the costs of production, purchase, and ownership of a product. Case Studies in Reliability and Maintenance serves as a valuable addition to the current literature on the subject of reliability by bridging the gap between theory and application. Conceived during the preparation of the editors' earlier work, Reliability: Modeling, Prediction, and Optimization (Wiley, 2000), this new volume features twenty-six actual case studies written by top experts in their fields, each illustrating exactly how reliability models are applied. A valuable companion book to Reliability: Modeling, Prediction, and Optimization, or any other textbook on the subject, the book features: * Case studies from fields such as aerospace, automotive, mining, electronics, power plants, dikes, computer software, weapons, photocopiers, industrial furnaces, granite building cladding, chemistry, and aircraft engines * A logical organization according to the life cycle of a product or system * A unified format of discussion enhanced by tools, techniques, and models for drawing one's own conclusions * Pertinent exercises for reinforcement of ideas Of equal value to both students of reliability theory as well as professionals in industry, Case Studies in Reliability and Maintenance should be required reading for anyone seeking to understand how reliability and maintenance issues can be addressed and resolved in the real world.

The Competitive Edge

Author : National Research Council,Division on Engineering and Physical Sciences,Board on Manufacturing and Engineering Design,Commission on Engineering and Technical Systems,Committee on Analysis of Research Directions and Needs in U.S. Manufacturing
Publisher : National Academies Press
Page : 185 pages
File Size : 55,9 Mb
Release : 1991-02-01
Category : Technology & Engineering
ISBN : 9780309047845

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The Competitive Edge by National Research Council,Division on Engineering and Physical Sciences,Board on Manufacturing and Engineering Design,Commission on Engineering and Technical Systems,Committee on Analysis of Research Directions and Needs in U.S. Manufacturing Pdf

To maintain competitiveness in the emerging global economy, U.S. manufacturing must rise to new standards of product quality, responsiveness to customers, and process flexibility. This volume presents a concise and well-organized analysis of new research directions to achieve these goals. Five critical areas receive in-depth analysis of present practices, needed improvement, and research priorities: Advanced engineered materials that offer the prospect of better life-cycle performance and other gains. Equipment reliability and maintenance practices for better returns on capital investment. Rapid product realization techniques to speed delivery to the marketplace. Intelligent manufacturing control for improved reliability and greater precision. Building a workforce with the multidisciplinary skills needed for competitiveness. This sound and accessible analysis will be useful to manufacturing engineers and researchers, business executives, and economic and policy analysts.

Medical Device Regulations

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 45,8 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.