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Toxicological Aspects Of Medical Device Implants
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Book Synopsis Toxicological Aspects of Medical Device Implants by : Prakash Srinivasan Timiri Shanmugam
Download or read book Toxicological Aspects of Medical Device Implants written by Prakash Srinivasan Timiri Shanmugam and published by Academic Press. This book was released on 2020-06-10 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Discusses the adverse toxicological effects of medical devices Covers a broad range of disease topics and disease specific implants Offers contributions from experts from across several disciplines
Book Synopsis Safety of Silicone Breast Implants by : Institute of Medicine
Download or read book Safety of Silicone Breast Implants written by Institute of Medicine and published by National Academies Press. This book was released on 2000-01-06 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Dow Corning case raised serious questions about the safety of silicone breast implants and about larger issues of medical device testing and patient education. Safety of Silicone Breast Implants presents a well-documented, thoughtful exploration of the safety of these devices, drawing conclusions from the available research base and suggesting further questions to be answered. This book also examines the sensitive issues surrounding women's decisions about implants. In reaching conclusions, the committee reviews: The history of the silicone breast implant and the development of its chemistry. The wide variety of U.S.-made implants and their regulation by the Food and Drug Administration. Frequency and consequences of local complications from implants. The evidence for and against links between implants and autoimmune disorders, connective tissue disease, neurological problems, silicone in breast milk, or a proposed new syndrome. Evidence that implants may be associated with lower frequencies of breast cancer. Safety of Silicone Breast Implants provides a comprehensive, well-organized review of the science behind one of the most significant medical controversies of our time.
Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Book Synopsis Degradation of Implant Materials by : Noam Eliaz
Download or read book Degradation of Implant Materials written by Noam Eliaz and published by Springer Science & Business Media. This book was released on 2012-08-21 with total page 521 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the current understanding of the mechanical, chemical and biological processes that are responsible for the degradation of a variety of implant materials. All 18 chapters will be written by internationally renowned experts to address both fundamental and practical aspects of research into the field. Different failure mechanisms such as corrosion, fatigue, and wear will be reviewed, together with experimental techniques for monitoring them, either in vitro or in vivo. Procedures for implant retrieval and analysis will be presented. A variety of biomaterials (stainless steels, titanium and its alloys, nitinol, magnesium alloys, polyethylene, biodegradable polymers, silicone gel, hydrogels, calcium phosphates) and medical devices (orthopedic and dental implants, stents, heart valves, breast implants) will be analyzed in detail. The book will serve as a broad reference source for graduate students and researchers studying biomedicine, corrosion, surface science, and electrochemistry.
Book Synopsis The Design and Manufacture of Medical Devices by : J Paulo Davim
Download or read book The Design and Manufacture of Medical Devices written by J Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device Offers a practical approach to recent developments in the design and manufacture of medical devices Presents a topic that is the focus of research in many important universities and centres of research worldwide
Book Synopsis Medical Device Regulations by : Michael Cheng
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Toxicity Testing in the 21st Century by : National Research Council
Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-11-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.
Book Synopsis Biomaterials and Medical Devices by : Ferdyansyah Mahyudin
Download or read book Biomaterials and Medical Devices written by Ferdyansyah Mahyudin and published by Springer. This book was released on 2016-02-26 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.
Book Synopsis Bio-Tribocorrosion in Biomaterials and Medical Implants by : Yu Yan
Download or read book Bio-Tribocorrosion in Biomaterials and Medical Implants written by Yu Yan and published by Elsevier. This book was released on 2013-09-30 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: During their service life, most biomaterials and medical implants are vulnerable to tribological damage. In addition, the environments in which they are placed are often corrosive. The combination of triobology, corrosion and the biological environment has been named ‘bio-tribocorrosion’. Understanding this complex phenomenon is critical to improving the design and service life of medical implants. This important book reviews recent key research in this area. After an introduction to the topography of bio-tribocorrosion, Part one discusses different types of tribocorrosion including fatigue-corrosion, fretting-corrosion, wear-corrosion and abrasion-corrosion. The book also discusses the prediction of wear in medical devices. Part two looks at biological effects on tribocorrosion processes, including how proteins interact with material surfaces and the evolution of surface changes due to bio-tribocorrosion resulting from biofilms and passive films. Part three reviews the issue of bio-tribocorrosion in clinical practice, including dental applications and joint replacement as well the use of coatings and test methods for bio-tribocorrosion. With its international team of contributors, Bio-tribocorrosion in biomaterials and medical implants is a standard reference for those researching and developing medical devices as well as clinicians in such areas as dentistry and orthopaedic surgery. Reviews recent research in bio-tribocorrosion and its role in improving the design and service life of medical implants Discusses types of bio-tribocorrosion including fatigue and wear corrosion Examines biological effects on bio-tribocorrosion processes including interaction of proteins with metal surfaces
Book Synopsis Radiologic Guide to Orthopedic Devices by : Tim B. Hunter
Download or read book Radiologic Guide to Orthopedic Devices written by Tim B. Hunter and published by Cambridge University Press. This book was released on 2017-05-11 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive reference on radiologic appearance, uses and complications of orthopedic devices, for radiologists, orthopedists, physicians, and students.
Book Synopsis Safe Medical Devices for Children by : Institute of Medicine
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Book Synopsis Metallic Biomaterials Processing and Medical Device Manufacturing by : Cuie Wen
Download or read book Metallic Biomaterials Processing and Medical Device Manufacturing written by Cuie Wen and published by Woodhead Publishing. This book was released on 2020-08-20 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering. Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization Bridges the gap between biomaterials design and medical device manufacturing Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices
Book Synopsis The Unofficial Guide to ECGs by : Ali B.A.K. Al-Hadithi
Download or read book The Unofficial Guide to ECGs written by Ali B.A.K. Al-Hadithi and published by Elsevier Health Sciences. This book was released on 2022-12-20 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: The unique and award-winning Unofficial Guides series is a collaboration between senior students, junior doctors and specialty experts. This combination of contributors understands what is essential to excel on your course, in exams and in practice – as well as the importance of presenting information in a clear, fun and engaging way. Packed with hints and tips from those in the know, when you are in a hurry and need a study companion you can trust, reach for an Unofficial Guide. The Unofficial Guide to ECGs is a straightforward yet complete guide to interpreting ECGs and easily translating this knowledge to clinical contexts. Edited by experts in cardiology, the book systematically goes through how an ECG is performed and what every part of the ECG tracing represents. It covers common conditions associated with ECG changes and explains the underlying pathophysiology of why these changes occur. An extensive collection of 40 clinical cases with fully annotated ECGs and 120 MCQs are included to allow readers to practise ECG interpretation. Primarily aimed at medical students, this new book will also be useful for all those who may need to brush up on ECGs, including junior doctors, nurses, paramedics, physicians’ associates and advanced nurse practitioners. Clearly defined and systematic structure that is accessible to new learners Explanations for every component of an ECG tracing and their changes to aid understanding and memorisation 40 cases with real-life ECGs, ranging in difficulty from beginner to advanced, and clinically-focused questions for the reader to test themselves Real-life fully annotated ECG images to clearly highlight features of ECG changes 120 MCQs with detailed explanations of correct and incorrect answers alongside annotated and unannotated ECGs A handy quick reference guide at the end of book covers ECG basics and important changes for rapid revision on the wards
Book Synopsis Polymers in Medical Applications by : B.J. Lambert
Download or read book Polymers in Medical Applications written by B.J. Lambert and published by iSmithers Rapra Publishing. This book was released on 2001 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of polymers in medical devices is growing at a steady rate. These materials are generally relatively cheap and versatile, qualities required in many bulk applications. In more specialised medical devices, polymeric components have been developed to meet challenging property and performance requirements. This review describes the process of developing polymeric products for medical applications from design requirements through to specific examples of medical devices and packaging. An additional indexed section containing several hundred abstracts from the Rapra Polymer Library database gives useful references for further reading.
Author :Mukesh G. Harisinghani Publisher :Springer Science & Business Media ISBN 13 :1441997679 Total Pages :185 pages Book Rating :4.4/5 (419 download)
Book Synopsis Atlas of Lymph Node Anatomy by : Mukesh G. Harisinghani
Download or read book Atlas of Lymph Node Anatomy written by Mukesh G. Harisinghani and published by Springer Science & Business Media. This book was released on 2012-11-27 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailed anatomic drawings and state-of-the-art radiologic images combine to produce this essential Atlas of Lymph Node Anatomy. Utilizing the most recent advances in medical imaging, this book illustrates the nodal drainage stations in the head and neck, chest, and abdomen and pelvis. Also featured are clinical cases depicting drainage pathways for common malignancies. 2-D and 3-D maps offer color-coordinated representations of the lymph nodes in correlation with the anatomic illustrations. This simple, straightforward approach makes this book a perfect daily resource for a wide spectrum of specialties and physicians at all levels who are looking to gain a better understanding of lymph node anatomy and drainage. Edited by Mukesh G. Harisinghani, MD, with chapter contributions from staff members of the Department of Radiology at Massachusetts General Hospital.
