Toxicological Aspects Of Medical Device Implants

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Toxicological Aspects of Medical Device Implants

Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Toxicological Aspects of Medical Device Implants Book PDF

Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 331 pages
File Size : 40,9 Mb
Release : 2020-06-10
Category : Medical
ISBN : 9780128209202

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Toxicological Aspects of Medical Device Implants by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam Pdf

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

Medical Device Regulations

Michael Cheng,World Health Organization
Medical Device Regulations Book PDF

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 45,7 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.

Wearable and Implantable Medical Devices

Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt
Wearable and Implantable Medical Devices Book PDF

Author : Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt
Publisher : Academic Press
Page : 280 pages
File Size : 53,9 Mb
Release : 2019-09-06
Category : Science
ISBN : 9780128156377

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Wearable and Implantable Medical Devices by Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt Pdf

Wearable and Implantable Medical Devices: Applications and Challenges, Fourth Edition highlights the new aspects of wearable and implanted sensors technology in the healthcare sector and monitoring systems. The book's contributions include several interdisciplinary domains, such as wearable sensors, implanted sensors devices, Internet-of-Things (IoT), security, real-time medical healthcare monitoring, WIBSN design and data management, encryption, and decision-support systems. Contributions emphasize several topics, including real-world applications and the design and implementation of wearable devices. This book demonstrates that this new field has a brilliant future in applied healthcare research and in healthcare monitoring systems. Includes comprehensive information on wearable and implanted device technology, wearable and implanted sensors design, WIBSN requirements, WIBSN in monitoring systems and security concepts Highlights machine learning and computing in healthcare monitoring systems based on WIBSN Includes a multidisciplinary approach to different healthcare applications and their associated challenges based on wearable and implanted technologies

Modern Methods of Clinical Investigation

Institute of Medicine,Committee on Technological Innovation in Medicine
Modern Methods of Clinical Investigation Book PDF

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 55,7 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

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.

Biocompatibility and Performance of Medical Devices

Jean-Pierre Boutrand
Biocompatibility and Performance of Medical Devices Book PDF

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Page : 586 pages
File Size : 53,8 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9780081026441

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Biocompatibility and Performance of Medical Devices by Jean-Pierre Boutrand Pdf

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

Degradation of Implant Materials

Noam Eliaz
Degradation of Implant Materials Book PDF

Author : Noam Eliaz
Publisher : Springer Science & Business Media
Page : 521 pages
File Size : 51,8 Mb
Release : 2012-08-21
Category : Technology & Engineering
ISBN : 9781461439424

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Degradation of Implant Materials by Noam Eliaz Pdf

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.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Public Health Effectiveness of the FDA 510 k Clearance Process Book PDF

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 52,6 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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.

Implantable Electronic Medical Devices

Dennis Fitzpatrick
Implantable Electronic Medical Devices Book PDF

Author : Dennis Fitzpatrick
Publisher : Elsevier
Page : 194 pages
File Size : 55,9 Mb
Release : 2014-11-05
Category : Technology & Engineering
ISBN : 9780124165779

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Implantable Electronic Medical Devices by Dennis Fitzpatrick Pdf

Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation therapy devices, and much more. Implantable Electronic Medical Devices equips the reader with essential background knowledge on the application of existing medical devices as well as providing an introduction to the latest techniques being used. A catalogue of existing implantable electronic medical devices Up-to-date information on the design of implantable electronic medical devices Background information and reviews on the application and design of up-to-date implantable electronic medical devices

Biomaterials and Medical Devices

Ferdyansyah Mahyudin,Hendra Hermawan
Biomaterials and Medical Devices Book PDF

Author : Ferdyansyah Mahyudin,Hendra Hermawan
Publisher : Springer
Page : 242 pages
File Size : 50,9 Mb
Release : 2016-02-26
Category : Technology & Engineering
ISBN : 9783319148458

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Biomaterials and Medical Devices by Ferdyansyah Mahyudin,Hendra Hermawan Pdf

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.

Biomaterials and Medical Device - Associated Infections

L Barnes,Ian Cooper
Biomaterials and Medical Device Associated Infections Book PDF

Author : L Barnes,Ian Cooper
Publisher : Elsevier
Page : 278 pages
File Size : 43,5 Mb
Release : 2014-11-21
Category : Technology & Engineering
ISBN : 9780857097224

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Biomaterials and Medical Device - Associated Infections by L Barnes,Ian Cooper Pdf

Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

The Design and Manufacture of Medical Devices

J Paulo Davim
The Design and Manufacture of Medical Devices Book PDF

Author : J Paulo Davim
Publisher : Elsevier
Page : 386 pages
File Size : 50,8 Mb
Release : 2012-10-16
Category : Medical
ISBN : 9781908818188

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The Design and Manufacture of Medical Devices by J Paulo Davim Pdf

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

Emerging Materials and Technologies for Bone Repair and Regeneration

Ashok Kumar,Sneha Singh,Prerna Singh
Emerging Materials and Technologies for Bone Repair and Regeneration Book PDF

Author : Ashok Kumar,Sneha Singh,Prerna Singh
Publisher : CRC Press
Page : 452 pages
File Size : 54,6 Mb
Release : 2024-08-01
Category : Technology & Engineering
ISBN : 9781040088616

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Emerging Materials and Technologies for Bone Repair and Regeneration by Ashok Kumar,Sneha Singh,Prerna Singh Pdf

This book covers advancements in the field of bone repair and regeneration. It introduces bone development, repair, and regeneration and details different biomaterials and technologies involved in the fabrication and characterization of bone-related scaffolds and implants. The book explores nanotechnological intervention and folklore phytomedicines and their prospects in regenerating bone including major bone related disease conditions, infection, and their tackling via tissue engineering strategies. FEATURES: Covers polymer materials and technologies for bone repair and regeneration based on tissue engineering Defines the interdisciplinary mechanism of bone tissue repair ranging from the fields of material science, nanotechnology, and phytomedicine includes basic sciences, scaffolds, and bone infection Examines fabrication and characterization methods for the bone repair materials Reviews fundamentals of interlinked mechanisms of bone development, repair, and regeneration. This book is aimed at graduate students and researchers in biomedical and tissue engineering and biomaterial sciences.

Safe Medical Devices for Children

Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Safe Medical Devices for Children Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher : National Academies Press
Page : 481 pages
File Size : 55,5 Mb
Release : 2006-01-20
Category : Medical
ISBN : 9780309096317

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Safe Medical Devices for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices Pdf

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.

The Unofficial Guide to ECGs

Ali B.A.K. Al-Hadithi,Alex Hobson,Senthil Kirubakaran
The Unofficial Guide to ECGs Book PDF

Author : Ali B.A.K. Al-Hadithi,Alex Hobson,Senthil Kirubakaran
Publisher : Elsevier Health Sciences
Page : 250 pages
File Size : 46,8 Mb
Release : 2022-12-20
Category : Medical
ISBN : 9780323932837

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The Unofficial Guide to ECGs by Ali B.A.K. Al-Hadithi,Alex Hobson,Senthil Kirubakaran Pdf

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

Toxicity Testing in the 21st Century

National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Board on Environmental Studies and Toxicology,Committee on Toxicity Testing and Assessment of Environmental Agents
Toxicity Testing in the 21st Century Book PDF

Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Board on Environmental Studies and Toxicology,Committee on Toxicity Testing and Assessment of Environmental Agents
Publisher : National Academies Press
Page : 217 pages
File Size : 43,5 Mb
Release : 2007-11-05
Category : Nature
ISBN : 9780309151733

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Toxicity Testing in the 21st Century by National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Board on Environmental Studies and Toxicology,Committee on Toxicity Testing and Assessment of Environmental Agents Pdf

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.