Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants
Author: Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publsiher: Academic Press
Total Pages: 358
Release: 2020-07-03
ISBN 10: 0128207280
ISBN 13: 9780128207284
Language: EN, FR, DE, ES & NL

Toxicological Aspects of Medical Device Implants Book Review:

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

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants
Author: Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publsiher: Academic Press
Total Pages: 330
Release: 2020-06-10
ISBN 10: 0128209208
ISBN 13: 9780128209202
Language: EN, FR, DE, ES & NL

Toxicological Aspects of Medical Device Implants Book Review:

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

Biological Safety European Medical Device Regulations

Biological Safety   European Medical Device Regulations
Author: Anonim
Publsiher: Quality First International
Total Pages: 135
Release: 2021
ISBN 10: 1903757002
ISBN 13: 9781903757000
Language: EN, FR, DE, ES & NL

Biological Safety European Medical Device Regulations Book Review:

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products
Author: Shayne Cox Gad,Samantha Gad-McDonald
Publsiher: CRC Press
Total Pages: 606
Release: 2015-12-01
ISBN 10: 1482248387
ISBN 13: 9781482248388
Language: EN, FR, DE, ES & NL

Biomaterials Medical Devices and Combination Products Book Review:

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Safety of Silicone Breast Implants

Safety of Silicone Breast Implants
Author: Institute of Medicine,Committee on the Safety of Silicone Breast Implants
Publsiher: National Academies Press
Total Pages: 560
Release: 2000-01-06
ISBN 10: 0309132754
ISBN 13: 9780309132756
Language: EN, FR, DE, ES & NL

Safety of Silicone Breast Implants Book Review:

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.

The Danger Within Us

The Danger Within Us
Author: Jeanne Lenzer
Publsiher: Little, Brown
Total Pages: 336
Release: 2017-12-12
ISBN 10: 0316343781
ISBN 13: 9780316343787
Language: EN, FR, DE, ES & NL

The Danger Within Us Book Review:

Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated

Surgical Implants and Other Foreign Bodies

Surgical Implants and Other Foreign Bodies
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1999
ISBN 10: 1928374650XXX
ISBN 13: OCLC:847882655
Language: EN, FR, DE, ES & NL

Surgical Implants and Other Foreign Bodies Book Review:

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
Author: Jean-Pierre Boutrand
Publsiher: Woodhead Publishing
Total Pages: 586
Release: 2019-11-21
ISBN 10: 0081026447
ISBN 13: 9780081026441
Language: EN, FR, DE, ES & NL

Biocompatibility and Performance of Medical Devices Book Review:

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

Biomaterials and Medical Device Associated Infections

Biomaterials and Medical Device   Associated Infections
Author: L Barnes,Ian Cooper
Publsiher: Elsevier
Total Pages: 278
Release: 2014-11-21
ISBN 10: 0857097229
ISBN 13: 9780857097224
Language: EN, FR, DE, ES & NL

Biomaterials and Medical Device Associated Infections Book Review:

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.

Silver in Healthcare

Silver in Healthcare
Author: Alan B. G. Lansdown
Publsiher: Royal Society of Chemistry
Total Pages: 274
Release: 2010-05-07
ISBN 10: 1849731799
ISBN 13: 9781849731799
Language: EN, FR, DE, ES & NL

Silver in Healthcare Book Review:

Silver in healthcare has many different facets and since the early concepts of microbiology of the 1880's, has been developed from usage in surgical clips, staples, foil wound dressings and surgical implants, to the widespread and clinically effective antiseptic wound dressings, sutures, catheters, bone and dental implants, and cardiovascular devices of today. From the dawn of human civilisation, silver has had a role of water purification and even now has a role in hospital water systems for control of MRSA and legionnaires disease. Biotechnological advances in recent years have extended the antimicrobial properties of silver into production of hygiene textiles and use in domestic products. Important advances have been made in understanding mechanisms of antimicrobial action of silver, the central importance of ionisation patterns in the presence of body fluids and secretion, and the genetical and molecular profiles of silver resistance. This publication is a comprehensive account of the history of silver in medicine, its clinical benefits and wide advantages as a broad spectrum antimicrobial agent. It is clear from the extensive array of publications in recognised and unofficial press, that many misconceptions and misleading conceptions have been perpetuated, leading to errors in evaluation of the safety of the metal in occupational, domestic and therapeutic situations. The book is unique in that it is the only comprehensive presentation of the toxicology of silver and it identifies the major misconceptions in the safety of silver and interpretation of argyria and argyrosis as central features of silver toxicity. In this book, Dr Lansdown reviews the literature from a clinical and experimental viewpoint, with the benefit of his many years research on silver and experience gained in working with clinicians, healthcare product manufacturers and microbiologists. There is also discussion in the book on the relevance of antimicrobial resistance to silver and deficiencies in present day clinical practice in not evaluating incidences of resistance on a routine basis. The subject matter is presented in a readable fashion and includes reference to use of the metal in such practices as acupuncture and treatment of tropical diseases as practised in some parts of the world, each of which is accompanied by special clinical risk. It is also a collation of current views on the use and efficacy of silver as a broad spectrum antibiotic. The chapters which deal specifically with toxicological aspects of silver in clinical, occupational and environmental issues are central to the book's value. The book is aimed at clinicians, research scientists and product manufacturers and will provide ideas for new research and academic endeavour. It is also essential reading for research students with an interest in metal toxicity and its management in mammalian tissues.

Polymer Additive Analytics

Polymer Additive Analytics
Author: Jan C. J. Bart
Publsiher: Firenze University Press
Total Pages: 378
Release: 2006
ISBN 10: 8884533791
ISBN 13: 9788884533791
Language: EN, FR, DE, ES & NL

Polymer Additive Analytics Book Review:

Biological Evaluation of Medical Devices Tests for Genotoxicity Carcinogenicity and Reproductive Toxicity

Biological Evaluation of Medical Devices  Tests for Genotoxicity  Carcinogenicity and Reproductive Toxicity
Author: Bristish Standards Institution,British Standards Institute Staff
Publsiher: Unknown
Total Pages: 26
Release: 2009-06-30
ISBN 10: 9780580656651
ISBN 13: 0580656659
Language: EN, FR, DE, ES & NL

Biological Evaluation of Medical Devices Tests for Genotoxicity Carcinogenicity and Reproductive Toxicity Book Review:

Medical equipment, Biological analysis and testing, Medical instruments, Dental equipment, Implants (surgical), Biological hazards, Toxic materials, Toxicity, Genotoxicity tests, Cytotoxicity tests, Reproductive system

Handbook on the Toxicology of Metals Specific metals

Handbook on the Toxicology of Metals  Specific metals
Author: Lars Friberg,Gunnar Nordberg,Velimir B. Vouk
Publsiher: Elsevier Science Limited
Total Pages: 704
Release: 1986
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015011641050
Language: EN, FR, DE, ES & NL

Handbook on the Toxicology of Metals Specific metals Book Review:

Chapters on specific metals include physical and chemical properties, methods and problems of analysis, production and uses, environmental levels and exposures, metabolism, levels in tissues and biological fluids, effects and dose-response relationships, carcinogenicity, mutagenicity, teratogenicity and preventative measures, diagnosis, treatment and prognosis.

Polymers in Medical Applications

Polymers in Medical Applications
Author: B.J. Lambert,F.-W. Tang,W. J. Rogers
Publsiher: iSmithers Rapra Publishing
Total Pages: 146
Release: 2001
ISBN 10: 9781859572597
ISBN 13: 1859572596
Language: EN, FR, DE, ES & NL

Polymers in Medical Applications Book Review:

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.

Safe Medical Devices for Children

Safe Medical Devices for Children
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publsiher: National Academies Press
Total Pages: 480
Release: 2006-01-20
ISBN 10: 0309096316
ISBN 13: 9780309096317
Language: EN, FR, DE, ES & NL

Safe Medical Devices for Children Book Review:

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.

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
Author: Shayne C. Gad,Marian G. McCord
Publsiher: CRC Press
Total Pages: 504
Release: 2008-10-20
ISBN 10: 1439809488
ISBN 13: 9781439809488
Language: EN, FR, DE, ES & NL

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition Book Review:

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Trends in Development of Medical Devices

Trends in Development of Medical Devices
Author: Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publsiher: Academic Press
Total Pages: 216
Release: 2020-01-25
ISBN 10: 0128209615
ISBN 13: 9780128209615
Language: EN, FR, DE, ES & NL

Trends in Development of Medical Devices Book Review:

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
Author: Shayne C. Gad,Marian G. McCord
Publsiher: CRC Press
Total Pages: 504
Release: 2008-10-20
ISBN 10: 9781420071641
ISBN 13: 1420071645
Language: EN, FR, DE, ES & NL

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition Book Review:

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices
Author: Institute of Medicine,Board on Health Sciences Policy,Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publsiher: National Academies Press
Total Pages: 112
Release: 2001-10-31
ISBN 10: 9780309183208
ISBN 13: 0309183200
Language: EN, FR, DE, ES & NL

Innovation and Invention in Medical Devices Book Review:

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Silver Nanoparticles for Antibacterial Devices

Silver Nanoparticles for Antibacterial Devices
Author: Huiliang Cao
Publsiher: CRC Press
Total Pages: 464
Release: 2017-05-18
ISBN 10: 1498725333
ISBN 13: 9781498725330
Language: EN, FR, DE, ES & NL

Silver Nanoparticles for Antibacterial Devices Book Review:

Since the potential toxicity of silver nanoparticles (Ag NPs) has raised serious concerns in the biomaterials and biomedical engineering community, Silver Nanoparticles for Antibacterial Devices: Biocompatibility and Toxicity brings together the synthesis, the physicochemical properties and the biological actions of Ag NPs, as well as the clinical demands for fabricating antibacterial medical devices, discussing how to suppress the side effects of nanomaterials and how to impart to them the selective toxicity. This book presents the two primary paradigms that have emerged in probing the antibacterial applications of Ag NPs, i.e. the active attacking releasing way and the conservative defending approach by taking advantage of various short-range actions; it shows readers how the ways in which Ag NPs have behaved can be engineered purposively. With contributions from leading international experts and extensive references listed in each chapter, this volume provides the general principles on controlling the physicochemical behaviors of nanomaterials and managing their toxicity risks.