Toxicological Aspects Of Medical Device Implants

Book Description :

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 Description :

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 Description :

Download Polymer Additive Analytics book written by Jan C. J. Bart, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Book Description :

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.

Book Description :

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

Book Description :

Handbook on the Toxicology of Metals, Fifth Edition, Volume I: General Considerations is the first volume of a two-volume work that gives an overview and reviews topics of general importance including reviews of various health effects of trace metals. The book emphasizes toxic effects in humans, along with discussions on the toxic effects of animals and biological systems in vitro when relevant. The book has been systematically updated with the latest studies and advances in technology and contains several new chapters. As a multidisciplinary resource that integrates both human and environmental toxicology, the book is a comprehensive and valuable reference for toxicologists, physicians, pharmacologists, and environmental scientists in the fields of environmental, occupational and public health. Contains peer-reviewed chapters that deal with the effects of metallic elements and their compounds on biological systems Includes information on sources, transport and the transformation of metals in the environment Covers the ecological effects of metals to provide a basis for better understanding of the potential for adverse effects on human health Provides critical information on the properties, use, biological monitoring, dose-response relationships, diagnosis, treatment and prevention of metallic elements and compounds

Book Description :

This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.

Book Description :

Handbook on the Toxicology of Metals, Fourth Edition bridges the gap between established knowledgebase and new advances in metal toxicology to provide one essential reference for all those involved in the field. This book provides comprehensive coverage of basic toxicological data, emphasizing toxic effects primarily in humans, but also those of animals and biological systems in vitro. The fourth edition also contains several new chapters on important topics such as nanotoxicology, metals in prosthetics and dental implants, gene-environment interaction, neurotoxicology, metals in food, renal, cardiovascular, and diabetes effects of metal exposures and more. Volume I covers “General Considerations and Volume II is devoted to “Specific Metals. A multidisciplinary resource with contributions from internationally-recognized experts, the fourth edition of the Handbook on the Toxicology of Metals is a prominent and indispensable reference for toxicologists, physicians, pharmacologists, engineers, and all those involved in the toxicity of metals. Contains 61 peer reviewed chapters dealing with the effects of metallic elements and their compounds on biological systems Includes information on sources, transport and transformation of metals in the environment and on certain aspects of the ecological effects of metals to provide a basis for better understanding of the potential for adverse effects on human health Covers the toxicology of metallic nanomaterials in a new comprehensive chapter Metal toxicology in developing countries is dealt with in another new chapter emphasizing the adverse effects on human health by the inadequate handling of "ewaste Other new chapters in the 4th edition include: Toxic metals in food; Toxicity of metals released from medical devices; Gene-environment interactions; Neurotoxicology of metals; Cardiovascular disease; Renal effects of exposure to metals; Gold and gold mining; Iridium; Lanthanum; Lithium and Rhodium

Book Description :

The success of any implant or medical device depends very much on the biomaterial used. Synthetic materials (such as metals, polymers and composites) have made significant contributions to many established medical devices. The aim of this book is to provide a basic understanding on the engineering and processing aspects of biomaterials used in medical applications. Of paramount importance is the tripartite relationship between material properties, processing methods and design. As the target audiences cover a wide interdisciplinary field, each chapter is written with a detailed background so that audience of another discipline will be able to understand. For the more knowledgeable reader, a detailed list of references is included.

Book Description :

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 Description :

Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.

Book Description :

LOCATE FREQUENTLY USED INFORMATION EASILY AND QUICKLY Working in the laboratory or office, you use a diverse assortment of basic information to design, conduct, and interpret toxicology studies and to perform risk assessments. The Second Edition of the best-selling Handbook of Toxicology gives you the information you need in a single reference source. NEW IN THIS EDITION: Expanded coverage of inhalation toxicology, neurotoxicology, and histopathology Additional regulatory chapters dealing with pesticides, medical devices, consumer products, and world-wide notification of new chemicals Areas of toxicology missing from the first edition such as ecotoxicology and in vitro toxicology A chapter providing extensive overview of the toxicology of metals Two chapters on basic male and female endocrinology and related toxicology Information on differences in physiological and biochemical parameters between children and adults References to Web site sources of valuable information Over 200 new tables and figures THE SINGLE SOURCE FOR THE INFORMATION YOU USE MOST FREQUENTLY Updated and expanded, this unique book includes practical reference information useful to toxicologists in the chemical and pharmaceutical industries, contract laboratories, regulatory agencies, and academia. To help you find information quickly and easily, data is arranged by toxicology subspecialty and each chapter begins with a detailed listing of information presented. Containing over 700 tables and figures, Handbook of Toxicology, Second Edition gives you a single source for the information you use most often.

Book Description :

Download Medical Devices Bulletin book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Book Description :

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 Description :

A comprehensive and authoritative compilation of up-to-date developments in stem cell research and its use in toxicology and medicine Presented by internationally recognized investigators in this exciting field of scientific research Provides an insight into the current trends and future directions of research in this rapidly developing new field A valuable and excellent source of authoritative and up-to-date information for researchers, toxicologists, drug industry, risk assessors and regulators in academia, industry and government

Book Description :

Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.

Book Description :

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 Description :

Founded on the paradox that all things are poisons and the difference between poison and remedy is quantity, the determination of safe dosage forms the base and focus of modern toxicology. In order to make a sound determination there must be a working knowledge of the biologic mechanisms involved and of the methods employed to define these mechanis

Book Description :

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.

Book Description :

Hayes' Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chap