Increasingly, pathologists are being confronted with the effects of a number of complex devices on the body. Cardiac pace-makers are becoming increasingly sophisticated, ventricular support systems for the heart are well established, and vascular and other protheses are being used in increasing numbers. New joint systems, contraceptive devices used as drug delivery systems, and the use of new cement materials all provide challenges in terms of their pathology. The articles in this text collectively form a body of information on these devices not available elsewhere and with an up-to-date bibliography.
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
Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to four separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 1, "Principles and the Practice of Toxicologic Pathology," covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Other volumes in this work round out the depth and breadth of coverage.Volume 2 encompasses "Toxicologic Pathology in Safety Assessment" and "Environmental Toxicologic Pathology". These two sections cover the application of toxicologic pathology in developing specific product classes, principles of data interpretation for safety assessment, and toxicologic pathology of major classes of environmental toxicants. Volumes 3 and 4 provide deep and broad treatment of "Target Organ Toxicity", emphasizing the comparative and correlative aspects of normal biology and toxicant-induced dysfunction, principal methods for toxicologic pathology evaluation, and major mechanisms of toxicity. These volumes comprise the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Each volume is being published separately. - Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology - Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology - Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations
Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.
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.
Covering all aspects of neuropathology, this updated volume in the Diagnostic Pathology series is an excellent point-of-care resource for pathologists at all levels of experience and training—both as a quick reference and as an efficient review to improve knowledge and skills. The third edition is an easy-to-use, one-stop reference for the most recent clinical, pathological, histological, and molecular knowledge in the field. It offers complete information on lesions of the brain, sellar region, and peripheral nerves, as well as benign cysts and selected infectious, inflammatory, reactive, vascular, and cortical dysplastic lesions, enabling you to arrive at the correct diagnosis and prepare actionable, useful reports. - Incorporates new WHO Classification of Tumors of the Central Nervous System, 5th Edition - Offers information on neoplasms of the brain, sellar region, and peripheral nerves, as well as benign cysts and selected infectious, inflammatory, reactive, and vascular lesions, aiding you in arriving at the correct diagnosis - Emphasizes surgical pathology but also provides significant content on nonneoplastic diseases that present with focal lesions, especially those that are potentially misinterpreted as neoplasms - Contains a detailed molecular diagnostics chapter with a section on methylation profiling, which has become indispensable as a method of tumor classification - Features new and updated chapters detailing several types of tumors that have been reclassified due to recent molecular driver information, cIMPACT-NOW recommendations, and the WHO Classification, 5th Edition
The most recent high-profile advocate for Americans with disabilities, actor Christopher Reeve, has highlighted for the public the economic and social costs of disability and the importance of rehabilitation. Enabling America is a major analysis of the field of rehabilitation science and engineering. The book explains how to achieve recognition for this evolving field of study, how to set priorities, and how to improve the organization and administration of the numerous federal research programs in this area. The committee introduces the "enabling-disability process" model, which enhances the concepts of disability and rehabilitation, and reviews what is known and what research priorities are emerging in the areas of: Pathology and impairment, including differences between children and adults. Functional limitationsâ€"in a person's ability to eat or walk, for example. Disability as the interaction between a person's pathologies, impairments, and functional limitations and the surrounding physical and social environments. This landmark volume will be of special interest to anyone involved in rehabilitation science and engineering: federal policymakers, rehabilitation practitioners and administrators, researchers, and advocates for persons with disabilities.
Cardiovascular Pathology, Fourth Edition, provides users with a comprehensive overview that encompasses its examination, cardiac structure, both normal and physiologically altered, and a multitude of abnormalities. This updated edition offers current views on interventions, both medical and surgical, and the pathology related to them. Congenital heart disease and its pathobiology are covered in some depth, as are vasculitis and neoplasias. Each section has been revised to reflect new discoveries in clinical and molecular pathology, with new chapters updated and written with a practical approach, especially with regards to the discussion of pathophysiology. New chapters reflect recent technological advances with cardiac devices, transplants, genetics, and immunology. Each chapter is highly illustrated and covers contemporary aspects of the disease processes, including a section on the role of molecular diagnostics and cytogenetics as specifically related to cardiovascular pathology. Customers buy the Print + Electronic product together! Serves as a contemporary, all-inclusive guide to cardiovascular pathology for clinicians and researchers, as well as clinical residents and fellows of pathology, cardiology, cardiac surgery, and internal medicine Offers new organization of each chapter to enable uniformity for learning and reference: Definition, Epidemiology, Clinical Presentation, Pathogenesis/Genetics, Light and Electron Microscopy/Immunohistochemistry, Differential Diagnosis, Treatment and Potential Complications Features six new chapters and expanded coverage of the normal heart and blood vessels, cardiovascular devices, congenital heart disease, tropical and infectious cardiac disease, and forensic pathology of the cardiovascular system Contains 400+ full color illustrations and an online image collection facilitate research, study, and lecture slide creation
This expert volume in the Diagnostic Pathology series is an excellent point-of-care resource for practitioners at all levels of experience and training. Covering all areas of neoplastic and nonneoplastic diseases of the digestive tract and accessory organs such as the pancreas and liver, it incorporates the most recent clinical, pathological, and molecular knowledge in the field to provide a comprehensive overview of all key issues relevant to today's practice. Richly illustrated and easy to use, Diagnostic Pathology: Hepatobiliary and Pancreas is a one-stop reference for accurate, complete pathology reports, ideal as a day-to-day reference or as a reliable training resource. - Analyzes hundreds of diagnoses, each of which include critical diagnostic information such as definitions, epidemiology, clinical presentation, macro- and microscopic features, differential diagnoses, and pathologic interpretation pearls. - Features thorough updates throughout, including novel immunohistochemical markers and other ancillary techniques (such as BAP1, INSM1, Rb, albumin in situ hybridization) that play an increasingly critical role in improving diagnoses - Addresses recent advances in molecular pathology—new diagnostic, immunohistochemical, molecular, and genetic techniques used for diagnosis, as well as new details about the genesis and activity of tumors in the liver, pancreas, and biliary systems - Includes details from the 2019 WHO Classification of Tumors of the Digestive System regarding important changes to diagnostic techniques, identification of new variants of cancers, and immunohistochemical markers and ancillary techniques that improve diagnosis and treatment options - Reflects recent WHO updates and updates from the AJCC's 8th Edition Cancer Staging Manual such as new terminology, new grading of neuroendocrine tumors and neuroendocrine carcinomas, and characteristic molecular alterations in hepatocellular adenoma, cholangiocarcinoma, and other tumors - Uses a templated page layout, bulleted text, and a generous number of high-quality images to help practicing and in-training pathologists reach a confident diagnosis
