Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Author: Shayne C. Gad

Publisher: Springer Nature

Published: 2020-02-24

Total Pages: 496

ISBN-13: 3030352412

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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Stimuli-Responsive Materials for Tissue Engineering
Stimuli-Responsive Materials for Tissue Engineering

Author: Senentxu Lanceros-Mendez

Publisher: John Wiley & Sons

Published: 2025-02-03

Total Pages: 386

ISBN-13: 3527350470

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Enables advanced tissue regeneration approaches via expertise from the fields of materials science and biology Stimuli-Responsive Materials for Tissue Engineering comprehensively reviews the use of stimuli-responsive materials in the context of advanced tissue engineering approaches, highlighting applications, challenges, and solutions and reporting on the current state of the art of smart and multifunctional materials being used for tissue engineering, focusing on material types and their properties. The progress that has already been achieved in the field is put into perspective by covering the remaining challenges in the research field of tissue engineering, and solutions are outlined to overcome those. By addressing challenges and ways to overcome them, Stimuli-Responsive Materials for Tissue Engineering is a highly practical resource on advanced tissue regeneration. Stimuli-Responsive Materials for Tissue Engineering contains information on: Smart and multifunctional materials for tissue engineering, covering electroactive and magnetoactive materials Shape memory, photo-responsive, and controlled degradation of stimuli-responsive materials Tissue regeneration strategies based on smart and active biomaterials, covering bone, heart, and neural tissue regeneration Main applications where these biomaterials can be applied, such as in bone, muscle, and skin regeneration Other potential areas where the covered biomaterials are expected to make a major impact in the next decade With comprehensive coverage of the subject, Stimuli-Responsive Materials for Tissue Engineering is an essential resource for materials scientists, bioengineers, engineering scientists, and biotechnologists seeking to understand advanced tissue regeneration approaches, current challenges, and potential solutions to advance progress in the field.

The Combination Products Handbook
The Combination Products Handbook

Author: Susan Neadle

Publisher: CRC Press

Published: 2023-05-16

Total Pages: 439

ISBN-13: 1000874583

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Medical Device Regulations
Medical Device Regulations

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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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.

Toxicity Testing in the 21st Century
Toxicity Testing in the 21st Century

Author: National Research Council

Publisher: National Academies Press

Published: 2007-10-05

Total Pages: 217

ISBN-13: 0309109922

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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.

Microbiological Methods for Environment, Food and Pharmaceutical Analysis
Microbiological Methods for Environment, Food and Pharmaceutical Analysis

Author: Abhishek Chauhan

Publisher: Springer Nature

Published: 2020-09-18

Total Pages: 515

ISBN-13: 3030520242

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This book provides a broad account of various applied aspects of microbiology for quality and safety evaluations in food, water, soil, environment and pharmaceutical sciences. The work is timely, as the safety and quality of various commodities such as water and wastewater, food, pharmaceutical medications and medical devices are of paramount concern in developing countries globally for improved public health quality in areas ranging from food security to disease exposure. The book offers an introduction to basic concepts of biosafety and related microbiological practices and applies these methodologies to a multitude of disciplines in subject-focused chapters. Each chapter offers experiments and exercises pertaining to the specific area of interest in microbiological research, which will allow readers to apply the knowledge gained in a laboratory or classroom setting to see the microbiological methods discussed in practice. The book will be useful for industrialists, researchers, academics and undergraduate/graduate students of microbiology, biotechnology, botany and pharmaceutical sciences. The text aims to be a significant contribution in effectively guiding scientists, analysts, lab technicians and quality managers working with microbiology in industrial and commercial fields.

Biomaterials, Medical Devices, and Combination Products
Biomaterials, Medical Devices, and Combination Products

Author: Shayne Cox Gad

Publisher: CRC Press

Published: 2015-12-01

Total Pages: 606

ISBN-13: 1482248387

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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

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

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-04

Total Pages: 141

ISBN-13: 0309162904

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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.

Medical Devices and the Public's Health
Medical Devices and the Public's Health

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-11-25

Total Pages: 318

ISBN-13: 0309212421

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.