Fda Regulations Of Medical Devices Including The Status Of Breast Implants Scholars Choice Edition

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Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach

Author : F.H. Silver
Publisher : Springer Science & Business Media
ISBN 13 : 9401107351
Total Pages : 310 pages
Book Rating : 4.4/5 (11 download)

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Book Synopsis Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach by : F.H. Silver

Download or read book Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach written by F.H. Silver and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.

Communicating Risks and Benefits

Author : Baruch Fischhoff
Publisher : Government Printing Office
ISBN 13 : 9780160901799
Total Pages : 244 pages
Book Rating : 4.9/5 (17 download)

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Book Synopsis Communicating Risks and Benefits by : Baruch Fischhoff

Download or read book Communicating Risks and Benefits written by Baruch Fischhoff and published by Government Printing Office. This book was released on 2012-03-08 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating.

Medical Devices and the Public's Health

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sensor Technologies

Author : Michael J. McGrath
Publisher : Apress
ISBN 13 : 1430260149
Total Pages : 321 pages
Book Rating : 4.4/5 (32 download)

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Book Synopsis Sensor Technologies by : Michael J. McGrath

Download or read book Sensor Technologies written by Michael J. McGrath and published by Apress. This book was released on 2014-01-23 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sensor Technologies: Healthcare, Wellness and Environmental Applications explores the key aspects of sensor technologies, covering wired, wireless, and discrete sensors for the specific application domains of healthcare, wellness and environmental sensing. It discusses the social, regulatory, and design considerations specific to these domains. The book provides an application-based approach using real-world examples to illustrate the application of sensor technologies in a practical and experiential manner. The book guides the reader from the formulation of the research question, through the design and validation process, to the deployment and management phase of sensor applications. The processes and examples used in the book are primarily based on research carried out by Intel or joint academic research programs. “Sensor Technologies: Healthcare, Wellness and Environmental Applications provides an extensive overview of sensing technologies and their applications in healthcare, wellness, and environmental monitoring. From sensor hardware to system applications and case studies, this book gives readers an in-depth understanding of the technologies and how they can be applied. I would highly recommend it to students or researchers who are interested in wireless sensing technologies and the associated applications.” Dr. Benny Lo Lecturer, The Hamlyn Centre, Imperial College of London “This timely addition to the literature on sensors covers the broad complexity of sensing, sensor types, and the vast range of existing and emerging applications in a very clearly written and accessible manner. It is particularly good at capturing the exciting possibilities that will occur as sensor networks merge with cloud-based ‘big data’ analytics to provide a host of new applications that will impact directly on the individual in ways we cannot fully predict at present. It really brings this home through the use of carefully chosen case studies that bring the overwhelming concept of 'big data' down to the personal level of individual life and health.” Dermot Diamond Director, National Centre for Sensor Research, Principal Investigator, CLARITY Centre for Sensor Web Technologies, Dublin City University "Sensor Technologies: Healthcare, Wellness and Environmental Applications takes the reader on an end-to-end journey of sensor technologies, covering the fundamentals from an engineering perspective, introducing how the data gleaned can be both processed and visualized, in addition to offering exemplar case studies in a number of application domains. It is a must-read for those studying any undergraduate course that involves sensor technologies. It also provides a thorough foundation for those involved in the research and development of applied sensor systems. I highly recommend it to any engineer who wishes to broaden their knowledge in this area!" Chris Nugent Professor of Biomedical Engineering, University of Ulster

Encyclopedia of Gender and Society

Author : Jodi O'Brien
Publisher : SAGE
ISBN 13 : 1412909163
Total Pages : 1033 pages
Book Rating : 4.4/5 (129 download)

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Book Synopsis Encyclopedia of Gender and Society by : Jodi O'Brien

Download or read book Encyclopedia of Gender and Society written by Jodi O'Brien and published by SAGE. This book was released on 2009 with total page 1033 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides timely comparative analysis from internationally known contributors.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Devices

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Devices by : World Health Organization

Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Surgery of the Breast

Author : Scott L. Spear
Publisher :
ISBN 13 : 9781451127706
Total Pages : 1632 pages
Book Rating : 4.1/5 (277 download)

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Book Synopsis Surgery of the Breast by : Scott L. Spear

Download or read book Surgery of the Breast written by Scott L. Spear and published by . This book was released on with total page 1632 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This heavily illustrated two-volume atlas is the most comprehensive "how-to" reference on surgery of the breast. The world's leading surgeons describe and demonstrate the most advanced and successful techniques for all types of general surgery, aesthetic, and reconstructive procedures--oncologic management of breast disease, breast reconstruction, reduction mammoplasty and mastopexy, and augmentation mammoplasty. The text is illustrated throughout with over 4,100 drawings and full-color preoperative, intraoperative, and postoperative photographs. Editorial comments at the end of each chapter provide an alternative perspective and address current controversies. This thoroughly updated Third Edition features a greatly expanded section on augmentation mammoplasty. Other new chapters cover deep inferior epigastric perforator flap breast reconstruction, skin preserving delayed breast reconstruction, and nipple-sparing mastectomy. Coverage also includes new information on managing oncoplastic surgery, surveillance following breast reconstruction, reconstruction following tumor recurrence, and the role of stem cells"--Provided by publisher.

Healthcare Reference Book

Author : Mergent
Publisher :
ISBN 13 : 9781592748952
Total Pages : 0 pages
Book Rating : 4.7/5 (489 download)

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Book Synopsis Healthcare Reference Book by : Mergent

Download or read book Healthcare Reference Book written by Mergent and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309672104
Total Pages : 427 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis by : National Academies of Sciences, Engineering, and Medicine

Download or read book Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.

A review of UK health research funding

Author : David Sir Cooksey
Publisher : The Stationery Office
ISBN 13 : 0118404881
Total Pages : 132 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis A review of UK health research funding by : David Sir Cooksey

Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).

Beyond the HIPAA Privacy Rule

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Cosmetic Breast Cases

Author : Michael J. Higgs
Publisher : Springer
ISBN 13 : 3319277146
Total Pages : 836 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Cosmetic Breast Cases by : Michael J. Higgs

Download or read book Cosmetic Breast Cases written by Michael J. Higgs and published by Springer. This book was released on 2017-08-25 with total page 836 pages. Available in PDF, EPUB and Kindle. Book excerpt: This well-illustrated book presents one hundred and eighty cases that have been consulted on by an international breast group (organized and run by Dr. Michael Higgs) that comprises experts in breast surgery and is dedicated to the solution of problems associated with aesthetic breast surgery. The focus of the book is accordingly on actual pre- and postsurgical problems in breast surgery. Each case study includes the history of the breast problem, photos, questions, recommendations for treatment, and discussions of relevant subjects from a variety of specialists. Outcomes of the selected treatments are also presented. The book is unique in covering the multitude of complications that can arise with breast surgery from the perspective of international experts. It will enable readers to identify appropriate methods of handling specific problems and to implement the recommendations in their practice.

Water Quality

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 924154533X
Total Pages : 431 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Water Quality by : World Health Organization

Download or read book Water Quality written by World Health Organization and published by World Health Organization. This book was released on 2001-07 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: The quality of water, whether it is used for drinking, irrigation or recreational purposes, is significant for health in both developing and developed countries worldwide. This book is based on a programme of work undertaken by an international group of experts during 1999-2001. The aim was to develop a harmonised framework of effective and affordable guidelines and standards to improve the risk assessment and management of water-related microbial hazards. This book will be useful to all those concerned with issues relating to microbial water quality and health, including environmental and public health scientists, water scientists, policy makers and those responsible for developing standards and regulations.

Finding What Works in Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Author : World Intellectual Property Organization
Publisher : WIPO
ISBN 13 : 9280523082
Total Pages : 259 pages
Book Rating : 4.2/5 (85 download)

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Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization

Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Accelerated Partial Breast Irradiation

Author : David E. Wazer
Publisher : Springer Science & Business Media
ISBN 13 : 3540880062
Total Pages : 447 pages
Book Rating : 4.5/5 (48 download)

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Book Synopsis Accelerated Partial Breast Irradiation by : David E. Wazer

Download or read book Accelerated Partial Breast Irradiation written by David E. Wazer and published by Springer Science & Business Media. This book was released on 2009-08-11 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated partial breast irradiation (APBI) is being rapidly introduced into the clinical management of early breast cancer. APBI, in fact, encompasses a number of different techniques and approaches that include brachytherapy, intraoperative, and external beam techniques. There is currently no single source that describes these techniques and their clinical implementation. This text is a concise handbook designed to assist the clinician in the implementation of APBI. This includes a review of the principles that underlie APBI, a practical and detailed description of each technique for APBI, a review of current clinical results of APBI, and a review of the incidence and management of treatment related complications.