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.
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.
Download or read book FDA Regulation of Medical Devices Including the Status of Breast Implants written by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations and published by . This book was released on 1996 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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.
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
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:
Download or read book Radiologic Guide to Orthopedic Devices written by Tim B. Hunter and published by Cambridge University Press. This book was released on 2017-05-11 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive reference on radiologic appearance, uses and complications of orthopedic devices, for radiologists, orthopedists, physicians, and students.
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.
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).
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.
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.
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.
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.
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.
Download or read book Breast Augmentation written by Melvin A. Shiffman and published by Springer Science & Business Media. This book was released on 2008-09-16 with total page 653 pages. Available in PDF, EPUB and Kindle. Book excerpt: All aspects of breast augmentation are covered in this comprehensive guide. It is divided into sections that include anatomy, preoperative consultation, the varieties of implants with pocket positioning, the varieties of surgical procedures and approaches, complications, mammography and medical legal aspects. The extensive array of information that is imparted to the surgeon without equal makes it a precious companion for students, residents and fellows, practicing surgeons and highly experienced surgeons in plastic surgery, cosmetic surgery, general surgery and other subspecialties.
Download or read book Center for Risk Management Newsletter written by and published by . This book was released on 1996 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt:
