Regulation of Medical Devices (Intrauterine Contraceptive Devices)
Author | : United States. Congress. House. Government Operations |
Publisher | : |
Total Pages | : 598 |
Release | : 1973 |
Genre | : |
ISBN | : |
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Author | : United States. Congress. House. Government Operations |
Publisher | : |
Total Pages | : 598 |
Release | : 1973 |
Genre | : |
ISBN | : |
Author | : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee |
Publisher | : |
Total Pages | : 666 |
Release | : 1973 |
Genre | : Intrauterine contraceptives |
ISBN | : |
Author | : |
Publisher | : World Health Organization |
Total Pages | : 130 |
Release | : 2010 |
Genre | : Business & Economics |
ISBN | : 9241563885 |
Medical Eligibility Criteria for Contraceptive Use reviews the medical eligibility criteria for use of contraception, offering guidance on the safety and use of different methods for women and men with specific characteristics or known medical conditions. The recommendations are based on systematic reviews of available clinical and epidemiological research. It is a companion guideline to Selected Practice Recommendations for Contraceptive Use. Together, these documents are intended to be used by policy-makers, program managers, and the scientific community to support national programs in the preparation of service delivery guidelines. The fourth edition of this useful resource supersedes previous editions, and has been fully updated and expanded. It includes over 86 new recommendations and 165 updates to recommendations in the previous edition. Guidance for populations with special needs is now provided, and a new annex details evidence on drug interactions from concomitant use of antiretroviral therapies and hormonal contraceptives. To assist users familiar with the third edition, new and updated recommendations are highlighted. Everyone involved in providing family planning services and contraception should have the fourth edition of Medical Eligibility Criteria for Contraceptive Use at hand.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 442 |
Release | : 2011-04-03 |
Genre | : Medical |
ISBN | : 0309158060 |
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author | : Elizabeth B. Connell |
Publisher | : |
Total Pages | : 126 |
Release | : 1978 |
Genre | : Intrauterine contraceptives |
ISBN | : |
Author | : World Health Organization. Reproductive Health and Research |
Publisher | : World Health Organization |
Total Pages | : 144 |
Release | : 2005 |
Genre | : Medical |
ISBN | : 9241562846 |
This document is one of two evidence-based cornerstones of the World Health Organization's (WHO) new initiative to develop and implement evidence-based guidelines for family planning. The first cornerstone, the Medical eligibility criteria for contraceptive use (third edition) published in 2004, provides guidance for who can use contraceptive methods safely. This document, the Selected practice recommendations for contraceptive use (second edition), provides guidance for how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate. The recommendations contained in this document are the product of a process that culminated in an expert Working Group meeting held at the World Health Organization, Geneva, 13-16 April 2004.
Author | : |
Publisher | : |
Total Pages | : 440 |
Release | : 1983 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Author | : Shelley McKellar |
Publisher | : JHU Press |
Total Pages | : 373 |
Release | : 2018-01-01 |
Genre | : Medical |
ISBN | : 1421423561 |
A comprehensive history of the development of artificial hearts in the United States. Artificial hearts are seductive devices. Their promissory nature as a cure for heart failure aligned neatly with the twentieth-century American medical community’s view of the body as an entity of replacement parts. In Artificial Hearts, Shelley McKellar traces the controversial history of this imperfect technology beginning in the 1950s and leading up to the present day. McKellar profiles generations of researchers and devices as she traces the heart’s development and clinical use. She situates the events of Dr. Michael DeBakey and Dr. Denton Cooley’s professional fall-out after the first artificial heart implant case in 1969, as well as the 1982–83 Jarvik-7 heart implant case of Barney Clark, within a larger historical trajectory. She explores how some individuals—like former US Vice President Dick Cheney—affected the public profile of this technology by choosing to be implanted with artificial hearts. Finally, she explains the varied physical experiences, both negative and positive, of numerous artificial heart recipients. McKellar argues that desirability—rather than the feasibility or practicality of artificial hearts—drove the invention of the device. Technical challenges and unsettling clinical experiences produced an ambivalence toward its continued development by many researchers, clinicians, politicians, bioethicists, and the public. But the potential and promise of the artificial heart offset this ambivalence, influencing how success was characterized and by whom. Packed with larger-than-life characters—from dedicated and ardent scientists to feuding Texas surgeons and brave patients—this book is a fascinating case study that speaks to questions of expectations, limitations, and uncertainty in a high-technology medical world.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-11-25 |
Genre | : Medical |
ISBN | : 0309212421 |
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.
Author | : Seeram Ramakrishna |
Publisher | : Woodhead Publishing |
Total Pages | : 253 |
Release | : 2015-08-18 |
Genre | : Medical |
ISBN | : 0081002912 |
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process