Regulation of Medical Devices

Regulation of Medical Devices
Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Publisher:
Total Pages: 666
Release: 1973
Genre: Intrauterine contraceptives
ISBN:

Medical Eligibility Criteria for Contraceptive Use

Medical Eligibility Criteria for Contraceptive Use
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.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
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.

Selected Practice Recommendations for Contraceptive Use

Selected Practice Recommendations for Contraceptive Use
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.

Artificial Hearts

Artificial Hearts
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.

Medical Devices and the Public's Health

Medical Devices and the Public's Health
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.

Medical Devices

Medical Devices
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