Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Download or read book Safe Medical Devices for Children written by and published by National Academy Press. This book was released on 2006-01-01 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 64 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 2011-10-25 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 Ensuring Safe Medicines and Medical Devices for Children written by United States Senate and published by . This book was released on 2019-09-08 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring safe medicines and medical devices for children: hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.
Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-22 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring safe medicines and medical devices for children : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007.
Download or read book ENSURING SAFE MEDICINES AND MEDICAL DEVICES FOR CHILDREN HRG S HRG 110 543 COM ON HEALTH EDUC LABOR AND PENSIONS U S SENATE 110TH CONG 1ST SESSION written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book S Hrg 110 543 written by U.S. Government Printing Office (Gpo) and published by BiblioGov. This book was released on 2013-10 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Government Printing Office (GPO) was created in June 1860, and is an agency of the U.S. federal government based in Washington D.C. The office prints documents produced by and for the federal government, including Congress, the Supreme Court, the Executive Office of the President and other executive departments, and independent agencies. A hearing is a meeting of the Senate, House, joint or certain Government committee that is open to the public so that they can listen in on the opinions of the legislation. Hearings can also be held to explore certain topics or a current issue. It typically takes between two months up to two years to be published. This is one of those hearings.
Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Committee on Health, Education, Labor, and Pensions. Senate. Congress and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Download or read book Safety of Electromedical Devices written by Norbert Leitgeb and published by Springer Science & Business Media. This book was released on 2010-05-06 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Download or read book FDA s Authority to Ensure that Drugs Prescribed to Children are Safe and Effective written by Susan Thaul and published by . This book was released on 2007 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs--the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003--and enacted a new law addressing devices--the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Download or read book America s Children written by Institute of Medicine and National Research Council and published by National Academies Press. This book was released on 1998-10-27 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: America's Children is a comprehensive, easy-to-read analysis of the relationship between health insurance and access to care. The book addresses three broad questions: How is children's health care currently financed? Does insurance equal access to care? How should the nation address the health needs of this vulnerable population? America's Children explores the changing role of Medicaid under managed care; state-initiated and private sector children's insurance programs; specific effects of insurance status on the care children receive; and the impact of chronic medical conditions and special health care needs. It also examines the status of "safety net" health providers, including community health centers, children's hospitals, school-based health centers, and others and reviews the changing patterns of coverage and tax policy options to increase coverage of private-sector, employer-based health insurance. In response to growing public concerns about uninsured children, last year Congress voted to provide $24 billion over five years for new state insurance initiatives. This volume will serve as a primer for concerned federal policymakers and regulators, state agency officials, health plan decisionmakers, health care providers, children's health advocates, and researchers.
