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
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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.

Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications
Author: United States. Superintendent of Documents
Publisher:
Total Pages: 1250
Release: 1979
Genre: Government publications
ISBN:
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February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index

Medical Devices and Systems

Medical Devices and Systems
Author: Joseph D. Bronzino
Publisher: CRC Press
Total Pages: 1404
Release: 2006-04-19
Genre: Medical
ISBN: 1420003860
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Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical d

Medical Device Regulations

Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
Total Pages: 54
Release: 2003-09-16
Genre: Medical
ISBN: 9241546182
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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Quality Management in the Imaging Sciences - E-Book

Quality Management in the Imaging Sciences - E-Book
Author: Jeffrey Papp
Publisher: Elsevier Health Sciences
Total Pages: 387
Release: 2023-09-18
Genre: Medical
ISBN: 0323833179
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Master all aspects of quality management and control in today's imaging environment! A true one-of-a-kind text, Quality Management in the Imaging Sciences, 7th Edition provides the information you need to ensure that radiographic equipment operates properly and that it functions within accepted standards. Step-by-step instructions provide a guide to evaluating equipment and documenting results. Also included is coverage of the latest federal regulations, advances in technology, and current QM certification requirements. Written by physics and diagnostic imaging educator Jeffrey Papp, this resource is an excellent tool to help you prepare for the ARRT® Quality Management Advanced Level Examination. - Coverage of quality management for all imaging sciences includes X-ray equipment, fluoroscopy, CT, MRI, sonography, and mammography. - Step-by-step QM procedures include detailed instructions on how to evaluate imaging equipment, and full-sized sample documentation forms offer practice in recording results. - Special icon and bolded type identify federal regulations important to quality management. - Learning features include chapter outlines, learning objectives, key terms (with definitions in the glossary), lab experiments, and review questions at the end of each chapter. - Useful appendix includes a review of the radiographic quality factors and a listing of agencies, organizations, and committees related to quality control and assurance. - Two 160-question practice exams on the Evolve website help you prepare for the ARRT advanced certification examination in Quality Management. - NEW! Updated content reflects the latest ARRT® Quality Management certification requirements. - NEW! Imaging updates include new technologies, current regulations, and ACR® accreditation requirements.