Medical Device Regulations

Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
Total Pages: 54
Release: 2003-09-16
Genre: Medical
ISBN: 9241546182

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.

Reopening America and the World

Reopening America and the World
Author: John R. Allen
Publisher: Brookings Institution Press
Total Pages: 252
Release: 2020-07-07
Genre: Political Science
ISBN: 0815738749

The coronavirus has imposed a heavy toll on people's lives, livelihoods, and connections with one another. As America and the world reopen from this devastating pandemic, we need to examine how the process is taking place, its impact on individual lives and livelihoods, and learn from the experiences of other nations. In this book, we look at the experiences of the United States and other countries to see what we can derive about the reopening and its economic, social, and policy impacts. We present the insights and observations of Brookings scholars who offer their thoughts and recommendations for future action. Our goals are to inform the public conversation about Covid-19, help business, government, and civic leaders take their next steps, and think about the immediate and longer-term consequences of the virus.

Medical Equipment Management

Medical Equipment Management
Author: Keith Willson
Publisher: CRC Press
Total Pages: 336
Release: 2013-12-07
Genre: Business & Economics
ISBN: 1420099590

Know What to Expect When Managing Medical Equipment and Healthcare Technology in Your OrganizationAs medical technology in clinical care becomes more complex, clinical professionals and support staff must know how to keep patients safe and equipment working in the clinical environment. Accessible to all healthcare professionals and managers, Medica

The Supply of Medical Isotopes

The Supply of Medical Isotopes
Author:
Publisher:
Total Pages: 122
Release: 2019
Genre:
ISBN: 9789264625099

This report explores the main reasons behind the unreliable supply of Technetium-99m (Tc-99m) in health-care systems and policy options to address the issue. Tc-99m is used in 85% of nuclear medicine diagnostic scans performed worldwide – around 30 million patient examinations every year. These scans allow diagnoses of diseases in many parts of the human body, including the skeleton, heart and circulatory system, and the brain. Medical isotopes are subject to radioactive decay and have to be delivered just-in-time through a complex supply chain. However, ageing production facilities and a lack of investment have made the supply of Tc-99m unreliable. This report analyses the use and substitutability of Tc-99m in health care, health-care provider payment mechanisms for scans, and the structure of the supply chain. It concludes that the main reasons for unreliable supply are that production is not economically viable and that the structure of the supply chain prevents producers from charging prices that reflect the full costs of production and supply.

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 112
Release: 2001-12-01
Genre: Medical
ISBN: 0309082552

The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.

Medical Devices

Medical Devices
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 147
Release: 2010
Genre: Medical
ISBN: 9241564040

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

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
Author: J. Paulo Davim
Publisher: Elsevier
Total Pages: 382
Release: 2012-10-16
Genre: Technology & Engineering
ISBN: 1908818182

Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. - Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device - Offers a practical approach to recent developments in the design and manufacture of medical devices - Presents a topic that is the focus of research in many important universities and centres of research worldwide

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 141
Release: 2010-10-04
Genre: Medical
ISBN: 0309162904

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

MDS-3

MDS-3
Author: Martha A. Embrey
Publisher:
Total Pages: 0
Release: 2013
Genre: Drugs
ISBN: 9781565495876

Managing Drug Supply (MDS) is the leading reference on how to manage essential medicines in developing countries. MDS was originally published in 1982; it was revised in 1997 with over 10,000 copies distributed in over 60 countries worldwide. The third edition, MDS-3: Managing Access to Medicines and Health Technologies reflects the dramatic changes in politics and public health priorities, advances in science and medicine, greater focus on health care systems, increased donor funding, and the advent of information technology that have profoundly affected access to essential medicines over the past 14 years. Nearly 100 experts from a wide range of disciplines and virtually every corner of the world have contributed to this third edition. In addition to many new country studies, references, and extensive revisions, MDS-3 offers new chapters on areas such as pharmaceutical benefits in insurance programs, pricing, intellectual property, drug seller initiatives, and traditional and complementary medicine. The revisions and new chapters echo the wide variety of issues that are important to health practitioners and policy makers today. MDS-3 will be a valuable tool in the effort to ensure universal access to quality medicines and health technologies and their appropriate use.