Medical Devices Bulletin

Medical Devices Bulletin PDF Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 8

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Book Description

Medical Devices Bulletin

Medical Devices Bulletin PDF Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 8

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Book Description


Hearing Health Care for Adults

Hearing Health Care for Adults PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309439264
Category : Medical
Languages : en
Pages : 325

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Book Description
The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices PDF Author: World Health Organization
Publisher:
ISBN: 9789241512350
Category : Law
Languages : en
Pages : 72

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Book Description
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.

Safe Management of Wastes from Health-care Activities

Safe Management of Wastes from Health-care Activities PDF Author: Yves Chartier
Publisher: World Health Organization
ISBN: 9241548568
Category : Medical
Languages : en
Pages : 327

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Book Description
This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).

Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 388

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Book Description


Monthly Catalogue, United States Public Documents

Monthly Catalogue, United States Public Documents PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1284

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Book Description


Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 442

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Book Description


National Library of Medicine Current Catalog

National Library of Medicine Current Catalog PDF Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 690

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Book Description
First multi-year cumulation covers six years: 1965-70.

Index of NLM Serial Titles

Index of NLM Serial Titles PDF Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1224

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Book Description
A keyword listing of serial titles currently received by the National Library of Medicine.

Equipment for Older Or Disabled People and the Law

Equipment for Older Or Disabled People and the Law PDF Author: Michael Mandelstam
Publisher: Jessica Kingsley Publishers
ISBN: 9781853023521
Category : Law
Languages : en
Pages : 570

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Book Description
This comprehensive book explains the provision, both law and practice, of equipment and home adaptations to assist older or disabled people in daily living. Characterised by ill-defined statutory reponsibilities and terminology, and an under-developed consumer retail market, the system of provision has long been recognised as chaotic and confusing for professionals and public alike. This is despite the fact that equipment and adaptations are meant to be a central plank of community care. Necessarily wide-ranging but maintaining its focus, the book aims critically to describe the system and thereby promote better practice. By exploring boundaries and breaking points, it will assist people to understand the law when things go wrong - from negligence to judicial review, and from contract to product safety legislation. The range of items covered is great, from alarms to artificial limbs, baths to bedrooms, chopping boards to crutches, electronic toothbrushes to environmental controls, hearing aids to hoists, incontinence pads to ironing equipment, rails to ramps, speech aids to stairlifts, and walking frames to wheelchairs.