Medical Device Regulations

Medical Device Regulations PDF Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54

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Book Description
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.

Medical Device Regulations

Medical Device Regulations PDF Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54

Get Book Here

Book Description
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.

2022 Hospital Compliance Assessment Workbook

2022 Hospital Compliance Assessment Workbook PDF Author: Joint Commission Resources
Publisher:
ISBN: 9781635852448
Category :
Languages : en
Pages :

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Book Description


HCI and Usability for Medicine and Health Care

HCI and Usability for Medicine and Health Care PDF Author: Andreas Holzinger
Publisher: Springer
ISBN: 354076805X
Category : Computers
Languages : en
Pages : 473

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Book Description
This book constitutes the refereed proceedings of the Third Usability Symposium of the Human-Computer Interaction and Usability Engineering Workgroup of the Austrian Computer Society, USAB 2007, held in Graz, Austria, in November 2007. The 21 revised full papers and 18 revised short papers presented together with one poster paper and one tutorial were carefully reviewed and selected from 97 submissions during two rounds of reviewing and improvement.

Medical Lasers and Their Safe Use

Medical Lasers and Their Safe Use PDF Author: David H. Sliney
Publisher: Springer Science & Business Media
ISBN: 1461392527
Category : Medical
Languages : en
Pages : 309

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Book Description
This text was designed for the physicians, nurses, technical personnel, and staff members of medical facilities using lasers for surgical, therapeutic, and diagnostic purposes. The objective is to provide an understanding of the potential health and safety hazards associated with the use of medical laser systems and the precautions needed to use them safely. To do this, it is necessary to have an awareness of applicable standargs and regula tions that apply to laser use. This book is not intended as a substitute for the American National Standards Institute (ANSI) Z-136. 3, "Safe Use of Lasers in Health Care Facilities," but to facilitate its implementation as well as the implementation of the many other related regulations and guidelines that are pertinent. These other regulations include the Medical Device Amendments to the Food and Drug Act, the Federal Laser Product Performance Standards issued under the Radiation Control for Health and Safety Act, and applicable regulations of the Occupational Safety and Health Administration (OSHA). The text is organized to provide first an overview of laser hazards, laser surgical applications, and laser biological effects. General safety control measures and safety standards are then presented. Because laser tech nology is rapidly evolving, these general guidelines will allow safe use of new laser systems as they become available. Finally, specific safety guide lines and precautions are provided for specialized laser applications in the different health care specialties.

Safe Use of Medical Electrical Equipment in Health Care

Safe Use of Medical Electrical Equipment in Health Care PDF Author: Standards Australia Limited
Publisher:
ISBN: 9781776862139
Category :
Languages : en
Pages :

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Book Description


Clinical Engineering Handbook

Clinical Engineering Handbook PDF Author: Joseph F. Dyro
Publisher: Academic Press
ISBN: 012226570X
Category : Medical
Languages : en
Pages : 696

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Book Description
As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.

Medical Equipment Maintenance

Medical Equipment Maintenance PDF Author: Binseng Wang
Publisher: Springer Nature
ISBN: 3031016556
Category : Technology & Engineering
Languages : en
Pages : 76

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Book Description
In addition to being essential for safe and effective patient care, medical equipment also has significant impact on the income and, thus, vitality of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand all of the relevant factors. This book presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance against equivalent performance levels at similar organizations. The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge. Table of Contents: Introduction / Regulatory Framework / Core Functions of Medical Equipment Maintenance and Management / CE Department Management / Performance Management / Discussion and Conclusions

Healthcare Hazard Control and Safety Management

Healthcare Hazard Control and Safety Management PDF Author: James T. Tweedy
Publisher: CRC Press
ISBN: 1420025465
Category : Business & Economics
Languages : en
Pages : 814

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Book Description
Surpassing the standard set by the first edition, Healthcare Hazard Control and Safety Management, Second Edition presents expansive coverage for healthcare professionals serving in safety, occupational health, hazard materials management, quality improvement, and risk management positions. Comprehensive in scope, the book covers all major issues i

Healthcare Technology Management Systems

Healthcare Technology Management Systems PDF Author: Rossana Rivas
Publisher: Academic Press
ISBN: 0128115602
Category : Technology & Engineering
Languages : en
Pages : 205

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Book Description
Healthcare Technology Management Systems provides a model for implementing an effective healthcare technology management (HTM) system in hospitals and healthcare provider settings, as well as promoting a new analysis of hospital organization for decision-making regarding technology. Despite healthcare complexity and challenges, current models of management and organization of technology in hospitals still has evolved over those established 40-50 years ago, according to totally different circumstances and technologies available now. The current health context based on new technologies demands working with an updated model of management and organization, which requires a re-engineering perspective to achieve appropriate levels of clinical effectiveness, efficiency, safety and quality. Healthcare Technology Management Systems presents best practices for implementing procedures for effective technology management focused on human resources, as well as aspects related to liability, and the appropriate procedures for implementation. - Presents a new model for hospital organization for Clinical Engineers and administrators to implement Healthcare Technology Management (HTM) - Understand how to implement Healthcare Technology Management (HTM) and Health Technology Assessment (HTA) within all types of organizations, including Human Resource impact, Technology Policy and Regulations, Health Technology Planning (HTP) and Acquisition, as well as Asset and Risk Management - Transfer of knowledge from applied research in CE, HTM, HTP and HTA, from award-winning authors who are active in international health organizations such as the World Health Organization (WHO), Pan American Health Organization (PAHO), American College of Clinical Engineering (ACCE) and International Federation for Medical and Biological Engineering (IFMBE)

Medical Devices and Diagnostic Products Standards Survey

Medical Devices and Diagnostic Products Standards Survey PDF Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 452

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Book Description