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Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
A Book

by Beth Ann Fiedler

  • Publisher : Elsevier
  • Release : 2016-09-10
  • Pages : 380
  • ISBN : 0128041927
  • Language : En, Es, Fr & De
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Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Medical Equipment Maintenance

Medical Equipment Maintenance
Management and Oversight

by Binseng Wang

  • Publisher : Morgan & Claypool Publishers
  • Release : 2012
  • Pages : 71
  • ISBN : 1627050566
  • Language : En, Es, Fr & De
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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

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants
A Book

by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam

  • Publisher : Academic Press
  • Release : 2020-06-10
  • Pages : 330
  • ISBN : 0128209208
  • Language : En, Es, Fr & De
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Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Discusses the adverse toxicological effects of medical devices Covers a broad range of disease topics and disease specific implants Offers contributions from experts from across several disciplines

Blockchain Technology and Innovations in Business Processes

Blockchain Technology and Innovations in Business Processes
A Book

by Srikanta Patnaik

  • Publisher : Springer Nature
  • Release : 2021
  • Pages : 329
  • ISBN : 981336470X
  • Language : En, Es, Fr & De
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Medical Device Regulations

Medical Device Regulations
Global Overview and Guiding Principles

by Michael Cheng,World Health Organization

  • Publisher : World Health Organization
  • Release : 2003-09-16
  • Pages : 43
  • ISBN : 9241546182
  • Language : En, Es, Fr & De
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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.

Operating Room Leadership and Perioperative Practice Management

Operating Room Leadership and Perioperative Practice Management
A Book

by Alan David Kaye,Richard D. Urman,Charles J. Fox, III

  • Publisher : Cambridge University Press
  • Release : 2018-12-31
  • Pages : 329
  • ISBN : 1108187099
  • Language : En, Es, Fr & De
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Effective leadership is critical to ensuring safety, efficiency and maximum productivity in the operating room (OR). This practical, evidence-based book unpicks the dynamics of a successful OR environment to underline the key techniques for management of policies, systems, staff members and teams. Fully updated to include recent clinical guidelines, the book provides the 'A-Z' of OR management, including sections on metrics, scheduling, human resource management, leadership principles, economics, quality assurance, recovery and ambulatory practice. New chapters include future healthcare models, emergency preparedness and budgets amongst other topics. Written by authors with unrivalled experience in the field, chapters are laid out in an easy and clinically helpful format to assist learning, and real-life case studies cover seventy-three different clinically relevant pain topics. This book is an essential guide for anyone working in the OR including anaesthesiologists, surgeons, nurses, and administrators.

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
Second Edition

by Jack Wong,Raymond Tong

  • Publisher : CRC Press
  • Release : 2018-03-28
  • Pages : 620
  • ISBN : 0429996764
  • Language : En, Es, Fr & De
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Clinical Engineering Handbook

Clinical Engineering Handbook
A Book

by Joseph F. Dyro

  • Publisher : Academic Press
  • Release : 2004
  • Pages : 674
  • ISBN : 012226570X
  • Language : En, Es, Fr & De
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Author Joseph Dyro has been awarded the Association for the Advancement of Medical Instrumentation (AAMI) Clinical/Biomedical Engineering Achievement Award which recognizes individual excellence and achievement in the clinical engineering and biomedical engineering fields. He has also been awarded the American College of Clinical Engineering 2005 Tom O'Dea Advocacy Award. As the biomedical engineering field expands throughout the world, clinical engineers play an evermore 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 1970's 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. * Clinical Engineers are the safety and quality faciltators in all medical facilities.

WHO Drug Information

WHO Drug Information
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2003
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Parliamentary Debates (Hansard).

Parliamentary Debates (Hansard).
Senate

by Australia. Parliament. Senate

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Medical Equipment Maintenance Programme Overview

Medical Equipment Maintenance Programme Overview
A Book

by World Health Organization

  • Publisher : Unknown Publisher
  • Release : 2012-08-01
  • Pages : 92
  • ISBN : 9789241501538
  • Language : En, Es, Fr & De
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WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. An effective medical equipment maintenance program consists of adequate planning, management and implementation. Planning considers the financial, physical and human resources required to adequately implement the maintenance activities. Once the program has been defined, financial, personnel and operational aspects are continually examined and managed to ensure the program continues uninterrupted and improves as necessary. Ultimately, proper implementation of the program is key to ensuring optimal equipment functionality.

Healthcare Financial Management

Healthcare Financial Management
Journal of the Healthcare Financial Management Association

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2006
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Medical Technology Into Healthcare and Society

Medical Technology Into Healthcare and Society
A Sociology of Devices, Innovation and Governance

by Alex Faulkner

  • Publisher : Health, Technology and Society
  • Release : 2009-01-15
  • Pages : 238
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Drawing from the sociology of medicine and from science and technology studies, the book develops new concepts to understand the changing patterns of control and promotion of medical technology, and its meaning in society. to explore new meanings of medicalisation and place evidence-based medicine in its policy context."--BOOK JACKET.

Health Care Technology Policy I

Health Care Technology Policy I
The Role of Technology in the Cost of Health Care : 27-29 April 1994, Arlington, Virginia

by Warren S. Grundfest

  • Publisher : Society of Photo Optical
  • Release : 1994
  • Pages : 476
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Introduction to Medical Equipment Inventory Management

Introduction to Medical Equipment Inventory Management
A Book

by World Health Organization

  • Publisher : Unknown Publisher
  • Release : 2012-10-25
  • Pages : 30
  • ISBN : 9789241501392
  • Language : En, Es, Fr & De
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WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. Once established, the inventory serves as the foundation for moving forward within the HTM system and ensuring safe and effective medical equipment. The inventory may be used to develop budgets for capital purchases, maintenance and running costs; to build and support an effective clinical engineering department, by allowing for workshop planning, hiring and training of technical support staff, and establishing and maintaining service contracts; to support an effective medical equipment management program, such as planning preventive maintenance activities and tracking work orders; and to plan the stock of spare parts and consumables. The inventory may also be used to support equipment needs assessment within the health-care facility and to record the purchase, receipt, retirement and discarding of equipment. Facility risk analysis and mitigation, and emergency and disaster planning, are also supported by an inventory.

Health Professionals in Management

Health Professionals in Management
A Book

by Beaufort B. Longest

  • Publisher : McGraw-Hill/Appleton & Lange
  • Release : 1996
  • Pages : 318
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Management of end-of-life electronic products within environmental benign manufacturing framework

Management of end-of-life electronic products within environmental benign manufacturing framework
A Book

by Hai-Yong Kang

  • Publisher : Unknown Publisher
  • Release : 2005
  • Pages : 376
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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A Comparative Analysis of Medical Device Regulations in the EU and the USA

A Comparative Analysis of Medical Device Regulations in the EU and the USA
A Book

by Ann-Marie Jahn

  • Publisher : GRIN Verlag
  • Release : 2016-01-12
  • Pages : 74
  • ISBN : 3668123217
  • Language : En, Es, Fr & De
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Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU). Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001). Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.

Drug and Medical Device Product Liability Deskbook

Drug and Medical Device Product Liability Deskbook
A Book

by James Beck,Anthony Vale

  • Publisher : Law Journal Press
  • Release : 2004
  • Pages : 1640
  • ISBN : 9781588521217
  • Language : En, Es, Fr & De
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This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

BNA's Health Care Policy Report

BNA's Health Care Policy Report
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2003
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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