Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book Medical Equipment Maintenance Programme Overview written by World Health Organization and published by . This book was released on 2011-12-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book 2022 Hospital Compliance Assessment Workbook written by Joint Commission Resources and published by . This book was released on 2021-12-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Human resources for medical devices the role of biomedical engineers written by World Health Organization and published by World Health Organization. This book was released on 2017-05-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Download or read book Introduction to Medical Equipment Inventory Management written by World Health Organization and published by World Health Organization. This book was released on 2011-12-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Innovation and Invention in Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 2001-12-01 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Equipment Maintenance written by Binseng Wang and published by Springer Nature. This book was released on 2022-05-31 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Anesthesia Equipment written by Jan Ehrenwerth, MD and published by Elsevier Health Sciences. This book was released on 2013-04-01 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anesthesia Equipment: Principles and Applications, 2nd Edition, by Dr. Jan Ehrenwerth and Dr. James B. Eisenkraft, offers expert, highly visual, practical guidance on the full range of delivery systems and technology used in practice today. It equips you with the objective, informed answers you need to ensure optimal patient safety. "This is a comprehensive, up-to-date reference textbook covering all aspects of physics and equipment for the modern American anaesthetist. It may be helpful to those studying for American fellowship examinations but is not suited to preparation for the UK FRCA examinations." Reviewed by: I.Wrench on behalf of the British Journal of Anaesthesia, Feb 2014 Make informed decisions by expanding your understanding of the physical principles of equipment, the rationale for its use, delivery systems for inhalational anesthesia, systems monitoring, hazards and safety features, maintenance and quality assurance, special situations/equipment for non-routine adult anesthesia, and future directions for the field. Ensure patient safety with detailed advice on risk management and medicolegal implications of equipment use. Apply the most complete and up-to-date information available on machines, vaporizers, ventilators, breathing systems, vigilance, ergonomics, and simulation. Visualize the safe and effective use of equipment thanks to hundreds of full-color line drawings and photographs. Access the complete text and images online, fully searchable, at www.expertconsult.com.
