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Needs Assessment For Medical Devices
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Book Synopsis Needs Assessment for Medical Devices by : World Health Organization
Download or read book Needs Assessment for Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2011-12-15 with total page 29 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. Needs assessment is a complex process, incorporating a number of variables, that provides decision-makers with the information necessary to prioritize and select appropriate medical devices at a national, regional or hospital level. This document describes and illustrates the objective, the general approach and the process of such a needs assessment. The main section, Specific Approach (Section 4), demonstrates in seven steps how to identify related needs, consider the requirements of baseline information, analyze the gathered information, appraise the options, and prioritize the specific requirements. Tools are being continuously developed to support this decision-making process, and this document also includes information on useful tools that will help in the execution of these steps.
Book Synopsis A Process and Outcomes Evaluation for a Needs Assessment on Children's Medical Devices in a Midwest Hospital by : Sadie R. Larson
Download or read book A Process and Outcomes Evaluation for a Needs Assessment on Children's Medical Devices in a Midwest Hospital written by Sadie R. Larson and published by . This book was released on 2013 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: An evaluation of a needs assessment for children's medical devices was conducted in the spring of 2011. An innovative new research process involving UW-Stout's Industrial Design Students and DesignWise Medical aimed towards developing new pediatric medical devices. The research process was a new process and needed an evaluation on the process and the outcome. The data was used to better the research process for future student projects. An evaluation was conducted simultaneously with the new process. Quantitative and qualitative data was collected for a mixed method approach. The evaluation involved different populations consisting of students and professionals from the medical and industrial design field. Data collection came from numerous surveys and interviews. Overall, there were many suggestions for improvement as well as some validation of the current processes taken in this new research approach. The Process Evaluation showed there were many areas to improve upon such as group size, parent involvement, compliance obstacles and involving professional staff earlier in the process while the Outcomes Evaluation indicated there was not a lot of thought behind their product to make it a successful for mass production.
Book Synopsis The Role of Human Factors in Home Health Care by : National Research Council
Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Book Synopsis A Process and Outcomes Evaluation from an Administration Perspective on a Needs Assessment with Children's Medical Devices in a Midwest Hospital by : Sadie R. Larson
Download or read book A Process and Outcomes Evaluation from an Administration Perspective on a Needs Assessment with Children's Medical Devices in a Midwest Hospital written by Sadie R. Larson and published by . This book was released on 2013 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: An evaluation of a needs assessment for children's medical devices was conducted in the spring of 2011. An innovative new research process involving UW-Stout's Industrial Design Students and DesignWise Medical aimed towards developing new pediatric medical devices. The research process was a new process and needed an evaluation on the process and the outcome. The data was used to better the research process for future student projects. An evaluation was conducted simultaneously with the new process. Qualitative data was collected in the interview process from two key stakeholders. The CEO of DesignWise and the Industrial Design Instructor were interviewed about the process and the outcomes of the research process. Overall, there were many suggestions for improvement as well as some validation of the current processes taken in this new research approach. The process evaluation showed there were many areas to improve upon such as group size, parent involvement, compliance obstacles and involving professional staff earlier in the process while the outcomes evaluation indicated there was not a lot of thought behind their product to make it a successful for mass production.
Author :World Health Organization Publisher :Who Medical Device Technical ISBN 13 :9789241501361 Total Pages :39 pages Book Rating :4.5/5 (13 download)
Book Synopsis Health Technology Assessment of Medical Devices by : World Health Organization
Download or read book Health Technology Assessment of Medical Devices written by World Health Organization and published by Who Medical Device Technical. This book was released on 2012-10-25 with total page 39 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.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis Assessing Medical Technologies by : Institute of Medicine
Download or read book Assessing Medical Technologies written by Institute of Medicine and published by National Academies Press. This book was released on 1985-02-01 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.
Book Synopsis Biomaterials, Medical Devices, and Combination Products by : Shayne Cox Gad
Download or read book Biomaterials, Medical Devices, and Combination Products written by Shayne Cox Gad and published by CRC Press. This book was released on 2015-12-01 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical
Book Synopsis WHO list of priority medical devices for management of cardiovascular diseases and diabetes by :
Download or read book WHO list of priority medical devices for management of cardiovascular diseases and diabetes written by and published by World Health Organization. This book was released on 2021-01-26 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The final goal of this publication is to guide on the selection of medical devices. This increases access to medical devices required to prevent, diagnose and treat cardiovascular diseases (including stroke) and diabetes, especially in low and middle resource settings. This publication is intended for Ministries of Health, public health planners, health technology managers, disease managers, researchers, policy-makers, funding and procurement agencies, and support and advocacy groups for patients suffering from cardiac diseases, stroke and diabetes. It serves to inform policy-makers and technical decision-makers on the selection of medical devices required for the package of benefits and interventions for a target population in the context of universal health coverage.
Book Synopsis Clinical Evaluation of Medical Devices by : Karen M. Becker
Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
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 396 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.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Medical Devices written by Carlo Boccato and published by Springer Nature. This book was released on 2022-02-24 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Book Synopsis Clinical Engineering Handbook by : Joseph F. Dyro
Download or read book Clinical Engineering Handbook written by Joseph F. Dyro and published by Academic Press. This book was released on 2004-08-27 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Medical Devices by : World Health Organization
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
Book Synopsis Health Technology Assessment of Medical Devices During Development by : Katarzyna Markiewicz
Download or read book Health Technology Assessment of Medical Devices During Development written by Katarzyna Markiewicz and published by . This book was released on 2016 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Development of Medical Device Policies by : World Health Organization
Download or read book Development of Medical Device Policies written by World Health Organization and published by . This book was released on 2012-10-25 with total page 39 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. The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.
