Impact Of Medical Device Regulation On Jobs And Patients
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United States. Congress,United States House of Representatives,Committee on Energy and Commerce
Author : United States. Congress,United States House of Representatives,Committee on Energy and Commerce Publisher : Createspace Independent Publishing Platform Page : 206 pages File Size : 55,9 Mb Release : 2017-12-20 Category : Electronic ISBN : 1981861238
Impact of Medical Device Regulation on Jobs and Patients by United States. Congress,United States House of Representatives,Committee on Energy and Commerce Pdf
Impact of medical device regulation on jobs and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, February 17, 2011.
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : Unknown Page : 216 pages File Size : 50,5 Mb Release : 2011 Category : Medical ISBN : MINN:31951D03457388U
Impact of Medical Device Regulation on Jobs and Patients by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : Unknown Page : 124 pages File Size : 44,6 Mb Release : 2012 Category : Business & Economics ISBN : MINN:31951D03556747Q
The Impact of Medical Device and Drug Regulation on Innovation, Jobs, and Patients by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Pdf
Medical Devices: FDA Should Enhance Its Oversight of Recalls by Marcia Crosse Pdf
Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.
United States. Congress. House. Committee on Energy and Commerce
Author : United States. Congress. House. Committee on Energy and Commerce Publisher : Unknown Page : 168 pages File Size : 49,8 Mb Release : 2011 Category : Energy policy ISBN : STANFORD:36105050598072
Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views by United States. Congress. House. Committee on Energy and Commerce Pdf
The Medical Device R&D Handbook by Theodore R. Kucklick Pdf
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
Author : Michael Cheng,World Health Organization Publisher : World Health Organization Page : 54 pages File Size : 46,7 Mb Release : 2003-09-16 Category : Medical ISBN : 9789241546188
Medical Device Regulations by Michael Cheng,World Health Organization Pdf
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.
Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Publisher : National Academies Press Page : 318 pages File Size : 54,6 Mb Release : 2011-10-25 Category : Medical ISBN : 9780309212458
Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf
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.
Managing Medical Devices within a Regulatory Framework by Beth Ann Fiedler Pdf
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
Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Publisher : National Academies Press Page : 318 pages File Size : 41,6 Mb Release : 2011-11-25 Category : Medical ISBN : 9780309212427
Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf
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.
The Ethical Challenges of Emerging Medical Technologies by Arthur L. Caplan,Brendan Parent Pdf
This collection of essays emphasizes society’s increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology’s strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare.
National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care Publisher : National Academies Press Page : 322 pages File Size : 54,8 Mb Release : 2010-11-14 Category : Medical ISBN : 9780309156295
The Role of Human Factors in Home Health Care by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care Pdf
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.
The Growing Spine by Behrooz A. Akbarnia,Muharrem Yazici,George H. Thompson Pdf
The second edition of The Growing Spine has been extensively revised to cover recent advances in knowledge and management. The book is intended as a comprehensive, one-stop reference for specialists and health professionals who care for young children with spinal deformities. In addition, it will effectively help to standardize the care of these patients. Depending on the etiology, children with spinal deformities are often cared for by multiple specialists, including pediatricians, pediatric orthopaedists or orthopaedic spine surgeons, neurologists, pediatric surgeons, pediatric neurosurgeons, oncologists, and pulmonologists. The multidisciplinary nature of care is reflected in The Growing Spine, which will be of value for all involved practitioners rather than just orthopaedic specialists. It will also be an ideal reference for nurses, physical therapists, and healthcare professionals in training, who are usually unfamiliar with spinal deformities in children.
Artificial Intelligence in Healthcare by Adam Bohr,Kaveh Memarzadeh Pdf
Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. Highlights different data techniques in healthcare data analysis, including machine learning and data mining Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks Includes applications and case studies across all areas of AI in healthcare data