Download or read book Medical Device Epidemiology and Surveillance written by S. Lori Brown and published by John Wiley & Sons. This book was released on 2007-03-13 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
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 2011-10-25 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 Disease Surveillance written by Joseph S. Lombardo and published by John Wiley & Sons. This book was released on 2012-11-09 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: An up-to-date and comprehensive treatment of biosurveillance techniques With the worldwide awareness of bioterrorism and drug-resistant infectious diseases, the need for surveillance systems to accurately detect emerging epidemicsis essential for maintaining global safety. Responding to these issues, Disease Surveillance brings together fifteen eminent researchers in the fields of medicine, epidemiology, biostatistics, and medical informatics to define the necessary elements of an effective disease surveillance program, including research, development, implementation, and operations. The surveillance systems and techniques presented in the text are designed to best utilize modern technology, manage emerging public health threats, and adapt to environmental changes. Following a historical overview detailing the need for disease surveillance systems, the text is divided into the following three parts: Part One sets forth the informatics knowledge needed to implement a disease surveillance system, including a discussion of data sources currently used in syndromic surveillance systems. Part Two provides case studies of modern disease surveillance systems, including cases that highlight implementation and operational difficulties as well as the successes experienced by health departments in the United States, Canada, Europe, and Asia. Part Three addresses practical issues concerning the evaluation of disease surveillance systems and the education of future informatics and disease surveillance practitioners. It also assesses how future technology will shape the field of disease surveillance. This book's multidisciplinary approach is ideal for public health professionals who need to understand all the facets within a disease surveillance program and implement the technology needed to support surveillance activities. An outline of the components needed for a successful disease surveillance system combined with extensive use of case studies makes this book well-suited as a textbook for public health informatics courses
Download or read book Principles and Practice of Public Health Surveillance written by Steven M. Teutsch and published by Oxford University Press, USA. This book was released on 2000 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This text presents an organized approach to planning, developing, and implementing public health surveillance systems. It has a broad scope, discussing legal and ethical issues as well as technical problems"--Jacket cover.
Download or read book Principles and Practice of Public Health Surveillance written by Lisa M. Lee PhD and published by Oxford University Press. This book was released on 2010-08-26 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health surveillance is the systematic, ongoing assessment of the health of a community, based on the collection, interpretation, and use of health data. Surveillance provides information necessary for public health decision making and interventions. In the third edition of Principles and Practice of Public Health Surveillance, the editors present an organized approach to planning, developing, and implementing public health surveillance systems in response to the rapidly changing field of public health. Substantially revised and expanded on, this edition continues to examine further the expansion of surveillance of disease and health determinants, as well as the recent advances in data management and informatics. Major sections of the book focus on bioresponse and preparedness, risk behaviors, and environmental exposure, while the ethical considerations and policy justification for public health surveillance are also explored. Drawing largely from the experience of the Centers for Disease Control and Prevention and other experts in the field, this book provides an excellent framework that collectively improves the surveillance foundation of public health. It will continue to serve as the standard text in the field, an invaluable resource for public health students and the desk reference for public health practitioners.
Download or read book Reauthorization of the Medical Device User Fee and Modernization Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Concepts and Methods in Infectious Disease Surveillance written by Nkuchia M. M'ikanatha and published by John Wiley & Sons. This book was released on 2023-09-12 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infectious disease surveillance has evolved at an extraordinary pace during the past several decades, and continues to do so. It is increasingly used to inform public health practice in addition to its use as a tool for early detection of epidemics. It is therefore crucial that students of public health and epidemiology have a sound understanding of the concepts and principles that underpin modern surveillance of infectious disease. Written by leaders in the field, who have vast hands-on experience in conducting surveillance and teaching applied public health, Concepts and Methods in Infectious Disease Surveillance is comprised of four sections. The first section provides an overview, a description of systems used by public health jurisdictions in the United States and legal considerations for surveillance. The second section presents chapters on major program-area or disease-specific surveillance systems, including those that monitor bacterial infections, foodborne diseases, healthcare-associated infections, and HIV/AIDS. The following section is devoted to methods for conducting surveillance and also approaches for data analysis. A concluding section summarizes communication of surveillance findings, including the use of traditional and social media, in addition to showcasing lessons learned from the New York City Department of Health’s experience in surveillance and epidemiology training. This comprehensive new book covers major topics at an introductory to intermediate level, and will be an excellent resource for instructors. Suitable for use in graduate level courses in public health, human and veterinary medicine, and in undergraduate programs in public-health-oriented disciplines, Concepts and Methods in Infectious Disease Surveillance is also a useful primer for frontline public health practitioners, hospital epidemiologists, infection control practitioners, laboratorians in public health settings, infectious disease researchers, and medical and public health informaticians interested in a concise overview of infectious disease surveillance.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2012-03-05 with total page 977 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.
Download or read book Practical Healthcare Epidemiology written by Ebbing Lautenbach and published by Cambridge University Press. This book was released on 2018-04-19 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.
Download or read book ANALYSIS OF PATIENT SAFETY MEASURES IN THE PRIVATE SECONDARY CARE HOSPITALS OF NANDED CITY written by Dr. KHAN GAZALA MD AMANULLAH and published by KY Publications. This book was released on 2018-03-01 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: ANALYSIS OF PATIENT SAFETY MEASURES IN THE PRIVATE SECONDARY CARE HOSPITALS OF NANDED CITY
Download or read book Advancing the Discipline of Regulatory Science for Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-07-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-10 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Federal Register written by and published by . This book was released on 2012-08 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Infectious Disease Informatics written by Hsinchun Chen and published by Springer Science & Business Media. This book was released on 2010-03-12 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Computer-based infectious disease surveillance systems are capable of real-time or near real-time detection of serious illnesses and potential bioterrorism agent exposures and represent a major step forward in disease surveillance. Infectious Disease Informatics: Syndromic Surveillance for Public Health and Bio-Defense is an in-depth monograph that analyzes and evaluates the outbreak modeling and detection capabilities of existing surveillance systems under a unified framework, and presents the first book-length coverage of the subject from an informatics-driven perspective. Individual chapters consider the state of the art, including the facilitation of data collection, sharing and transmission; a focus on various outbreak detection methods; data visualization and information dissemination issues; and system assessment and other policy issues. Eight chapters then report on several real-world case studies, summarizing and comparing eight syndromic surveillance systems, including those that have been adopted by many public health agencies (e.g., RODS and BioSense). The book concludes with a discussion of critical issues and challenges, with a look to future directions. This book is an excellent source of current information for researchers in public health and IT. Government public health officials and private-sector practitioners in both public health and IT will find the most up-to-date information available, and students from a variety of disciplines, including public health, biostatistics, information systems, computer science, and public administration and policy will get a comprehensive look at the concepts, techniques, and practices of syndromic surveillance.
Download or read book The Ethical Challenges of Emerging Medical Technologies written by Arthur L. Caplan and published by Routledge. This book was released on 2020-09-10 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
