Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
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.
Registries for Evaluating Patient Outcomes
The Danger Within Us
Author: Jeanne Lenzer
Publisher: Little, Brown
ISBN: 0316343781
Category : Medical
Languages : en
Pages : 306
Book Description
Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated
Publisher: Little, Brown
ISBN: 0316343781
Category : Medical
Languages : en
Pages : 306
Book Description
Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated
Implantable Cardiac Devices Technology
Author: David Korpas
Publisher: Springer Science & Business Media
ISBN: 1461469074
Category : Medical
Languages : en
Pages : 123
Book Description
Development in a majority of medicine branches today is based on technological advancement. This is the case in cardiology, where medical devices designed to correct heart rhythm – pacemakers, cardioverters-defibrillators and biventricular systems – are implanted in order to help a sick heart. Medical pacing devices today are only developed and produced globally by a several producers who make different technical solutions, algorithms, system parameters etc. The book Implantable Cardiac Devices Technology is targeted at biomedical, clinical engineers, technicians in practice, students of biomedical disciplines, and all medical staff who are required to understand the basics of pacing technology. The book is comprised of fourteen chapters that are further subdivided according to specific topics. Chapters dealing with basic heart anatomy, physiology and arythmology are included for the sake of comprehensiveness. Chapters avoid the description of special functions, but cover general procedures and parameters common for the systems of all producers. The book is intended to serve as a monothematic textbook. In order to make the text comprehensible and well arranged for a reader, references to professional literature are only provided once in a respective chapter.
Publisher: Springer Science & Business Media
ISBN: 1461469074
Category : Medical
Languages : en
Pages : 123
Book Description
Development in a majority of medicine branches today is based on technological advancement. This is the case in cardiology, where medical devices designed to correct heart rhythm – pacemakers, cardioverters-defibrillators and biventricular systems – are implanted in order to help a sick heart. Medical pacing devices today are only developed and produced globally by a several producers who make different technical solutions, algorithms, system parameters etc. The book Implantable Cardiac Devices Technology is targeted at biomedical, clinical engineers, technicians in practice, students of biomedical disciplines, and all medical staff who are required to understand the basics of pacing technology. The book is comprised of fourteen chapters that are further subdivided according to specific topics. Chapters dealing with basic heart anatomy, physiology and arythmology are included for the sake of comprehensiveness. Chapters avoid the description of special functions, but cover general procedures and parameters common for the systems of all producers. The book is intended to serve as a monothematic textbook. In order to make the text comprehensible and well arranged for a reader, references to professional literature are only provided once in a respective chapter.
Handbook of Neuroengineering
Author: Nitish V. Thakor
Publisher: Springer Nature
ISBN: 9811655405
Category : Technology & Engineering
Languages : en
Pages : 3686
Book Description
This Handbook serves as an authoritative reference book in the field of Neuroengineering. Neuroengineering is a very exciting field that is rapidly getting established as core subject matter for research and education. The Neuroengineering field has also produced an impressive array of industry products and clinical applications. It also serves as a reference book for graduate students, research scholars and teachers. Selected sections or a compendium of chapters may be used as “reference book” for a one or two semester graduate course in Biomedical Engineering. Some academicians will construct a “textbook” out of selected sections or chapters. The Handbook is also meant as a state-of-the-art volume for researchers. Due to its comprehensive coverage, researchers in one field covered by a certain section of the Handbook would find other sections valuable sources of cross-reference for information and fertilization of interdisciplinary ideas. Industry researchers as well as clinicians using neurotechnologies will find the Handbook a single source for foundation and state-of-the-art applications in the field of Neuroengineering. Regulatory agencies, entrepreneurs, investors and legal experts can use the Handbook as a reference for their professional work as well.
Publisher: Springer Nature
ISBN: 9811655405
Category : Technology & Engineering
Languages : en
Pages : 3686
Book Description
This Handbook serves as an authoritative reference book in the field of Neuroengineering. Neuroengineering is a very exciting field that is rapidly getting established as core subject matter for research and education. The Neuroengineering field has also produced an impressive array of industry products and clinical applications. It also serves as a reference book for graduate students, research scholars and teachers. Selected sections or a compendium of chapters may be used as “reference book” for a one or two semester graduate course in Biomedical Engineering. Some academicians will construct a “textbook” out of selected sections or chapters. The Handbook is also meant as a state-of-the-art volume for researchers. Due to its comprehensive coverage, researchers in one field covered by a certain section of the Handbook would find other sections valuable sources of cross-reference for information and fertilization of interdisciplinary ideas. Industry researchers as well as clinicians using neurotechnologies will find the Handbook a single source for foundation and state-of-the-art applications in the field of Neuroengineering. Regulatory agencies, entrepreneurs, investors and legal experts can use the Handbook as a reference for their professional work as well.
Toxicological Aspects of Medical Device Implants
Author: Prakash Srinivasan Timiri Shanmugam
Publisher: Academic Press
ISBN: 0128209208
Category : Medical
Languages : en
Pages : 331
Book Description
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
Publisher: Academic Press
ISBN: 0128209208
Category : Medical
Languages : en
Pages : 331
Book Description
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
Active Middle Ear Implants
Author: Klaus Böheim
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805594704
Category : Medical
Languages : en
Pages : 95
Book Description
In recent years, methods for coupling active implants to the middle ear, round window or combinations of passive middle ear prostheses have progressed considerably. Patient selection criteria have expanded from purely sensorineural hearing losses to conductive and mixed hearing losses in difficult-to-treat ears. This book takes into consideration recently developed methods as well as devices in current use. It begins with a fascinating and authentic history of active middle ear implants, written by one of the main pioneers in the field. In the following chapters, leading scientists and clinicians discuss the relevant topics in otology and audiology. Treatments for sensorineural hearing loss, conductive and mixed hearing losses, and results on alternative coupling sites such as the stapes footplate and the oval window are also covered, as well as articles on candidacy and cost-effectiveness. This publication is a must for ENT professionals and surgeons seeking out the latest knowledge on current research and clinical applications of active middle ear implants for all types of hearing loss.
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805594704
Category : Medical
Languages : en
Pages : 95
Book Description
In recent years, methods for coupling active implants to the middle ear, round window or combinations of passive middle ear prostheses have progressed considerably. Patient selection criteria have expanded from purely sensorineural hearing losses to conductive and mixed hearing losses in difficult-to-treat ears. This book takes into consideration recently developed methods as well as devices in current use. It begins with a fascinating and authentic history of active middle ear implants, written by one of the main pioneers in the field. In the following chapters, leading scientists and clinicians discuss the relevant topics in otology and audiology. Treatments for sensorineural hearing loss, conductive and mixed hearing losses, and results on alternative coupling sites such as the stapes footplate and the oval window are also covered, as well as articles on candidacy and cost-effectiveness. This publication is a must for ENT professionals and surgeons seeking out the latest knowledge on current research and clinical applications of active middle ear implants for all types of hearing loss.
Biomaterials for Artificial Organs
Author: Michael Lysaght
Publisher: Elsevier
ISBN: 0857090844
Category : Technology & Engineering
Languages : en
Pages : 313
Book Description
The worldwide demand for organ transplants far exceeds available donor organs. Consequently some patients die whilst waiting for a transplant. Synthetic alternatives are therefore imperative to improve the quality of, and in some cases, save people's lives. Advances in biomaterials have generated a range of materials and devices for use either outside the body or through implantation to replace or assist functions which may have been lost through disease or injury. Biomaterials for artificial organs reviews the latest developments in biomaterials and investigates how they can be used to improve the quality and efficiency of artificial organs.Part one discusses commodity biomaterials including membranes for oxygenators and plasmafilters, titanium and cobalt chromium alloys for hips and knees, polymeric joint-bearing surfaces for total joint replacements, biomaterials for pacemakers, defibrillators and neurostimulators and mechanical and bioprosthetic heart valves. Part two goes on to investigate advanced and next generation biomaterials including small intestinal submucosa and other decullarized matrix biomaterials for tissue repair, new ceramics and composites for joint replacement surgery, biomaterials for improving the blood and tissue compatibility of total artificial hearts (TAH) and ventricular assist devices (VAD), nanostructured biomaterials for artificial tissues and organs and matrices for tissue engineering and regenerative medicine.With its distinguished editors and international team of contributors Biomaterials for artificial organs is an invaluable resource to researchers, scientists and academics concerned with the advancement of artificial organs. - Reviews the latest developments in biomaterials and investigates how they can be used to improve the quality and efficiency of artificial organs - Discusses commodity biomaterials including membranes for oxygenators and cobalt chromium alloys for hips and knees and polymeric joint-bearing surfaces for total joint replacements - Further biomaterials utilised in pacemakers, defibrillators, neurostimulators and mechanical and bioprosthetic heart valve are also explored
Publisher: Elsevier
ISBN: 0857090844
Category : Technology & Engineering
Languages : en
Pages : 313
Book Description
The worldwide demand for organ transplants far exceeds available donor organs. Consequently some patients die whilst waiting for a transplant. Synthetic alternatives are therefore imperative to improve the quality of, and in some cases, save people's lives. Advances in biomaterials have generated a range of materials and devices for use either outside the body or through implantation to replace or assist functions which may have been lost through disease or injury. Biomaterials for artificial organs reviews the latest developments in biomaterials and investigates how they can be used to improve the quality and efficiency of artificial organs.Part one discusses commodity biomaterials including membranes for oxygenators and plasmafilters, titanium and cobalt chromium alloys for hips and knees, polymeric joint-bearing surfaces for total joint replacements, biomaterials for pacemakers, defibrillators and neurostimulators and mechanical and bioprosthetic heart valves. Part two goes on to investigate advanced and next generation biomaterials including small intestinal submucosa and other decullarized matrix biomaterials for tissue repair, new ceramics and composites for joint replacement surgery, biomaterials for improving the blood and tissue compatibility of total artificial hearts (TAH) and ventricular assist devices (VAD), nanostructured biomaterials for artificial tissues and organs and matrices for tissue engineering and regenerative medicine.With its distinguished editors and international team of contributors Biomaterials for artificial organs is an invaluable resource to researchers, scientists and academics concerned with the advancement of artificial organs. - Reviews the latest developments in biomaterials and investigates how they can be used to improve the quality and efficiency of artificial organs - Discusses commodity biomaterials including membranes for oxygenators and cobalt chromium alloys for hips and knees and polymeric joint-bearing surfaces for total joint replacements - Further biomaterials utilised in pacemakers, defibrillators, neurostimulators and mechanical and bioprosthetic heart valve are also explored
Medical Device Regulatory Practices
Author: Val Theisz
Publisher: CRC Press
ISBN: 9814669113
Category : Medical
Languages : en
Pages : 578
Book Description
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Publisher: CRC Press
ISBN: 9814669113
Category : Medical
Languages : en
Pages : 578
Book Description
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
Implants for Surgery. Active Implantable Medical Devices. General Requirements for Safety, Marking and for Information to Be Provided by the Manufacturer
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580726392
Category :
Languages : en
Pages : 64
Book Description
Implants (surgical), Prosthetic devices, Medical equipment, Electrical medical equipment, Electrically-operated devices, Protected electrical equipment, Performance, Reliability, Design, Safety measures, Accident prevention, Marking, Instructions for use, Hazards, Packaging, Packages, Sterile equipment, Delivery, Compatibility, Biological analysis and testing, Electrical safety, Electrical testing, Dielectric-strength tests, Impulse-voltage tests, Electrostatics, Electric charge, Leakage currents, Voltage, Defibrillators, Temperature, Durability, Life (durability), Mechanical testing, Environmental testing, Thermal testing, Endurance testing, Radio-wave hazards, Ultrasonic hazards, Ultrasonic testing, Testing conditions, Test equipment, Electromagnetic compatibility
Publisher:
ISBN: 9780580726392
Category :
Languages : en
Pages : 64
Book Description
Implants (surgical), Prosthetic devices, Medical equipment, Electrical medical equipment, Electrically-operated devices, Protected electrical equipment, Performance, Reliability, Design, Safety measures, Accident prevention, Marking, Instructions for use, Hazards, Packaging, Packages, Sterile equipment, Delivery, Compatibility, Biological analysis and testing, Electrical safety, Electrical testing, Dielectric-strength tests, Impulse-voltage tests, Electrostatics, Electric charge, Leakage currents, Voltage, Defibrillators, Temperature, Durability, Life (durability), Mechanical testing, Environmental testing, Thermal testing, Endurance testing, Radio-wave hazards, Ultrasonic hazards, Ultrasonic testing, Testing conditions, Test equipment, Electromagnetic compatibility