Measuring the Physiologic Use Conditions of Medical Devices

Measuring the Physiologic Use Conditions of Medical Devices PDF

Author: Walt Baxter

Publisher: Springer

Published: 2024-08-31

Total Pages: 0

ISBN-13: 9783031627637

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The physiologic use conditions medical devices are subjected to during implant and long-term in vivo use are critical to ensuring device reliability, efficacy, and safety. This book highlights advanced analyses for measuring the physiologic use conditions of medical devices, introducing important challenges facing engineers. The chapters include: A working definition for the physiologic in vivo use conditions used to further improve medical device performance in patients. Introductions to common approaches used to measure medical device use conditions so that engineers can use similar techniques where useful. Detailed case studies that highlight problem statements, approaches for measuring physiologic use conditions, and example outputs from such analyses. This book provides an up-to-date resource for device engineers so that they can accurately measure conditions that devices experience during and after implantation—key to reliability testing, computational modeling, and choosing optimum designs. This is an ideal book for medical device engineers and scientists designing and manufacturing devices for human use, students interested in understanding how devices interact with anatomy, and academic researchers seeking to apply advanced analyses to unmet use condition needs in the medical device field.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1990-02-01

Total Pages: 241

ISBN-13: 0309042860

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Monitoring Metabolic Status

Monitoring Metabolic Status PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-08-29

Total Pages: 469

ISBN-13: 0309091594

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The U.S. military's concerns about the individual combat service member's ability to avoid performance degradation, in conjunction with the need to maintain both mental and physical capabilities in highly stressful situations, have led to and interest in developing methods by which commanders can monitor the status of the combat service members in the field. This report examines appropriate biological markers, monitoring technologies currently available and in need of development, and appropriate algorithms to interpret the data obtained in order to provide information for command decisions relative to the physiological "readiness" of each combat service member. More specifically, this report also provides responses to questions posed by the military relative to monitoring the metabolic regulation during prolonged, exhaustive efforts, where nutrition/hydration and repair mechanisms may be mismatched to intakes and rest, or where specific metabolic derangements are present.

Definition of Serious and Complex Medical Conditions

Definition of Serious and Complex Medical Conditions PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1999-10-19

Total Pages: 127

ISBN-13: 0309172608

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In response to a request by the Health Care Financing Administration (HCFA), the Institute of Medicine proposed a study to examine definitions of serious or complex medical conditions and related issues. A seven-member committee was appointed to address these issues. Throughout the course of this study, the committee has been aware of the fact that the topic addressed by this report concerns one of the most critical issues confronting HCFA, health care plans and providers, and patients today. The Medicare+Choice regulations focus on the most vulnerable populations in need of medical care and other services-those with serious or complex medical conditions. Caring for these highly vulnerable populations poses a number of challenges. The committee believes, however, that the current state of clinical and research literature does not adequately address all of the challenges and issues relevant to the identification and care of these patients.

The British Chess Magazine; Volume 16

The British Chess Magazine; Volume 16 PDF

Author: Anonymous

Publisher: Franklin Classics

Published: 2018-10-07

Total Pages: 508

ISBN-13: 9780341777472

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This work has been selected by scholars as being culturally important and is part of the knowledge base of civilization as we know it. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. To ensure a quality reading experience, this work has been proofread and republished using a format that seamlessly blends the original graphical elements with text in an easy-to-read typeface. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Medical Device Regulations

Medical Device Regulations PDF

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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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.

The Physiological Measurement Handbook

The Physiological Measurement Handbook PDF

Author: John G. Webster

Publisher: CRC Press

Published: 2014-12-11

Total Pages: 620

ISBN-13: 1439808473

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The Physiological Measurement Handbook presents an extensive range of topics that encompass the subject of measurement in all departments of medicine. The handbook describes the use of instruments and techniques for practical measurements required in medicine. It covers sensors, techniques, hardware, and software as well as information on processing systems, automatic data acquisition, reduction and analysis, and their incorporation for diagnosis. Suitable for both instrumentation designers and users, the handbook enables biomedical engineers, scientists, researchers, students, health care personnel, and those in the medical device industry to explore the different methods available for measuring a particular physiological variable. It helps readers select the most suitable method by comparing alternative methods and their advantages and disadvantages. In addition, the book provides equations for readers focused on discovering applications and solving diagnostic problems arising in medical fields not necessarily in their specialty. It also includes specialized information needed by readers who want to learn advanced applications of the subject, evaluative opinions, and possible areas for future study.

Medical Devices and the Public's Health

Medical Devices and the Public's Health PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-10-25

Total Pages: 318

ISBN-13: 0309212456

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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.

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