Table Of Content

Medical Devices This book provides an overview of the wide variety of medical devices that are an integral part of clinical practice. This practical book includes descriptions of medical devices by both clinical specialty and purpose, thus ensuring that a wide variety of devices are included, covering important elements such as body contact, duration of contact, the mechanism of each device, its intended use, single and/or mul- tiple use, benefts and any side/adverse/toxicological effects to the patient, and how to avoid user error. Authored by clinicians, researchers, and educators who are experienced in medical device use, regulation, and research, the content will be of beneft to postgraduate clinicians and employees of medical device companies. Medical Devices A Practical Guide Edited by Prakash Srinivasan Timiri Shanmugam First edition published 2023 by CRC Press 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742 and by CRC Press 4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN CRC Press is an imprint of Taylor & Francis Group, LLC © 2023 Taylor & Francis Group, LLC This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors or contributors are personal to them and do not necessarily refect the views/opinions of the publishers. The information or guid- ance contained in this book is intended for use by medical, scientifc or health-care professionals and is provided strictly as a supplement to the medical or other professional’s own judgement, their knowledge of the patient’s medical history, relevant manufacturer’s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dosages, procedures or diagnoses should be independently verifed. The reader is strongly urged to consult the relevant national drug formulary and the drug companies’ and device or material manufacturers’ printed instructions, and their websites, before administering or utilizing any of the drugs, devices or materials mentioned in this book. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the medical professional to make his or her own professional judgements, so as to advise and treat patients appropriately. The authors and publishers have also attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microflming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, access www .copyright .com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. For works that are not available on CCC please contact mpkbookspermissions@ tandf. co. uk Trademark notice: Product or corporate names may be trademarks or registered trademarks and are used only for identifcation and expla- nation without intent to infringe. Library of Congress Cataloging-in-Publication Data Names: Shanmugam, Prakash Srinivasan Timiri, editor. Title: Medical devices : a practical guide / [edited by] Prakash Srinivasan Timiri Shanmugam. Other titles: Medical devices (Shanmugam) Description: First edition. | Boca Raton : CRC Press, 2023. | Includes bibliographical references and index. | Summary: “An overview of the wide variety of medical devices that are an integral part of clinical practice. This practical book includes descriptions of medical devices by both clinical specialty and purpose, thus ensuring that a wide variety of devices are included”-- Provided by publisher. Identifers: LCCN 2022017833 (print) | LCCN 2022017834 (ebook) | ISBN 9781032062525 (hardback) | ISBN 9781032116051 (paperback) | ISBN 9781003220671 (ebook) Subjects: MESH: Equipment and Supplies | Prostheses and Implants Classifcation: LCC R857.M3 (print) | LCC R857.M3 (ebook) | NLM W 26 | DDC 610.28/4--dc23/eng/20220701 LC record available at https://lccn.loc.gov/2022017833 LC ebook record available at https://lccn.loc.gov/2022017834 ISBN: 9781032062525 (hbk) ISBN: 9781032116051 (pbk) ISBN: 9781003220671 (ebk) DOI: 10.1201/9781003220671 Typeset in Times by Deanta Global Publishing Services, Chennai, India Contents Contributor List vii 1 Introduction 1 Thamizharasan S, Sandhiya Thamizharasan, Krithaksha V, and Prakash Srinivasan Timiri Shanmugam 2 Cosmetic Devices 15 Thamizharasan S, Sandhiya Thamizharasan, Krithaksha V, and Prakash Srinivasan Timiri Shanmugam 3 General Hospital Devices and Supplies 40 Pugazhenthan Thangaraju and Hemasri Velmurugan 4 Home Health and Consumer Devices 60 Sree Sudha T Y, Hemasri Velmurugan, K. S. B. S. Krishna Sasanka, T. Y. Sri Hari, Yakaiah Vangoori, and Pugazhenthan Thangaraju 5 Implants and Prosthetics 94 Sree Sudha T Y, Anjaly Mary Varghese, Z. Naveen Kumar, K. S. B. S. Krishna Sasanka, T. Y. Sri Hari, and Pugazhenthan Thangaraju 6 Pediatric Medical Devices 126 K. P. G. Uma Anitha, Gayathri Segaran, and Mythili Sathiavelu 7 Medical Device Use for Cardiovascular Diseases 141 Sameer Khasbage, Sayan Kumar Das, Surjit Singh, and Shobhan Babu Varthya 8 Neurological Devices 158 Shalini Pattabiraman, Harini Sriram, Basanta Manjari Naik, and Indumathy Jagadeeswaran 9 Dental Devices 184 B. Karthika, Shamsul Nisa, and M. Pavani Index 235 v Contributor List K. P. G. Uma Anitha Shalini Pattabiraman Vellore Institute of Technology School of Health Professions Chennai, India Rutgers, The State University of New Jersey New Brunswick, New Jersey, USA Sayan Kumar Das Department of Pharmacology, M. Pavani Manipal-TATA Medical College, Jamshedpur, Tamil Nadu Dr. MGR Medical University Manipal Academy of Higher Education, Chennai, India Manipal, India Thamizharasan S T. Y. Sri Hari Department of Pharmacology and Consultant Critical Care Toxicology Omni Hospital Saveetha Medical College and Hospital Hyderabad, Telangana, India SIMATS Chennai, India Indumathy Jagadeeswaran Department of Biological Sciences K. S. B. S. Krishna Sasanka Southern Methodist University Department of ENT University Park, Texas, USA All India Institute of Medical Sciences Deoghar, India B.Karthika Tamil Nadu Dr. MGR Medical University Mythili Sathiavelu Chennai, India Vellore Institute of Technology Chennai, India Sameer Khasbage Department of Pharmacology Gayathri Segaran All India Institute of Medical Sciences Vellore Institute of Technology Bhopal, India Chennai, India Z. Naveen Kumar Prakash Srinivasan Timiri Department of Physiology Shanmugam Santhiram Medical College Global Product Safety and Toxicology Nandyal, India Avanos Medical Inc Alpharetta, Georgia, USA Basanta Manjari Naik Department of Physiology Surjit Singh Jawaharlal Institute of Postgraduate Medical Additional Professor Education and Research Department of Pharmacology Pondicherry, India AIIMS Jodhpur, India. Shamsul Nisa Bharati Vidyapeeth Harini Sriram Pune, India Covabind Joint Research Private Limited Hosur, India vii viii Contributor List Sandhiya Thamizharasan Yakaiah Vangoori Saasha Smile Clinic Department of Pharmacology Saasha Garden Santhiram Medical College Chennai, India Nandyal, India Sree Sudha T. Y. Anjaly Mary Varghese Department of Pharmacology Department of Pharmacology All India Institute of Medical Santhiram Medical College Sciences Nandyal, India Deoghar, India Shobhan Babu Varthya Pugazhenthan Thangaraju Department of Pharmacology Department of Pharmacology All India Institute of Medical Sciences All India Institute of Medical Sciences Jodhpur, India Raipur, India Hemasri Velmurugan Krithaksha V Department of Pharmacology Georgian National University SEU All India Institute of Medical Sciences Tbilisi, Georgia Raipur, India 1 Introduction Thamizharasan S, Sandhiya Thamizharasan, Krithaksha V, and Prakash Srinivasan Timiri Shanmugam Medical devices play an important role in the delivery of many health care services. “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specifc purposes of: • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability • investigation, replacement or modifcation of the anatomy or of a physiological or pathological process or state • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations • and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means (1) The following products shall also be deemed to be medical devices: • devices for the control or support of conception • products specifcally intended for the cleaning, disinfection or sterilization of devices The term applies to everything from common medical supplies such as latex gloves and syringes to advanced imaging equipment and implantable devices such as cardiac defbrillators. The medical device industry is thus an important component of the larger health care system and plays an essential role by developing new medical technologies that can improve the ability to diagnose and treat illness. Some types of medical devices include: • single-use devices (i.e. syringes, catheters) • implantable (i.e. hip prothesis, pacemakers) • imaging (i.e. ultrasound and CT scanners) • medical equipment (i.e. anesthesia machines, patient monitors, hemodialysis machines) • software (i.e. computer aided diagnostics) • in vitro diagnostics (i.e. glucometer, HIV tests) DOI: 10.1201/9781003220671-1 1