Download the full version of the textbook now at textbookfull.

com

Clinical Engineering Handbook 2nd Edition

Ernesto Iadanza (Ed.)

https://textbookfull.com/product/clinical-
engineering-handbook-2nd-edition-ernesto-iadanza-
ed/

Explore and download more textbook at https://textbookfull.com

 Recommended digital products (PDF, EPUB, MOBI) that
you can download immediately if you are interested.

Nuclear Engineering Handbook 2nd Edition Kenneth D. Kok

(Ed.)

https://textbookfull.com/product/nuclear-engineering-handbook-2nd-
edition-kenneth-d-kok-ed/

textbookfull.com

The Foundation Engineering Handbook 2nd Edition Manjriker

Gunaratne (Editor)

https://textbookfull.com/product/the-foundation-engineering-
handbook-2nd-edition-manjriker-gunaratne-editor/

textbookfull.com

Handbook of Clinical Psychiatry - A Practical Guide 2nd

Edition Varuni De Silva

https://textbookfull.com/product/handbook-of-clinical-psychiatry-a-
practical-guide-2nd-edition-varuni-de-silva/

textbookfull.com

Weaving Fate The Omega Prophecy 2 1st Edition Nora Ash

https://textbookfull.com/product/weaving-fate-the-omega-
prophecy-2-1st-edition-nora-ash/

textbookfull.com
Biomimetic Microengineering 1st Edition Hyun Jung Kim
(Editor)

https://textbookfull.com/product/biomimetic-microengineering-1st-
edition-hyun-jung-kim-editor/

textbookfull.com

C++20 for Lazy Programmers: Quick, Easy, and Fun C++ for
Beginners 2nd Edition Will Briggs

https://textbookfull.com/product/c20-for-lazy-programmers-quick-easy-
and-fun-c-for-beginners-2nd-edition-will-briggs/

textbookfull.com

Encounters with Popular Pasts Cultural Heritage and

Popular Culture 1st Edition Mike Robinson

https://textbookfull.com/product/encounters-with-popular-pasts-
cultural-heritage-and-popular-culture-1st-edition-mike-robinson/

textbookfull.com

Practical Soft Tissue Pathology: A Diagnostic Approach: A

Volume in the Pattern Recognition Series 2nd Edition Jason
L. Hornick
https://textbookfull.com/product/practical-soft-tissue-pathology-a-
diagnostic-approach-a-volume-in-the-pattern-recognition-series-2nd-
edition-jason-l-hornick/
textbookfull.com

Monads, Composition, and Force: Ariadnean Threads Through

Leibniz’s Labyrinth Richard T W Arthur

https://textbookfull.com/product/monads-composition-and-force-
ariadnean-threads-through-leibnizs-labyrinth-richard-t-w-arthur/

textbookfull.com
Conn's handbook of models for human aging 2nd Edition Ram

https://textbookfull.com/product/conns-handbook-of-models-for-human-
aging-2nd-edition-ram/

textbookfull.com
Clinical Engineering Handbook

Second Edition
Clinical Engineering
Handbook
Second Edition

Editor-in-Chief

Ernesto Iadanza
IFMBE HTA Division Chair, Adjunct Professor in Clinical Engineering
at the School of Engineering
Università degli Studi di Firenze
Florence, Italy
Academic Press is an imprint of Elsevier
125 London Wall, London EC2Y 5AS, United Kingdom
525 B Street, Suite 1650, San Diego, CA 92101, United States
50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States
The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom
Copyright © 2020 Elsevier Inc. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical,
including photocopying, recording, or any information storage and retrieval system, without permission in writing
from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies
and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing
Agency, can be found at our website: www.elsevier.com/permissions.
This book and the individual contributions contained in it are protected under copyright by the Publisher (other than
as may be noted herein).

Notices
Knowledge and best practice in this field are constantly changing. As new research and experience broaden our
understanding, changes in research methods, professional practices, or medical treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any
information, methods, compounds, or experiments described herein. In using such information or methods they
should be mindful of their own safety and the safety of others, including parties for whom they have a professional
responsibility.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for
any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from
any use or operation of any methods, products, instructions, or ideas contained in the material herein.
Library of Congress Cataloging-in-Publication Data
A catalog record for this book is available from the Library of Congress
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
ISBN 978-0-12-813467-2

For information on all Academic Press publications

visit our website at https://www.elsevier.com/books-and-journals

Publisher: Mara Conner

Acquisition Editor: Mara Conner
Editorial Project Manager: Lindsay Lawrence
Production Project Manager: Paul Prasad Chandramohan
Designer: Miles Hitchen

Typeset by SPi Global, India

 Dedication

This Handbook is dedicated to the memory of my first mentor,

Professor ­Silvano Dubini.
 Section Editors

Saide Jorge Calil Almir Badnjević

Department of Biomedical Engineering, Faculty of Department of Genetics and Bioengineering, Faculty of
Electrical Engineering and Computing, University of Engineering and Natural Sciences, International Burch
Campinas, Campinas, Brazil University; Medical Device Inspection Laboratory Verlab
Ltd.; Medical Devices Verification Laboratory Verlab Ltd.,
Thomas M. Judd Sarajevo, Bosnia and Herzegovina
Clinical Engineering Division, IFMBE, Marietta, GA;
Health & Information Technology & Quality, The Elliot B. Sloane
Permanente Journal, Portland, OR; Foundation for Living, Foundation for Living, Wellness, and Health, Osprey, FL;
Wellness, and Health, Osprey, FL; Computing Sciences, Computing Sciences, Villanova University, Villanova, PA,
Villanova University, Villanova, PA; Quality Assessment, United States
Improvement and Reporting, Kaiser Permanente Georgia
Region, Atlanta, GA, United States Ricardo J. Silva
Computing Sciences, Villanova University, Villanova, PA;
James O. Wear Foundation for Living, Wellness, and Health, Orlando,
Scientific Enterprises, North Little Rock, AR, FL, United States; Montenegro Institute for Cognitive
United States Disabilities, Guayaquil, Ecuador

Mladen Poluta
Monique Frize
Western Cape Government: Health, Cape Town, South Africa
Systems and Computer Engineering, Carleton University,
Ottawa, ON, Canada
Leandro Pecchia
School of Engineering, University of Warwick, Coventry,
Gerald R. Goodman United Kingdom
Health Care Administration, Texas Woman’s University,
Houston, TX, United States Raj M. Ratwani
National Center for Human Factors in Healthcare, MedStar
Luca Radice Health; Georgetown University School of Medicine,
Medical Device Industries Consulting, Seveso, Italy Washington, DC, United States

xxxiii
Contributors

Numbers in paraentheses indicate the pages on which the authors’ Simone Borsci (807,829) Department of Cognitive
contrbutions begin. Psychology and Ergonomics, Faculty of Behavioural
Natalie Abts (871) National Center for Human Factors Management and Social Sciences, University of Twente,
in Healthcare, MedStar Institute for Innovation, Enschede, The Netherlands; National Institute for
Washington, DC, United States Health Research, London IVD Co-operative, Faculty of
Medicine, Department of Surgery & Cancer, Imperial
Arti Devi Ahluwalia (7) Research Center E. Piaggio and
College, London; School of Creative Arts, University of
Department of Information Engineering, University of
Hertfordshire, Hertfordshire, United Kingdom
Pisa, Pisa, Italy
Alen Bošnjaković (731,753) Institute of Metrology
Hashem O. Al-Fadel (111) Temos Assessors Advisory
of Bosnia and Herzegovina, Sarajevo, Bosnia and
Board, Temos International Healthcare Accreditation,
Herzegovina
Germany
Russell J. Branaghan (847) Human Systems Engineering
Martina Andellini (812) HTA Unit, Bambino Gesù
Program, Ira A. Fulton Schools of Engineering, Arizona
Children’s Hospital, IRCCS, Rome, Italy
State University, Mesa, AZ, United States
Ryan Arnold (858) Drexel University College of Medicine, Marta Bravi (52) Health Technologies Procurement—
Philadelphia, PA, United States ESTAR, Florence, Italy
Roberto Ayala (82) Health Technology Excellence Rebecca L. Butler (865) National Center for Human
National Center, Mexico City, Mexico Factors in Healthcare; Quality and Safety, MedStar
Almir Badnjević (477,478,484,491,498,503,509,514,520, Health; Georgetown University School of Medicine,
713,715,722,731,774,780) Department of Genetics and Washington, DC, United States
Bioengineering, Faculty of Engineering and Natural Sam S. Byamukama (161) Mark Biomedical Limited,
Sciences, International Burch University; Medical Kampala, Uganda
Device Inspection Laboratory Verlab Ltd.; Devices
Verification Laboratory Verlab Ltd., Sarajevo, Bosnia Saide Jorge Calil (61) Department of Biomedical
and Herzegovina Engineering, Faculty of Electrical Engineering and
Computing, University of Campinas, Campinas – SP,
Matthew F. Baretich (208,349,384,667,674) Baretich Brazil
Engineering, Inc., Fort Collins, CO, United States
Javier Enrique Camacho-Cogollo (33) Biomedical
Paula Berrio (181,186) Clinical Engineering Department, Engineering, EIA University, Envigado, Colombia
Hospital Pablo Tobón Uribe, Medellin, Colombia;
Joel R. Canlas (436) Clinical Engineering and Technology
COLCINC, Bogota, CO, United States
Management Department, Beaumont Services
Li Bin (114) Shanghai Medical Equipment Quality Control Company, LLC, Royal Oak, MI, United States
Center, Shanghai, China
Carole C. Carey (764) C3-Carey Consultants, LLC, Fulton,
J.J.B. Pierre Blais (357) INNOVAL Failure Analysis, MD, United States
Ottawa, ON, Canada
Rossana Castaldo (799) School of Engineering, University
H. Joseph Blumenthal (887) National Center for Human of Warwick, Coventry, United Kingdom
Factors in Healthcare, MedStar Health, Washington, Mario Castañeda (178,281) President, HealthiTek, Inc., San
DC, United States Rafael, CA; Clinical Engineering Division, IFMBE,
Isis Bonet (33) Computer and Systems Engineering, EIA Marietta, GA; Health & Information Technology & Quality,
University, Envigado, Colombia The Permanente Journal, Portland, OR, United States

xxxv
xxxvi  Contributors

Noel C. Castro (101) Montenegro Institute for Cognitive School of Public Health; Center for TeleHealth and
Disabilities, Guayaquil, Ecuador; Department of Biomedical Engineering Department, Texas Children’s
Electronics and Circuits, Simon Bolivar University, Hospital; Global Clinical Engineering Journal, Houston,
Caracas, Venezuela TX, United States
Claudio Cecchini (128) Department of Clinical Engineering, Carol Davis-Smith (393) Carol Davis-Smith & Associates,
ASST Valtellina e Alto Lario, Sondrio, Italy LLC, Phoenix, AZ, United States
Emel Çetin (742) Medical Metrology Laboratory, TÜBİTAK Roxana di Mauro (812) HTA Unit, Bambino Gesù
National Metrology Institute, Kocaeli, Turkey Children’s Hospital, IRCCS, Rome, Italy
Anthony Chan (321) Biomedical Engineering Technology, Licia Di Pietro (7) Research Center E. Piaggio and
School of Health Sciences, British Columbia Institute Department of Information Engineering, University of
of Technology; School of Biomedical Engineering, Pisa, Pisa, Italy
University of British Columbia, Vancouver, BC,
Canada David Dickey (222) Medical Equipment Organization,
Bristol, United Kingdom; Medical Technology
Guo Chenchen (114) Clinical Engineering, Children’s Management, Inc., Clarkston, MI, United States
Hospital of Zhejiang University School of Medicine,
Hangzhou, China Hüseyin Okan Durmuş (742) Medical Metrology
Laboratory, TÜBİTAK National Metrology Institute,
Michael Cheng (321,353,357) Biomedical Engineer, Kocaeli, Turkey
Patient Safety/Education Advocate, Ottawa, ON, Canada
Hala Durrah (881) MedStar Health Research Institute and
Oriana Ciani (789,795) Center for Research on Health MedStar National Center for Human Factors in Healthcare,
and Social Care Management, SDA Bocconi, Milan, MedStar Health, Washington, DC, United States
Italy; Evidence Synthesis & Modelling for Health
Improvement, University of Exeter Medical School, Zijad Džemić (715,722,731) Institute of Metrology
Exeter, United Kingdom of Bosnia and Herzegovina, Sarajevo, Bosnia and
Herzegovina
Daniel Clark (63) Clinical Engineering, Nottingham
University Hospitals NHS Trust; Faculty of Engineering, Antony Easty (330) Institute of Biomaterials & Biomedical
University of Nottingham, Nottingham, United Kingdom Engineering (IBBME), University of Toronto, ON,
Canada
J. Tobey Clark (227,281,410) WHO Collaborating Center
for Health Technology Management, Technical Services Alice L. Epstein (186,196,308,335,699) Allied Health Risk
Partnership, University of Vermont, Burlington, VT; Control, CNA; CNA Insurance, Durango, CO, United
Clinical Engineering Division, IFMBE, Marietta, GA; States
Health & Information Technology & Quality, The Jonathan Erskine (321,353) European Health Property
Permanente Journal, Portland, OR, United States Network, Durham University, Durham, United Kingdom
Theodore Cohen (208,384,543) Clinical Engineering, UC Lourdes Escobar (871) Hospital Universitario Marqués de
Davis Health, Fair Oaks, CA, United States Valdecilla, Santander, Spain
Giovanni Conte (52) Health Technologies Procurement—
Carlo Federici (789,799) Center for Research on Health
ESTAR, Florence, Italy
and Social Care Management, SDA Bocconi, Milan,
Todd Cooper (611) True Health Trust, San Diego, CA, Italy; School of Engineering, University of Warwick,
United States Coventry, United Kingdom
Bonacini Daniele, CEO (458) Roadrunnerfoot Engineering Jose Alberto Ferreira Filho (108) Instituto de Engenharia
srl, Pregnana Milanese; Politecnico of Milan, Milan, de Sistemas e Tecnologia da Informação, Universidade
Italy Federal de Itajubá, Itajubá, Minas Gerais, Brazil
Luis Danyau (143) School of Biomedical Engineering, G. Fico (807) IFMBE, HTA Division, Eindhoven, The
University of Valparaiso, Valparaiso, Chile Netherlands; Department of Photonics and Biomedical
Lida Z. David (829) Department of Cognitive Psychology Engineering, Life Supporting Technologies Research
and Ergonomics, Faculty of Behavioural Management Group, Universidad Politécnica de Madrid, Madrid,
and Social Sciences, University of Twente, Enschede, Spain
The Netherlands Allan Fong (876) National Center for Human Factors in
Yadin David (15,148,166,243,362,550) Biomedical Healthcare, MedStar Health, Washington, DC, United
Engineering Consultants, LLC; University of Texas States
 Contributors  xxxvii

William Frank (670) Medical Gas Services, Inc., Webster, Peter Heimann (236) Healthcare, Luxembourg
NH, United States Development, Vientiane, Laos
Ella S. Franklin (852) National Center for Human Antonio Hernandez (178,243,259,276,281) Consultant on
Factors in Healthcare, MedStar Institute for Innovation, Healthcare Technology, Washington, DC; University
Washington, DC, United States of Texas School of Public Health, Houston, TX;
Monique Frize (329,330) Systems and Computer PAHO Health Technology Regional Adviser; Health
Engineering, Carleton University, Ottawa, ON, Canada Technology Consultant, Washington, DC; Clinical
Engineering Division, IFMBE, Marietta, GA; Health
Tidimogo Gaamangwe (321,353) Clinical Engineering & Information Technology & Quality, The Permanente
Program, Winnipeg Regional Health Authority, Journal, Portland, OR, United States
Winnipeg, MB, Canada
Diógenes Hernández (694) PAHO/WHO, Panama City,
Jonathan A. Gaev (428) International Programs, ECRI, Panama
Plymouth Meeting, PA, United States
Laura Herrero-Urigüen (871) Valdecilla Biomedical
Beatriz Galeano (181,186) Universidad Pontificia Research Institute (IDIVAL), Santander, Spain
Bolivariana, Medellín, Colombia; COLCINC, Bogota,
CO, United States Ethan Hertz (736) Clinical Engineering Department, Duke
Health Technology Solutions, Duke University Health
Pedro Galvan (87) Biomedical Engineering Department, System, Durham, NC, United States
Health Sciences Research Institute, San Lorenzo,
Paraguay Aaron Zachary Hettinger (876,887) National Center
for Human Factors in Healthcare, MedStar Health;
William M. Gentles (72,205,208,268) BT Medical
Georgetown University School of Medicine,
Technology Consulting; University of Toronto;
Washington, DC, United States
Canadian Medical & Biological Engineering Society,
Toronto, ON, Canada Rabeh Robert Hijazi (219) Healthcare Technology
Professional, Detroit, MI, United States
Germán Giles (125) Engineering Department, Medical
Foundation of Mar del Plata, Mar del Plata; National Daniel J. Hoffman (887) National Center for Human
Technological University - San Nicolas Regional Factors in Healthcare, MedStar Health, Washington,
College, San Nicolás, Buenos Aires, Argentina DC, United States
Gerald R. Goodman (377,378,728) Health Care Jessica L. Howe (865) National Center for Human
Administration, Texas Woman’s University, Houston; Factors in Healthcare; Quality and Safety, MedStar
Houston Institute of Health Sciences, Texas Women’s Health; Georgetown University School of Medicine,
University, TX, United States Washington, DC, United States
Stephen L. Grimes (253,290) Strategic Healthcare Xia Huiling (114) Clinical Engineering, Inner Mongolia
Technology Associates, LLC, Swampscott, MA, United Autonomous Region People’s Hospital, Hohhot, China
States J.M. Hummel (807) IFMBE, HTA Division; Philips
C. Guillermo Avendaño† (143) School of Biomedical Research, Royal Philips, Eindhoven, The Netherlands
Engineering, University of Valparaiso, Valparaiso, Chile Bruce Hyndman (657,662) Community Hospital of the
Lejla Gurbeta Pokvić (478,484,491,498,503,509,514,520, Monterey Peninsula, Monterey, CA, United States
753,774) Department of Genetics and Bioengineering, Ernesto Iadanza (1,3,33,42,128,330,832) IFMBE HTA
Faculty of Engineering and Natural Sciences, International Division, School of Engineering, University of Florence,
Burch University; Medical Device Inspection Laboratory Florence, Italy
Verlab Ltd., Sarajevo; Technical Faculty University of
Bihać, Bihać, Bosnia and Herzegovina Andrea Garcia Ibarra (181,186) Drugs and Health
Technology Department, MoH Colombia, Bogotá,
Jay W. Hall (436) John D. Dingell VA Hospital-Detroit, Colombia
Detroit, MI, United States
Hiroki Igeta (105) Dept. of Clinical Engineering, Aso
Gary H. Harding (186,196,308,335,699) Health Care, Iizuka Hospital, Iizuka, Japan
Greener Pastures, Durango, CO, United States
Rohit Inamdar (616) Applied Solutions, ECRI Institute,
Plymouth, PA, United States
Andrei Issakov (236) Process Management System, Sarl,
†
Deceased Geneva, Switzerland
xxxviii  Contributors

Akhila Iyer (852) National Center for Human Factors Marcelo Lencina (125) Engineering Department, Medical
in Healthcare, MedStar Institute for Innovation, Foundation of Mar del Plata, Mar del Plata; National
Washington, DC, United States Technological University - San Nicolas Regional
Jadwiga Jodi Strzelczyk (677) Radiological Sciences College, San Nicolás, Buenos Aires, Argentina
Division, University of Colorado, Health Sciences Alessio Luschi (42) Department of Information
Center, Denver, CO, United States Engineering, University of Florence, Florence, Italy
Thomas M. Judd (15,165,166,178,236,243,259,280, Douglas Magagna (682) Engenhária Clínica Ltda., São
281,290,530,648) Clinical Engineering Division, Paulo, Brazil
IFMBE, Marietta, GA; Health & Information Technology
Lúcio Flávio de Magalhães Brito (682) Engenhária
& Quality, The Permanente Journal, Portland, OR;
Clínica Ltda., São Paulo, Brazil
Foundation for Living, Wellness, and Health, Osprey,
FL; Computing Sciences, Villanova University, Carmelo De Maria (7) Research Center E. Piaggio and
Villanova, PA; Quality Assessment, Improvement and Department of Information Engineering, University of
Reporting, Kaiser Permanente Georgia Region, Atlanta, Pisa, Pisa, Italy
GA, United States Ranjana K. Mehta (839) Industrial and Systems
Baki Karaböce (742) Medical Metrology Laboratory, Engineering, Texas A&M University, College Station,
TÜBİTAK National Metrology Institute, Kocaeli, TX, United States
Turkey Haris Memić (715,722) Department for Legal Metrology,
James P. Keller (451) Business Development Director, Institute of Metrology of Bosnia and Herzegovina,
Emergo by UL, Austin, TX, United States Sarajevo, Bosnia and Herzegovina
Kathryn M. Kellogg (865) National Center for Human Kristen E. Miller (858,876) National Center for Human
Factors in Healthcare, MedStar Health; Quality and Factors in Healthcare, MedStar Health; Georgetown
Safety, MedStar Health; Georgetown University School University School of Medicine, Washington, DC,
of Medicine, Washington, DC, United States United States
Eben Kermit (390) Biomedical Engineering, Stanford Michael B. Mirsky (421) Clinical Engineering Solutions
Health Care, Stanford, CA, United States Yorktown Heights, Yorktown Heights, NY, United States
Baset Khalaf (321) Clinical Engineering, Tshwane Brian Moher (321,353) Health Law & Medical Devices;
University of Technology, Pretoria, South Africa Patient Safety, Toronto, ON, Canada
Niranjan D. Khambete (132) Department of Clinical Luis Montesinos (821) School of Engineering and Sciences,
Engineering, Deenanath Mangeshkar Hospital and Tecnologico de Monterrey, Mexico City, Mexico
Research Centre, Pune, India
Massimiliano Monti (52) Health Technologies - AOU
Tracy C. Kim (865) National Center for Human Factors Careggi/Meyer—ESTAR, Florence, Italy
in Healthcare, MedStar Health; Quality and Safety,
Yoon Moonsoo (321) Global Health Department, Public
MedStar Health; Georgetown University School of
Health Graduate School, Yonsei University, Seoul,
Medicine, Washington, DC, United States
South Korea
Gary Klein (858) Shadowbox, LLC, Dayton, OH, United
Ed Napke (321,353) Health Canada; World Health
States
Organization Drug Adverse Event Expert, Queen
Zheng Kun (114) Clinical Engineering, Children’s Hospital Elizaberth Jubilee Medal, Ottawa, ON, Canada
of Zhejiang University School of Medicine, Hangzhou,
Åke Öberg (446) Linköping University, Linköping, Sweden
China
Stacie Lafko (847) Human Systems Engineering Program, Frank R. Painter (393) University of Connecticut, Storrs,
Ira A. Fulton Schools of Engineering, Arizona State CT, United States
University, Mesa, AZ, United States Tadeusz Pałko (137) Institute of Metrology and Biomedical
Andres Diaz Lantada (7) Department of Mechanical Engineering, Warsaw Technical University, Warsaw,
Engineering, Universidad Politécnica de Madrid, Poland
Madrid, Spain Nicolas Pallikarakis (832) University of Patras, Patras, Greece
Leo Lehtiniemi (321,353) Health Canada; Methodology W. David Paperman (362) Clinical Engineering
Consultant, Ottawa, ON, Canada Consultant, Cut and Shoot, TX, United States
Visit https://textbookfull.com
now to explore a rich
collection of eBooks, textbook
and enjoy exciting offers!
 Contributors  xxxix

Leandro Pecchia (330,787,799,818,821,832) School of Pamela Y. Shuck (436) McLaren Health Care, Flint, MI,
Engineering, University of Warwick, Coventry, United United States
Kingdom Ricardo J. Silva (101,527,530,556,611,638,644)
Davide Piaggio (818,832) School of Engineering, Computing Sciences, Villanova University, Villanova,
University of Warwick, Coventry, United Kingdom PA; Foundation for Living, Wellness, and Health,
Ledina Picari (151) Medical Devices and Systems Unit, Orlando, FL, United States; Montenegro Institute for
Ministry of Health of Albania, Tirana, Albania Cognitive Disabilities, Guayaquil, Ecuador
Julie Polisena (330,795) Medical Devices & Clinical Hardeep Singh (858) Michael E. DeBakey Veterans Affairs
Interventions, CADTH; Canadian Agency for Drugs and Medical Center, Baylor College of Medicine, Houston,
Technologies in Health (CADTH), Ottawa, ON, Canada TX, United States
Mladen Poluta (156,655) Western Cape Government: Elliot B. Sloane (527,530,556,569,611,638,644,648)
Health, Cape Town, South Africa Foundation for Living, Wellness, and Health, Osprey,
Luca Radice (427,469) Medical Device Industries FL; Computing Sciences, Villanova University,
Consulting, Seveso, Italy Villanova, PA, United States

Arjun H. Rao (839) Industrial and Systems Engineering, Peter Smithson (222) Medical Equipment Organization,
Texas A&M University, College Station, TX, United States Bristol, United Kingdom; Medical Technology
Management, Inc., Clarkston, MI, United States
Raj M. Ratwani (837,876) National Center for Human Factors
in Healthcare, MedStar Health; Georgetown University Ira Soller (421) Scientific and Medical Instrumentation,
School of Medicine, Washington, DC, United States SUNY Health Science Center at Brooklyn, Brooklyn,
NY, United States
Alice Ravizza (7) Department of Mechanical and Aerospace
Engineering, Politecnico di Torino, Torino, Italy Lemana Spahić (478,484,491,514) Department of Genetics
and Bioengineering, Faculty of Engineering and Natural
Adrian Richards (140) Biomedical Engineering, The
Sciences, International Burch University, Sarajevo,
Women’s and Children’s Health Network, Adelaide,
Bosnia and Herzegovina
SA, Australia
Robert T. Ssekitoleko (161) College of Health Sciences,
Malcolm G. Ridgway (373) Retired Clinical Engineer,
Makerere University, Kampala; Knowledge for Change
Woodland Hills, CA, United States
(K4C), Fort Portal, Uganda
Matteo Ritrovato (812) HTA Unit, Bambino Gesù
Lucy Stein (852) National Center for Human Factors
Children’s Hospital, IRCCS, Rome, Italy
in Healthcare, MedStar Institute for Innovation,
Rossana Rivas (94) Eng. Dep. & Health Technopole Washington, DC, United States
CENGETS, Pontifical Catholic University of Peru
PUCP, Lima, Peru Arif Subhan (219) Department of Veterans Affairs, Los
Angeles, CA, United States
Stanislao Rizzo (52) Department of Ophthalmology,
University of Florence, Florence, Italy David Tacconi (473) CoRehab, Trento, Italy
Elena Rojo (871) Hospital Virtual Valdecilla, Santander, Nilgün Tokman (742) Medical Metrology Laboratory,
Spain TÜBİTAK National Metrology Institute, Kocaeli, Turkey
Jiang Ruiyao (114) Clinical Engineering, Shanghai 6th Eduardo Toledo (94) Eng. Dep. & Health Technopole
People’s Hospital, Shanghai, China CENGETS, Pontifical Catholic University of Peru
PUCP, Lima, Peru
Farzan Sasangohar (839) Industrial and Systems
Engineering, Texas A&M University, College Station; P. Trbovich (330) Institute of Health Policy, Management
Center for Outcomes Research, Houston Methodist and Evaluation, University of Toronto, ON, Canada
Hospital, Houston, TX, United States Priyanka Upendra (390) Technology Management,
Francesca Satta (52) Health Technologies - AOU Careggi/ Banner Health, Phoenix, AZ, United States
Meyer—ESTAR, Florence, Italy Luis Vilcahuaman (94) Eng. Dep. & Health Technopole
Peter A. Schilder (707) Saftek Consulting (Pty) Ltd., Cape CENGETS, Pontifical Catholic University of Peru
Town, South Africa PUCP, Lima, Peru
Garrett Seeley (402) Biomedical Equipment Technology, Jorge Enrique Villamil Gutiérrez (75) Manuela Beltrán
Texas State Technical College, Waco, TX, United States University, Bogotá D.C., Colombia
xl  Contributors

Maja Peklić Vitt (715,753) Regulatory and Clinical Affairs Deliya B. Wesley (881) MedStar Health Research Institute and
Expert, Freiburg im Breisgau, Germany MedStar National Center for Human Factors in Healthcare,
Dijana Vuković (780) Faculty of Economics, University of MedStar Health, Washington, DC, United States
Bihac, Bihac, Bosnia and Herzegovina Dinsie Williams (795) Canadian Agency for Drugs and
Sam S.B. Wanda (161) Uganda National Association for Technologies in Health (CADTH), Ottawa, ON, Canada
Medical and Hospital Engineers, Kampala, Uganda Axel Wirth (253) US Healthcare Industry, Symantec
James O. Wear (289,297,377,416) Scientific Enterprises, Corporation
North Little Rock, AR, United States Rachel Wynn (881) MedStar Health Research Institute and
Danielle L.M. Weldon (887) National Center for Human MedStar National Center for Human Factors in Healthcare,
Factors in Healthcare, MedStar Health, Washington, MedStar Health, Washington, DC, United States
DC, United States Ewa Zalewska (137) Nalecz Institute of Biocybernetics
Joseph P. Welsh (648) Foundation for Living, Wellness, and Biomedical Engineering PAS, Warsaw, Poland
and Health, Osprey, FL; Computing Sciences, Villanova Raymond Peter Zambuto (166,384) Ashland; CEO
University, Villanova, PA, United States Technology in Medicine, Inc., Holliston, MA, United States
Foreword

The Sustainable Development Goals were launched in in science, technology, and clinical research. Revolutions of
2015 as 17 goals to transform the world. The health-related such scale and complexity are unprecedented in human his-
one, number 3, on good health and well-being, requires tory, and they require professionals to be aware and open
availability and appropriate use of medical technologies, to take coherent advantage of the burgeoning discoveries to
which is precisely the scope of this Clinical Engineering impact people’s health.
Handbook. While the modern world has many forms of “vertical”
Therefore, it is imperative to be ethical and professional, intelligence sectors—organized in academia, government,
and constantly attempt to improve the way all medical tech- industry, patients, and general population—a new challenge
nology is managed, to ensure universal health coverage, is to provide “horizontal” intelligence that enables the verti-
support health emergencies and outbreaks, and improve cal expertise to interact and evolve coherently in a respon-
population well-being. These goals are our professional re- sible, ethical, and conscious way to aim for a better world.
sponsibility and together we can accomplish it. As clinical The disjointed results in medical technology are often
engineers, let us continue to strive for it, wherever we live, costly, wasteful, stressful, inefficient, and sometimes even
wherever we are, for patients all around the world. Fifteen cause adverse events in health care. Clinical engineering at-
years ago, the first edition of this outstanding Handbook tempts to reduce these dysfunctions through a comprehen-
was published by Joe Dyro, and exponential developments sive program of professional education and specializations
in science and technology have impacted the health sector that fill critical gaps in institutional plans and processes.
since then. This second edition, led by Ernesto Iadanza and At the same time that new technologies are extending
multiple global authors, who have much advanced the clini- diagnostic and therapeutic capabilities from the macro level
cal engineering profession in their own settings, from hospi- down to the molecular and nanoscales of granularity, health-
tals and governments, to regional and global organizations, care services in many countries are expanding dramatically
all around the world, and have reinforced the development outward, beyond the traditional hospital-centric model into
and implementation of each of the facets hereby presented. homes, gyms, schools, and wearable sensors, as well as
The World Health Organization (WHO) has a specific via cellphones, tablets, mobile clinics, teleconsultations,
unit dedicated to medical devices that has collected global and portable diagnostic devices to remote, low-resource
information and developed guidance on policies, regulatory regions. This veritable flood of innovations poses signifi-
process, procurement, health technology assessment, com- cant, often destabilizing challenges for healthcare systems
puterized maintenance systems, and even lists of essential and worldwide, because public expectations escalate easily and
priority medical devices for clinical interventions by disease most hospitals and health authorities are not well equipped
areas, searching for an international nomenclature which will to track, evaluate, and incorporate changes of such mag-
support the global management of medical devices across nitude, complexity, cost, and functional interdependency.
healthcare sector stakeholders and produce guidance for all These changes originate across a wide spectrum of “verti-
countries. All of these tools form the standard direction to cal” scientific, technological, and clinical disciplines that
support better healthcare technology management and serve in many cases do not consider the ultimate impacts of such
as a basic framework for the compilation of resources pre- changes on the healthcare systems, and systems of sys-
sented throughout the various sections of this Handbook. tems that ultimately must integrate these innovations suc-
As can be noted in the Handbook, the role of the clini- cessfully and affordably for the benefit of patients and the
cal engineer has increased in scope and has overcome ­general population.
challenges globally. However, many challenges remain, es- The current innovation revolutions range across areas
pecially in low resource settings, and need to be tackled in a as diverse as biomimetic engineering, electronic medical
global and interactive manner. records, telehealth technologies, crowd-sourced pandemic
The world of health care is going through multiple revo- tracking, Big Data, telemedicine, robotics, 3D print-
lutions simultaneously as a result of accelerating innovations ing of prosthetics and organ tissue to nano- and molecular

xli
xlii  Foreword

e­ ngineering, m­ iniaturization of lab ­analytics, disaster man- s­ ectors in a more methodical and proactive manner as indi-
agement, microbiomes, and epigenetics. These innovations cated in the WHO medical devices technical series—from
put considerable change pressure on all healthcare systems, national policy, regulation, technical standards, professional
organizationally and individually—from national to local education, academic and industry R&D, device and service
levels—requiring increased attention to the design and as- design, prototyping, clinical research and trials, technology
sessment of medical devices, and to the multiple interdepen- assessment, contracting, supply chain and service strategy,
dencies that exist between medical devices, clinical and IT deployment, integration with IT and business systems, op-
processes, business systems, accreditation standards, staffing erational monitoring, process reengineering, device main-
models, scopes of professional practice, and expanding ser- tenance and repairs, hazard alerts and recalls, inventory
vice models oriented toward wellness promotion, the “medi- analysis, and replacement planning. This “lifecycle” intel-
cal home,” and “care anywhere.” ligence is an essential professional resource for any 21st-
Clinical engineering is a profession whose purpose is century healthcare innovator, manufacturer, planner, care
to understand, manage, and improve the lifecycle of oper- provider, or relevant government agency.
ational complexities of medical devices, systems, and ser- Clinical engineering is emerging as a mission-critical
vices in a disciplined and skilled manner, building on core profession for 21st-century health care, helping to or-
competencies that are augmented over time with specialized chestrate the diverse technical, clinical, and operational
training and project work with diverse stakeholders spanning concerns within a systems orientation that is dynamic, com-
the healthcare sector. Clinical engineers increasingly work prehensive, and evolutionary, in keeping with the enormous
across the entire spectrum of employment sectors to improve promise of the times. This book is a major contribution to
the design of medical devices and services, to improve stan- the evolution of the profession itself, and serves as a call to
dards and policies, to bring practical clinical experience into institutional leaders to look to clinical engineering to ex-
biomedical engineering projects at academic and R&D (re- pand the professional capabilities that healthcare systems
search and development) settings, and to provide ongoing need worldwide as they grapple with the often overwhelm-
expertise in the integration of healthcare innovations in hos- ing complexities, always keeping the end-user perspective
pitals, clinics, and decentralized services worldwide. of patients, and healthcare workers’ needs globally.
Through evidence-based understanding of the “system
lifecycle” of medical innovations, clinical engineers can Adriana Velazquez
help to integrate the vertical intelligences of the various Senior Advisor on Medical Devices, World Health Organization
Acknowledgments

I thank all the authors for their patience, professionalism, My special thanks goes to my father, to my children, and
and friendship shown throughout the long and demanding to my beloved better half, Gabriella, who has never spared
process of writing this important Handbook. A very heart- her support and her patience throughout these long two
felt thanks to all the section editors, who honor me with years of writing.
their friendship and have masterfully coordinated the work
of many colleagues.

xliii
Introduction

Clinical engineering e­ lectromagnetic interference in hospitals and a retrospec-

tive look at electrical safety round out this section.
The purpose of this second edition of the Clinical Engineering
Handbook is to provide a body of knowledge to all clinical
engineers who intend to practice their profession. The level Professionalism, education, and ethics
of medical equipment complexity and the required skills to
manage it are expanding at a tremendous rate. This is clearly Many aspects of professionalism have been addressed
reflected in the first section of the book, where hot topics over the years by some important associations, including
such as open-source medical devices, RFID, and facilities the International Federation for Medical and Biological
management are described, together with a long list of suc- Engineering (IFMBE) and the American College of Clinical
cess stories about clinical engineers from all over the world. Engineering (ACCE). Programs for certification and intern-
ship, training, distance education, in-service education, and
ethics are discussed in Section 6.
Worldwide clinical engineering practice
The context of clinical engineering can vary tremendously
from country to country. A highly detailed panorama of Medical devices: Design, manufacturing,
the situation in 21 countries, from all the continents of the evaluation, control, utilization, and
world, is provided in Section 2. service
Clinical engineers are very much involved in the whole
Health technology management ­lifecycle of a medical device, including its earliest stages,
One of the core disciplines in clinical engineering is the such as design and manufacturing. Comparative evaluations
management of healthcare technologies, involving assess- influence medical device research and design. Cutting-
ment, evaluation, procurement, control, asset management, edge technologies, such as surgical robots, are the result of
maintenance and repair, replacement planning, and more choral teamwork involving clinical engineers as core pro-
tasks. Sections 3 and 4 provide the reader with 22 chapters, fessional figures. Sections 7 and 8 provide the reader with
which dig into the details of each of these essential processes both a comprehensive picture of the above topics as well
and reflect the profound experience of professional leaders as a detailed description of the utilization and service of
from all over the world. Many tools, techniques, and some anesthesia machines, cardiovascular techniques and tech-
tricks can be found here, ready to be used in daily practice. nology, devices inspections, hospital beds, equipment for
intensive care units, devices for imaging, and incubators.
Safety
Information technology and mobile apps
The safety of patients, users, and healthcare structures is
one of the main reasons why clinical engineering simply ex- Twenty-first-century hospitals are steeped in computer sci-
ists. Preventing and managing the risks related to the use of ence. Designing the information systems and the integration
medical devices, in particular, is a core activity that requires and convergence of medical and information technologies
the perfect mastery of the techniques, programs, and regu- are key roles for clinical engineers today, as opposed to only
lations described in Section 5. Today wireless technologies a few short years ago. Clinical decision support systems,
are pervasive; numerous devices produce and are recep- very often exploiting artificial intelligence techniques, are
tive to electromagnetic fields, requiring attention to the ef- overwhelmingly entering our healthcare structures, some-
fects of interference caused by this energy. Key chapters on times revolutionizing the traditional chain of procurement

xlv
xlvi  Introduction

and management. This new scenario implies new aspects p­ roperties, effects and/or impacts of health technologies
about emerging interoperability standards for apps and the and interventions. It covers both the direct, intended con-
internet of things. Also, management of these complex in- sequences of technologies and interventions and their indi-
teroperable systems poses new challenges for clinical en- rect, unintended consequences.” Mastering these concepts
gineers, often involving forensic engineering. All of these and tools is vital to “inform policy and decision-making in
topics are thoroughly addressed in Section 9. health care, especially on how best to allocate limited funds
to health interventions and technologies.”
In Section 12, readers are exposed to many aspects of
Engineering the clinical environment, HTA that are particularly significant for assessing medical
medical device standards, regulations, devices: health economics, early stage HTA, tools such as
and the law multicriteria decision analysis (MCDA), how to teach HTA
It is critical to ensure a safe and well-run environment in all to biomedical engineers, and many others.
the places where medical care is offered to patients. The en-
gineering of physical plants, heating, ventilation, electrical Introduction to human factors
power, the design and management of medical gas systems,
Section 13 closes this Handbook with an interesting intro-
and disaster planning are just some of the key topics ad-
duction to human factors engineering, a journey through
dressed by Section 10. In Section 11, the reader will find an
the physiological and psychological aspects, cognitive er-
up-to-date overview of the most important regulations and
gonomics, safety science and cognitive informatics, which
laws for both hospital facilities safety and medical device
will enrich the reader’s cultural background with skills and
manufacturing and management, from a global perspective.
tools that are rarely covered in normal training courses for
biomedical and clinical engineering.
Health technology assessment Ernesto Iadanza
The World Health Organization defines health technol- Editor-in-Chief
ogy assessment (HTA) as “the systematic evaluation of Florence, Italy
Section 1

Clinical engineering
Ernesto Iadanza
IFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy

Ask any clinical engineer what other work he would have the hard task of acting as a mediator between such d­ ifferent
done if he had not become an engineer. The answer, with cultures, basing his work on the multidisciplinary nature of
very few exceptions, will always be the same: the doctor! his own skills.
In the word “clinical” itself the closeness of this profes- The dizzying speed at which healthcare technologies are
sional figure to the patient is inherent. A proximity, even progressing complicates things. Today’s hospitals are built
physical, represents an absolute exception in the vast field and managed in an extremely different way from what it has
of engineering. The clinical engineer is immersed in the been just 30 years ago. Telecommunications networks and
healthcare environment, without any doubt the most com- infrastructure in general have changed dramatically over the
plex environment imaginable, both from the point of view last 20 years. Today’s medicine is very different from that
of the quantity of risks present and from the point of view of just 10 years ago.
of the highly advanced technology present. All these require that the clinical engineer constantly
Try to compare a hospital to any other production process renew his skills, his way of working, and even his own lan-
(yes, this is what is done in hospitals: producing health!) and guage, throughout his professional life.
you will immediately realize the very high complexity that In this section of the Clinical Engineering Handbook we
characterizes every healthcare structure. The very presence wanted to give a “bird’s eye” picture of the above.
of the patient inside the structure introduces a high quantity The first chapter illustrates the evolution of the profes-
of risk factors which must be taken into account for safety sion, describing the high level of complexity of today’s
purposes. He is in fact in a condition of vulnerability and clinical engineering and underlining that such a high level
weakness due on the one hand to his health condition and of complexity on the scene requires a director and a team
on the other to the fact that he is in a structure in which he that must work in perfect harmony and with the total ability
knows nothing: neither spaces, nor people, nor technology. to manage complexity.
The number of electro-medical devices that are nowadays In the second chapter we face very modern issues such
connected to the patient, physically or not, easily exceeds as the creation of open-source medical devices. This chap-
two dozen. Minor indecision from the operator can cause ter takes the reader to a little-known world, showing how
harm to the patient. A minimum breakdown can be very dan- collaborative design of open-source medical devices can
gerous. On the other hand, accurate planning of the entire enhance the access to medical technologies, thanks to a fea-
life cycle of a hospital’s technological equipment can make sible reduction in design, management, maintenance, and
life easier for operators and can have a fantastic positive im- repairing costs.
pact on patients themselves and on the whole process. The third chapter provides a very long list of success
The conductor of this orchestra is the clinical engineer, stories from hundreds of clinical engineers from around the
who must have the right skills to understand when it is time world. The idea was born in Hangzhou China, in October
to turn to the pianist, when to the drummer, when to the gui- 2015, where the world’s leading experts gathered to devise
tarist, and when to all the instrumentalists together. Unlike a path to promote clinical engineering in the world. On the
what happens in a common musical orchestra, however, the occasion of the first Global Clinical Engineering Summit,
musicians in this case do not all speak the well-coded lan- we realized how much need there was to let a wide audience
guage of music, but they can use very different languages. A know what clinical engineers do for the benefit of the com-
medical device manufacturer, a manager, a patient, a doctor, munity. As a result, we collected hundreds of success stories
a technician, and an economist have extremely different cul- from 125 different countries! In this chapter many of them
tural and linguistic backgrounds. The clinical engineer has are listed and properly linked.

1
2 SECTION | 1 Clinical engineering

This section provides a complete overview of the use into the procurement process management of innovative
of RFID (radio-frequency identification) technologies in medical technologies, close this rich section of the Clinical
the health sector. Two focuses: one showing how computer- Engineering Handbook.
aided facility management relates to the profession of to- Enjoy the reading!
day’s clinical engineers and the other providing deep insight
Chapter 1

Clinical engineering
Ernesto Iadanza
IFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy

Medicine core tasks, such as diagnosis and therapy, have Actually a general and simple definition of clinical en-
always been intimately linked to using tools ranging from gineering could be the application of engineering skills
stethoscopes to plasters and gauzes. Today’s medicine is and methodologies and approach for the benefit of the
grounded on the use of a huge amount of these tools called patient.
medical devices. The simplest stethoscopes, plasters, and Over the years some organizations have provided their
gauzes are still there, but they are now in the good com- definition for “clinical engineer,” reflecting their vision.
pany of the most cutting-edge technologies. Not a single Among them, the American College of Clinical Engineers
activity in today’s modern healthcare setting would be pos- (ACCE) in 1992 provided the following definition:
sible without making use of dozens of pieces of equipment,
A Clinical Engineer is a professional who supports and ad-
both hardware and software. This brings a whole new set
vances patient care by applying engineering and managerial
of ­exciting possibilities. Nevertheless, such a high level of
skills to healthcare technology.
complexity on the scene requires a director and a team that
must work in perfect harmony and with the total ability to (American College of Clinical Engineering, 2019)
manage complexity. To quote Uncle Ben (yes, Spider-Man’s
A broader definition was provided at the first Global
uncle): “with great power comes great responsibility!”
Clinical Engineering Summit (Hangzhou, China, October
23, 2015) where 36 representatives from national and in-
What is clinical engineering? ternational societies convened. As a result of that summit,
a document has been outlined to define the main activities
Since words are important, a quick online search on the
describing biomedical engineers and clinical engineers. The
Online Etymology Dictionary for the word “clinical” brings
clinical engineer was described as
us to this result:
A professional who is qualified by education and/or registra-
clinical (adj.)
tion to practice engineering in the health-care environment
1780, “pertaining to hospital patients or hospital care,” from
where technology is created, deployed, taught, regulated,
clinic + -al (2). […]
managed, or maintained related to health services. Other
(Online Etymology Dictionary, 2019) related terms used for the CE role in developing countries
include biomedical engineer, and rehabilitation engineer.
If we carry on searching for “clinic” on the same dic-
tionary, this is the result: (IFMBE/CED Definitions, 2019)

clinic (n.) The World Health Organization (WHO) noted in 2018

1620s, “bedridden person, one confined to his bed by sick- that it is critical that “trained and qualified medical engi-
ness,” from French clinique (17c.), from Latin clinicus “phy- neering professionals are required to design, evaluate, regu-
sician that visits patients in their beds,” from Greek klinike late, maintain, and manage medical devices, and train on
(techne) “(practice) at the sickbed,” from klinikos “of the their safe use in health systems around the world. This role
bed,” from kline “bed, couch, that on which one lies,” from is referred to as clinical engineering (CE), biomedical en-
suffixed form of PIE root *klei- “to lean.” gineering (BE), and/or healthcare technology management
(HTM) dependent on regional terminology.” WHO often
(Online Etymology Dictionary, 2019)
uses the term “biomedical engineer” as one who practices
Therefore, the concept of leaning on the patient is clinical engineering (IFMBE/CED CE-HTM Definitions,
embedded in the actual “clinical engineering” locution. 2019).

Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00001-8

Copyright © 2020 Elsevier Inc. All rights reserved. 3
Visit https://textbookfull.com
now to explore a rich
collection of eBooks, textbook
and enjoy exciting offers!
4 SECTION | 1 Clinical engineering

In the first edition of the same book, Joseph D. Bronzino • Field service support
provided the following list of some typical pursuits, that is • Security/privacy/cybersecurity
still valid: • Forensic engineering/investigation
• Manufacturing practices such as QMS (quality manage-
• Supervision of a hospital clinical engineering depart-
ment system), GMP (good manufacturing practice)
ment that includes clinical engineers and biomedical
• Medical imaging
equipment technicians (BMETs)
• Project management
• Prepurchase evaluation and planning for new medical
• Robotics
technology
• Virtual environments
• Design, modification, or repair of sophisticated medical
• Risk management
instruments or systems
• EMI (electromagnetic interference)/EMC (electromag-
• Cost-effective management of a medical equipment cal-
netic compatibility) compliance
ibration and repair service
• Technology innovation strategies
• Safety and performance testing of medical equipment
• Population- and community-based needs assessment
by BMETs
• Engineering asset management
• Inspection of all incoming equipment (new and return-
• Environmental health
ing repairs)
• Systems science
• Establishment of performance benchmarks for all
equipment This list, far from wanting to be exhaustive of all the
• Medical equipment inventory control possible topics, gives quite an impressive idea—if read to-
• Coordination of outside services and vendors gether with the previous one—of how quickly the role of the
• Training of medical personnel for the safe and effective clinical engineer is expanding. Today’s clinical engineers
use of medical devices and systems must face a dramatically increased set of scenarios, compe-
• Clinical application engineering, such as custom modi- tences, and skills. Agreeing that this cannot be a task for a
fication of medical devices for clinical research or eval- single professional, the clinical engineer is today asked to
uation of new noninvasive monitoring systems be a capable and competent manager of a larger and larger
• Biomedical computer support team of collaborators and professionals.
• Input to the design of clinical facilities where medical
technology is used [e.g., operating rooms (ORs) or in-
tensive care units] Fields of knowledge
• Development and implementation of documentation
Section VII in this book treats the subject of education
protocols required by external accreditation and licens-
exhaustively. Here the syllabus of two Master’s Degrees
ing agencies (Bronzino, 2004)
in Clinical Engineering, designed by the author for the
On the occasion of the aforementioned first Global University of Florence, is just briefly reported. For a better
Clinical Engineering Summit (Hangzhou, China, October comprehension it is worth explaining that “first level mas-
23, 2015), a document has been outlined to define the ter” refers to a 1-year program for graduates with a 3-year
main activities describing biomedical engineers and clini- degree, while “second level master” refers to a 1-year pro-
cal engineers. In that document, as described by Iadanza gram for postgraduate candidates holding a 5-year laurea
(2018), there is quite a long list of subtopics of biomedical degree.
engineering, listed as “Application and operation: Clinical First level master in clinical engineering
Engineering” and reported here:
• Fundamentals of bioengineering
• Technology management • Fundamentals of clinical engineering
• Quality and regulatory assurance • General and organizational models
• Education and training • Audits and technology management
• Ethics committee and clinical trials • Evaluate technologies and systems
• Disaster preparedness • Medical devices, software, and systems
• e-health (telemedicine, m-health) • Electrical medical systems
• Wearable sensors/products • Elements of instrumentation and biomedical technologies
• Health economics • Biomedical instrumentation
• Health systems engineering • Systems diagnostic imaging
• Health technology assessment/evaluation • Innovative applications
• Health informatics • Management tools
• Service delivery management • Wireless systems
 Clinical engineering Chapter | 1 5

Service General For example, if it is true that computer support in terms

HTM delivery management of maintenance does certainly not become a regular part
management
of clinical engineers’ duties (with some exceptions), it is
Risk
Education of
management CE-IT also certainly true that there is almost no piece of medi-
others /safety cal equipment that does not embed a computer, today. In
that sense, clinical engineers are managing the whole life
Testing, Disaster
Facilities
evaluation, cycle of these “computers!” Moreover, all kinds of mobile
management preparedness
modification devices and apps are currently used by healthcare personnel
for managing every aspect of their profession. Managing
HTA Lean thinking
such complex processes will be daily bread for the clinical
Quality
engineers of tomorrow.
Let us continue our journey back in time and read what
Bronzino said about telecommunications: “Hospitals are
Procurement Mobile apps Models also making increased use of facsimile (fax) transmission.
This equipment allows documents, such as patient charts,
to be sent via telephone line from a remote location and re-
FIG. 1 Some of the fields of knowledge involving clinical engineering.
constructed at the receiving site in a matter of minutes. […]
Some newer equipment allows pictorial information, such
Second level master as patient slides, to be digitally transmitted via a phone
• General and organizational models line and then electronically reassembled to produce a video
• Organization of health systems and regional models image” (Bronzino, 2004). Well, knowing what happened
• Planning, monitoring, and evaluation of performance since then puts a smile on our face. Our future readers will
• Human resource management definitely have the same smile reading the description of
• Economic and financial instruments in health care today’s virtual/augmented reality applications in surgery,
• Project management in health care the current three-dimensional (3D) printing facilities, and
• Principles and methods of Health Technology Assessment the brand new 5G (fifth-generation) networks. One thing is
(HTA) sure: safe and powerful telecommunications infrastructures
• Methodology, research, and review are today (and will be more and more) as necessary for hos-
• Technical, economic, and social aspects pitals as water for human beings.
• Design, innovation, and sustainability Similar considerations can be made for facilities
• Legal aspects of clinical engineering ­operations and strategic planning. The modern hospitals
• Data management and information are designed using the most advanced Building Information
• Health information systems Modeling (BIM) tools, providing a 3D virtual model of the
• Telematics, telemedicine, and health services in the area whole structure, including the plants (e.g., medical gasses)
and the embedded technologies. These systems have already
Fig. 1 summarizes just some of the fields in which to- become everyday tools to effectively manage all kinds of
day’s clinical engineers are involved. healthcare activities, including clinical engineering services.
New approaches are continuously appearing on the scene
New challenges of clinical engineering, a discipline in continuous evolution.
Planning the maintenance based on real evidence (Evidence
As an exercise, let us go back about 15 years and read Based Maintenance, EBM) has started to become a real-
again what Bronzino identified as topics for the “Future of ity in some facilities (Gonnelli et al., 2018; Iadanza et al.,
Clinical Engineering” at the end of his chapter “Clinical 2019). The growing availability of big data, the interoper-
Engineering: Evolution of a Discipline” in the first edition ability of systems as well as the rapid diffusion of machine
of his book (Bronzino, 2004): learning and deep learning techniques will certainly provide
• Computer support the clinical engineers of the future with new sophisticated
• Telecommunications approaches and techniques.
• Facilities operations
• Strategic planning References
Well, maybe not surprisingly, nowadays the above list American College of Clinical Engineering, 2019. Retrieved from: https://
of topics forms a good part of the core services provided by accenet.org/about/Pages/ClinicalEngineer.aspx.
clinical engineering departments all over the world, maybe Bronzino, J.D., 2004. Clinical engineering: evolution of a discipline.
not in the sense that was conceived back in 2004, but it is. In: Dyro, J.F. (Ed.), Biomedical Engineering, Clinical Engineering
6 SECTION | 1 Clinical engineering

Handbook. Academic Press, ISBN: 9780122265709, pp. 3–7. https:// test procedure, risk analysis, and technical solution. Proc. IEEE 98 (9),
doi.org/10.1016/B978-012226570-9/50003-X. http://www.sciencedi- art. no. 5508336, 1656–1662.
rect.com/science/article/pii/B978012226570950003X. Iadanza, E., Marzi, L., Dori, F., Gentili, G.B., Torricelli, M.C., 2007.
Gonnelli, V., Satta, F., Frosini, F., Iadanza, E., 2018. Evidence-based ap- Hospital health care offer. A monitoring multidisciplinar approach. In:
proach to medical equipment maintenance monitoring. In: IFMBE IFMBE Proceedings, vol. 14 (1), pp. 3685–3688.
Proceedings, vol. 65. Springer, Singapore. Iadanza, E., Dori, F., Miniati, R., Corrado, E., 2010. Electromagnetic in-
Iadanza, E., 2018. IFMBE/Clinical Engineering Division projects for the terferences (EMI) from active RFId on critical care equipment. In:
advancement of the profession of clinical engineering. In: IFMBE IFMBE Proceedings. 29, pp. 991–994.
Proceedings, vol. 65. Springer, Singapore. Iadanza, E., Baroncelli, L., Manetti, A., Dori, F., Miniati, R., Gentili, G.B.,
Iadanza, E., Gonnelli, V., Satta, F., Gherardelli, M., 2019. Evidence-based 2011. An rFId Smart container to perform drugs administration reduc-
medical equipment management: a convenient implementation. Med. ing adverse drug events. In: IFMBE Proceedings, vol. 37, pp. 679–682.
Biol. Eng. Comput. https://doi.org/10.1007/s11517-019-02021-x. Iadanza, E., Chini, M., Marini, F., 2013. Electromagnetic compatibility:
IFMBE/CED CE-HTM Definitions, 2019. Retrieved from: https://ced.if- RFID and medical equipment in hospitals. In: IFMBE Proceedings,
mbe.org/resources/ce-htm-definitions.html. vol. 39. IFMBE, pp. 732–735.
IFMBE/CED Definitions, 2019. Retrieved from: http://cedglobal.org/ Luschi, A., Belardinelli, A., Marzi, L., Frosini, F., Miniati, R., Iadanza,
definitions/. E., 2014a. Careggi Smart hospital: a mobile app for patients, citizens
Online Etymology Dictionary, 2019. Retrieved from: https://www.etymon- and healthcare staff. In: 2014 IEEE-EMBS International Conference
line.com. on Biomedical and Health Informatics, BHI 2014, art. no. 6864320.
pp. 125–128.
Luschi, A., Marzi, L., Miniati, R., Iadanza, E., 2014b. A custom decision-
Further reading support information system for structural and technological analysis in
Badnjevic, A., Gurbeta, L., Jimenez, E.R., Iadanza, E., 2017. Testing of healthcare. In: IFMBE Proceedings, vol. 41, pp. 1350–1353.
mechanical ventilators and infant incubators in healthcare institutions. Miniati, R., Dori, F., Iadanza, E., Fregonara, M.M., Gentili, G.B., 2011.
Technol. Health Care 25 (2), 237–250. Health technology management: a database analysis as support of
Biffi Gentili, G., Dori, F., Iadanza, E., 2010. Dual-frequency active RFID technology managers in hospitals. Technol. Health Care 19 (6),
solution for tracking patients in a children’s hospital. Design method, 445–454.
Chapter 2

Open-source medical devices:

Healthcare solutions for low-,
middle-, and high-resource
settings
Carmelo De Mariaa, Licia Di Pietroa, Alice Ravizzab, Andres Diaz Lantadac,
Arti Devi Ahluwaliaa
a
Research Center E. Piaggio and Department of Information Engineering, University of Pisa, Pisa, Italy,
b
Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Torino, Italy, cDepartment of
Mechanical Engineering, Universidad Politécnica de Madrid, Madrid, Spain

Increasing the access to medical devices: l­ ow-income countries more than 80% of medical equipment
The need for alternative strategies for is donated, but only 10%–30% of these become operational,
given the high operating cost, the lack of personnel, and the
innovation frequent failures due to harsh environment, extreme climate
Medical technology is one of the pillars of an effective conditions, humidity, dust, and power instability (Steinberg
healthcare system, as recognized by the United Nations et al., 2015; World Health Organization, 2010a,b; Iadanza
Member States in the 2030 Agenda for Sustainable and Dyro, 2004; Malkin, 2007; Lustick and Zaman, 2011).
Development Goals (SDGs) (UN, 2019), which strives These conditions are usually not taken into account during
for the achievement of inclusive and sustainable develop- the design phase causing more frequent failures and deter-
ment, drawn on the principle of “leaving no one behind.” mining a higher request for spare parts, which are expensive
Furthermore, increasing the access to medical devices and difficult to find, making maintenance and repairing as
(MDs) has been included by the World Health Organization problematic as acquisition (Malkin, 2007).
(WHO) as one of the six leadership priorities to promote Developing sustainable medical technologies to make
health throughout the whole lifetime. health care affordable to a larger population, and thus re-
However, the overall high costs of MDs create a barrier ducing global inequalities, can only be performed taking
for achieving this target. The necessity to guarantee efficacy into account the cultural, socioeconomic context, and the
of the device and safety for patients, healthcare providers, ­environment-climate constraints in which these will be applied
bystanders and, in the broader view, the health and thus (Malkin, 2007; Lustick and Zaman, 2011; Douglas, 2011).
the wealth of a country (Lissel et al., 2016) has brought to However, in many cases patients’ or medical profession-
strict norms and to control each step of the long life cycle als’ needs are considered as a minor part of the decision-
of a MD (design, prototyping, manufacturing, labeling and making process and, under the pressure of marketing and
packaging, provision, installation, operation, maintenance, immediate payback, often clinical needs of rare pathologies
repair and disposal). This “safety by design” and the qual- and of low-resource settings are left unattended (Fasterholdt
ity control determine a higher production cost. It has been et al., 2018).
estimated that developing a MD from the idea to the mar- In contrast with the biomedical industry, many product
ket has a cost of around $31 million for a low-to-moderate- fields have experienced a paradigm shift from a “close” to
risk device, and around $94 million for high-risk products an “open innovation,” by now involving often stakehold-
(Steinberg et al., 2015). ers and future users since the beginning of the product de-
Removing the charge on a single step could not make velopment process (Ng and Jee, 2014; Gao and Bernard,
the difference. For example, the WHO estimates that in 2017).

Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00002-X

Copyright © 2020 Elsevier Inc. All rights reserved. 7
8 SECTION | 1 Clinical engineering

Thanks to the web and the social networking, with the on the web (Niezen et al., 2016); however only some of
support of cloud-based design and prototyping (Wu et al., them have been designed to be compliant with MD legisla-
2015), this new approach of social product development tion (GammaCardioSoft S.r.l., 2019; Ferretti et al., 2017;
has taken place, with the creation of virtual communities Arcarisi et al., 2019) (Fig. 1).
that actively develop innovative solutions (Perilli, 2017; Open-source medical devices (OSMDs) and their
Sarmah and Rahman, 2017), freely shared on online reposi- boundaries should be adequately defined, to have a real im-
tories, such as Thingiverse or GrabCAD, born in the wake pact on the medical industry and healthcare systems. In the
of the “Makers” movement (Gershenfeld, 2005; Rosenfeld following sections, a reasoned definition of OSMD is pro-
Halverson and Sheridan, 2014). posed, and the underlying enabling technologies and sup-
Indeed, the benefit of collaborative and open-source de- porting practices are provided.
sign, in terms accessibility, sustainability, lower costs, im-
proved performance, and safety, has been widely exploited Open-source medical device definition
in software development (Lessig et al., 2005) and is under
consideration also in the academic research in several fields The construction of the OSMDs definition is based on the
from biology to nanotechnology (Oberloier and Pearce, currently recognized statement on MD endorsed by WHO
2018; Mushtaq and Pearce, 2018). (World Health Organization, 2019) and on the successful ex-
However, more safety and security-sensitive fields, in- amples of the open-source software (Open Source Initiative,
cluding health care, are still reluctant to taking advantage of 2019) and hardware movements (Open Source Hardware
the enormous potentials of open-source and collaborative Association, 2019), and on the principles expressed in the
approach toward a social development of MDs, although it Kahawa Declaration (Ahluwalia et al., 2018a), a manifesto
has the potential to increase the access to medical technolo- for the democratization of medical technologies, signed by
gies, thanks to a feasible reduction in design, management, representatives of biomedical engineering (BME) commu-
maintenance, and repairing costs, due to the open access nity in Europe and Africa.
to device blueprints (De Maria et al., 2018). In the medi-
cal industry, it is crucial to ensure the safety and efficacy
Medical device
requirements of medical technology and for this reason the
adoption of open resources must follow the standards and According to the International Medical Device Regulators
the current regulations (DeMaria et al., 2015). Several ex- Forum (IMDRF) [ref] and recognized by WHO (World
amples of healthcare-related technologies have appeared Health Organization, 2019), “Medical device means any

(A)
HV-board Internal
Charging
power Capacitor H-bridge discharge
circuit
supply Inner Selector
circuit

Connector Connector
Battery Patient
Outer Selector
High-voltage Board

PSOC
C-board
power I/O
supply
Control Board

(B) (C)
FIG. 1 Examples of open-source medical devices: Prosthetic hand (e-NABLE Community, 2019) (A); Device for breast self-examination (Arcarisi
et al., 2019) (B); schematic of an open-source automatic external defibrillator compliant to standards (C) (Ferretti et al., 2017).
Random documents with unrelated
content Scribd suggests to you:
 "Stuff and nonsense!" said Jack, laughing heartily. "As if
it mattered who took the letter, so long as the doctor gets
it? and Mike will be there long before you would; so it's a
good job, whichever way you look at it."

"Perhaps I had better go with Mike," I said, "if he'll be

so good as to give me a lift."

"But Mike isn't coming back again," said Jack; "he's

going to stay in Calvington all day at his aunt's; aren't you,
Mike? And so you'd just have to toil these weary miles back
again in the heat and dust. Don't be a fool now, Peter!"

I did not like being called a fool, and so, although my

conscience told me I was doing wrong, I handed my letter
to Mike, and he drove away.

"Now come along with me, Peter," said Jack, when Mike
had disappeared round a turning in the road.

"Come where?" I asked.

"Down to the sea," said Jack; "we can be there in three

minutes across this field."

"Oh, no," I said. "I must go home now."

"Nonsense about going home!" he said. "That's the very

thing you mustn't do! Your mistress will soon smell a rat if
you go home now. She'll want to know why you've been so
quick, and then it will all come out. Let us see, if you
walked to Calvington, you could not be back here before
two o'clock at the earliest; so we've two hours and a half, at
least, to enjoy ourselves. I'll take you to the Robber's Cave.
You've never seen it, have you?"
 "No, never," I said. "I should like to see it very much;
but I think I ought to go back."

"Don't be such a stupid!" said Jack, as he sprang over

the stile which led into the field.

I knew I was doing wrong, and yet I followed him, for—

I am ashamed to say—I was afraid of him. I could not bear
to be laughed at, or to be called a fool or a stupid, so I did
what my conscience told me, again and again, that I ought
not to do.

Yet for a time all seemed very pleasant. I told

conscience to be quiet, and made up my mind to enjoy
myself till two o'clock.

It was cool and pleasant by the sea, and we had a

bathe, and then we climbed along the cliff to the Robber's
Cave. It was a very curious place, and we examined every
nook and corner of it, and we sat inside it for some time, for
it was so pleasant and refreshing to get out of the glare and
heat of the sun.

But while we were sitting down in the cave talking and

laughing we suddenly heard a rumble of distant thunder.

"It seems to be a storm coming up," said Jack; "let's

climb up and see."

The sky was wonderfully changed since we went into

the cave about half an hour before; it was quite black now,
and the birds flew about wildly in all directions.

We climbed down from the cave, and picked our way

along the shore over the rough rocks and shingles, until we
came to the pathway leading up to the top of the cliffs. As
we went along, the storm increased; and by the time we
reached this path it had begun to rain.

"We shall have a pelter in a minute," said Jack; "let's

run for it."

We went at a tremendous pace up the cliff, and then

tore across the field, for the rain was coming down very fast
now. We did not stop to breathe till we had rushed through
the open door of a public-house which stood on the road,
about a hundred yards from the path leading down to the
sea.

"Now," said Jack, "we're all right; that was well done!
But we're only just in time," he said, as there came a vivid
flash of lightning, a loud clap of thunder, and a tremendous
downpour of rain.

"What will you drink, Peter?" he said. "Whiskey or

beer?"

"Nothing, thank you," I said; "I never take anything of

the kind."

"Oh, rubbish," he said; "you must drink something. Now

you've come to take shelter here, for the good of the house
you couldn't be so mean as to come in and to take nothing."

A third time conscience raised her warning voice, and a

third time I would not listen to her, and for the very same
reason—because I was a coward, afraid to do that which I
knew was right.

"Two for whiskey," said Jack to the landlord, as he

opened the door of the little inn parlor.
 CHAPTER X.
THE STORM.

WE were sitting with our glasses in our hands, and Jack

was making all sorts of absurd speeches, and was proposing
my health, and the landlord's health, and the health of the
rest of the company in the room, when there came art
unusually bright flash of lightning, which made us all start,
followed immediately by a peal of thunder, which sounded
as if the house were falling over our heads.

"Good gracious!" said Jack. "That was a whacker! I shall

have to drink Mr. Thunder's health next!"

But I could not join in the laugh with which he followed

this silly speech. That flash of lightning had made me think
of the storm on the night of Salome's fifth birthday; and
with the thought of the storm came the remembrance of
Salome's text:
 "One shall be taken, and the other left," and of
Salome's sorrowful words, as she clung to me that night:

"You mustn't be left, Peter; they must take you too!"

Then I thought of the first rule on my card: "Do nothing

that you would not like to be doing when Jesus comes." I
certainly should not like to be sitting drinking whiskey and
neglecting my duty, as I was doing then.

I thought of the second rule on my card: "Go to no

place where you would not like to be found when Jesus
comes." I certainly should not like to be found in this public-
house, and in the company of the idle drinking fellows with
whom the room was filled.

I thought of the third rule on my card: "Say nothing

that you would not like to be saying when Jesus comes."
There were a great many silly and foolish things I had said
since I came into that place which I should not like to have
been saying if that flash of lightning had been the flash of
glory at the appearing of the Lord Jesus Christ. What if He
were really to come while I was there!

I felt very much afraid, and Jack told me I was as glum

as an old sulky owl. I was very glad when the rain was over,
and I could get outside again. Then I bid Jack good-day,
and hurried home as fast as I could.

I took off my tidy clothes, and went at once into the

stable to clean and polish the harness. I kept an anxious
eye on the road all the afternoon, hoping to see the doctor's
carriage on its way to the house. But the hours went by,
and tea-time came, and he had not arrived.

"Master Reggie has got a bad turn, he has," said Bagot

to his wife; "it's going to be croup, our lady thinks. I wish
that doctor would look sharp; I do indeed."

But time still went on, and no doctor appeared. Could

Mike have delivered my letter, or was it possible that he had
forgotten it? I got more and more anxious every moment.

At last I could bear it no longer, and I did what I ought

to have done long before—I told the whole story to Bagot. I
did not omit to tell him of the storm, and how it had
reminded me of the three forgotten rules.

"Ay, Peter, my lad," he said, "it's a sad tale, that is; but
I'm glad you've made a clean breast of it, I am, and I'm
very thankful the Lord didn't come to-day and find you
wandering out of His ways. I'll step across and tell our lady,
and see what she thinks had best be done."

"Wait a minute, Bagot," I said; "tell her I've gone off

now to see if the doctor has got the letter. I will start at
once, and go as quick as ever I can."

"Get a bit of supper first, my lad," said Bagot, kindly.

But I would not hear of waiting a moment, and I set off

at a running pace towards Calvington. Of course I could not
keep this up long, and it seemed a long way; but the air
was cooler than in the morning, which was a great help to
me.

It must have been about ten o'clock when I reached the

doctor's house. His gig was standing at the door, and the
doctor came out and jumped into it as I came up. He was
just setting off for Grassbourne. He had only received my
mistress's letter a few minutes before. The careless Mike
had dropped it on the road, and some one had picked it up
and brought it to the doctor's house.
 I told him how ill Master Reggie was, and that my
mistress thought that he was going to have croup; and he
ran back into his surgery to get several things that might be
wanted, and then drove off at a tremendous pace towards
Grassbourne.

I went home more slowly than I had come, and it was

near midnight when I reached the avenue gate. To my
surprise, I found Bagot standing there, leaning against the
gate, as if he were waiting for me. He was very kind to me
—more kind than I deserved, I thought; but he seemed
very downcast.

"Is he worse, Bagot?" I asked.

"No, he's a wee bit better, he is," said Bagot. "The

doctor is going to stay till morning, though. I've been
helping his man to take the horse out, I have."

He took me in, and Mrs. Bagot was still up, and had a
good supper ready for me on the table. She, too, was more
kind to me than ever; but neither of them spoke much while
I was eating my supper.

As soon as I had finished, Bagot said, taking an

envelope from his pocket—"Shall I give it him now, old
wife?"

"Yes, Jem," she said, "now that he's had his supper, you
had best let him read it."

Bagot handed me a telegram, and I read as follows:

"Salome is very ill indeed, and cries for you. Can you be
spared to come and see her?"

I sat looking at it for a long time without speaking.

 Then Bagot said, "Poor lad, I'm awful sorry for you, I
am; but cheer up—maybe she'll be better soon."

"Can I go, do you think, Bagot?" I said.

"Yes, I'm sure you may," he said. "Run over with the
letter to the house, and ask to speak a word with our lady.
They're all sitting up with the child."

I went as he advised me, and the cook gave me a jug of

hot water to carry, which was wanted upstairs, and I took it
as quietly as I could into the sickroom.

I TOOK IT AS QUIETLY AS I COULD INTO THE SICK-ROOM.

Master Reggie was in great pain, gasping for breath,

and the doctor and his mother and the nurse were standing
round him, doing all they could to help him. He saw me
come in, and smiled, and tried to speak, but I could not tell
what he said.

My mistress followed me out of the room.

"Can you ever forgive me, ma'am?" I said.

"I do forgive you, Peter," she answered, "for I know how

sorry you are. And I think—I hope—it would not have made
much difference if the doctor had been here before, for he
says that I had done all that could have been done before
he came."

Then I handed her the telegram, and tears came in her

eyes as she read it, for I had told her about Salome, and
she knew how much I loved her.

"Trouble everywhere, Peter," she said. "Yes, you may

go, and you may stay a few days if you can be of any use."

I thanked her very much, and she crept into the room
again.

We did not go to bed for a long time after that. We sat

round the kitchen fire, and Bagot stepped over to the house
every half-hour to ask in the kitchen how the child was; and
it was not until he brought us word that Master Reggie was
asleep, and that the doctor said all danger was over for the
present, and that he was preparing to go home, that we
could make up our minds to go upstairs.

I had a very short night, for the train started at eight

o'clock, and I had to walk to the station.

When I arrived at home, I went at once upstairs to

Salome's room, and I found my mother, looking very worn
and tired, watching beside her. Salome seemed to be quite
unconscious; she did not know me when I went in, though
my mother said she had called for me many times in the
night. She was talking wildly and strangely, and I thought
she looked very ill indeed. My mother said she did not know
what was the matter with her; she had been ill now for
some days, and every day she grew worse.

The doctor came soon after I arrived, and my mother

went downstairs with him, and left me with Salome. When
she came back, she said—

"Peter, it's a bad job; we oughtn't ever to have sent for

you; the doctor says he is pretty certain now that it's scarlet
fever, which hasn't come out properly. Whatever shall we
do?"

And my poor mother burst into tears.

 CHAPTER XI.
A TERRIBLE TIME.

OF course my going back to Grassbourne, to carry the

infection with me, was out of the question. I wrote to my
mistress, and told her the state of the case, and then I was
able to relieve my poor mother very much, by taking entire
charge of Salome.

She was very ill, and as the days went by she grew
worse. The doctor was proved right in his opinion of the
complaint, for the very day after I arrived Bartholomew and
Jude were both taken ill with the fever, and two days after
that Thomas fell ill, and about a week after, Matthew and
Simon were also smitten.

It was a terrible time. As I look back upon it now, I

wonder how we ever bore up as we did. We had six of them
ill at once, so ill that the doctor shook his head each time
he saw them, and said he was afraid they would none of
them pull through. My poor mother was up night and day,
going from one bed to another with a white and anxious
face.

My father said little, as was his nature under all

circumstances, but he felt it deeply. He would wander about
the house sighing loudly, and would stand beside the doors
of the two sick-rooms for hours together, that he might be
at hand to fetch or to carry anything, or to help us in any
way he could. He felt it all the more, I think, from his
having so little to do. He was a very honorable man, and he
made no secret of our having the fever in the house. As
soon as the doctor had told him that it was a case of
malignant scarlet fever, he had let all his customers know,
for he thought that concealment in such a case was both
cruel and wicked.

So few came to the shop, and the till was very empty
during that time of sorrow.

I had much time for thought during the weeks which

followed. As I was sitting up at night, watching beside
Salome and Jude and Simon, my mind was very busy, and
my heart was very much troubled. And yet I could not pray.
I felt as if there were a great wall between me and God,
and if I tried to pray, the words seemed to come back to
me, as if they could not pierce the separating wall. It was
my sin which had come between me and my Master. I knew
that well enough, and I was very miserable when I thought
of it.

But one night I took up Salome's Testament, the one I

had given her on her fifth birthday, which was lying on a
table near her bed. I opened it to see if I could get any
word of comfort, and my eyes fell upon these words:

"The Lord turned, and looked upon Peter."

If an angel had said them to me, they could not have

seemed to come more direct from heaven.

I had sinned against my Lord, the Lord who had loved

me so much, yet now He was turning His face not away
from me, but towards me; He was looking at me, not with
anger, nor with scorn, but with tender, sorrowful love. Oh!
How could I ever grieve such a Master as that. Like Peter in
the Gospels, as I sat in that quiet sickroom, I wept bitterly.

And then came comfort; I could pray now. That look of

the Lord Jesus had taken away the wall. I could call on Him
now and ask Him to forgive me, and never to let me leave
Him again.

If I had not come back to the Lord Jesus that night, and
had the comfort of feeling His presence very near me, I do
not know how I should have gone through the next terrible
week. Sickness and sorrow had been in our home before;
but now the angel of death drew near.

I had felt sure from the very first that Salome would
die. She seemed to me so unlike every one else, and so fit
for heaven, that I had no doubt whatever in my own mind
that the Master's voice would call her to Himself.

"'One shall be taken, and the other left,'" I said to

myself over and over again, as I sat beside her at night,
"Salome taken—Peter left."

Even the sound of her breathing seemed to be saying

the same words to me in the dark, silent night. "'One taken,
another left; one taken, another left.'" And the steps of the
passers-by in the street, when morning dawned, echoed the
same words, "'One taken, another left.'"

But the words were to come true in a different way from

what I had expected.
 CHAPTER XII.
SALOME'S RECOVERY.

IT was the night on which Salome seemed most ill;

indeed, her face looked so altered and strange, that I
thought every breath might be her last. I felt sure that the
angel of death was in the room that night.

He was in the room, but it was not for Salome that he

had come. Little Jude was taken, and Salome was left. And
two days afterwards the angel of death came again, and
Bartholomew was taken; and then after a few more days,
Simon and Thomas were taken, and still Salome was left.
But the doctor still would give very little hope; she might
pull through, he said, but he did not think it was likely that
she would.

That was a terrible time for us all.

It was a terrible time for my poor father, for he loved

his children very deeply, and after he and I had followed
one little coffin after another to the grave, he would come
home and sit for hours with his head resting on his hands,
not speaking a word, but full of sorrowful thought.

It was a terrible time for my poor mother. I felt sure she

would be ill when it was all over. She had cried bitterly when
little Jude was taken; but after that she seemed as if she
could not cry, as if her tears were locked up, and as if she
were doing everything she did in her sleep. Indeed, I
believe it seemed to her more like an awful dream than a
real trouble.

Poor father and mother, they had no heavenly

comforter; the Lord was not at that time their Friend and
their Saviour! But this very sorrow, which seemed the worst
thing which could have happened to us, was to be used by
God to bring them to Himself.

One night—I think it was the night after Simon and

Thomas had been laid in the grave—we were sitting in
Salome's room. She was conscious now, and the fever had
quite left her; but she was very weak—so weak that I was
afraid to let her talk; so weak that she was as helpless as a
little baby. Matthew was much better; he had not had the
fever so badly as the others, and he was sitting up in bed.

"There seems nothing to do," said mother that night, as

she sat by the fire in her black dress; and for the very first
time since little Jude had died she burst into tears.

I knew it would do her good to cry, so I did not stop her,

but I laid my head on her shoulder, and we cried together,
and my father, who was sitting near Salome's bed, groaned
aloud.

We sat in silence for a long time, and we thought

Salome was asleep, for she had her eyes shut, but she
suddenly opened them, and said:

"Read a bit, please, dear Peter."

I took up her Testament and read aloud:

 "The Lord Himself shall descend from heaven with a
shout, with the voice of the archangel, and with the trump
of God: and the dead in Christ shall rise first:

"Then we which are alive and remain shall be caught up

together with them in the clouds, to meet the Lord in the
air: and so shall we ever be with the Lord.

"Wherefore comfort one another with these words."

"Don't you wish Jesus would come to-night, father," said

Salome, "and bring Simon, and Thomas, and Bartholomew,
and Jude with Him? We would all go flying up to meet them
then; wouldn't we, father?"

My father did not speak; but he took hold of Salome's

thin hand and kissed it.

"She's always talking about that, Peter," said my

mother. "Ever since you gave her that Testament, her head
has been running on that.

"'Mother,' she says, 'would the angels take you?'

"'Jude,' she says, 'would you be taken, or left?'

"'Thomas,' she says, 'wouldn't it be nice if Jesus came

to-day?'

"And the boys listened to her wonderful; they did,

indeed. Simon, he talked a deal about it just before he died,
and about his sins being washed away. I don't know much
about it," said poor mother, crying more than ever; "I've
toiled, and worked, and slaved to get you food and clothes,
and to keep you clean and decent. But I haven't thought
about these things as I should, and it seems to me, if the
Lord was to come, the angels would be carrying you all
away, and leaving me behind."

"And me!" said father, with another groan.

"Oh, no!" said little Salome, with all the strength she
had. "Father and mother must come, too; mustn't they,
Peter? Kneel down and ask Jesus to wash their sins away,
and then He won't forget to send the angels for them when
He comes in the sky."

So I knelt down and said a very simple little prayer; and

when I rose from my knees both my father and mother
were crying.

They said nothing more then, but I have every reason

to believe that they did indeed come to the Lord Jesus as
their Saviour that very night, and that, from that time, both
father and mother loved and served the Lord Jesus, and
longed for His appearing, feeling sure that in that great day
they would be taken, and not left.
 CHAPTER XIII.
GREAT SORROW.

SALOME grew stronger every day, and the doctor was

astonished at her recovery.

How good God has been to spare her to me! I said to

myself again and again. It seemed almost like getting her
back from the dead.

But just as things at home grew a little brighter, and I

was rejoicing over Salome's first going downstairs, I got a
letter from Bagot, which filled me with sorrow and grief. For
it told me that little Master Reggie, whom we all loved so
dearly, had been taken away from us. The Master had
come, and had called for him, and the child had heard His
voice, and had gladly hastened to meet Him. It was another
severe attack of croup which had carried him off, and a few
hours after he was taken ill, the call had come.

Bagot wrote in great distress, and he said my poor

mistress was very ill, and very much broken down. She
wished him to say that she would be glad if I could come
back whenever the doctor thought it was safe for me to do
so. She sent me her kindest sympathy in my trouble, and
she wished me to tell my poor mother how often she had
thought of her, and had prayed that the Lord would be her
Comforter.

I felt leaving home very much, for they all seemed to

cling to me and to lean on me after that time of sorrow. My
father had aged a great deal, and had turned in a few
weeks into an elderly man.
 My poor mother said over and over again that she had
nothing to do.

"Oh, Peter," she said one day, "I used to grumble, and
to think I had a hard time of it, with so many to cook for,
and so many clothes to mend, and so many stockings to
darn, and such lots of things to wash and to iron, and so
much to see after. But now, God knows, I would give all I
have to have one of those busy days back again. I didn't
know, till they were gone, how much I should miss them all.
God forgive me if I ever grumbled at having to work for
them!"

It was a very different home now—so quiet and still,

with so many empty beds and silent rooms, with so much
space at the large dinner-table, which used to be so well
filled, with so many vacant chairs, and with a row of caps
hanging on the pegs in the passage, which were never
taken down from their places, but which mother seemed as
if she could not take away. Every one who came to the
house must have noticed the difference in our once merry,
noisy home.

Yet it was a different home in another way, for now both

father and mother were leading their children in the way to
heaven.

It was a great effort to my father to open the Bible and

begin family prayer, but he made it. It was a great effort for
my mother to put on her bonnet, and, in the face of
astonished neighbors, to go to church again, but she made
it. And when I left them, I had the joy of knowing that
whenever the cry was heard:

"Behold the Bridegroom cometh: go ye out to meet

Him!"
 We should, as a family, be all ready to obey the
summons; for in that great day when the King shall gather
together His own, every one of us would be taken—none of
us would be left behind.

I went to Calvington by the early train, and walked from

the station to Grassbourne. Mrs. Bagot gave me a warm
welcome when I arrived at the cottage.

"I'm glad to see you, my lad," she said; "I am, indeed.
The master and me have been awful lonesome without you,
we have, indeed. What with our lady's trouble, and the loss
of that dear boy, we've been very dull and low altogether."

She told me I should find Bagot in the garden, and I

went to look for him.
 I MET MY MISTRESS COMING OUT OF THE HOUSE.

On my way there I met my mistress coming out of the

house with a large basket on her arm. I knew what basket it
was, and guessed at once where she was going. She spoke
very kindly to me, and she said, "Peter, you and I have both
had great sorrow since I saw you last; but we must never
forget God sends it in love; we must never doubt for a
moment that God is good.
 "'He doeth all things well,
We say it now with tears;
But we shall sing it with those we love,
Through bright eternal years.'"

My mistress let me carry the basket for her, and we

went together to feed Master Reggie's children. We both of
us felt it very much, and we scarcely spoke a word the
whole time.

"He would be so pleased if he knew we were taking care

of them," my mistress said, with tears in her eyes, when
our work was done, and we were walking towards the
house. "He missed you very much, Peter, and asked many
times when you were coming back. He was able to get out
again after that bad attack that he had the day before you
went home, and he seemed so much better and stronger
that I felt very hopeful about him. But he took cold again,
and the croup came back, and nothing could be done to
save him.

"Only that last afternoon, as he lay on the sofa beside

me, he was talking of you. He said:

"'Dear mother, is Peter sorry that the Lord Jesus came

for his little brothers?'

"I told him you were very sorry, for you would miss
them very much.

"'But it's very nice for the little brothers, dear mother;
isn't it?' he said.
 "And that very night the Lord Jesus came for him; and
now I must try to remember what he said, that it's 'very
nice' for him. And, Peter," she said, "I shall go to him,
though he will not return to me."

My poor mistress could say no more, but hastened into

the house, and I went away to look for Bagot.

From this time, it was part of my daily work to carry the

basket for my mistress when she went to feed Master
Reggie's children, and she often, at these times, talked to
me about him. She never spoke of him as dead, but as
living—living in the Father's home, happy and well attended,
but still loving her as much as ever, and ready at the King's
call to go in the King's train to meet her, and to welcome
her when her waiting time should be done.

CHAPTER XIV.
AFTER TWENTY YEARS.
 IT is twenty years since all this happened, and yet the
twenty years have passed away so fast that I can hardly
realize that they have gone. I can scarcely bring myself to
believe that I have lived so many years in this pretty
cottage with my dear old friend, Jem Bagot. Our life here
has been so peaceful, so far removed from the bustle and
constant stir of the busy town, so little has happened to
mark the time, or to make any break in our quiet lives, that
the days and weeks and months and years have gone by as
swiftly as I think days and weeks and months and years
could possibly go.

When I had been three years at Grassbourne, my

mistress offered to keep her promise, and to find me a
situation as footman; but I was so happy here, and Bagot
and his wife were good enough to say they were so fond of
me, that my mistress very kindly said I might still stay on
with her, if I would like to do so.

Very soon after this, Bagot had a terrible attack of

rheumatic fever, and during his long illness I took entire
charge of the garden and hothouse, and then, when Bagot
got better, he was very weak and feeble, and could not have
managed to keep pace with the work, if he had only had a
young, inexperienced boy to help him.

And so it came to pass that I never left Grassbourne,

and now Bagot is getting old and infirm; he is seventy-five
years old, and he can do no hard work. But I have stepped
into his place, and he enjoys helping me, and doing any
little job which he can manage without tiring himself.

Dear old Bagot, I believe he loves me as much as if I

were really his own son. Ever since his wife died—and she
has been dead now more than ten years—he has leaned on
me more than ever. He felt her death very much.

"The missus and me always pulled together, Peter," he

said, as he cried like a child on the night she died; "it was a
long pull, and a strong pull, and a pull both together, it was,
and the boat went bravely over the waves. But now, my lad,
it has landed her on the other shore, it has; and how I shall
ever pull on without her, Peter, it beats me to think."

"But the Lord is in the boat, Bagot," I said. "He won't

leave you to pull on alone."

"You 're right there, Peter," he sobbed, "you are. I was

forgetting that, like an old foolish-headed fellow, I was; but
I wish, Peter—I can't help wishing, my lad—that we had
both got to the shore together."

I did all I could to cheer him and to comfort him when

we were left alone together. And when Kate came, the old
man felt he had a daughter as well as a son to take care of
him. I never saw any two people take to each other so well
as Bagot took to Kate, and Kate took to Bagot. He wanted
to go away when he knew I was going to be married, but I
would not hear of that, and Kate would not hear it either,
and we could not be a happier little family than we are now.

Bagot's great pleasure is in the children. Little Jude and

the tiny Kitty are his constant playmates, and they follow
him about wherever he goes. Little Kitty is wild with joy
whenever she hears Bagot's step coming in from his work,
and she toddles to meet him, and climbs up into his arms,
saying, "Dear daddy Baggy, dear daddy Baggy."

My mistress has aged very much since I first came to

Grassbourne. Her hair is growing white now, and her face
has lost much of the beauty which made her so much
admired when she was younger; but sometimes I think she
looks more like an angel now than even when first I saw
her. She is twenty years nearer the end of the journey now,
and the twenty years of patient waiting, the twenty years of
busy working, the twenty years of discipline in the Lord's
school of sorrow, the twenty years of learning daily more
and more of His love, have all left their mark upon her, and
have made her even more beautiful in the eyes of those
who know her best, than she was in those by-gone years.

I sometimes think the waiting time may not be much

longer for her now; it seems, at times, as if a gleam of glory
from the Heavenly City were shining on her face, and I
tremble as I think that the gates may even now be opening
to let her in. I tremble for ourselves, and for all those whom
she helps, and teaches, and comforts; but I can but rejoice
for her, if the wilderness way is growing shorter, and the
welcomes in the Father's Home are drawing nearer.

Yet the thought often comes to me, "Oh that we could

all go together! Oh that, instead of the Master's voice
calling us one by one, instead of the terrible parting with
one dear one after another, as they go gladly at the sound
of His voice, He would come again, and receive all, all to
Himself, He would appear to gather together in one His
children scattered abroad, and that we, all of us together,
might gladly go, hand in hand, to meet Him!"

The "Rules for To-day" still hang over the chimney-piece

in their old place, and we are still trying; by God's grace, to
carry them out in our daily lives. And the blessed hope of
the Lord's appearing still stirs us up to live very near to
Him, and to keep very far from sin, and still comforts and
cheers us in all the sorrows and anxieties of our every-day
life.
 My old home has been broken up a long time now. My
poor mother died the same year as Mrs. Bagot, and she
rests from her labors in that Home where the weary are at
rest. My brothers are all doing well for themselves, and
have wives and families of their own.

My father gave up the business when Salome married,

and went to live with her. He often comes over to see me,
and the quiet of this country place is a great enjoyment to
him. He is as silent as ever, and it is amusing to see him
and Bagot sitting together over the fire. They have quite
renewed their old friendship, and are very fond of each
other; but when they talk together, it is an equal division of
labor, for Bagot does all the talking, and my father does all
the listening, and yet it seems to give them both the
greatest satisfaction.

Salome came over to see us last week with her little

girl, and in the evening I drove them to Calvington in the
light cart. It was Salome's birthday, and she came over to
see me for her birthday treat, for she and I love each other
as much as ever.

It was a lovely evening, and as we drove along the sun

was setting behind the distant hills. The sky was full of
glory, golden clouds floated along in the deepest blue, like
islands of glory on an azure sea, and then there were deep
rose-colored and crimson clouds beyond, which looked like
the glorious shores of this lovely sea, and which were
constantly changing, both in form and color.

We were in good time, and we pulled up in a quiet bit of

the road, and looked at the sunset.

"Don't you think it will look something like that,

Salome," I said, "when the Lord comes?"
 "I was just thinking so, Peter," she said. "When I was a
child, ever after you and I heard that sermon on my
birthday, whenever such a sky as that came, I thought it
was the Lord coming in glory."

"But He hasn't come yet," I said, with a sigh.

"No," answered Salome, "not yet, Peter.

"'But the Day is nearer now,

Far nearer,—
And the signs of His approach
Far clearer!'"

"That's a very comforting thought, Salome," I said.

"You would like that hymn, Peter," said my sister. "I had
a copy of it given me the other day, and I will send it to
you."

And this morning the hymn arrived, and I have just

been reading it to Bagot and Kate.

"'YE SEE THE DAY APPROACHING.

"'When we were little children, and heard of Jesus'

love,
We often wished that He would come, and take us all
above.
But the Day is nearer now,
Far nearer,—
 And the signs of His approach
Far clearer!

"'And oft, with childish fancy, at the closing of the day,

We hoped that in those golden clouds the King was
on His way.
But the Day is nearer now,
Far nearer,—
And the signs of His approach
Far clearer!

"'Lord, we are growing older, those days and years are

fled;
And time and change have done their work; and
some we loved are dead.
But the Day is nearer now,
Far nearer,—
And the signs of Thine approach
Far clearer!

"'Lord, make us ever ready, as each day hurries by,

To raise the welcome shout of joy,—"The Lord our
King is nigh!"
But the Day is nearer now,
Far nearer,—
And the signs of Thine approach
Far clearer!'"

"Amen," said Bagot, when I had finished reading. "'Even

so, come, Lord Jesus.'"
 THE END.

University Press: John Wilson & Son, Cambridge.