Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.
Table of Contents
Chapter 1 Clinical Engineering in the Healthcare System
Chapter 2 Taking a Systems Engineering Approach
Chapter 3 Key Standards, Regulations and Guidelines
Chapter 4 Life cycle management of medical equipment
Chapter 5 The Healthcare Technology Management System - Strategic
Chapter 6 Developing Equipment Support Plans in the context of the HTM Programme
Chapter 7 The Extended Role of Clinical Engineers – Advancing Healthcare
Chapter 8 The Clinical Engineering Department – Achieving the Vision
Chapter 9 Medical Device Governance
Chapter 10 Health Technology Management (HTM) adding value
Francis Hegarty is is a founding member of the Medical Physics and Bioengineering Department in St James’s Hospital, Dublin, Ireland. Over the course of a thirty year career he has served within this department as a Biomedical Engineering Technician, Chief Technologist and later as Principal Physicist leading the Clinical Engineering group. In this time he has managed teams providing equipment management services and he is familiar with the application of healthcare technology in a broad range of clinical departments. He was instrumental in establishing the department’s management structure and is an advocate for multidisciplinary team working between clinicians and engineers. He led on the implementation of the department’s healthcare technology management systems. Central to this was his development of an innovative medical equipment management database system. He has led a number of multidisciplinary hospital projects where medical equipment was integrated in clinical information systems.
He has contributed to hospital management committees and chaired the hospital’s multidisciplinary medical device vigilance committee. During his career, St James’s Hospital underwent significant redevelopment and as a result Francis gained extensive experience in the design, planning and commissioning of new hospital facilities. Francis has also acted as a consultant in this regard to a number of other hospital projects in Ireland and overseas. At the time of the publication of this book he is the Chief Healthcare Technology Officer for Ireland’s new national children’s hospital project.
Francis studied electrical and electronic engineering at Dublin Institute of Technology and in 1994 complete an MSc in Physical Sciences in Medicine through the faculty of Health Sciences in Trinity College Dublin. His research interests include clinical measurement, clinical informatics, medical optics, assisted living technologies, art in health and healthcare technology management. He has published and presented widely on these topics. In 1998 he led the establishment of a Postgraduate Diploma in Clinical Engineering at Trinity College Dublin and acted as the course co-ordinator until 2005. He lectures on a number of undergraduate and post graduate courses and is a member of the Faculty of Health Sciences, Trinity College Dublin as well as being a Chartered Engineer, a member of the Institute of Physics and Engineering in Medicine (IPEM) and an Affiliate of the Royal College of Anaesthetists.
John Amooreretired in 2015 following a career spanning over 40 years, largely applying engineering to healthcare in academia, industry and health care. He gave nearly 30 years service to the National Health Service in Scotland both in Lothian and in Ayrshire and Arran from where he retired as Head of the Medical Physics Department where his responsibilities included budget responsibility for the procurement and maintenance of medical equipment. Academic training began with a BSc in Electrical Engineering which laid the foundation for his career and the recognition that engineering is about people and money as well as technology. Continuing professional development throughout his career followed, with part-time study in physiology (MSc) and biomedical engineering (PhD) and gaining skills in healthcare technology, its deployment and management.
John’s academic career included appointment as a Senior Lecturer in the Biomedical Engineering Department at the University of Cape Town, South Africa, developing lecture courses and supporting postgraduate students. He helped develop the new Biomedical Engineering Society of Southern Africa during the 1980s. Since moving to the UK he has continued research projects and served as external examiner for PhD theses. His publications (over 60 journal publications, 5 chapters in books and over 100 conference presentations) span several areas: theoretical modelling to better understand the cardiovascular system; medical device safety and risk management; infusion device management; blood pressure measurement; characteristics of specific medical devices; and healthcare technology management. He continues to serve as an external reviewer of manuscripts submitted to journals for publication. He has served on expert groups advising on blood pressure measurement technology.
Clinical engineering contributions include developing structured databases for medical equipment management, pioneering medical device training for clinicians, helping establish the first medical equipment library in his area of Scotland, leading the development of multi-disciplinary groups to advise on the management of medical devices, developing service level agreements to provide clinical engineering services, developing medical device incident reporting initiatives and helping the successful move of a major academic hospital (~800 beds). He has experience of responsibility for all medical equipment for a regional health area including budgetary responsibility for the procurement and maintenance of medical devices from clinical thermometers to major imaging equipment.
He recognized the importance of understanding the clinical situation in which medical equipment is deployed and the need for a team approach and ergonomic analysis in medical equipment selection. From the core clinical engineering aim of ensuring the safe application of medical technologies evolved an interest in understanding the causes and prevention of adverse events involving medical equipment. This, and collaboration with clinicians, led to an interest in person centred care.
During his working career he was registered professionally as an engineer and clinical scientist and contributed to engineering, medical engineering/physics and medical professional societies, including the organization of professional conferences and seminars.
Paul Blackettstarted his career working for the inventor of the world’s first blood glucose meter in a small business unit in Consett, County Durham. After spending several years in medical electronics manufacturing in South Tyneside, Paul joined the NHS in 1985. Initially working at the Freeman Hospital in Newcastle Upon Tyne as an Electronics Technician Paul also spent some time at South Tyneside General Hospital, before eventually moving southwards to take up a post at the Royal Preston Hospital as a Senior Medical Engineer.
Paul is currently Medical Engineering Manager at Lancashire Teaching Hospitals NHS Foundation Trust which comprises two acute hospital sites at Chorley and Preston. Through workshops at these two hospitals, the medical engineering team delivers a comprehensive service to their own trust and through service level contracts, to neighbouring organizations.
Paul is a member and past chair of the Clinical Engineering (North) National Performance Advisory Group and is an active member of IPEM, working as an external moderator for the technologist training scheme and a past member of the Clinical Engineering Special Interest Group. He has presented at scientific meetings on the subject of risk, key performance indicators, standardization and cross-Atlantic differences in Clinical Engineering guidance. Paul has also been part of the Department of Health working party on Modernising Scientific Careers and a member of the Northwest Healthcare Science Workforce Board. Paul is currently IPEM representative on the Register of Clinical Technologists Management Panel.
Paul graduated with BSc (Hons) after completing a part-time degree in Computing and Electronics. Keen on systems and standardisation, Paul’s current work interests lie in unique device identification (UDI) and risk analysis.
Justin McCarthyhas a BSc (Hons) degree in Electrical and Electronic Engineering from Manchester University. He has had 40 years NHS experience in the field of Clinical Engineering. In his early career he was involved in developing new medical devices and equipment. He worked as part of the multi-disciplinary team in Cardiff that developed and brought into clinical use the first commercially available intravenous Patient Controlled Analgesia (PCA) apparatus. This gained him a research MSc degree.
In later years, as Head of Clinical Engineering, he led the teams that provided the healthcare technology management and maintenance services to the Cardiff NHS Trust’s medical equipment, introducing a formal ISO 9000 quality management system in 1991. He advised the Trust on risk, procurement and healthcare technology regulatory issues. He helped establish the Clinical Engineering MSc course at Cardiff University and continues as an Honorary Senior Lecturer teaching on the undergraduate Medical Engineering course.
He has contributed to fourteen peer reviewed published papers, seven journal articles and five text books as well as over 80 conference proceedings and presentations.
He retired from the NHS in 2009 but continues to present at meetings, publish, and sit on professional working groups as well as to provide consultancy services to Trusts and small businesses. He acted as an expert for the NHS Confederation at a European Commission policy conference in 2010 and has recently been leading, on behalf of IPEM, their input to the European Council, the European Parliament and the MHRA regarding the new Medical Devices Regulations. He continues to be involved in formal Standards at UK and international level and is Chair of the IEC SC62A sub-committee, responsible for IEC 60601-1, the primary safety Standard for medical electrical equipment.
He is a Chartered Engineer and a Fellow of the Institution of Engineering and Technology (IET) and of IPEM.
Richard Scottis a consultant clinical scientist and chartered engineer, working as Head of Clinical Engineering at Sheffield Teaching Hospitals NHS Foundation Trust. Additionally he is the Professional Lead for Clinical Engineering and Reconstructive Science at the UK’s National School of Healthcare Science, (part of Health Education England).
An engineering placement in the Division of Anaesthetics at the Clinical Research Centre, Harrow, completed as part of an electronics degree at North Staffordshire Polytechnic, encouraged Richard to pursue a career in clinical engineering. Upon graduating in 1984 he joined the Wessex Regional Medical Physics Service, based at the Royal United Hospital, Bath, providing scientific support for clinical instrumentation and undertaking a range of research projects. He obtained an MSc in medical electronics and physics from St Bartholomew's Medical College, followed by a PhD at the University of Bath, investigating the frequency dependence of respiratory mechanics via the oscillatory airflow technique. Subsequently he specialised in the management of medical devices and contributed to establishing the local medical equipment management service. In 1995, the opportunity arose to become head of the Medical Equipment Management Department at Sherwood Forest Hospitals NHS Foundation Trust in Nottinghamshire. In December 2016 he moved to Sheffield and continues to encourage healthcare scientists to work together to play a key role in adopting innovative practices and driving service transformation for patient benefit.
Richard has contributed to curriculum development for UK NHS clinical engineering education programmes across the career framework and has been keen to develop engineering personnel with skills to ensure that healthcare technologies are effectively managed and care advanced for patient benefit. He led the Clinical Biomedical Engineering Higher Specialist Scientist Training scheme curriculum writing group on behalf of the Royal College of Surgeons, which has pioneered a new NHS consultant clinical engineer role.
Richard is active in the development of international electro-medical safety standards, serving on a range of British Standards Institution committees and is immediate past President of the Hospital Physicists' Association. He is a Fellow of the Institute of Physics and Engineering in Medicine, served as their Vice President: Professional and has acted as a professional advisor to the UK Department of Health Modernising Scientific Careers team. Richard is one of the first UK clinical engineers to be admitted to the Academy for Healthcare Sciences Higher Specialist Scientist register.
"Medical equipment management is a large and diverse area. Therefore, it is perhaps not surprising that books comprehensively covering the topic are few and far between. I was pleased when I heard about the publication of Healthcare Technology Management: A Systematic Approach. Other books I have read which cover medical equipment management have taken a rather hands-off approach to the topic…This book presents a loftier ambition, inviting the reader to apply a systematic approach to the management of healthcare technology… At the end of each chapter are self-directed learning points and case studies. These help emphasise that the authors intended this book to be actively engaged with, not just read. In particular, I was impressed with the effort that has clearly gone into putting the case studies together. Evidently written based upon the authors’ personal experiences within clinical engineering, these painted a colourful picture of how the various topics discussed may apply to real-life situations… The standard of writing remains high throughout the book and, combined with a distinct lack of errors for a first edition, make the text a pleasure to read… For anyone within this profession, I would not hesitate to recommend it…This book is unique in the guidance it gives to the established clinical engineer to better utilise the medical equipment at their disposal."
—Dr Michael Ayers in IPEM Scope Reviews, September and December 2017
"Congratulations to the team of authors...who have given the world of clinical engineering this fantastic resource, which will go on our frequently-accessed shelves...This is a must-have, on-desk reference book for all clinical engineers...This book is a gift because it overviews all aspects of health technology management and then digs deeper, offers tools, and brings all of the relevant and up to date information together in one place. I recommend, a reasonably thorough read of the whole book in the first instance, and then holding it readily accessible for reference...This publication is not just a resource for practitioners but a roadmap for new entrants to clinical engineers and a shop front for one of the most rewarding, fast-moving, and exciting engineering disciplines."
—Meabh Smith, in BEAI Spectrum, Summer 2017
"The book’s value is that it gives us a different perspective – new ways of thinking about old problems…I liked this book a lot and plan to dig more deeply into some of the material for use in my consulting practice. The text is clearly written and is informed by the wide-ranging experience of the authors. Numerous tables and figures to illustrate the text are included…The fundamental chapters all include case studies."
—Matthew F. Baretich, PhD, in Biomedical Instrumentation & Technology, March/April 2017
"A delightful book; something for everyone. This book crosses national borders and regional variations to get to the heart of the matter: the explosive growth of technology in healthcare has simultaneously increased both our capabilities - as well as risk - and clinical engineers are the experts at managing both. This book divulges the secrets of the behind-the-scenes experts of system design - tools which will help anyone who wishes to harness the power of technology to optimize any process for both effectiveness and safety. This book is at once a compelling quick-read as well as a detailed reference manual. It would serve as both an ideal primer for clinicians as well as a library staple for anyone interested in understanding how to manage the complexity of the entire continuum of patient care."
—Michael Appel, MD, Chief Patient Safety Officer, Northeast Georgia Health System, Inc., USA
"This book is a comprehensive, up to date, and accurate exploration of clinical engineering within the health care system. Tackling every important aspect of this work in a very understandable way, the authors make clear the potential benefits of clinical engineering and its importance for advancing healthcare. This book is ideal for those just beginning their careers as biomedical technicians and clinical engineers, in addition to senior engineers and technicians, who will discover new perspectives for their work. I would also recommend the book to managers in other industries that are willing to try healthcare technology management."
—Magnus Stridsman, MSc, Region Östergötland University Hospital, Sweden
"Normally technical books can be quite boring to read. You search through the index, go directly to the information required, extract what is needed for your article or practice, and put the book back on the bookshelf.
When I started reading this book, my expectation was that this would be just another technical book. However, to my surprise, I really enjoyed it and wanted to keep reading! In particular, I was impressed with the book’s range of subjects and the ways in which the authors presented each chapter: the figures are well-designed and the information, tools, and processes are explained thoroughly. The sequence of subjects follows a logical order, making it easy for the reader to understand what is presented, using the knowledge gained from the previous chapters.Each chapter also features a series of useful questions and case studies, enabling the reader to test their comprehension and further explore the practical applications of the topics.
This text covers most of the topics needed for a Clinical Engineer to develop a good and strong management system in a health environment. As a teacher and coordinator of a Clinical Engineering training course, as well as a graduating course of Biomedical Engineering, I am always looking for new and good sources of material regarding Clinical Engineering, and I can fully recommend this book for those interested in learning how to improve the activities in their profession."
—Saide Jorge Calil, MSc, PhD, University of Campinas (UNICAMP) - Brazil
"This book is a comprehensive treatment of Healthcare Technology Management (HTM) written in an easy and engaging style. The authors set out to provide a systematic approach to the topic and certainly succeed in doing so. The wealth of experience captured in this book is clear and makes this a significant, and perhaps unique, reference text particularly within an NHS context. It should be seen as essential reading for students and trainees looking to specialise in this exciting and challenging field. The book utilises the Asset Management Standard (ISO 55000) as a key reference which is a helpful way to present and describe the challenges of HTM and enables a clear description for organisations to set out their approach to this topic."
—Dan Clark, Head of Clinical Engineering, Nottingham University Hospitals NHS Trust
"Since concluding my doctorate in public health, I have been looking for a new approach to clinical engineering service (CES) with the aim to reposition it within the healthcare service and I found exactly what I was looking for in this book. Much of the existing literature on the subject focuses only on managerial technical work restricted to CES traditional activities. But in Healthcare Technology Management, the authors add strategic activities to this essentially technical role that go beyond the limits of the CES; inputting responsibility in the sustainability of the healthcare service as a whole, as well as in safety and patient / client satisfaction. It also identifies the clinical engineer as a prominent professional in the important processes and projects of the healthcare unit.
This innovative approach is done in a masterful way. The authors use simple language, which is easy-to-understand even for those whose mother tongue is not English. They also provide a complete and vibrant perspective on the subject, in addition to a rich bibliography and many case studies that facilitate further learning. I am sure this new book will be quickly adopted as an essential text for courses related to health technology management around the world - I just wish I had been given the opportunity to study clinical engineering with it!"
—Mara Souza, Professor of Instituto Federal da Bahia, Brazil
"Healthcare Technology Management is a comprehensive treatment of the field of Clinical Engineering. It is well researched, with an excellent mix of explanation, self-study, and case studies. Examples within the text help highlight the concepts shared in the sections, while the self-study and case study sections provide a mechanism to thoroughly understand the chapters’ topics. I am especially impressed with the excellent coverage and emphasis of Systems Engineering; I recommend using that chapter as a reference for others in healthcare to educate them on Clinical Engineering’s Systems Engineering capabilities. It also provides convincing arguments for, and examples of, basing the HTM department on relevant standards, such as ISO 55000, 80001 and 60601.
Healthcare Technology Management effectively links the HTM department operation to organizational goals, as well as emphasizing the balance of ‘ideal’ goals with real world limitations. This book is well researched and will be suitable as both a textbook for students and as an excellent reference for experienced professionals, especially those seeking certification."
—Paul Sherman, CCE, FACCE
"This book brings together all elements of modern Healthcare Technology Management that can be applied and recognised globally. Its practical case studies and extensive references make it a universal reference text that will be of use for all involved in the Healthcare Technology business. The text is well researched and written to provide a comprehensive guide for clinical engineering practitioners and for those aspiring to a career in clinical engineering. The authors should be applauded for their efforts in bridging the gap between the theoretical principles of Health Technology Management and their application in everyday clinical engineering practice. This is a highly recommended text, which will become a corner stone reference text for the Biomedical Engineering profession."
—Kyril Belle, Director Biomedical Engineering, Australian Capital Territory Health, Australia
"What a fantastic treasure is this book - a thorough and academic, but practical, overview of the whole subject of Healthcare Technology Management! Its many chapters cover everything you need to know and, to give more value, each chapter has self-directed learning questions, many useful case studies, and comprehensive references. This book would be an excellent course book, and would be suitable for undergraduates and postgraduates, in addition to individuals interested in medical engineering and management.
Healthcare Technology Management is evolving rapidly with changes in finance, legislation, IT interaction, and how apps are coming into the picture. This book covers these subjects, but also encourages the reader to think much wider and to take a systems approach to the whole strategy of advancing and supporting healthcare technology. There are frequent references to UK, US, and other country regulatory requirements and learned papers so the reader is quickly appraised of current thinking. Applying this knowledge could easily help hospitals and medical centres reduce costs through effective management whilst maintaining patient safety."
—Peter H. Smithson, Consultant Clinical Engineer CliniBizTech Solutions Ltd. (Previously Head of Medical Equipment Management Organisation, University Hospitals Bristol NHS Foundation Trust)
"As the healthcare technology employed by clinicians and healthcare providers has evolved, diversified and become more complex over the past few decades, so have the skills and knowledge required to effectively manage the technology and the environment in which it is used. This book provides the reader, whether studying for a career in clinical engineering or well established in their career, with a comprehensive manual on healthcare technology management. For the student, it is an excellent text. For the experienced, a thorough subject matter reference. Well written, the text provides a methodical and practice approach to establishing a healthcare technology management framework, which is patient care focused and value adding to the responsible organisation."
—Phillip Thorburn, Senior Biomedical Engineer, Australian Capital Territory Health, Australia