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Human Factors Health Technology Safety Human Factors For Health Technology Safety: Evaluating and Improving the Use of Health Technology In The Real World Andrea Cassano-Piché, Patricia Trbovich, Melissa Griffin, Ying Ling Lin and Tony Easty HumanEra @ UHN Global Centre for eHealth Innovation University Health Network International Federation of Medical and Biological Engineering Clinical Engineering Division Cover Design: Brent Bily - Envisioneering Foreword One characteristic of the healthcare field is its constant and extremely fast technological development. While in the past its progress relied on expertise coming mostly from medicine, today it receives contributions from many different areas of research such as electronics, chemistry, biology, physics, mathematics, mechanical engineering, materials engineering, and informatics. Such fast development has produced an immense variety of well-accepted equipment and medical procedures for diagnosis and therapy. However, it also requires the development, transference and adaptation of safety programs, formerly developed in other industries, to be implemented in medical procedures as well as equipment operation, equipment design and production, hospital interoperability, medical records, cloud storage, and so on. Clinical engineers, used to dealing mostly with medical equipment management techniques, found themselves overwhelmed by safety demands associated with the use of such technologies. Worse, few academics worldwide are familiar with safety programs applied to the healthcare area. As one of the participants in the implementation of the academic curriculum for Clinical Engineering training courses, and the coordinator of one such training course for more than 20 years in Brazil, I am excited by the release of this book, explaining the practical use of safety tools by clinical engineers and technologists. As a researcher and supervisor of a post-graduate Biomedical Engineering program at the University of Campinas for more than 30 years, I had several opportunities to discuss with my students and coordinators of Clinical Engineering training courses, subjects regarding risk management for the healthcare area. These discussions were about the urgent need to include safety tools and programs dedicated to healthcare environments within our Clinical Engineering academic program. Despite our belief of the urgency of this work, it was extremely difficult to find instructors familiar with this subject. The ones we found, despite great knowledge on very efficient safety tools, had no idea how to translate them to the healthcare area for practical use. It is important to mention that my participation as chairman of the Clinical Engineering Division of the International Federation for Medical and Biological Engineering – CED/IFMBE, showed me that this is not just a local problem but a worldwide lack of knowledge. In 2011, I had the privilege to work with the HumanEra group, from the University Health Network in Toronto, Canada, that specializes in the use of human factors tools to develop their activities. I witnessed the important work they were leading for the Ministry i of Health and Long-Term Care of Ontario, regarding preventive studies and investigations on adverse events within the healthcare area. The results and conclusions they obtained produced very reliable recommendations to mitigate risks associated with the use of healthcare technologies. I also became aware that some of the human factors engineering (HFE) tools could be used to develop safety programs with relative facility. From then on, I persistently asked HumanEra to write a book describing how these tools can be practically used by clinical engineers to develop and implement safety programs for the healthcare environment. Fortunately in 2014, they found time to dedicate to the development of this book. With years of experience on the practical use of HFE tools, the HumanEra team knew exactly what kind of previous knowledge clinical engineers must have before learning about the use of such tools. Hence, the initial chapters of this book explain what it is necessary to learn before the presentation of the HFE tools. The book also gives an explanation of other tools such as Failure Mode and Effect Analysis (FMEA) and Root Cause Analysis (RCA), that have also been adapted and used in the healthcare environment. It shows you how these tools can be applied in conjunction with other HFE tools, to uncover the underlying issues that compromise safety in healthcare. I believe the best characteristic in this book is the way the HFE tools are presented. It explains not only “What” to do but also “How” to develop the activities needed to implement a safety program in the healthcare environment. Detailed examples are given on how to develop all documents as part of the investigative process, and what must be learned from people involved either in adverse events or simulations. It also provides, in straightforward language, all the necessary steps to develop the simulation tool, as well as when and how to conduct a task analysis. Together with the heuristic analysis, these three tools provide extensive possibilities for not only the investigation of adverse events but also their mitigation. In summary, this book not only gives you a theoretical view of “What” to do when implementing the HFE tools but also “How” to implement them through detailed examples using case studies. After reading it, clinical engineers must move ahead to develop a safety program in the healthcare area they are working in. The contents of this book can also be easily used and translated to lectures by Clinical Engineering scholars with the mission to design and implement a healthcare safety discipline within Clinical Engineering training courses. ii Finally, regarding the implementation of safety programs within the healthcare environment, clinical engineers have now an extremely useful source of information that will be freely available on the Web, provided by the HumanEra Team and sponsored by the Clinical Engineering Division of the International Federation of Medical and Biological Engineering – CED/IFMBE. Professor Saide Calil, UNICAMP, Campinas Brazil. May 2015 iii Preface Thank you for taking a step toward exploring the positive role that human factors can play in helping to improve health technology safety by reading this book. Throughout the world the use of medical technology is on the rise, with many beneficial outcomes for patients. However, health technology does not always behave as intended, and can be awkward and confusing to use. Far too often, this leads to adverse events. The good news is that there are methods that can be applied to help to identify and overcome these problems, and that is the aim of this book. Often, the people who are best-placed to engage in this approach are those who service and support technology in healthcare. In some settings, this will be a large team of people, including engineers and technologists. In others, this may be a lone technician doing what he or she can to provide support. This book refers to the “biomedical technology professional”. We chose this title carefully, wanting it to be as inclusive as possible, and relevant to many different settings in high-, medium-, and low-income healthcare environments. No matter where you work, I encourage you to read this book and start applying some of the methods described here. At first, they may seem a little hard to follow, but there is nothing magic about them, and they can lead to surprising results. Once you get started and see for yourself how helpful these methods can be, I am sure you will be hooked, just as I was when I first started to use them. These methods change the way you view technology and its role in our world, and they can make a great difference to the safety of the healthcare system that you work in, too. Many of the examples are based on our experiences in Canada but to some extent they reflect specific issues in our system, and so as you read the book, please substitute examples that you have experienced directly, in your own work environment. I am sure that you will quickly identify technologies that could benefit from the approaches described here, and I encourage you to make a start on applying them. I would like to thank the co-authors of this book, who have worked hard to try to ensure that the methods described are as accessible as possible. I would also like to thank the reviewers, whose comments have helped in numerous ways to improve and clarify the messages that we sought to share. Any errors and omissions remain the sole responsibility of the authors. I owe a special thank you to Professor Kim Vicente of the University of Toronto, who first opened my eyes to the power and relevance of these methods, and helped me learn to apply them. A truly life-changing experience! Finally, I would like to thank the Clinical Engineering Division of the International Federation for Medical & Biological Engineering and its Chair, Professor Saide Calil, for commissioning us to write iv this book. Without this invaluable support, we would not have been able to complete this work. Tony Easty, Toronto, Canada. May 2015. v Acknowledgements We are extremely grateful to Professor Saide Calil for his vision and encouragement. Calil was the catalyst for this book and succeeded in securing funding for from the Clinical Engineering Division of the International Federation of Medical and Biomaterials Engineering, to whom we offer our sincere thanks. While only some of the members of HumanEra formally authored this text, this book is truly the work of the entire team. Each team member, with their unique training, experiences and passion, has helped to evolve each of the methods presented in this book. Under the leadership of Tony Easty and Patricia Trbovich, HumanEra members include: Andrea Cassano-Piché, Christopher Colvin, Mark Fan, Rachel Gilbert (nee White), Melissa Griffin, Caterina Masino, and Sonia Pinkney. HumanEra has also had the privilege of working with many dedicated and talented students over the years, one of whom co- authored this book (YLL).
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