Human Factors for Clinical Engineering - The Realization of a Guidance Text

A. C. Easty1,2, A. L. Cassano-Piché1, M. Griffin1, Y-L. Lin1, P. Trbovich1,2,3

1.HumanEra, University Health Network, Toronto, ON M5G 1L7, Canada; 2.Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, ON M5S 3G9, Canada; 3.Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON M5T 3M6, Canada

Abstract:Industries such as aviation and nuclear power have greatly improved their safety performance through the application of human factors methods to the design, development, selection and deployment of a range of technologies and work processes. Health care safety performance generally lags behind these industries and would benefit from a similar application of human factors methods. Clinical engineers are in an ideal position to acquire and apply this human factors knowledge, and lead its adoption in health care. This paper describes a text that has been written specifically for clinical engineers and others who design, develop, select and support the use of health care technologies, to enable them to learn the key methods of human factors and adopt them as part of their ongoing work. Early indications are that these approaches help to ensure that health care technologies are used more safely and effectively, and it is hoped that large-scale adoption will result in a noticeable and worthwhile improvement in overall health care safety. The described text is now ready and has been published in English on the IFMBE website. It is available as a free download in PDF format. Clinical engineers and others working around the world in the area of health technology are encouraged to learn and adopt these methods, and use them as appropriate in their local setting. At time of writing, plans are underway for a translation of this book into Spanish. Once completed, this version will also be made available online at no charge. The authors encourage readers to contact them with their experiences, and the aim is to build a worldwide community that gradually adopts these methods and helps to drive safety improvements in health care.

Key words:human factors; usability; safety; textbook; education

0 INTRODUCTION

The American College of Clinical Engineering has the following definition of a clinical engineer, “A Clinical Engineer is a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology”. Further, the College states that, “Clinical Engineering education is based in classical engineering, supplemented with a combination of courses in physiology, human factors, systems analysis, medical terminology, measurement and instrumentation”[1]. This definition hints at the breadth of knowledge that is required to perform well as a clinical engineer, and the profession tends to attract those who enjoy the complexity of this field.

Despite this definition, most clinical engineers receive little formal training on human factors methods, and the majority view human factors as a distinct discipline that requires extensive training to gain sufficient knowledge to be applicable to health technologies and associated processes of care. Human factors methods have played a major role in the reduction oferrors in other safety-critical industries such as aviation[2]. The value that human factors methods can bring to health care safety improvement is gradually being recognized, and one indication of that is the emergence of the Human Factors and Ergonomics Society’s HFES International Symposia on Human Factors and Ergonomics in Health care, which have been held annually since 2012[3].

Given the low rate of adoption of human factors in health care in general and clinical engineering in particular, the Clinical Engineering Division (CED) of the International Federation for Medical & Biological Engineering (IFMBE) identified the need for an accessible text to guide the adoption and practice of human factors methods for the clinical engineering field. The Head of the CED, Professor Saide Calil of the State University of Campinas, Campinas, Brazil, approached the HumanEra Team at University Health Network/ University of Toronto, to commission the production of this text.

1 THE DEVELOPMENT OF THE TEXT

The HumanEra Team was considered well-positioned to take on the development of this text for several reasons: First, its core focus is on the application of human factors methods and principles to the field of health care safety, considering the application of health care technologies, practices and environments of use. Second, its team members have academic backgrounds in clinical engineering, human factors engineering and psychology. Third, the hands on experience gained through multiple projects in a variety of clinical environments provides a core understanding of what is required of clinical engineers to start applying human factors methods and how such a program can develop over time.

The blending of two major disciplines is never an easy task, and in trying to make knowledge of one discipline accessible to another, there are a number of challenges to be overcome. Specifically, the text has to be placed in the context of what clinical engineers know and do as core aspects of their profession. Also, human factors principles and methods need to be introduced and explained in the context of these core clinical engineering activities, and with sufficient detail and background that the depth and complexity of human factors as a discipline is not lost, while avoiding the trap of making the body of human factors knowledge so daunting that clinical engineers become overwhelmed and decide that there is too steep a learning curve for these methods to be understood and applied. Finally, in recognition that the field of Clinical Engineering is practiced world-wide, and that human factors has an important role to play regarding the safe application of health technologies in clinical environments whether they are resource-rich or poor, the guide needs to be written in a way that is accessible to clinical engineers in different resource settings. Furthermore, care must be taken to avoid specifying resources such as state of the art usability labs, which are beyond the reach of many resource settings and, while nice to have, are not essential to the sound application of many human factors methods in health care.

Initial text development was informed in part by courses and lectures that HumanEra team members have given to a variety of clinical teams including clinical engineers, and also drew on knowledge gained through collaborations with health care professionals in Brazil and Spain, where joint projects have been undertaken to support the incorporation of human factors methods into steps to improve the safety of health technologies there. The book, entitled Human Factors for Health Technology Safety: Evaluating and Improving the use of Health Technology in the Real World, is now complete and is available at no cost as a PDF download on the IFMBE website homepage[4]. At the time of writing, plans are being made to translate the book into Spanish under the leadership of Vladimir Quintero of the Universidad Simon Bolivar, Baranquilla, Colombia. This version will also be made available at no charge once completed.

2 THE STRUCTURE OF THE DOCUMENT

The full development of the text was undertaken by one of the authors (ACP) when it was realized that a project on this scale cannot easily be completed if the primary author is concurrently engaged in other work. This is an intense activity that requires focus and dedication, and it proceeds more slowly, or fails altogether, if regular interruptions to the work occur.

The text has been developed in English, since this is the first language of the authors, and the language in which other IFMBE texts are developed. As mentioned above, a Spanish version is in preparation, and it is possible that it will be translated into additional languages at a later date.

Given the challenges discussed in the previous section, the decision was made to adopt the following structural approach to the document, with the text broken into three main parts. Itis worth noting that there was considerable debate concerning the order of Parts II and III. It was initially felt that the case studies should come second, but following internal debate and external review, it was decided that the human factors methods should be presented second, with the case studies following. While this places the more theoretical material at an earlier stage, it was decided that it was essential to provide a solid grounding on methods before proceeding to the case studies themselves. Readers are encouraged not to be put off by this more theoretical section since it subsequently becomes clear that these methods have very practical and helpful applications in the field of health technology management. With this in mind, the book is devided into three main parts:

Part I: The Need For Human Factors in Health Technology Management provides a brief background on the disciplines of clinical engineering and human factors, and the need for these disciplines to come together to improve health technology safety. In this section, topics that are key aspects of the clinical engineer’s role are identified:

(1) Participating in the planning process and in the assessment of new technology.

(2) Assuring regulatory compliance in the medical technology management area.

(3) Investigating incidents involving the use of medical technology.

(4) Actively participating in training and education of technical and medical personnel.

(5) Overseeing Biomedical Equipment Technicians (or Technologists), who are responsible for the support, service and repair of medical technology.

(6) Creating systems to manage medical technology inventory.

This is a brief overview of the general discipline of human factors, its application in other fields, and its gradual incorporation into health care.

Part II: Handbook of Human FactorsMethodsprovides a detailed description of the key human factors methods that can be deployed in assessing health technologies and health delivery systems that include technology components. The key methods are:

(1) Heuristic Analysis.

(2) Usability Testing.

(3) Human Factors Informed Failure Mode and Effects Analysis (HFFMEA).

(4) Human Factors Informed Root Cause Analysis (HFRCA).

(5) Human Factors Informed Procurement (HFPIP).

In each case, the method is briefly described, along with an explanation of what it accomplishes and when it should be used. Detailed descriptions are then given on preparing for and completing assessments using each method, followed by guidance on what to do with the findings of the method and its associated limitations.

The human factors methods are described according to best practices for formally applying these methods, but the available resources to formally apply a particular human factors method may not be feasible in certain situations. In these circumstances it is recommended that the human factors methods approaches be adapted to suit the available resources rather than not applied at all. In an effort to make the methods presented in this book accessible to the global community, consideration has been given to minimizing the need for any specialized or costly equipment and descriptions of abridged approaches to employing some of the methods are provided.

Part III: Case Studies: Applying Human Factors to Health Technology Management describes how human factors methods can be incorporated into clinical engineering tasks and uses case studies and examples to illustrate the output of each step. In this major section, three main topics are covered:

(1) Procurement Support.

(2) Identifying Issues and Investigating Incidents.

(3) Training and Education.

To some degree, this may be considered the heart of the text, since it aims to provide clinical engineers with practical examples of the application of a selection of human factors methods to key tasks in clinical engineering and the health care environment. This “how to” guide is meant to enable clinical engineers to understand the potential that human factors methods can offer to the field of clinical engineering, and to explain in an accessible manner how this can be achieved.

3 CONCLUSION

Following the completion of the final first draft of the book, it was sent for external review to an international roster of people with backgrounds in human factors, clinical engineering, or both disciplines. Much helpful criticism was obtained at this stage, and where possible, reviewers’ feedback was incorporated into the revised final text. It is recognized thatmany of the examples provided, which come from HumanEra’s direct work experience, have a North American flavour to them in terms of the deployment of technologies and associated health care processes. Readers are encouraged not to be put off by this, since it is clear that these methods can be broadly applied in health care environments around the world, and it may be helpful to think of possible local applications of the methods described when reading the text.

The authors hope to make this a living document and so encourage feedback from users regarding their experiences interacting with the text. This feedback will help to inform revisions to the text over time, as more experience is gained in the field.

At the completion of the text, some members of the HumanEra Team have moved on to other employment. However, when the text was prepared, all authors were members of the team, the team affiliation is shown at the top of this article.

Finally, it is hoped that this text will stimulate clinical engineers in diverse work environments to take their first steps toward the adoption of human factors methods in their work practices, and that this in turn will help to facilitate improvements in the safe and effective use of health care technologies. Indeed, this text is targeted toward anyone who works in support of health technology, whether they have the title Clinical Engineer or another title. For this reason, the text refers to Biomedical Technology Professional, and in using this phrase, the intent is to encourage all those whose work involves the design, development or clinical support of health technology to engage in and benefit from the application of human factors methods.

4 ACKNOWLEDGMENTS

The authors would like to acknowledge the financial support of the Clinical Engineering Division of the International Federation for Medical & Biological Engineering to assist the preparation of the text, and particularly the visionary leadership and encouragement of Professor Saide Calil, who has done much to champion the introduction of human factors methods into the field of Clinical Engineering. In addition, thanks are due to the following people, who reviewed one or more sections of the text: Sandra Ahedo, Fernando Andrade, Guilherme Araujo Wood, Victor Batista Tsukahara, Ann Blandford, Saide Calil, Peter Doyle, Karina Gomide, Julie Greenall, Laura Herrero, Sylvia Hyland, Leonardo Novaes Nascimento, Ryan Pinto Ferreira, Kim J. Vicente, Carlos Alessandro Bassi Viviani and James Wear.

REFERENCES:

1 http://www.accenet.org/default.asp?page=about&section=definition.

2 Wiener EL,Nagel DC.Human factors in aviation:Access OnlineviaElsevier,1988.

3 http://www.hfes.org/web/hfesmeetings/2014healthcaresymposium.

4 IFMBE.Available at http://www.ifmbe.org.

[CLC number]R197.39 [Document code] A

doi:10.3969/j.issn.1674-1633.2016.03.001

[Article ID]1674-1633(2016)03-0001-04

Correspondence to:Anthony Easty, PhD, Institute for Biomaterials & Biomedical Engineering, University of Toronto, Toronto, ON M5S 3G9, Canada.