Inclusive design has unique challenges because it aims to improve usability for a wide range of users. This typically includes people with lower levels of ability, as well as mainstream users. This paper examines the effectiveness of two methods that are used in inclusive design: user trials and exclusion calculations (an inclusive design inspection method). A study examined three autoinjectors using both methods (n= 30 for the user trials). The usability issues identified by each method are compared and the effectiveness of the methods is discussed. The study found that each method identified different kinds of issues, all of which are important for inclusive design. We therefore conclude that a combination of methods should be used in inclusive design rather than relying on a single method. Recommendations are also given for how the individual methods can be used more effectively in this context.@en

As part of the investigations into a surgical incident involving the accidental retention inside a patient's venous system of a guide wire for central venous catheterisation (CVC), the Human Error Assessment and Reduction Technique (HEART) was used to examine the potential for further occurrences. It was found to be time-efficient and to yield plausible probabilities of human error, although its use in healthcare has challenges, suggesting adaptation would be beneficial.@en

Background: Central Venous Catheterisation (CVC) is a medical procedure that has been linked with cases of retained guidewires in a patient after surgery. Whilst this is theoretically a completely avoidable complication, a guidewire of up to 60cm being retained in a patient's vascular system poses a major risk. In recently reported cases, guidewires retained inside patients have not been detected for several years. Aims: The ultimate aim was to develop appropriate, operator-centred safe design solutions that reduce guidewire retention errors. Method: This paper focuses specifically on the application of Nielsen's ten usability heuristics 1 to the issue of retained guidewires. Following the development of a task analysis of the procedure, three researchers (from medical, safety and human factors backgrounds) independently applied the usability heuristics, then met to analyse the findings. Results: A range of usability problems were identified in the Central Venous Catheterisation procedure, and solutions to the identified issues were then proposed: These focused on the design of equipment, or the wider guidewire insertion procedure. The paper details the identified usability problems and possible redesign solutions from the 10 usability heuristics. Conclusion: Overall, the application of the usability heuristics was found to be a useful method both to explore medical device interface problems and to generate possible countermeasures. Further work to eliminate/engineer out the possibility of guidewires being retained is briefly reported.

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In this article we call for a new approach to patient safety improvement, one based on the emerging field of evidence-based healthcare risk management (EBHRM). We explore EBHRM in the broader context of the evidence-based healthcare movement, assess the benefits and challenges that might arise in adopting an evidence-based approach, and make recommendations for meeting those challenges and realizing the benefits of a more scientific approach.

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Root cause analysis is perhaps the most widely used tool in healthcare risk management, but does it actually lead to successful risk control? Are there categories of risk control that are more likely to be effective? And do healthcare risk managers have the tools they need to support the risk control process? This systematic review examines how the healthcare sector translates risk analysis to risk control action plans and examines how to do better. It suggests that the hierarchy of risk controls should inform risk control action planning and that new tools should be developed to improve the risk control process.

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Although it is probably the best-known prospective hazard analysis (PHA) tool, failure mode and effects analysis (FMEA) is far from the only option available. This article introduces one of the alternatives: The structured what-if technique (SWIFT). SWIFT is a flexible, high-level risk identification technique that can be used on a stand-alone basis, or as part of a staged approach to make more efficient use of bottom-up methods like FMEA. In this article we describe the method, assess the evidence related to its use in healthcare with the use of a systematic literature review, and suggest ways in which it could be better adapted for use in the healthcare industry. Based on the limited evidence available, it appears that healthcare workers find it easy to learn, easy to use, and credible. Especially when used as part of a staged approach, SWIFT appears capable of playing a useful role as component of the PHA armamentarium.

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Most risk management activity in the healthcare sector is retrospective, based on learning from experience. This is feasible where the risks are routine, but emergency operations plans (EOP) guide the response to events that are both high risk and rare. Under these circumstances, it is important to get the response right the first time, but learning from experience is usually not an option. This case study presents the rationale for taking a proactive approach to improving healthcare organizations' EOP. It demonstrates how the Prospective Hazard Analysis (PHA) Toolkit can drive organizational learning and argues that this toolkit may lead to more efficient improvement than drills and exercises.

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Background: Health advisory bodies have suggested that external disciplines such as engineering and design, with their creative, structured approaches to user-focused problem solving, may contribute useful tools and techniques to healthcare service designers. However if external disciplines are to add value to healthcare systems, they need an understanding of current service design practice, and of the environment in which healthcare service designers operate. Method: In this ongoing study, using a grounded theory approach, data were collected from 20 anonymous participants connected to a UK NHS hospital. Semi-structured interviews were used to gather information on current design practice within 79 change projects, focusing on requirements elicitation. Open coding produced over 400 codes, organised under four main categories: Projects, Requirements Process, Design Methods (including tools and techniques), and Stakeholders. Via further analysis using theoretical memos and axial coding, the topic of barriers to effective design emerged as a strong theme that is discussed further in this paper. Results: Pragmatic barriers to the effective use of design include issues such as high impact of change, difficulties engaging stakeholders in design activities, cultural and behavioural differences, and problems with inherited systems. Such barriers reflect the highly complex nature of healthcare. Staff adopted a variety of approaches to help resolve complexity, but negative emotional reactions to the use of design methods themselves invite further investigation into whether their cause is the tools themselves, the types of projects they are used in, or the conditions in which they are used. Conclusion: This paper concludes that if design thinking is to become more prevalent in healthcare, there is a need for more awareness of, and investigation into, the interplay between pragmatic and emotional barriers to design.@en

The UK health service, which had been diagnosed to be seriously out of step with good design practice, has been recommended to obtain knowledge of design and risk management practice from other safety-critical industries. While these other industries have benefited from a broad range of systems modelling approaches, healthcare remains a long way behind. In order to investigate the healthcare-specific applicability of systems modelling approaches, this study identified 10 distinct methods through meta-model analysis. Healthcare workers' perception on 'ease of use' and 'usefulness' was then evaluated. The characterisation of the systems modelling methods showed that each method had particular capabilities to describe specific aspects of a complex system. However, the healthcare workers found that some of the methods, although potentially very useful, would be difficult to understand, particularly without prior experience. This study provides valuable insights into a better use of the systems modelling methods in healthcare. Statement of Relevance: The findings in this study provide insights into how to make a better use of various systems modelling approaches to the design and risk management of healthcare delivery systems, which have been a growing research interest among ergonomists and human factor professionals.

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In the light of a number of serious incidents in the UK resulting from accidental overdoses of methotrexate, this study investigated how the design of methotrexate packaging can influence patient safety, and aimed to collect evidence to provide a basis for the development of new concepts for revised designs by the pharmaceutical industry. The research found that patients using methotrexate experience a number of difficulties in using their medicines packaging, and as a result, resourcefully adopt a variety of " coping strategies" which may increase the risk of dosing errors. By investigating both the practice of methotrexate users, and the design of the system that supports methotrexate use, additional problems were observed across the healthcare system, meaning that the function of medicines packaging in ensuring safety may be even more critical than first suspected. As a result of this research the National Patient Safety Agency responded with a UK-wide programme of work to improve safety for patients, and continues to work with the pharmaceutical industry to develop more user-friendly packaging and labelling.

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Systems mapping workshops have been applied to the problem of medication errors in healthcare. The workshops were designed using experiential group work principles. They involved a range of stakeholders from within the health service as well as those who supply the health sector, including designers who may be able to enhance the safety of products and systems used in healthcare. Research has shown that the method encourages stakeholder participation, provides robust results within a limited time and enhances understanding across specialist interest groups. Additional, creative design workshops that considered the same topic showed significant promise in developing concepts from which potential solutions could be developed further.@en

Objective. The role of process modelling has been widely recognized for effective quality improvement. However, application in health care is somewhat limited since the health care community lacks knowledge about a broad range of methods and their applicability to health care. Therefore, the objectives of this paper are to present a summary description of a limited number of distinct modelling methods and evaluate how health care workers perceive them. Methods. Various process modelling methods from several different disciplines were reviewed and characterized. Case studies in three different health care scenarios were carried out to model those processes and evaluate how health care workers perceive the usability and utility of the process models. Results. Eight distinct modelling methods were identified and characterized by what the modelling elements in each explicitly represents. Flowcharts, which had been most extensively used by the participants, were most favoured in terms of their usability and utility. However, some alternative methods, although having been used by a much smaller number of participants, were considered to be helpful, specifically in understanding certain aspects of complex processes, e.g. communication diagrams for understanding interactions, swim lane activity diagrams for roles and responsibilities and state transition diagrams for a patient-centred perspective. Discussion. We believe thatit is important to make the various process modelling methods more easily accessible to health care by providing clear guidelines or computer-based tool support for health care-specific process modelling. These supports can assist health care workers to apply initially unfamiliar, but eventually more effective modelling methods.

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The complexity of the health care environments necessitates an holistic and systematic ergonomics approach to understand the potential for accidents and errors to occur. The health service is also a socio-technical system, and design needs must be met within this context. This paper aims to present the design challenges and emphasises the specialised needs of the health care sector, when dealing with patient safety. It also provides examples of approaches and methods that ergonomists can bring to help inform our knowledge of these systems and the potential towards improving their safety. Mapping workshops provide an example of such methods. Results from these are used to illustrate how the knowledge base required for better design requirements can be generated. The workshops were developed specifically to help improve the design of medication packaging and thereby reduce the probability of medication error. The issues raised are now the subject of further research, design requirements guidance and new design concepts. The paper illustrates the need to engage with the design community and, through the use of robust scientific methods, to generate appropriate design requirements.@en

The Design for Patient Safety Study showed that the National Health Service (NHS) is seriously out of step with modern thinking and practice with regard to design. The study emphasises the need to move to a user-centred systems approach to designing in healthcare, without which patient safety will remain a significant challenge for the foreseeable future. The development of the MRC/EPSRC/ESRC Design for Patient Safety Network is addressing some of the research issues raised by the need for a systems approach.@en

The Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the NHS. The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the health care system as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.@en

Solid oral Methotrexate (Methotrexate in tablet form) has been used for many years as an effective measure to treat severe rheumatoid arthritis and severe psoriasis. When taken at the right frequency and dose Methotrexate is a safe medication. However, in the community in the UK between 1993 and 2000, Methotrexate has been implicated in the deaths of some 25 patients and a further 26 cases of serious harm which have required hospitalisation [1,2]. In 2003 the National Patient Safety Agency (NPSA) began a programme of work to investigate the causes of errors with Methotrexate and to develop and implement solutions in response. Since then, three projects have been undertaken: The development of a new patient treatment diary; An investigation of IT systems in GP's surgeries and community pharmacies; and An assessment of the packaging and labelling of Methotrexate with patients and healthcare practitioners and the identification of changes which should improve patient safety. This paper describes the research and results from the third project.

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The UK and USA are currently undergoing a period of considerable change in their attitude towards medical error and their understanding of its causes and magnitude. In both countries, with increasing rapidity, a disturbing situation is being revealed. This paper presents the results of an investigation into medical errors in the UK and the USA, and focuses in particular on the magnitude and causes of errors when using medical devices. Contrary to the traditional approach of blaming users, it is suggested here that many such errors are caused partly by poor device design, which fails to account adequately for the needs of users. In response, this paper also discusses the basics of a Human Factors Engineering (HFE) approach as a step towards overcoming this problem and offers a challenge to device users and design companies (manufacturers) to follow HFE principles in order to improve the efficiency of operation and reduce errors during device use.

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In 2002 the UK Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the National Health Service (NHS). The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries in order to ascertain how the design of systems - equipment and other physical artefacts, working practices and information - could contribute to patient safety. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the healthcare system, including the users of that system, as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.

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There are many examples from the medical device design industry where poor requirements capture practice has led to post-market problems, including patient morbidity and mortality. There is a clear need to improve this process. The purpose of this paper is to present the results of several years of study by five researchers into the requirements capture process in this area of industry and to highlight the need by industry for further guidance. Various research methods were used to investigate the requirements capture problem and to develop and evaluate a workbook which provides guidance for designers. The workbook consists of a package of methods: a functional analysis approach, a matrix-based checklist and advice on regulatory requirements. It has been refined over the years and is now published [1] The matrix also forms part of a publication for the UK Department for Trade and Industry [2], and a web version is under development.

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