Inclusive Design in Practice: Designing for Patient Safety

Roger Coleman, Helen Hamlyn Research Centre, Royal College of Art, UK

John Clarkson, Engineering Design Centre, University of Cambridge, UK

James Ward, Engineering Design Centre, University of Cambridge, UK

Peter Buckle, Robens Centre for Health Ergonomics, University of Surrey, UK

Dave Stubbs, Robens Centre for Health Ergonomics, University of Surrey, UK

Scope and Rationale

This paper gives background to an important new development in the UK health service, the Design for Patient Safety Initiative (DPSI). It presents key research findings and recommendations, outlines future work, and advocates a systems-wide approach to patient safety that the UK is adopting under the leadership of the Chief Medical Officer. It will be of interest to all those involved in healthcare and the design and development of medical products, processes and systems, and associated information, packaging and environments.

The relation to universal design lies in the process of user and stakeholder consultation embedded at the heart of the systems-wide approach, and the importance of understanding user needs across the UK National Health Service (NHS), from patients and carers to senior consultants and managers. Products and services that do not understand and reflect the full range of potential users and contexts of use are inherently unsafe. This is seen by the authors as an important extension of the concept of universality in design.

Collaborators

The DPSI study was undertaken jointly by the Helen Hamlyn Research Centre at the Royal College of Art, the Roben's Centre for Health Ergonomics at the University of Surrey, and the Engineering Design Centre at the University of Cambridge, with input from the Design Council UK.

Context

Improving patient safety is a major UK Government priority, with important consequences for healthcare policies and programmes worldwide, since errors with similar causes and solutions are as likely to occur in fee-for-service and insurance-based systems, as in the UK's state-funded (NHS). Inclusive design thinking can make products, services, processes and environments more intuitive and simple to understand and use, more convenient, comfortable and consequently less likely to lead to accidental misuse, error and accidents. Inclusive design guidelines and an audit of current design failure have potential to make future designs less complex, less confusing and unwieldy by highlighting present areas of difficulty in healthcare and encouraging potential solutions.

The DPSI is a response to the Government's drive to learn from medical accidents, which has already led to a strategy for reporting, analysing and drawing lessons from medical accidents and adverse incidents. The goal is to raise awareness across the NHS, and engage stakeholders and users, not just in reporting accidents and incidents, but also in the design of safer and more user-friendly products and environments. A further goal is to learn from other safety-critical industries such as transport, aerospace and the nuclear industry, and introduce risk assessment in a systematic way, along with a systems-wide approach to the delivery of safer healthcare.

Methodology

Understanding the implications of how design is or is not used in a huge and complex organization like the UK NHS is a daunting task. Even from the narrower focus of medication and associated equipment, the challenge is considerable. Medication error results in a very large number of annual incidents within the NHS, and the consequential costs are high. For example, around 1200 patients in England and Wales died in 2000 because of medication errors in hospital. Given that the study was short in duration, yet expected to produce conclusions on which an action programme could be based, the research team utilised a range of research methods to reveal the nature and extent of the problem, how and why error arises, the perception of stakeholders, and barriers to change.

It would not have been realistic to identify a random and representative sample of every primary care health professional to participate in the workshops. However, the study design has attempted to minimise such biases by relying on more than one method to address each of the major study objectives. By identifying areas of agreement resulting from the application of different methods (by using a form of triangulation) greater confidence can be placed in the results. Research methods were drawn from both academic and design practice, and ranged from literature review, through interviews with practitioners, patient representatives and experts from other industries (both national and international), and on to stakeholder workshops, focus groups and design workshops with critical users. Considerable effort went into the design of stakeholder workshops to ensure a high level of engagement and participation and also to capture data in an anonymised way.

Main conclusions of the Study

There is little evidence of design understanding or practice within the NHS equivalent to that which is commonplace in other safety critical industries and leading commercial organizations.

There was cause to question not simply the design of medical devices, products, packaging and information, but the way the NHS as a whole uses design, and its understanding of what design thinking can bring to an organization.

Medical equipment interface.
Figure 1: Graphic from the report 1 p 19 -
"Confusing, complex, unwieldy designs are at best
less effective, at worst they are dangerous to either
medical staff or the patient, or both."

[ Figure 1 Description ]

There are no quick fixes. On the contrary, it is of the utmost importance that single design initiatives are seen in the context of the 'big picture' of the healthcare system as a whole and the way they might impact on patient safety and risk management.

Graphic showing the identical tops of prescription medicine containers.
Figure 2: Graphic from the report 1 p 24 -
"Different drugs, held in bottles with identical
tops, are stored next to each other. In a hurry, it is
possible to grab the wrong one, or accidentally swap two
bottles around as they are put back in the tray."

[ Figure 2 Description ]

A major lesson was a recognition of the ability of people from all levels of the NHS - from senior managers, policy makers and clinicians, to nurses, paramedics and neighbourhood doctors - to work together as professionals, once outside the normal and considerably hierarchical environment of the healthcare system, and their collective commitment to finding solutions and improving the quality of the services they deliver. This led the research team to advocate placing user and stakeholder involvement at the heart of any response.

Graph depicting number of interruptions to work of emergency physicians.
Figure 3: Graphic from the report 1 p 23 -
"In one study, emergency physicians reported ten
interruptions to their primary task of work each hour.
If these pressures are not anticipated through design,
errors become much more likely."

[ Figure 3 Description ]

A further realisation was the extent to which medications and associated equipment have to function in extremely varied environments - from the ward and theatre, to the roadside (often in the dark), to the hospice, and in the home of potentially distraught or confused patients and carers. This variation is neither adequately quantified and described, nor made clear to the designers or packaging and delivery systems, such as blister packs and infusion devices, nor are users conventionally involved or consulted in the design process. As a consequence, information, packaging, interfaces and ergonomic factors are unlikely to function as expected in many situations. In addition, a mapping of relationships and medication pathways across the NHS revealed a highly complex system with many interfaces and points of transfer - of care giving, medication, information and/or patient - each of which could be a potential source of error. Again, bringing stakeholders and users together made it possible to quickly verify and modify prior mapping based on desk research, and also identify key risky moments, situations, individuals and pieces of equipment/packaging, etc. This allowed the team to focus in on potential points of intervention, whilst developing the bigger picture that began to show how these could interact with other elements of the system in complex and unexpected ways.

A further significant factor revealed by the study was the almost complete absence of understanding of design within the NHS and how it can be effectively employed to improve quality and reduce risk. This was exemplified by a lack of recognised usability criteria for the purchase of medical devices, and the consequent paucity of attention given by manufacturers to factors other than the cost of their products. In short, no mechanisms were in place to encourage competition by manufacturers and suppliers on the basis of safety and usability.

The central conclusion from the study was presented in the form of a diagram outlining the key elements of a systems-based, user-centred approach to healthcare design. Thirteen recommendations made to achieve this, supported by 45 action points, with eight early projects singled out for immediate action.

Although approach this has been built up from research into the UK NHS, there is real potential for transferring and applying the model in other national and local contexts. On a global scale, a better understanding of the contexts in which healthcare is delivered and how design can be used to increase patient safety will be of benefit to all.

Graphic depicting healthcare design model.
Figure 4: A systems-based, user-centred approach to healthcare design 1 p 45.

[ Figure 4 Description ]

The provision of safe medical care (shown in box 1 of figure 4) cannot be achieved in isolation of the system or environment into which it will be introduced. The system needs to be understood, as well as the needs of people that work within it, illustrated in the model by the 'build knowledge base' element. This improved understanding will support a number of activities (shown in box 2). It will lead to the setting of more effective design requirements by the NHS, which provide a strong foundation for successfully designing the product and the system it is to fit into (box 3). Effective design requirements are also a prerequisite to improvements in procurement and innovation practice.

The design of the product and the system is linked, as knowledge about the system should affect the product, and vice versa. The product and system designs need to be delivered (i.e. purchased and put into use with any necessary user training). The effectiveness and outcome of the delivery process must also be evaluated. This process will be unique to a particular product or service and be actively managed to minimise technical and commercial risk. Only from this basis can safe medical care be provided. The whole of this approach would be informed and assisted by an advisory panel made up of industry, academic and healthcare experts and require proactive promotion to all stakeholders.

The recommendations for change, which align with the boxes of figure 4, are as follows:

  1. Build an effective knowledge base to underpin better design decision-making.
    • Develop a better understanding of:
      • healthcare contexts at each specific point where the system interacts with the patient, so as to inform the design process;
        • how the interactions both within and between healthcare organisations impact on patient safety;
      • what is actually going on in healthcare situations at the level where individuals undertake specific tasks;
      • the user requirements, from which safer designs can be achieved that function as required for all users and across the range of situations in which they will be used.
    • Effectively manage knowledge and information, with regard to patient notes.
    • Ensure the provision of timely and appropriate information regarding use, including monitoring and maintenance, of equipment in primary/ secondary care and the home environment.
    • Capture best practice examples of designing for patient safety from around the world, which can be used to inspire change in behaviour within industry and across the NHS.
  2. Define effective design requirements for the NHS.
    • Enable the design of safe products, packaging, information and services through the setting by the NHS of more effective design requirements.
    • Better understand user needs and capacities by actively involving stakeholders in a more systematic way at all stages of the design process, from problem/requirements capture to post-implementation evaluation.
    • Ensure the effective collaboration of the appropriate agencies in design and risk management so as to improve the delivery of safe products and systems through a seamless representation of drug, device and organisational interests.
  3. Effectively evaluate healthcare services and products within a system context with regard to patient safety.
  4. Put in place strategies for risk identification, control and management that will deliver effective procedures and protocols for identifying, capturing and reporting risks.
  5. Develop a common understanding of the importance of design and procurement approaches within industry and the NHS for the delivery of safe services and products.
  6. Establish an advisory panel to oversee the delivery of the design-led approach to patient safety.

The recommendations enable a start to be made in addressing these design issues and patient safety. In order to execute these recommendations the Department of Health will have to acquire expertise in design management, with specific reference to systems design, and in risk assessment and management.

In summary, without a sound understanding - from a design perspective - of the healthcare services as a complex system of interacting organisations, professions, care environments, procedures and tasks, and of the way risk arises within that system, there can be no certainty that discrete design solutions will contribute to patient safety.

Project Outcome

A short form report was published by the NHS and UK Design Council in October 20031, which is intended for wide circulation throughout the NHS and associated industries and suppliers. The full research findings have been published by Cambridge University as: 'Designing for Patient Safety: A scoping study to identify how the effective use of design could help to reduce medical accidents'2. Both reports make numerous recommendations to allow for better design decision making through increased knowledge of NHS systems, lay down design standards for equipment and packaging, and evaluate and monitor designs based on how they contribute to patient safety. It also recommends setting up a strategic advisory panel to work with the National Patient Safety Agency in bringing in a design-led approach to safety across the system, and the engagement of stakeholders from all levels of the NHS in the process.

Current Status and Future Expectations

The report was made public at a launch event in the UK Design Council offices in London in February 2004. The UK Government's Chief Medical Officer has committed himself to leading a multi-agency program and a board of stakeholders and expert advisers to consider how best to implement the recommendations and spread this thinking more widely. The UK National Patient Safety Agency will take a major role in developing this.

Conclusions

Complex systems, such as the UK NHS, which have evolved over time in the context of rapid technological advances, can exhibit unacceptable levels of risk and consequential costs. Although healthcare is inherently risky, a better understanding of user needs at all levels, of the complexity of interactions within the system, and the diversity of contexts in which care is delivered, can lead to greatly enhanced patient safety. Design is a key factor in this process, but its relevance and use is poorly understood. It is therefore imperative that the issue of patient safety is tackled at the system level and in a consistent way across the NHS. A key to achieving this lies in finding ways of unlocking the considerable experience and insight of stakeholders and users at all levels of the system, and engaging them in the design process. As the UK moves in this direction it is highly likely that process lessons and design exemplars will emerge that have considerable potential for transfer into very different and less technology driven healthcare systems and situations.

References

  1. Buckle P, Clarkson J, Coleman R, Lane R, Stubbs D, Ward J, Jarrett J and Bound J (2003) Design for Patient Safety: a system-wide design-led approach to tackling patient safety in the NHS, NHS and Design Council, (based on the scoping study below).


  2. Buckle P, Clarkson J, Coleman R, Lane R, Stubbs D, Ward J, Jarrett J and Bound J (2004), Designing for Patient Safety: A scoping study to identify how the effective use of design could help to reduce medical accidents, Cambridge University, ISBN: 0-9545243-0-6

Text Descriptions of Figures

  1. Graphic depicting a finding of the report: "Confusing, complex, unwieldy designs are at best less effective, at worst they are dangerous to either medical staff or the patient, or both."
    [ Return to Figure 1 ]
  2. Graphic depicting a finding of the report: "Different drugs, held in bottles with identical tops, are stored next to each other. In a hurry, it is possible to grab the wrong one, or accidentally swap two bottles around as they are put back in the tray."
    [ Return to Figure 2 ]
  3. Graphic depicting a quote from the report: "In one study, emergency physicians reported ten interruptions to their primary task of work each hour. If these pressures are not anticipated through design, errors become much more likely."
    [ Return to Figure 3 ]
  4. Diagram depicting a systems-based, user-centred approach to healthcare design, which is explained in the immediately following text.
    [ Return to Figure 4 ]

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