Article Text

What should WHO be doing about patient safety and technology?
1. Oliver T Mytton1,2,
2. Felix E C Greaves1,2,
3. Emma A I Stanton2,
4. Liam J Donaldson1,2
1. 1WHO Patient Safety, Richmond House, London, UK
2. 2Department of Health, Richmond House, London, UK
1. Correspondence to Dr Oliver Mytton, WHO Patient Safety, Richmond House, Richmond House, 79 Whitehall, London SW1A 2NL, UK; myttono{at}who.int

## Introduction

Technology has promised a great deal as a tool for potentially reducing harm in healthcare, but has frequently failed to deliver. It can present risks to patients if used incorrectly. Technology can also mitigate against risk by reducing error through improved design of processes or equipment.1–3 Technology is an important thread running through many areas of patient safety: reporting and learning, systems thinking, human factors, training and culture change.3

The opportunities for technology to improve patient safety are wide-ranging. Commonly described technological solutions include information technology, such as computerised physician order entry,4 5 as well as design solutions to make equipment safer to use, such as single-use injection needles.6 However, such examples fail to capture the full breadth of opportunities for technology to improve patient safety.1

At a macro level, regulation is required to ensure that new technology is introduced safely;7 however, regulation can also act as a barrier to innovation and lead to delays in implementation. New technological solutions can increase costs. At a micro level, workarounds, occurring on the introduction of technology intended to make care safer, can make care less safe.8 Healthcare professionals may resist the implementation of technological change.9

WHO Patient Safety is looking to develop a technology programme. As a first step to understand the relationship between technology and patient safety, WHO Patient Safety identified four key areas (box 1). Working with Imperial College London, they established four working groups of five to 10 experts for each of these areas. These groups sought to clarify the role of technology in improving patient safety, in both the developed and developing world.

#### WHO Patient Safety Technology Programme: priority-setting exercise

WHO Patient Safety and its stakeholders undertook a scoping exercise to identify and clarify the role of technology in improving patient safety in both the developed and developing world. Four working groups of international experts were created. Group members had relevant expertise in either technology or patient safety and reflected the different needs of developed and developing countries.

The four groups were:

• introducing new technology safely

• making existing technology safer in healthcare

• information technology for patient safety

• training and simulation for patient safety

Their reports are published as papers alongside this paper.2 7 10 11 The group members producing these papers were invited to a 1-day conference, held at Imperial College in May 2009 (the WHO expert meeting), to present their work. In addition, at this expert meeting, the groups were invited to present two suggested projects to WHO Patient Safety, within their area. These proposals are presented in this paper. This paper draws on this work (the WHO expert meeting, the papers and the project proposals) and considers the wider themes emerging from this work. The paper, together with the group papers, provides the foundation for the next stage of the technology programme.

## Evaluation of project proposals

Each of the four working groups proposed two projects to WHO Patient Safety. The working groups were advised that their projects would be considered alongside the priorities of WHO Patient Safety. Projects might then be undertaken by WHO Patient Safety as part of the next phase of its technology programme. The eight project proposals are shown in table 1.

Table 1

Proposed projects assessed by the delegates

Delegates from the four working groups attended the WHO expert meeting, where they presented their proposals. This expert meeting consisted of a series of break-out discussions in small groups to identify the strengths and weakness of each project. Each delegate at the expert meeting ranked each project on a five-point scale, against five criteria:

• burden of the problem;

• global nature of the solution and problem;

• potential for the solution to solve the problem;

• value for money;

• ability to use existing technology to solve the problem.

Scores on the five criteria were summed, with each criterion being given equal weight. The summed scores were averaged. Overall, the two simulation projects scored the highest. Both of the simulation projects had immediate face validity and addressed problems of global importance. The handover project was the most highly recommended project; delegates at the WHO expert meeting felt that poor communication at handovers was a global concern. It was proposed that a structured education tool be developed to promote uptake. It was suggested that such a tool could have worldwide impact, as the problem is universal, and would use low-fidelity simulation, making it easy to adapt or transfer at lower cost.

## Challenges for technology to improve patient safety

Several themes emerged from the group papers,2 7 10 11 the WHO expert meeting and the project proposals. Those of particular interest are discussed.

### Theme 1: information management to understand errors

We live in an information age. The total volume of digital data is predicted to increase more than five times by 2012.12 The challenge for patient safety is twofold. First, to manage the rapidly increasing volume of data so that healthcare professionals have access to the right information at the right time to provide safe and timely care. Second, to use, and often share, electronically captured information to facilitate learning and improvements in patient safety. These themes are strongly echoed in the information technology paper, focussing on information transaction.2 Such changes take place against a backdrop of concerns about data protection13 14 and a growing enthusiasm for some patients to own their medical records.

### Theme 4: regulation

Any attempt to use technology to improve patient safety will need to tackle the challenge of regulation. Regulation supports the safe introduction of technology by ensuring the quality and safety of new devices;7 however, it can also delay or prevent safer innovative technology from wider use.7 Concern was expressed at the WHO expert meeting about how regulation affects developing countries. Regulatory systems are often absent or weak in developing countries allowing misguided use of technology.7 The lack of recognised regulatory bodies for these countries means that medications and devices intended solely for developing countries, particularly when deployed by international organisations, are mandated to pass a regulatory assessment. This has to occur in a developed country. There is little incentive for manufacturers to develop devices solely for developing countries, because the costs associated with regulatory assessment and the necessary over engineering are prohibitive. This theme was reflected in project 8, which proposed different regulatory standards for developing and developed countries.

A dual standard could be unethical, as it might promote differential rights to safe care for people living in different countries. However, the absence of dual standards might be acting to prohibit the introduction of appropriate technologies into developing countries.34 A different regulatory structure, or at least a different regulatory decision for different environments, may be seen as ethical, as it could facilitate the introduction of appropriate technology leading to better and safer healthcare in those settings. Different regulatory decisions would seem reasonable, given a different background incidence of disease, tolerance of error and funding possibilities in the developing world. A similar debate has taken place in research.35 The original standard was that any new innovation had to be tested against the best standard worldwide. This inhibited research to show the benefit of new technology or medicines that conferred a benefit in a particular setting where there might be other constraints preventing the routine use of the world ‘gold standard’. The modern test is the local gold standard. This allows research into appropriate and affordable solutions for the setting.

One theme emerging from the WHO expert meeting was the need to understand human factors and ergonomics to produce smarter designs. Devices are often regulated in isolation and tested under ideal conditions, rather than realistic work conditions. Healthcare practitioners, particularly in developed countries, are also heavily regulated. However, no body ‘regulates’ the interaction between technology and healthcare practitioners. Most medical errors occur not because of individual failure or ‘device failure’ (a device not doing the task it was designed for), but because of how the design was used in the real world (the interaction between healthcare practitioner and technology).11 The need for a greater consideration of device–user interaction is reflected in projects 5, 6 and 7. Simulated ward environments could be used more routinely to develop devices to promote patient safety and feed directly into regulatory decisions.

### Theme 5: using technology to improve safety in developing countries

There have been significant technological advances in healthcare in the most affluent nations, but concern was expressed at the expert meeting that their spread to developing countries has been poor. Funding is a crucial issue. Donor money can establish a market, as occurred with fixed-dose combination therapy for tuberculosis36; however, in the present economic climate, the sustainability of such projects remains uncertain.37

There is a paucity of appropriate technology for developing countries, reflected by the proposal in project 7. Donations of developed world technology are often unsuitable for local needs and left unused.7 38 Technology designed for the developed world is often too expensive and is often poorly designed for the environment where it will be used. These technologies might be overly complicated, difficult to maintain or incompatible with other devices.7 11

Education is important for sustainable development in developing countries,39 as well as being vital for improving healthcare. The two simulation projects reflect this priority. Simulation is a hands-on way of learning, which could be well suited to the developing world.

## Conclusion: WHO patient safety technology programme, a long-term vision

Technology is, and will continue to be, an important theme for patient safety. For WHO Patient Safety to take a lead internationally in improving patient safety, it needs to continue to incorporate technology within its current thinking and future work. The technology programme will support WHO Patient Safety in this role.

The WHO expert meeting, and the four papers presented here,2 7 10 11 highlighted the breadth and complexity of the relationship between technology and patient safety. It will be challenging for WHO Patient Safety alone to develop a technology programme that has sufficient breadth and depth of skill to support the needs of its other programmes. A more flexible approach is required that can tap into a wide global and diverse skill matrix in academia, industry and policy.

The technology programme, like WHO Patient Safety, needs to balance implementation, delivering projects with measurable outcomes, with thought leadership and standard setting. The latter role might be more influential, pushing the boundaries and challenging present thinking. Such a balance can be achieved by choosing original and innovative projects that demonstrate new approaches, yet still support other areas of WHO Patient Safety's work.

In the short term, both of the simulation projects, concerning safe childbirth and promoting safe handovers, are of great interest. These projects align with other areas of work by WHO Patient Safety. The technology programme should support WHO Patient Safety in its aim to promote and make patient care safer throughout the developed and developing world. This principle should remain at the heart of future developments for the technology programme.

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## Footnotes

• Fundings The project was funded by WHO Patient Safety.

• Competing interests LJD is the Chair of WHO Patient Safety and the Chief Medical Officer for England. From July 2010, he will become the Chair of National Patient Safety Agency in the UK. OTM, FECG and EAIS have all been clinical advisors to LJD, working for either WHO Patient Safety or the Department of Health.

• Provenance and peer review Not commissioned; externally peer reviewed.

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