Adaptive regulation or governmentality: patient safety and the changing regulation of medicine

Studies from across the world have shown that clinical mistakes are a major threat to the safety of patient care (World Health Organisation 2004). For the National Health Service (NHS) of England and Wales it is estimated that one in ten hospital patients experience some form of error, and each year these cost the service over £2billion in remedial care (Department of Health 2000). Unsurprisingly, ‘patient safety’ is now a major international health policy priority, questioning the efficacy of existing regulatory practices and proposing a new ethos of learning. Within England and Wales, the National Patient Safety Agency (NPSA) has been created to lead policy development and champion service-wide learning, whilst throughout the NHS the National Reporting and Learning System (NRLS) has been introduced to enable this learning (NPSA 2003). This paper investigates the extent to which, in seeking to better manage the threats to patient safety, this policy agenda represents a transition in medical regulation.

Doctors' thinking about the system as a threat to patient safety

‘Systems thinking’ is an important feature of the emerging ‘patient safety’ agenda. As a key component of a ‘safety culture’, it encourages clinicians to look past individual error to recognise the latent factors that threaten safety. This paper investigates whether current medical thinking is commensurate with the idea of ‘systems thinking’ together with its implications for policy. The findings are based on qualitative semistructured interviews with specialist physicians working within one NHS District General Hospital in the English Midlands. It is shown that, rather then favouring a 'person-centred’ perspective, doctors readily identify ‘the system’ as a threat to patient safety. This is not necessarily a reflection of the prevailing safety discourse or knowledge of policy, but reflects a tacit understanding of how services are (dis)organised. This line of thinking serves to mitigate individual wrong-doing and protect professional credibility by encouraging doctors to accept and accommodate the shortcomings of the system, rather than participate in new forms of organisational learning.

Safety and complexity: the inter-departmental threats to patient safety in the operating department

Purpose: Current thinking about ‘patient safety’ emphasises the causal relationship between the work environment and the delivery of clinical care. This research draws on the theory of Normal Accidents to extend this analysis and better understand the ‘organisational factors’ that threaten safety. Methods: Ethnographic research methods were used, with observations of the operating department setting for 18 month and interviews with 80 members of hospital staff. The setting for the study was the Operating Department of a large teaching hospital in the North-West of England. Results: The work of the operating department is determined by inter-dependant, ‘tightly coupled’ organisational relationships between hospital departments based upon the timely exchange of information, services and resources required for the delivery of care. Failures within these processes, manifest as ‘breakdowns’ within inter-departmental relationships lead to situations of constraint, rapid change and uncertainty in the work of the operating department that require staff to break with established routines and work with increased time and emotional pressures. This means that staff focus on working quickly, as opposed to working safely. Conclusion: Analysis of safety needs to move beyond a focus on the immediate work environment and individual practice, to consider the more complex and deeply structured organisational systems of hospital activity. For departmental managers the scope for service planning to control for safety may be limited as the structured ‘real world’ situation of service delivery is shaped by inter-department and organisational factors that are perhaps beyond the scope of departmental management.

Capturing User Requirements in Medical Device Development: The Role of Ergonomics

Measuring and fulfilling user requirements during medical device development will result in successful products that improve patient safety, improve device effectiveness and reduce product recalls and modifications. Medical device users are an extremely heterogeneous group and for any one device the users may include patients, their carers as well as various healthcare professionals. There are a number of factors that make capturing user requirements for medical device development challenging including the ethical and research governance involved with studying users as well as the inevitable time and financial constraints. Most ergonomics research methods have been developed in response to such practical constraints and a number of these have potential for medical device development. Some are suitable for specific points in the device cycle such as contextual inquiry and ethnography, others, such as usability tests and focus groups may be used throughout development. When designing user research there are a number of factors that may affect the quality of data collected including the sample of users studied, the use of proxies instead of real end-users and the context in which the research is performed. As different methods are effective in identifying different types of data, ideally more than one method should be used at each point in development, however financial and time factors may often constrain this.

MATCH: a new industry-focused approach to medical device development

MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the product lifecycle in order to achieve devices that truly meet the requirements of their users. A review of the published literature indicates that user requirements are mainly collected during the design and evaluation stage of the product lifecycle whilst other areas, including the concept stage, have less user involvement. Complementing the literature review is an in-depth consultation with the medical device industry, which has identified a number of barriers encountered by companies when attempting to capture user requirements. These will be addressed by a number of case study projects, performed in collaboration with our industrial partners, that will examine the application and utility of different approaches to collecting and analysing data on user requirements. MATCH is focused on providing advice to device developers on how to select and apply methods that have maximum theoretical strength, practical application, cost-effectiveness and likelihood of wide sector acceptance. Feedback will be sought in order to ensure that the needs of the diverse medical device sector are met.

Theory and language of climate change communication

Climate change communication has become a salient topic in science and society. It has grown to be something like a booming industry alongside more established ‘communication enterprises’, such as health communication, risk communication, and science communication. This article situates the theory of climate change communication within theoretical developments in the field of science communication. It discusses the importance and difficulties inherent in talking about climate change to different types of publics using various types of communication tools and strategies. It engages with the difficult issue of the relationship between climate change communication and behavior change, and it focuses, in particular, on the role of language (metaphors, words, strategies, frames, and narratives) in conveying climate change issues to stakeholders. In the process, it attempts to provide an overview of emerging theories of climate change communication, theories that recently have begun to proliferate quite dramatically. In some cases, we can, therefore only provide signposts to the most relevant research that is being carried out with regard to climate change communication without being able to engage with all its aspects. We end with an assessment of how communication could be improved in light of the theories and practices discussed in this article.