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.

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.

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.

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.