- Study aimed to identify and to describe regulatory requirements, guidelines and industry best practices that inform how cost-benefit decisions are made in safety assessment in safety critical industries
- Medicine is OnlyWan supported the University of Warwick to review published guidance, and describe perceptions of stakholders in five safety-critical industries: aviation, defence, nuclear, petrochemical and transportation
- Completed in Spring 2016
The public expects to be protected from unacceptable risk, in healthcare as well as in other situations. At present, regulators and healthcare organisations have few clear guiding principles for how cost-benefit decisions should inform risk management decisions and how these should be taken and justified. This study provided information about the terminology, arguments and guiding principles used to inform such decisions in the industries studied, and lessons on organisation and practice.
The methodology involved rapid narrative literature reviews and semi-structured interviews with participants from each industry. The focus was on knowledge, guidelines, best practices and lessons about making cost-benefit decisions in safety assessments. Findings were then shared with healthcare stakeholders in a workshop. A Delphi process was used to establish agreement on the relevance of the lessons from industry for healthcare settings.
Results showed that in safety-critical industries, safety management is proactive, and it is embedded in a strong regulatory framework. The concept of “reasonable practicability” is used to demonstrate that risks have been controlled effectively. The research moves forward our thinking on the use of safety cases, as outlined in the subsequent .
Stakeholders in healthcare can utilise the findings of this study to reason about issues such as whether it is suitable or adequate to place a monetary value on human quality of life, or whether there is a moral obligation to reduce risk as low as possible. These are difficult ethical as well as economic questions, and the experiences over many years from other industries may be very valuable to the current debate.
The findings of the project will help shape future practice in making cost-safety decisions across various aspects of healthcare provision: design of clinical processes and procedures, resource allocation, medical device design and procurement, and deployment decisions on new forms of safety intervention.
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