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The development of safety cases for healthcare services: Practical experiences, opportunities and challenges

Author

Listed:
  • Sujan, Mark
  • Spurgeon, Peter
  • Cooke, Matthew
  • Weale, Andy
  • Debenham, Philip
  • Cross, Steve

Abstract

There has been growing interest in the concept of safety cases for medical devices and health information technology, but questions remain about how safety cases can be developed and used meaningfully in the safety management of healthcare services and processes. The paper presents two examples of the development and use of safety cases at a service level in healthcare. These first practical experiences at the service level suggest that safety cases might be a useful tool to support service improvement and communication of safety in healthcare. The paper argues that safety cases might be helpful in supporting healthcare organisations with the adoption of proactive and rigorous safety management practices. However, it is also important to consider the different level of maturity of safety management and regulatory oversight in healthcare. Adaptations to the purpose and use of safety cases might be required, complemented by the provision of education to both practitioners and regulators.

Suggested Citation

  • Sujan, Mark & Spurgeon, Peter & Cooke, Matthew & Weale, Andy & Debenham, Philip & Cross, Steve, 2015. "The development of safety cases for healthcare services: Practical experiences, opportunities and challenges," Reliability Engineering and System Safety, Elsevier, vol. 140(C), pages 200-207.
    • Handle: RePEc:eee:reensy:v:140:y:2015:i:c:p:200-207
    DOI: 10.1016/j.ress.2015.03.033
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    Citations

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    Cited by:

    1. Sujan, Mark A. & Habli, Ibrahim & Kelly, Tim P. & Gühnemann, Astrid & Pozzi, Simone & Johnson, Christopher W., 2017. "How can health care organisations make and justify decisions about risk reduction? Lessons from a cross-industry review and a health care stakeholder consensus development process," Reliability Engineering and System Safety, Elsevier, vol. 161(C), pages 1-11.
    2. Hernandez-Perdomo, Elvis & Guney, Yilmaz & Rocco, Claudio M., 2019. "A reliability model for assessing corporate governance using machine learning techniques," Reliability Engineering and System Safety, Elsevier, vol. 185(C), pages 220-231.
    3. Kaya, Gulsum Kubra & Hocaoglu, Mehmet Fatih, 2020. "Semi-quantitative application to the Functional Resonance Analysis Method for supporting safety management in a complex health-care process," Reliability Engineering and System Safety, Elsevier, vol. 202(C).
    4. Sujan, Mark A. & Embrey, David & Huang, Huayi, 2020. "On the application of Human Reliability Analysis in healthcare: Opportunities and challenges," Reliability Engineering and System Safety, Elsevier, vol. 194(C).

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