Should healthcare providers do safety cases? : Lessons from a cross-industry review of safety case practices

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Abstract

Healthcare organisations are often encouraged to learn from other industries in order to develop proactive and rigorous safety management practices. In the UK safety–critical industries safety cases have been used to provide justification that systems are acceptably safe. There has been growing interest in healthcare in the application of safety cases for medical devices and health information technology. However, the introduction of safety cases into general safety management and regulatory practices in healthcare is largely unexplored and unsupported. Should healthcare as an industry be encouraged to adopt safety cases more widely? This paper reviews safety case practices in six UK industries and identifies drivers and developments in the adoption of safety cases. The paper argues that safety cases might best be used in healthcare to provide an exposition of risk rather than as a regulatory tool to demonstrate acceptable levels of safety. Safety cases might support healthcare organisations in establishing proactive safety management practices. However, there has been criticism that safety cases practices have, at times, contributed to poor safety management and standards by prompting a “tick-box” and compliance-driven approach. These criticisms represent challenges for the adoption of safety cases in healthcare, where the level of maturity of safety management systems is arguably still lower than in traditional safety–critical industries. Healthcare stakeholders require access to education and guidance that takes into account the specifics of healthcare as an industry. Further research is required to provide evidence about the effectiveness of safety cases and the costs involved with the approach.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH)
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Industrial safety
Journal or Publication Title: Safety Science
Publisher: Elsevier Science BV
ISSN: 0925-7535
Official Date: 2 January 2016
Dates:
Date
Event
2 January 2016
Published
14 December 2015
Accepted
26 July 2015
Submitted
Volume: 84
Number of Pages: 9
Page Range: pp. 181-189
DOI: 10.1016/j.ssci.2015.12.021
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons open licence)
Date of first compliant deposit: 21 January 2016
Date of first compliant Open Access: 21 January 2016
Funder: Health Foundation (Great Britain) (HF)
URI: https://wrap.warwick.ac.uk/75863/

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