Safety Cases: Pragmatic Review & Lessons for Healthcare

funded by the Health Foundation (2011)

Overview

The purpose of a Safety Case (or more generically Assurance Case) can be defined as communicating a clear, comprehensive and defensible argument that a system is acceptably safe to operate in a particular context. In addition, a Safety Case is a valuable tool for bringing about a systematic approach to safety and for providing a record of management’s commitment to safety. In many safety-critical industries the use of Safety Cases is a regulatory requirement. In healthcare, there have been first attempts at adopting the Safety Case concept for medical devices promoted by the US Food & Drug Association.

The aims of this study are to provide:

• A clear description of Safety Case use in selected safety-critical industries
• Pragmatic recommendations for the adoption of Safety Cases in healthcare
• Outlines of possible healthcare application scenarios

Project description on the Health Foundation website.

An earlier paper on goal-based safety cases for medical devices: MA Sujan, F Koornneef, U Voges (2007). Goal-Based Safety Cases for Medical Devices: Opportunities & Challenges. Lecture Notes in Computer Science 4680;pp14-27, Springer Verlag

Results

Programme of the project workshop, March 29th 2011.

The final report is available on the Health Foundation website (Bloomfield, Chozos, Embrey et al. "Using Safety Cases in Industry and Healthcare", December 2012). The Health Services Journal did a review of the implications of this research in February 2013 . The Clincial Services Journal included coverage of the report in June 2013 .

Publications

A paper describing some recommendations for the adoption of safety cases for medical devices and health IT has been accepted for publication:

Sujan M, Koornneef F, Chozos N et al. Safety Cases for Medical Devices and Health IT - Involving Healthcare Organisations in the Assurance of Safety. Health Informatics Journal 2013;19(3):165-182

A paper describing two examples of how safety cases might be applied in healthcare has been published in Reliability Engineering & System Safety:

Sujan M, Spurgeon P, Cooke, M, Weale A, Debenham P, Cross S. The development of safety cases for healthcare services: practical experiences, opportunities and challenges. Reliability Engineering & System Safety 2015;140:200-207 (Open Access)

Should healthcare do safety cases? Reflections on the use of safety cases have been published in Safety Science (Open Access).

SUJAN, M. A., HABLI, I., KELLY, T. P., POZZI, S. & JOHNSON, C. W. 2016. Should healthcare providers do safety cases? Lessons from a cross-industry review of safety case practices. Safety Science, 84, 181-189.

Project team

Mark-Alexander Sujan (PI)

Adelard: Prof Robin Bloomfield, Dr Nick Chozos

Deep Blue: Alberto Pasquini, Dr Simone Pozzi

Human Reliability: Dr David Embrey, Jamie Henderson

University of Delft: Dr Floor Koornneef

University of York: Dr Tim Kelly