Abstract
In virtually all safety-critical industries the operators of systems have to demonstrate a systematic and thorough consideration of safety. This is increasingly being done by demonstrating that certain goals have been achieved, rather than by simply following prescriptive standards. Such goal-based safety cases could be a valuable tool for reasoning about safety in healthcare organisations, such as hospitals. System-wide safety cases are very complex, and a reasonable approach is to break down the safety argument into sub-system safety cases. In this paper we outline the development of a goal-based top-level argument for demonstrating the safety of a particular class of medical devices (medical beds). We review relevant standards both from healthcare and from other industries, and illustrate how these can inform the development of an appropriate safety argument. Finally, we discuss opportunities and challenges for the development and use of goal-based safety cases in healthcare.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Kelly, T.: A Systematic Approach to Safety Case Management. In: Kelly, T. (ed.) Proc. of SAE 2004 World Congress (2004)
Bishop, P., Bloomfield, R., Guerra, S.: The Future of Goal-Based Assurance Cases. In: Proc. Workshop on Assurance Cases, pp. 390–395 (2004)
Toulmin, S.: The Uses of Argument. Cambridge University Press, Cambridge (1958)
DS 00-56 Issue 3: Safety Management Requirements for Defence Systems, Ministry of Defence (2004)
Kelly, T., McDermid, J., Weaver, R.: Goal-Based Safety Standards : Opportunities and Challenges. In: Proc. of the 23rd International System Safety Conference (2005)
Kelly, T., McDermid, J.: A Systematic Approach to Safety Case Maintenance. Reliability Engineering and System Safety 71, 271–284 (2001)
Kelly, T.: Arguing Safety, DPhil Thesis, University of York (1998)
Bloomfield, R., Bishop, P., Jones, C., Froome, P.: ASCAD – Adelard Safety Case Development Manual, Adelard (1998)
McDermid, J.: Support for safety cases and safety argument using SAM. Reliability Engineering and System Safety 43(2), 111–127 (1994)
Emmet, L., Cleland, G.: Graphical Notations, Narratives and Persuasion: a Pliant Approach to Hypertext Tool Design. In: Proc. of ACM Hypertext (2002)
Chinneck, P., Pumfrey, D., McDermid, J.: The HEAT/ACT Preliminary Safety Case: A case study in the use of Goal Structuring Notation. In: 9th Australian Workshop on Safety Related Programmable Systems (2004)
Sujan, M., Harrison, M., Pearson, P., Steven, A., Vernon, S.: Demonstration of Safety in Healthcare Organisations. In: Górski, J. (ed.) SAFECOMP 2006. LNCS, vol. 4166, Springer, Heidelberg (2006)
Medical Devices Regulations 2002. The Stationery Office Limited, London (2002)
European Council: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal L 169, 12/07/1993, pp. 0001 – 0043 (1993)
Standards for Better Health, UK Department of Health (2004)
Bloomfield, R., Littlewood, B.: On the use of diverse arguments to increase confidence in dependability claims. In: Besnard, D., Gacek, C., Jones, C.B. (eds.) Structure for Dependability: Computer-Based Systems from an Interdisciplinary Perspective, pp. 254–268. Springer, Heidelberg (2006)
IEC 60601-1 – Ed. 3.0 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC Geneva (2005)
ISO 14971:2007 – Application of risk management to medical devices. ISO Geneva (2007)
IEC 62304 – Ed. 1.0 – Medical device software – Software life cycle processes. IEC Geneva (2006)
IEC 62366 – Ed. 1.0 – Medical devices – Application of usability engineering to medical devices. Draft. IEC Geneva (2006)
2nd EWICS MeD Workshop, Edinburgh (unpublished report) (2004)
Moore, S.: Integrating the Healthcare Enterprise - IHE NA 2007 Connectathon Fact Sheet (2006) Retrieved from (accessed 2007-03-19), www.ihe.net/Connectathon/upload/NA_2007_Connectathon_Fact_Sheet_1.pdf
IEC 60601-2-52 – Ed. 1.0 – Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds. Draft. IEC Geneva (2006)
RVSM Pre-Implementation Safety Case, Eurocontrol (2001)
CENELEC EN 50129 – Railway Applications – Safety related electronic systems for signaling, CENELEC Brussels (2003)
Nordland, O.: Safety Case Categories – Which One When? In: Redmill, F., Anderson, T. (eds.) Current issues in security-critical systems, pp. 163–172. Springer, Heidelberg (2003)
Kelly, T.: Managing Complex Safety Cases. In: Proc. 11th Safety Critical Systems Symposium, Springer, Heidelberg (2003)
Author information
Authors and Affiliations
Editor information
Rights and permissions
Copyright information
© 2007 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Sujan, MA., Koornneef, F., Voges, U. (2007). Goal-Based Safety Cases for Medical Devices: Opportunities and Challenges. In: Saglietti, F., Oster, N. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2007. Lecture Notes in Computer Science, vol 4680. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-75101-4_2
Download citation
DOI: https://doi.org/10.1007/978-3-540-75101-4_2
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-75100-7
Online ISBN: 978-3-540-75101-4
eBook Packages: Computer ScienceComputer Science (R0)