Goal-Based Safety Cases for Medical Devices: Opportunities and Challenges

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 goalbased 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 goalbased 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.