A case study on applying formal methods to medical devices: computer-aided resuscitation algorithm

Abstract

The design and functional complexity of medical devices have increased during the past 50 years, evolving from the use of a metronome circuit for the initial cardiac pacemaker to functions that include electrocardiogram analysis, laser surgery, and intravenous delivery systems that adjust dosage based on patient feedback. As device functionality becomes more intricate, concerns arise regarding efficacy, safety, and reliability. It thus becomes imperative to adopt a standard or methodology to ensure that the possibility of any defect or malfunction in these devices is minimized. It is with these facts in view that regulatory bodies are interested in investigating mechanisms to certify safety-crictical medical devices. These organizations advocate the use of formal methods techniques to evaluate safety-critical medical systems. However, the use of formal methods is keenly debated, with most manufacturers claiming that they are arduous and time consuming.

In this paper we describe our experience in analyzing the requirements documents for the computer-aided resuscitation algorithm (CARA) designed by the Resuscitative Unit of the Walter Reed Army Institute of Research (WRAIR). We present our observations from two different angles – that of a nonbeliever in formal methods and that of a practitioner of formal methods. For the former we catalog the effort required by a novice user of formal methods tools to carry out an analysis of the requirements documents. For the latter we address issues related to choice of designs, errors in discovered requirements, and the tool support available for analyzing requirements .