Balancing the failure modes in the electronic circuit of a cardiac pacemaker: A decision analysis

Cardiac pacemaker malfunctions are of continuous concern to the medical profession as well as to the electronics industry. Certain failures in cardiac pacemaker performance are critical and can result in patient deaths. Cardiac pacemakers are vulnerable to certain malfunctions in the electrode, batteries and the electronic circuit. This paper focuses on failures and reliability of the electronic circuit and how they affect its choice and design. The paper discusses the issues of balancing the various failure modes by considering both failure rates and failure outcomes. As the choice of an appropriate pacemaker is a decision problem under conditions of uncertainty, we employ decision analysis as the analytical and conceptual framework. Use of utility theory enables a systematic quantitative evaluation of such seeming intangibles as the various failure outcomes. Probabilities are assessed using specific engineering and reliability literature. The method is demon­strated on a choice problem between two specific electronic circuit designs. The methodology can be useful in designing the electronic circuit to meet certain reliability specifications, deciding whether or not to introduce redundancy, decisions affecting components and technology, and establishing minimal reliability standards, with regard not only to cardiac pacemakers but to other electronics as well.