The process of gaining informed consent from a patient is both complex and challenging, and the subsequent validity of that consent may be ethically open to question. Part of the process involves disclosure of risk, but with new devices the longer-term risks may not be fully known or explained to patients. In addition, with implantable cardioverter defibrillators (ICDs), it is the intended effect of the device (rather than an undesired side-effect) that becomes a potential risk and source of distress at the end of life. The duration of consent to treatment is another dimension that is often overlooked. The case study discussed within this article suggests that consent of an active device, such as an ICD, needs reviewing at times of significant change in condition, while the patient is still competent to make an autonomous decision.
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Bridget Withell (2006) studied this question.
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