What Pacemakers Can Teach Us about the Ethics of Maintaining Artificial Organs

Abstract

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software-particularly software that can be remotely accessed-in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered.

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices

“…Lacking access to care may expose patients with implanted devices to risks. 72 Posttrial care responsibilities for neural devices are amplified, as the brain holds special meaning to patients and atypical effects may occur (eg, personality changes). 32 Experience with other invasive devices suggests that neural devices' complexity, limited knowledge about their long-term effects, and expected rapid evolution are also sources of vulnerability for participants that warrant consideration and long-term planning.…”

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

“…However, as discussed above, many new devices do not claim to be ''new'' in principle, mode of action or materials, nor do they claim superior relative efficacy. 41 If superiority is not claimed, and harm signals are best evaluated using other methods, the basis for requiring an RCT is seriously undermined, especially since it may entail important costs and delays, and may be impractical due to the volume of devices being produced. We argue, based on the principle of justice, that devices which do not claim superior efficacy and do not claim to be new in terms of mechanism of action should not be subjected to randomized trials.…”

The ethics of explantation

“…Fewer but more thoroughly tested models of joint replacements would have increased patient safety. The situation is similar for other implants, not least pacemakers, which also have a short production life-cycle due to frequent changes [21]. Just as for follow-up drugs ("me-too drugs"), it is important for regulators to distinguish between products that contribute to incremental improvement and products that offer no demonstrable advantages over already available models [22].…”