Ethics and the Cardiac Pacemaker: More Than Just End-of-life Issues

Katrina Hutchison; Robert Sparrow

Disclosures

Europace. 2018;20(5):739-746. 

In This Article

Re-use of Explanted Devices

Pacemakers are sometimes removed while still functioning and with significant battery life remaining. This can occur either due to the death of the patient, or because the implanted pacemaker is no longer appropriate for their clinical needs. Despite being officially stipulated as a single use device by regulatory bodies in most developed countries, some countries have humanitarian re-use schemes that collect, export and clean explanted pacemakers for re-use in charitable hospitals in developing countries.[55] One organisation operating in the US promotes the donation of devices with at least 70% battery remaining for re-use in low and middle income countries.[56,57] In Africa, the Pan-African Society of Cardiology also has a taskforce dedicated to a pacemaker and ICD recycling program.[58] Historically the reuse of pacemakers was also accepted in developed countries such as Australia.[59]

A number of ethical issues arise in association with the reuse of explanted pacemakers. First, there are issues associated with the safety of potential recipients. There are a number of risks, including evidence that reused devices have a higher malfunction rate than new devices, concern about infections and prion disease transmission, and ensuring appropriate informed consent processes and appropriate patient follow-up.[60,61] The decision to donate devices to those who may not otherwise have access is typically motivated by moral considerations about the rights of others to affordable healthcare. Thus considerations regarding potential risks to recipients and concerns that patients in the global South are receiving devices that would not meet the standard of care required in wealthy Northern nations must be weighed against the benefit associated with receiving a device in a context where treatment may otherwise be unaffordable. Finally, there are considerations related to ownership and rights over the device—should patients with a pacemaker have the right to decide what happens to it after it is removed or after their death? For at least some devices there is an expectation that the explanted device will be returned to the manufacturer for quality control and post market surveillance. Does this mean that the manufacturer retains ownership rights over the device while it is inside the patient? And are the people who remove devices obliged to respect the interests of either the patient or the manufacturer when they remove a device? Clinicians need to be aware of the contentious issues here. Table 6 provides a list of questions to guide decision making in the context of pacemaker reuse.

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