Pacemaker reuse: Systematic review of the technical, ethical and regulatory policy aspects

Reimplantation of Implantable Cardiac Devices—An Ethical Controversy?

“…Similar studies have been conducted in subsequent years, without showing significant differences in infection rates, device malfunction, premature battery depletion, and therefore device-related deaths; thus, in 2018, a meta-analysis was performed on studies from the period 2009–2017 (2114 patients) 34 ; in 2021, a systematic review and a meta-analysis were published based on the articles that had a control group from 1989 to 2020 12 ; in 2022, the analysis was performed on 36 studies, of which 3 were meta-analyses or systematic reviews and 13 cohort and case-control studies. 9…”

“…34 Similar studies have been conducted in subsequent years, without showing significant differences in infection rates, device malfunction, premature battery depletion, and therefore device-related deaths; thus, in 2018, a meta-analysis was performed on studies from the period 2009-2017 (2114 patients) 34 ; in 2021, a systematic review and a meta-analysis were published based on the articles that had a control group from 1989 to 2020 12 ; in 2022, the analysis was performed on 36 studies, of which 3 were metaanalyses or systematic reviews and 13 cohort and case-control studies. 9 The findings of the abovementioned studies are unanimous: given the available data, based on the necessity to obtain maximum benefits taking into account that otherwise treating patients in poor countries not be possible because of financial reasons, without the risk of early battery depletion or infection, it is an ethical option to reuse them, obeying the protocols regarding not only the cleaning and sterilization but also those regarding functional testing, developed from 1990 to 2010. 35,36 The conclusion of a group of researchers in Nepal, who analyzed the ethical and legal aspects of the issue, is that "The risk-benefit ratio requires that the potential benefits of any procedure outweigh its risks and disadvantages.…”

“…Therefore, measures must be urgently taken to reduce these disparities 9,27,39 but also for ensuring the organizational and legal framework to be able to achieve clear standards to reuse the devices, to select donors, comply with ethical principles, and last but not least to avoid arbitrariness in the process of collecting, preparation, and reimplantation.…”

“…Pacemakers have become a standard of caring patients with CVD, especially those with heart failure or heart rhythm disturbances, although the accessibility of many patients to them is difficult and up to 3 million people die annually due to the limited or no access to these devices. 9,10…”

“…Pacemakers have become a standard of caring patients with CVD, especially those with heart failure or heart rhythm disturbances, although the accessibility of many patients to them is difficult and up to 3 million people die annually due to the limited or no access to these devices. 9,10 PMs are devices that apparently do not represent a very high cost for patients in developed countries, explaining why countries such as France, the United States, or the United Kingdom implant more than 500 PMs per million inhabitants every year. On the other hand, where the cost of these devices (between $2500 and $10,000) is believed to be burdensome, less than 30 devices can be implanted annually, as in Sudan, Bangladesh, India, or Peru.…”