Reimplantation of Implantable Cardiac Devices-An Ethical Controversy?

Abstract

Background: Cardiovascular diseases are an important public health problem, the main cause of death in both men and women, with a continuous increasing prevalence and consequences upon morbidity in economic, physical, and psychological terms.The new technology have made possible the development of innovative devices, which have increased the possibility of therapeutic interventions today, extending the life of the population with cardiovascular pathology, transforming the patient care, and providing a complex, personalized therapeutic approach.

Fields of uncertainty: The aim of the study was to evaluate from an ethical perspective the need, feasibility, and safety of reusing cardiac pacemakers to revise the legal terms and requirements.In recent years, the problem of accessibility to cardiovascular drugs has been increasingly accompanied by the accessibility to technology, interventional cardiology advancing recently, and becoming an increasingly important standard of care.

Data sources: A review of the specialized literature was performed in March 2023, using keywords such as implantable cardiac devices, reuse, ethics from PubMed, Scopus, Web of Science, and Google Scholar, as well as official documents issued at the international level (World Health Organization).

Ethics and therapeutic advances: An ethical analysis assesses the extent to which a medical act (PM reimplantation) is covered by the 4 universally accepted principles: nonmaleficence, beneficence, autonomy (respect for the person), and social justice, the analysis addressing to the risk-benefit ratio based on studies that analyzed the phenomenon over the past 50 years. The ethical analyzed issues start from the fact that although 80% of pacemakers, most of them working perfectly, with a battery life of more than 7 years are buried with their owners, while approximately 3 million patients die annually due to the lack of access to these devices in undeveloped and developing countries.But beyond the ethical issues, legal practice has meant that in many countries, reusing of these devices is prohibited, mostly being single-use devices. Low-income countries continue to accept this practice as the only one economically accessible to them, considering the prohibition of reusing them to be an economic rather than a medical issue.

Conclusions: Reusing implantable cardiac devices is of great interest because of the costs, being in certain situations, the only possibility that certain people can have access to a therapeutic method that ensures their health recovery and increases their quality of life. But this is not possible without clear procedures, without clear criteria on how sterilization should be performed, how the technique should be performed, without obtaining a truly informed consent, and especially without a proper patient's follow-up.