Determination of death by cardio-circulatory criteria and “controlled donation”: ethical and legal aspects

9 December 2021


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The Committee returns to the issue of the determination of death and organ donation for transplantation, in response to a request for clarification of the emerging bioethical aspects, received from the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI), from the Italian National Transplant Center (CNT) and the Italian Organ Transplant Society (SITO), request attached to the opinion.

The document deals with the problem of determining death according to the cardiocirculatory criterion and "controlled donation" which concerns patients who die in healthcare facilities in intensive care, whose death is subsequent to the limitation of treatments and the withdrawal of treatments, due to their ascertained ineffectiveness and non-proportionality from the point of view of the clinical outcome or by decision of the patient (refusal or renunciation). The Italian Committee for Bioethics (ICB) elaborates this reflection within the framework of the ethically relevant principles of respect for the dignity of the dying person, respect for the body of the deceased, sharing in the grief of the relatives of the deceased, solidarity towards those seriously ill and those awaiting transplantation.

The opinion highlights some ethical requirements for "controlled" donation after circulatory death: the requirement for the declaration of death to be determined according to criteria validated by the scientific community to guarantee the "dead donor rule"; retaining the observation time of 20 minutes after cardiac arrest, a protective rule, with regard to the certainty of declaring death; the necessary independence of the medical team that carries out the withdrawal of treatments from the donation team for transplant purposes; the importance of the clinical bioethics service or of an ethics committee at the time of identifying cases of unreasonable obstinacy of treatment and the separation of the withdrawal of treatments from the donation, to the extent possible given the strict time constraints; the independence of the medical team determining death from the medical team retrieving the organs; the importance that the procedures prior to the determination of death be aimed exclusively at organ preservation in view of donation, without causing any harm or suffering to the dying person and without hastening death, and for which adequate information has been provided; the importance of providing information to citizens (with the implementation of Law No. 91/1999) and for the information given to family members to be delivered in a manner that respects both the situation and setting aside adequate time. Given the organisational complexity, the Committee underlines the bioethical importance of introducing a single operational model coordinated by the competent authority, communication with family members is to take place in such a way as to be of real support for informed choices, providing transparent information for citizens.

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