Death Determination, the Dying Process and the Dead Donor Rule: A Critical Analysis of the Italian 20‐Minute No‐Touch Period in Controlled Donation After Circulatory Determination of Death

In Italy, controlled Donation after Circulatory Determination of Death (cDCDD) requires a 20-min no-touch period documented by continuous electrocardiographic monitoring. Since Italian law adopts a single brain-based definition of death, this procedure serves as an indirect determination of the irreversible cessation of all brain functions. This differs from other countries using 5-min no-touch periods and focusing on permanent cessation of circulation. This paper argues that the Italian 20-min no-touch period lacks a convincing scientific and ethical basis. No evidence shows that 20 min is the minimum period required to establish beyond doubt the irreversible cessation of all brain functions after circulatory arrest. Moreover, the Italian legal definition of death relies on a standard that is not fully verifiable in practice, both regarding the cessation of all brain functions and irreversibility. It further maintains that the dead donor rule is vulnerable insofar as it is closely tied to legal definitions of death that do not fully capture the complexity of dying as a biological process. Donor protection should instead be based on what can be biologically proven, clinically confirmed, and ethically justified. The paper suggests a partial reformulation of the dead donor rule, based on the diagnosis of a permanent dying process that will inevitably lead to complete biological death. On this ground, Italy should reduce its no-touch period to the 5-min standard and revise death-determination protocols to document the permanent cessation of effective systemic circulation rather than the disappearance of cardiac electrical activity.