When it comes to organ donationone of the most frequent questions is also the one that causes the greatest fear: “how can we be sure that the organ harvesting does not take place when the donor is still alive?” The answer lies in the rigidity of the medico-legal protocols which regulate the assessment of death in Italy: procedures based on precise scientific criteria, established by law and controlled by independent medical teams. The certification of death in Italy is defined by law 578/1993 and is based on the irreversible cessation of encephalic functions.
The confirmation of death? Scientific and legal protocols
From a scientific, medical and legal point of view, death coincides with death irreversible cessation of all brain functions, i.e. cerebrum, cerebellum and brainstem. In the common imagination it is often thought that death coincides with the heart stopping, but this is not the case. In fact, even in cardiac arrest, the ultimate cause of death is always the brain: deprived of blood and oxygen, it suffers irreversible damage.
When the brain definitively stops functioning, in addition to there being no consciousness, there is no control of the functions essential for life, including spontaneous breathing, vital reflexes, cardiovascular regulation, temperature regulation.
For this reason, it is said that death is only one: what changes is the way in which it is ascertained, through neurological criteria or cardiac criteria.
The Italian regulatory framework on the verification of death
In Italy, the verification of death is regulated by precise rules:
- Law no. 578 of 29 December 1993which defines death as the irreversible cessation of brain function
- Ministerial Decree of 11 April 2008which establishes the operational assessment methods
A fundamental element of the death certification procedure is the separation between medical teams involved: the treatment team, which is responsible for doing everything possible to save the patient’s life, is distinct and independent from the team that ascertains and certifies the death. Only after official certification is it verified whether the patient can be a potential donor, and only at that point does a third group, the transplant team, come into play.
Irreversible cardiac arrest (Donation with a stopped heart)
In the event of cardiac arrest, all available resuscitation maneuvers are performed. If they are unsuccessful, the absence of cardiac activity is documented, but this is not yet equivalent to certification of death.
The reason is precise: even in this scenario, death occurs because the brain, deprived of blood and oxygen due to cardiac arrest, suffers irreversible damage. It is always the cessation of encephalic functions that defines death, cardiac arrest is the cause, not the sufficient criterion.
For this reason, Italian law provides for a observation period of 20 consecutive minutes without cardiac activity before being able to officially declare death: an interval that serves to exclude any possibility of spontaneous resumption of cardiac activity and, consequently, to guarantee that the brain damage is irreversible. This is one of the most precautionary standards in Europe, in many other countries the same assessment is carried out after 5 minutes.
Only after this period is the death declared and, possibly, a donation process initiated.
Brain Death (Beating Heart Donation)
In the event that the patient has suffered irreversible brain damage, all functions dependent on it, including breathing, would cease if not supported by machines. In particular, mechanical ventilation supports the supply of oxygen to the heart and maintains its activity. If ventilation were turned off, no more oxygen would reach the heart and it would stop working.
The functions of the brain have ceased permanently: without the machinery, breathing and heartbeat would stop in a short time. The heart beats only because the body is supported artificially, not because the person is alive.
To certify the death in this case, one intervenes commission of three independent doctors: an anesthetist-resuscitator, a neurologist or neurophysiopathologist and a forensic doctor (or anatomo-pathologist). This commission observes the patient for a period of at least 6 consecutive hourssimultaneously verifying the presence of all the following conditions:
- deep non-reversible coma
- absence of brainstem reflexes
- absence of spontaneous breathing (apnea test)
- flat electroencephalogram (EEG).
If all these conditions persist for the entire duration of the observation period, death can be certified. Once the patient is declared deceased, there are two scenarios: in the first case, we proceed with the operations that will take the deceased to the mortuary; in the second case, if the patient in life had declared that he wanted to be a donor (or at the time of death, his family declared that they wanted to donate the organs of the loved one), only then is the process that will lead to the donation activated.
Brain death and coma: two radically different conditions
Another point that is often misunderstood is the difference between brain death and coma. They are not the same thing, neither clinically nor legally.
In the comathe brain is seriously compromised but maintains electrical activity detectable on the electroencephalogram, some reflexes may be present and, above all, there is the possibility of recovery. In the brain deathhowever, there is no brain activity, there are no brainstem reflexes, there is no autonomic breathing, the EEG is flat and the condition is irreversible by definition.
The donation does not anticipate death
The central point of this whole system is only one: under no circumstances can organ donation hasten death. Doctors have the obligation to ascertain death, using neurological or cardiac criteria, regardless of any other consideration, including possible donation.
Having rigorous protocols ensures absolute certainty of death before any other decisions are made.
Criteria for the verification and certification of death
