Is the Italian consent to transfusion really informed? A medico-legal analysis between old ghosts and new evidence.

ABSTRACT

In healthcare systems of developed countries, obtaining informed consent is a necessary and fundamental requirement for the administration of any medical treatment. In Italy, for the administration of the recipient's informed consent for a blood transfusion, a pre-printed form is used in line with the Decree of the Ministry of Health dated 2 November 2015. This paper aims to analyse this form in light of the European legal provisions and following the enactment of Italian Law No. 219 of 2017 on informed consent and advance treatment directives. Our review shows that the structure of the form can be improved in light of the new direction provided by Italian law, the scientific advancement on transfusion risks, and the potential to reduce the use of blood components. Revising this form could be the opportune time to include written information on Patient Blood Management strategies. Though not exhaustive, this proposal may stimulate debate on the point and produce further contributions.