Biovigilance for the Quality and Safety of Medical Products of Human Origin

Vasiliki Gkioka, Panagiotis Tsirigotis, Markos Sarris, Sotiris Soulis, Athanasios Apostolou, Michel Noutsias, Georgios Dimitriadis, Alkiviadis Kostakis, Ioannis Boletis, Andreas Karabinis

Abstract


Progress in science and technology in the health services has led to the development of methods of regenerating and replacing solid organs, tissues and cells, using human body components to create medical products of human origin intended for clinical use. In the activities in which products of human origin are used, however, from the point of donation and harvesting to the subsequent care of the recipient, medical products of human origin are exposed to the risk of specific complications related to the transmission of infectious diseases, and further side-effects. Biovigilance system application is a basic requirement for ensuring the quality and safety of tissues and cells intended for human use. The quality system focuses on error prevention, maintaining a consistent pattern of agreed assays for tissues and cells intended for clinical use. The implementation of quality and safety standards, the development of medical protocols and cooperation protocols between member states, the implementation of Single European Code (SEC), and the development of electronic traceability systems, all aim at vigilance and the surveillance of medical products of human origin from donation to transplantation.




J Clin Med Res. 2018;10(12):857-867
doi: https://doi.org/10.14740/jocmr3549w

Keywords


Assurance; Biovigilance; Cells; Safety; Serious adverse event; Serious adverse reaction; Tissues

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