PERSPECTIVE: Potential impact of the forthcoming european union substances of human origin regulation on the programme of allotransplantation of cryopreserved vascular tissue grafts

The Czech vascular tissue transplantation programme has operated under the conditions set by European Union (EU) directives since 2013. The aim of this analysis was to assess the impact of the new EU regulation on it and to analyse potential non-conformance. The impact of the new regulation was assessed based on the texts of the regulation and the recommendations of the European Directorate for Quality of Medicines and Healthcare (EDQM) and the European Centre for Disease Control (ECDC). Areas requiring improvements in the future were identified. The non-compliance analysis was performed on a group of 30 vascular tissue donations. We found that the areas requiring attention are: 1) inclusion of West Nile Fever testing of donors; 2) more frequent particle counting and aeroscopy during processing; 3) determination of shelf life on the basis of a cryostability study; 4) implementation of the ISBT 128 standards for product labelling; 5) use of European Good Tissue Practice II (EURO GTP II) and Microbiologcal Risk Critical Assessment (MiRCA) tools for risk assessment; 6) implementation of the clinical outcome monitoring plan; and 7) staff participation in EDQM e-learning courses. The analysis showed a high level of compliance with the EDQM microbiological criteria for tissue procurement and processing. The temperature during processing complied with the EDQM limits, while relatively high non-compliance with the relative humidity limits occurred. In conclusion, the new regulation, which should be implemented by 2027, represents an important step towards improving vascular tissue transplantation safety. Our plans aim to meet its requirements within this period.