Annual report 2022 on the supervision of the quality and safety of transplants of human origin has been published

Fimea's Substances of Human Origin (SoHO) division is responsible for supervising the quality, safety and traceability of transplants of human origin, such as blood products, tissue transplants, germ cell and stem cell transplants, and organ transplants in Finland. The supervision covers licence procedures and the maintenance of operator registers, the regular inspection activities and the monitoring of serious adverse events and adverse reactions observed in the activities.

In 2022, the division processed 42 organ transplantation permits, 23 operational change notifications and 111 serious adverse events or adverse reactions reported in SoHO activities, 29 of which took place another EU country. In addition, 32 inspections of blood service and tissue establishments were carried out.

Among other things, operators supervised by Fimea reported more than 200,000 blood products, 371 organ transplantations, more than 2,000 fertility treatments with donated sperm and about 700 with donated egg cells, 368 stem cell transplantations and approximately 2,000 patients treated with tissue transplants. The number of fertility treatments for single women and female couples continued to increase. In 2022, a total of 1,224 fertility treatments for female couples or single women were performed. The majority of fertility treatments with donated sperm were carried out with imported sperm.

Read more:

Fimea’s supervision of the use of transplants of human origin in 2022 (pdf, in Finnish)