Legal regulation of bone banks in the Russian Federation

Abstract

Autologous bone grafts are considered the gold standard for bone grafting, but in cases where their use is limited or impossible, allogeneic bone tissues become the first alternative. To date, the legal status of the activity on manufacturing bone grafts from femoral heads after total hip replacement surgery has not been defined. This somewhat hampers the development of this technology in Russia. Specialized institutions typically use internal instructions developed and approved taking into account existing legal norms in various fields. The creation of uniform operating rules, standards, instructions, clinical guidelines for working with donor tissues, as well as relevant sufficient regulatory and legal support would promote the development of tissue transplantology, bioimplantology and tissue engineering. This, in turn, would open up wide opportunities for the development of new methods of treatment of diseases, injuries, traumas and their consequences.