Current standards in tissue banking

Abstract

The transplantation of human tissues and cells (musculoskeletal tissues, corneal tissue, cardiovascular tissue, skin and skin substitutes) is a strongly expanding field of medicine which offers great opportunities for the treatment of tissue defects. The quality and safety of these substances should be guaranteed, particularly to prevent the transmission of diseases. As tissue and cell therapy is a field in which an intensive worldwide exchange is taking place, it is desirable to achieve worldwide standards. The European Community should therefore endeavour to promote the highest possible level of protection to safeguard public health regarding quality and safety of tissues and cells. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of ‘Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells’ and their complementary Directives 2006/17/EC and 2006/86/EC are now implemented into national law in the countries of the European Union. Mainly, the regulations in the recent Tissue Acts have significantly changed the working situation for tissue establishments. The transmission of viral and non‐viral infectious pathogens continues to be the most serious of the potential adverse effects of allogenic tissue transplants. Therefore, tissue banks must focus on comprehensive and robust quality assurance in the areas of donation (local sterile area), testing, processing and preservation. While serologic testing for anti‐HIV‐1 and ‐2, anti‐HCV, HBsAg, anti‐HBc and Treponema pallidum infection is mandatory, there is, until now in most countries, no explicit demand for nucleic acid amplification technique (NAT) testing to detect human immunodeficiency virus, hepatitis B and C virus (HIV, HBV, HCV) infection. Reports on viral transmission events, tissue‐specific issues, manufacturing and inactivation procedures should be evaluated regarding the significance of HIV, HCV and HBV detection by NAT in donors of various types of tissues. In view of numerous synergy effects with transfusion medicine, it would be advantageous for tissue banks to co‐operate with blood bank laboratories in performing virological tests. Whenever possible, a validated inactivation procedure should be included in the manufacturing process of musculoskeletal tissue transplants. Tissue establishments should follow a documented quality management system on the basis of good practice procedures which is maintained to the current standards. Deviations from the stipulated quality and safety standards must result in documented investigations which include decisions on options for correctional and preventive measures. Donor tissue can only be released if defined criteria are met. Any suspicion of severe undesired reactions and events for the recipient of a tissue transplant must be registered with the authorities. To properly identify the donors, secure traceability of all donated material and provide information about characteristic features and properties of tissues and cells, the European Union demands a single European coding system for cells and tissues.