The tissue bank operations in Finland have changed significantly as the result of the new EU Tissues and Cells Directives as well as the National Tissue Act that was enacted on 1 June 2007. Where the tissue bank operations were earlier performed in the hospitals alongside the surgical operations without uniform practices, specific quality controls or regulatory oversight, today’s tissue bank’s goal is to ensure the safety and quality of the tissues for clinical use together with the overseeing authorities.
Strict quality and safety standards for the tissue banks are set by the EU Tissues and Cells Directives and the National Tissue Act that correspond to the standards set for the pharmaceutical industry. If the tissue is exposed to the environment between the procurement and the transplantation, its handling is required to be performed in an area where the conditions (particle counts and the microbiological conditions) have been defined.
A tissue institution is required to have an up-to-date quality control system, which means a more stringent documentation than before, and a seamless chain of control so that the donor, the tissues, samples, materials and the reagents are well known and traceable for at least 30 years after the clinical use of the tissue. Detailed, written standard operating protocols are required for all aspects of the tissue bank operations. The competence of the staff must also be ensured through regular training. The law stipulates that the safety of the human organs and tissues, as well as the products thereof used for the treatment of an illness or injury on humans must be studied with appropriate methods. A detailed guidance of the required study methods are written in the subsidiary directives 2006/17/EC and 2006/86/EC of the EU tissue and cell directive, as well as in the National Agency for Medicines statute 3/2007.
The unification and equality of the tissue bank practices in the European Union area enable a safer tissue acquisition from outside of Finland as well. The goals of the new tissue bank practices are, among other things, the improvement of the patient safety, the modernization of the tissue bank operations, and the increasing of the transparency of the tissue bank operations.
As the result of the changes in the law, a tissue institution must receive a tissue establishment license to operate as a tissue bank. The license is issued by the National Agency for Medicines, which also inspects the tissue bank operations on a regular basis. Regea Tissue Bank is the first multi-tissue bank in Finland that meets the EU Tissues and Cells Directive issued in April 2004 and enacted in April 2006, as well as the National Tissue Act enacted in the summer of 2007.