Erhebung zur Entwicklung und aktuellen Situation allogener Knochenbanken in Deutschland

Introduction: The use of allogenic femurheadtransplantants provides an established method for surgical treatment of defections on the skeletal system. As alternative to the autologous bone-replacement the allogenic bone has the advantage of being available in almost any amount. At the same time it possesses similar biological characters as the autologous bone transplant. However, the disadvantage lies in the risk of transmitting various germs. In order to offer biologically highly valuable and non-infectious allogenic bone transplants there are allogenic bone- and tissue banks at numerous clinical facilities. The working procedures in these banks are regulated by the National Medical Chamber (Bundesärztekammer, BÄK). The purpose of this survey was to evaluate the amount of such institutions at German surgical hospitals and to precisely investigate the different working procedures concerning processing, storing and usage of allogenic bone transplants. Material and methods: The enquiry by mail using a multi-page questionnaire was done nationwide in the year 2000 at the request of the Department of Bone Transplantation of the DGOC. The acquired data were evaluated and compared to the results of former similar surveys. Through this the development tendency of German surgical bone banks in the last 15 years could be reproduced and the impact of the guidelines of the BÄK on running a bone bank in the daily practice could be investigated. Results: Selection of the donor – The first step in the risk-reduction is carried out through using detailed anamnesis, careful clinical examinations and laboratory tests. The comparison of studies concerning the diagnosis of HIV and hepatitis leads to a clear positive development in the selection of the donor. In 1999 the HIV and hepatitis serology was routinely carried out in all bone banks whilst in 1987 many institutions did not carry out these tests. By using a comparison table it is shown that the publishing of the guidelines on running an allogenic bone bank and their amendment has led to an improvement in the selection of the donor. Examination of the transplant – At the time the transplant is obtained, a number of bacteriological smear tests are carried out in the bone bank as further steps. Whilst in 1987 only about 79 % such examinations were carried out, the number was raised to about 91 % in 1999. Also in this aspect a clear improvement in observance of the current regulations can be seen. 123 Treatment of the transplant – The secondary sterilisation/disinfection plays an important role in the security concept of the bone banks. At the moment the most commonly used method for germ-deterging is the thermodesinfection at a temperature of 80°C. This temperature related and validated method leads to inactivation of viral and bacterial germs, at the same time preserving the biological potential of the transplant. This development is also attributed to the guidelines for allogenic bone banks and to the interpretation of the infection problem which have led to an increase in the use of sterilisation methods. Conservation and storage of the transplant – According to actual scientific knowledge transplants can be stored at a temperature of -80°C up to a period of 5 years, without losing their biological values. Here also, there has been a clear positive development in the use of correct storage temperature. Discussion: The results of the survey show, in comparison to past evaluations, a steady improvement in the working procedures of German bone banks. Nevertheless, security relevant conditions are only partly fulfilled. Due to the careless handling of allogenic transplants there is a serious risk for the transplant receiving patients. Hence the following demands are made of future conduct of allogenic bone banks: - By intensifying further educational programmes by the orthopaedic/surgical societies in the form of teachings, seminars and congresses, the operators of tissue banks should be more sensitized to the risks of bone banking - Setting up inspectors of higher status who regularly check that the BÄK guidelines are followed and the new law on tissue utilization is observed. - With the rising need for allogenic bone transplants, regional bone banks should be set up so that the small non bone banking institutions are provided for.