Flören M, Kappe T, Reichel H
Orthopädische Universitätsklinik, Universitäts- und Rehabilitationsklinikum (RKU), Oberer Eselsberg 45, 89081 Ulm.
Orthopade. 2007 Jul;36(7):667-72. doi: 10.1007/s00132-007-1093-4.
The EU guidelines 2004/23/EG and 2006/17/EG and their national implementation redefine the framework for allogenic bone banking and transplantation. Against this background an established internal hospital bone bank was analysed concerning threshold of allogenic bone and cost effectiveness in comparison to alternative methods.
Over a 30-month period we registered all arrivals and outgoings of our bone bank and their destination. We further noted all declined donations. We analysed all costs incurred and calculated costs for alternative methods.
By means of our bone bank we are currently able to meet our own demand for bone substitutes. The maintenance costs are below the prices of alternative methods. Some donations (8%) have to be discarded due to procedural errors.
Maintaining an internal hospital bone bank utilizing fresh-frozen allogenic bone is an efficient and cost-effective method of supplying bone substitutes even under the new EU guidelines if the existing process covers most conditions of the producer authorisation according to section sign 13 AMG. By harmonizing the organizational process it is possible to further improve its effectiveness.
欧盟2004/23/EG号和2006/17/EG号指南及其国家实施细则重新界定了同种异体骨库和移植的框架。在此背景下,对一家医院现有的内部骨库进行了分析,比较了同种异体骨的阈值和与替代方法相比的成本效益。
在30个月的时间里,我们记录了骨库的所有进出情况及其去向。我们还记录了所有被拒绝的捐赠。我们分析了所有产生的成本,并计算了替代方法的成本。
通过我们的骨库,目前能够满足我们自身对骨替代物的需求。维护成本低于替代方法的价格。由于操作失误,一些捐赠(8%)不得不被丢弃。
维持一家使用新鲜冷冻同种异体骨的医院内部骨库,即使在新的欧盟指南下,如果现有流程涵盖了《德国药品法》第13条规定的生产者授权的大多数条件,也是一种提供骨替代物的高效且具有成本效益的方法。通过协调组织流程,有可能进一步提高其效率。