Hahn A, Thanos M, Reinhard T, Seitz B, Steuhl K-P, Meller D
Klinik für Erkrankungen des vorderen Augenabschnitts, Zentrum für Augenheilkunde, Universität Duisburg-Essen, Essen, Deutschland.
Ophthalmologe. 2010 Nov;107(11):1020-31. doi: 10.1007/s00347-010-2269-6.
A cornea/tissue bank must have an organizational structure in which responsibility and authority to issue directives are clearly defined. It must also use a documented quality management system on the basis of good practice procedures which is maintained to the current standards. The personnel of a cornea/tissue bank must be present in sufficient numbers and be suitably qualified. A cornea/tissue bank must be in possession of appropriate facilities which are suitable for the main purpose of preparation of cryopreserved human amniotic membranes from donor placentas. All equipment must be designed and maintained corresponding to the intended purpose. Deviations from the stipulated quality and safety standards must give rise to documented investigations which include decisions on options for correctional and preventive measures. Acquisition of donors and tissue sampling must be strictly controlled and documented. This also applies to entry of donor tissue in the cornea/tissue bank. Cryopreserved human amniotic membranes can only be preserved from donors undergoing caesarean section and who did not present any known infection of the abdominal cavity or any systemic blood borne infection. Contamination of media used for cryopreservation of donor placenta must be ruled out at least once. Measures must be taken to keep the risk of contamination as low as possible. Cryopreserved human amniotic membranes from donor placentas can only be released if defined criteria are fulfilled. Any suspicion of severe undesired reactions and events for the recipient of an amniotic membrane transplant must be registered with the authorities. The activities of a cornea/tissue bank must maintain and adapt to the state-of-the-art with respect to scientific progress.
角膜/组织库必须具备一种组织结构，其中发布指令的职责和权限应明确界定。它还必须基于良好实践程序使用文件化的质量管理体系，并保持符合现行标准。角膜/组织库的人员数量必须充足且具备适当资质。角膜/组织库必须拥有适合从供体胎盘制备冷冻保存人羊膜主要目的的适当设施。所有设备的设计和维护都应符合预期用途。与规定的质量和安全标准的偏差必须引发文件化调查，包括关于纠正和预防措施选项的决策。供体的获取和组织采样必须严格控制并记录在案。这也适用于供体组织进入角膜/组织库。冷冻保存的人羊膜只能从接受剖宫产且无任何已知腹腔感染或任何系统性血源性感染的供体获取。用于供体胎盘冷冻保存的培养基污染必须至少排除一次。必须采取措施将污染风险降至最低。只有在满足既定标准时，才能发放来自供体胎盘的冷冻保存人羊膜。对羊膜移植受者的任何严重不良反应和事件的怀疑都必须向当局报告。角膜/组织库的活动必须随着科学进步保持并适应最新技术水平。
