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20世纪9O年代,欧美发达国家的组织库已从小规模的作坊式生产发展到大规模的产业化经营。而在国内,虽然大大小小组织库不下几十家,但仅局限于医院内部使用,没有形成规模。山西省医用组织库现任主任李宝兴教授用敏锐的观察力看到了中国组织库的未来发展方向:组织移植事业要发展壮大,就必须汲取国外先进经验,从作坊式走向产业化,从实验室走向市场。于是在坚持进行科研开发的同时,他开始着手组织库的产品注册,1999年建立山西奥瑞生物材料有限公司、2000年和2001年同种骨产品先后获国家食品药品监督管理局的试产注册和准产注册,使山西省医用组织库成为国内首家获得同种骨产品注册的组织库。经过几年的快速发展。山西省医用组织库的同种骨产品已发往除台湾以外的所有省份的数百家医院,累计向临床提供近10万件同种骨移植材料。使数万名骨病患者得以康复。取得了良好的社会效益。组织移植材料属于植入人体的生物材料,它的质量直接关系到患者的康复效果。山西组织库在建立伊始,就把向临床提供安全有效的植人材料作为自已的质量目标:严格按照ISO9000建立了产品的质量保证体系;按国家标准建设了万级洁净生产区;采用国际先进的组织制备技术。为了紧密跟踪国际组织库发展中的新技术、新方法、新理论,定期参加各种国际交流;加强与美国组织库协会(AATB)、欧洲组织库协会(EATB)及亚太外科组织库协会(APASTB)各成员国之间的交流与合作;作为中国代表参加制定国际组织库协会行业标准,推动了组织移植事业的发展。
In the 1990s, the organizational libraries of developed countries in Europe and America have evolved from small-scale workshop-style production to large-scale industrialization. In China, although there are no fewer than a dozen large and small organizations, it is limited to the internal use of hospitals and has not formed scale. Professor Li Baoxing, the current director of the Medical Organization Library of Shanxi Province, used keen observation to see the future direction of development of the China Library: To grow and expand the organization of transplants, it is necessary to learn advanced foreign experience from the workshop to the industrialization and from the laboratory to the market. . So while he insisted on scientific research and development, he began to organize the product registration of the library. In 1999, the establishment of Shanxi Ori Bio-Materials Co., Ltd., and the same kind of bone products in 2000 and 2001 were successively awarded trial production registration by the State Food and Drug Administration. With the approval of the Quasi-producing registration, the Shanxi Medical Organization Bank became the first organization in the country to obtain the registration of the same kind of bone products. After several years of rapid development. The same kind of bone products of the Shanxi Medical Tissue Bank have been sent to hundreds of hospitals in all provinces except Taiwan, and nearly 100,000 bone graft materials of the same kind have been provided to the clinic. Tens of thousands of bone patients recovered. Has achieved good social benefits. Tissue transplantation materials are biological materials that are implanted into the human body and its quality is directly related to the patient’s rehabilitation effect. Since the beginning of the establishment of the Shanxi Tissue Bank, it has provided clinically safe and effective planting materials as its own quality objectives: it has established a quality assurance system for its products in strict accordance with ISO9000; it has established a 10,000 clean production area in accordance with national standards; it adopts international advanced technology. Tissue preparation technology. In order to closely follow the new technologies, new methods, and new theories in the development of the international organization library, we regularly participate in various international exchanges; strengthen the association with the American Association of Organizational Banks (AATB), the European Association of Tissue Banking Associations (EATB), and the Association of Asia-Pacific Surgical Associations (APASTB). ) Exchanges and cooperation between member countries; Participation in the development of industry standards for the International Association of Library Associations as a representative of China has promoted the development of the organization’s transplant business.