Yusof Norimah
UMMC Bone Bank, National Orthopaedic Centre of Excellence in Research and Learning (NOCERAL), Department of Orthopaedic Surgery, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.
Cell Tissue Bank. 2018 Jun;19(2):175-186. doi: 10.1007/s10561-017-9651-4. Epub 2017 Oct 11.
Under the auspices of the IAEA tissue banking programme on "Radiation Sterilisation of Tissue Graft" conducted from 1985 to 2004, many scientists and surgeons were involved in various regional research and development (R&D) projects mainly in dealing with radiation dose selection, radiation effects on human tissues and quality system in radiation sterilisation. New findings on radiation effects, tissue processing and preservation were shared during the regional and interregional meetings and workshops. Many tissue banks started to use radiation (25 kGy) to sterilize tissue grafts for tissue safety and efficacy and still continue to use it. The IAEA Code of Practice for Radiation Sterilization of Tissues Allografts developed in 2007 offered simpler methods to conduct radiation dose setting and dose validation experiments for tissue grafts. Advances in dose selection and dose mapping are continued under the quality management system when banks need to be certified to continue their operation. The combination of good tissue processing and preservation as well as good radiation practice will ensure the tissue products are properly sterilised thus safe and of high quality. Experience in meeting challenges in using radiation sterilisation and achievements reported by the tissue bankers are shared here.
在1985年至2004年国际原子能机构开展的“组织移植物辐射灭菌”组织库项目的支持下,许多科学家和外科医生参与了各种区域研发项目,主要涉及辐射剂量选择、辐射对人体组织的影响以及辐射灭菌中的质量体系。在区域和区域间会议及研讨会上分享了关于辐射效应、组织处理和保存的新发现。许多组织库开始使用辐射(25千戈瑞)对组织移植物进行灭菌,以确保组织安全和有效性,并且仍在继续使用。2007年制定的国际原子能机构同种异体组织移植物辐射灭菌实践准则提供了更简单的方法来进行组织移植物的辐射剂量设定和剂量验证实验。当组织库需要获得认证以继续运营时,在质量管理体系下,剂量选择和剂量映射方面的进展仍在持续。良好的组织处理和保存以及良好的辐射操作相结合,将确保组织产品得到适当灭菌,从而安全且质量高。本文分享了组织库在应对辐射灭菌挑战方面的经验以及所报告的成果。