Currently, there are no harmonized guidelines which govern skin banking in the Asia Pacific region. Therefore, skin banks are either unregulated or rely on their nation’s legislation or international accreditation to uphold their quality standards. A new set of skin banking guidelines was developed through a comprehensive review and collation of best international practices for the Asia Pacific Burn Association (APBA) members, from donor screening and testing, to skin recovery, processing, storage and distribution, and quality assurance. National regulatory requirements reviewed include the European directives, Australia’s Therapeutic Goods Administration and Singapore’s tissue banking standards. Further technical and quality management recommendations are referenced from the American Association of Tissue Banks (AATB), the United States Food and Drug Administration standards and guidance documents, various relevant European guides, Japanese Society of Tissue Transplantation guidelines and the Asia Pacific Association of Surgical Tissue Banking. Adapted mainly from the AATB standards, the new Asia Pacific Burn Association Guidelines for Skin Banking in Therapeutic Applications offer a comprehensive manual, addressing: governance and contracts; staff responsibilities; quality management; facilities, equipment and supplies management; donor consent and testing; and recommendations of good practices pertaining to skin recovery, processing, storage and distribution. Besides complementing current generic regulations, they provide technical specifications of major aspects unaddressed in most legislations. This inaugural set of new regional skin banking guidelines would be a start for regional members of the APBA to adopt, and will hopefully culminate in a set of standards so that, in the long run, skin allografts from this region can be of similar quality, which can simplify import process and facilitate the exchange of allografts between members.

中文翻译：

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全球皮肤库指南和标准回顾：亚太烧伤协会 (APBA) 各地区治疗应用皮肤库指南的协调一致

目前，亚太地区没有统一的皮肤库管理指南。因此，皮肤库要么不受监管，要么依赖其国家立法或国际认证来维持其质量标准。通过对亚太烧伤协会 (APBA) 成员的最佳国际实践进行全面审查和整理，制定了一套新的皮肤库指南，涵盖从供体筛选和测试到皮肤恢复、加工、储存和分配以及质量保证的各个方面。审查的国家监管要求包括欧洲指令、澳大利亚治疗产品管理局和新加坡的组织库标准。进一步的技术和质量管理建议参考了美国组织库协会 (AATB)、美国食品和药物管理局标准和指导文件、各种相关欧洲指南、日本组织移植协会指南和亚太外科组织协会银行业。主要改编自 AATB 标准，新的亚太烧伤协会皮肤库治疗应用指南提供了一本全面的手册，涉及：治理和合同；员工职责；质量管理; 设施、设备和物资管理；捐赠者同意和测试；以及有关皮肤回收、加工、储存和分销的良好做法的建议。除了补充现行的通用法规外，它们还提供了大多数立法中未涉及的主要方面的技术规范。这套首套新的区域皮肤库指南将成为 APBA 区域成员采用的开始，并有望最终形成一套标准，以便从长远来看，来自该地区的同种异体皮肤移植物可以具有相似的质量，可以简化进口流程，方便会员之间同种异体移植物的交换。