A review of skin banking guidelines and standards worldwide: Towards the harmonization of guidelines for skin banking in therapeutic applications for the regions under the asia pacific burn association (APBA)

Wee Ling Heng, Qi Wei Wang, Renuka Sornarajah, Jacynthe Tremblay, Nandita Melati Putri, Suzina Sheikh Ab Hamid, Pornthep Pungrasmi, Hsian Jenn Wang, Dong Chul Kim, Daizo Saito, Nhu Lam Nguyen, Wan Azman Wan Sulaiman, Aditya Wardhana, Vinita Puri, Hajime Matsumura, Niann Tzyy Dai, Rajeev B. Ahuja, Gaoxing Luo, Weifeng He, Si Jack ChongAlvin Wen Choong Chua

研究成果: 雜誌貢獻文章同行評審

1 引文 斯高帕斯(Scopus)

摘要

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 devel-oped 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 Sin-gapore 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, address-ing: 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.

原文英語
文章編號019
期刊Burns and Trauma
8
DOIs
出版狀態已發佈 - 2020

ASJC Scopus subject areas

  • 重症監護和重症監護醫學
  • 急診醫學
  • 手術
  • 生物醫學工程
  • 皮膚科
  • 免疫學和過敏

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