TY - JOUR
T1 - A review of skin banking guidelines and standards worldwide
T2 - Towards the harmonization of guidelines for skin banking in therapeutic applications for the regions under the asia pacific burn association (APBA)
AU - Heng, Wee Ling
AU - Wang, Qi Wei
AU - Sornarajah, Renuka
AU - Tremblay, Jacynthe
AU - Putri, Nandita Melati
AU - Hamid, Suzina Sheikh Ab
AU - Pungrasmi, Pornthep
AU - Wang, Hsian Jenn
AU - Kim, Dong Chul
AU - Saito, Daizo
AU - Nguyen, Nhu Lam
AU - Sulaiman, Wan Azman Wan
AU - Wardhana, Aditya
AU - Puri, Vinita
AU - Matsumura, Hajime
AU - Dai, Niann Tzyy
AU - Ahuja, Rajeev B.
AU - Luo, Gaoxing
AU - He, Weifeng
AU - Chong, Si Jack
AU - Chua, Alvin Wen Choong
N1 - Publisher Copyright:
© 2020 BioMed Central Ltd.. All rights reserved.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Skin allografts
KW - Skin banking
KW - Skin transplantation
KW - Tissue banking
KW - Tissue donation
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U2 - 10.1093/BURNST/TKAA019
DO - 10.1093/BURNST/TKAA019
M3 - Article
AN - SCOPUS:85107238081
SN - 2321-3868
VL - 8
JO - Burns and Trauma
JF - Burns and Trauma
M1 - 019
ER -