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)

Abstract

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.

Organization of Hannover Skin Bank: Sterile culture and procurement protocols for viable cryopreserved allogeneic skin grafts of living donors

“…There are currently high quality standards due to increasing regulations and accreditations to run a skin tissue bank. 45,46 We presented and validated a procurement and processing protocol for allogeneic skin grafts of living donors. Throughout skin tissue banks worldwide, allogeneic skin grafts are mainly obtained from cadaveric donors sharing all of the disadvantages of allogeneic transplants such as disease transmission, graft rejection, immunogenicity and secondary infection.…”

“…Skin allografts continue to be an important therapeutic tool in the management of severely burned patients and the development of skin banking in individual burn units has given way to the establishment and management of large regional and national skin banks. There are currently high quality standards due to increasing regulations and accreditations to run a skin tissue bank 45,46 . We presented and validated a procurement and processing protocol for allogeneic skin grafts of living donors.…”

Human Amniotic Membrane Usage from Bench to Bedside in Congenital Defects and Wounds in Paediatric Surgery: A Systematic Review

“…To overcome the issues of sterility, some countries introduced electron-beam sterilization as a sterile and nonimmunogenic AM, which eliminates viruses, bacteria, and spores, achieving sterility levels. The World Health Organization's regulations, on Key Safety Requirements for Essential Minimally Processed Human Cells and Tissues for Transplantation and Resolution -Human Organ and Tissue Transplantation, are based on the principle of non-commercialization of human cells, tissues and organs for transplantation 62 . In addition, it also addresses ethical issues relating to tissue recovery for transplantation, procedures to be followed to uphold the quality and safety of tissues, and encourages collaboration in information sharing, especially with regard to adverse events and post-transplantation adverse reactions 61 .…”

Legality of therapeutic contract of stem cell treatment in Indonesia

“…Singapore does not have specific legislation to regulate stem cell treatment processes and products, although they broadly fall within the scope of The Medicines Act. Stem cells processed and stored for human transplantation in hospitals and medical clinics are covered under the Guidelines for Healthcare Institutions Providing Tissue Banking [43]. This guidance includes "all constituent parts of the human body, including surgical residues" but excludes solid organs, placenta, blood and blood products, and reproductive tissues, and does not include tissues that have been "processed in such a manner that their functional, structural and biological characteristics have been altered."…”