Their Roles and Functions of the Tissue Banks.
- Author:
Baek Yong SONG
1
;
Soo Ik AWE
;
Byoung Suck KIM
Author Information
1. Department of Orthopedic Surgery, College of Medicine, Eulji University, Seoul, Korea. bskimos@eulji.ac.kr
- Publication Type:Review
- Keywords:
Tissue bank;
Law;
Role
- MeSH:
Brain Death;
Cadaver;
Donor Selection;
Financing, Organized;
Gift Giving;
Humans;
Informed Consent;
Jurisprudence;
Korea;
Product Packaging;
Quality Control;
Quarantine;
Reward;
Social Control, Formal;
Tissue Banks;
Tissue Donors;
Transplantation, Homologous;
Transportation;
United States Food and Drug Administration;
Writing
- From:Journal of Korean Burn Society
2009;12(1):1-11
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
Tissue bank with profer personnels (medical director, tissue bank speciality, and so on), facilities, equipments, standard of procedures (SOP) and quality control (QC) programs should get the permission from Korea Food and Drug Administration (KFDA). All kinds of tissues are donated from live donors, cadavers or brain deaths without any rewards. Permission to acquire tissues shall be obtained through the granting of informed consent by a consenting person in accordance with applicable Korean law and regulations for anatomical gifts. One or two more tissue banks participate in recovery, preservation, quarantine, processing, packaging, storage, and/or distribution. The relationship and responsibilities of each shall be delineated in writing and that documentation shall be maintained at each participating bank or facility. Each tissue bank should keep the safety for all tissues under the strict SOP and QC programs, including donor screening, donor testing and donor exclusion criteria. And also, the final human tissue products should keep in sterile package and transfer to medical facilities for reconstruction of patients' defects under profer temperature within transportation containers. Potential adverse reactions, suspected transmission of disease or complications, directly or indirectly related the allograft, shall be reported to KFDA for the further safety
