|
KMID : 0922220130130010001
|
|
Journal of the Korean Musculoskeletal Transplantation Society
2013 Volume.13 No. 1 p.1 ~ p.8
|
|
|
Current Status of Tissue Banking in USA
|
|
Kang Yong-Koo
Park Jang-Su
|
|
|
Abstract
|
|
|
USA were excellent to ensure the safety of tissue products. A huge number of tissue donors were collected, and tissues were procured in proper manner. Screening requirements were very strict and showed absolute rule out to risks of potential mistakes. Inspection team has reviewed the donor charts randomly selected, and found that donor records were adequately maintained at all cases. Records for causes of death, results of serology, time of death, time of refrigeration, first incision for recovery and bacterial culture results were properly placed in donor charts. There was proper documentation on the donor registration form indicating that the donor was properly selected before procurement. However, some donors showed high in process bio-burden. These high in process bioburden, then may be related with inadequate techniques by OPO/tissue recovery agencies.
To increase number of donors, they have tried to have overseas recovery agencies. However, systems of tissue banking in third countries (eg. eastern Europe) were poor in documentation, facilities and instruments for procurement. Even in tissue donor from USA, there was a trend of loose donor selection criteria and tight processing condition for safety of tissues. A tissue bank has been shown post processing bioburden was as high as 0.05%, then KFDA inspection team have advised the tissue bank to adopt the final sterilization process for ensuring the tissue safety. The inspection team has found the efficacy of on-site audit, and continuous audit will be necessary to ensure the safety and quality improvement of imported tissues.
|
|
|
KEYWORD
|
|
|
Human tissue, Tissue bank, Quality controal
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|