Quality control in tissue banking--ensuring the safety of allograft tissues.
DESPITE FEDERAL REGULATIONS for tissue-banking practices, inadequate quality control led to the largest allograft tissue recall in history in October 2005. THE RECALL INCLUDED all allograft tissues obtained from 761 donors and distributed by five tissue banks. Many of these tissues already had been implanted and were unrecoverable. THIS ARTICLE DESCRIBES the many tissue-banking industry variables, including donor selection and testing and tissue recovery, processing, and preservation. QUESTIONS THAT HEALTH CARE providers can ask to determine which tissue banks' quality control measures best ensure the safety of the allografts they provide also are included.
Humphries
Linda K
LK
LifeLink Tissue Bank, Tampa, Fla., USA.
Mansavage
Vicki L
VL
D003140:Communicable Disease Control; D005161:Facility Regulation and Control; D005607:Fraud / Q000517:prevention & control; D006801:Humans; D011786:Quality Control; D017751:Safety Management / Q000331:legislation & jurisprudence / Q000592:standards*; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D014019:Tissue Donors; D014481:United States