UWMC last used recalled tissue provider in 1999
August 21, 2002
A spokesperson for UW Medical Center (UWMC) confirmed Monday that donor tissue from CryoLife Inc. was last used in surgery at the Center in 1999.
The Food and Drug Administration (FDA) ordered the Georgia-based tissue center to recall some of its donor tissue last Wednesday. Tissue from Oct. 3, 2001, to the present was recalled due to allegations of poor handling. Contamination in CryoLife-processed tissue is connected with the death of a man in Minnesota and numerous other cases of infected tissue grafts.
UWMC primarily receives its donor tissue from three vendors: Seattle-based Northwest Tissue Center, the American Red Cross Tissue Center and the Musculoskeletal Transplant Foundation. All three providers are accredited by the American Association of Tissue Banks (AATB), a voluntary organization of tissue-processing firms with standards for the preservation and transportation of human tissue.
"CryoLife is not an accredited member and never has been," said Bob Rigby of the AATB.
The FDA has its own industry guidelines and charged that CryoLife's refusal to comply with preventative procedures resulted in the infection of about 26 tissue grafts. CryoLife was contacted several times but had no comment.
UWMC spokesperson Pam Sowers was unsure why the unaccredited company was used, adding, "UWMC seeks alternative tissue sources only when absolutely necessary."
The FDA said that infections in skin grafts usually develop within weeks of an operation and individuals who received tissue any earlier need not worry. Nevertheless, those concerned should feel free to visit their doctors.
The operating-room division of UWMC, which orders some 100 pieces of tissue per year, had a management meeting yesterday in which the issue was discussed. After that meeting, Sowers said the division decided to gather more information before setting any new policy on buying tissue from CryoLife.
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