New Regulations for Cryolife
September 6, 2002
Under a new agreement with the U.S. Food and Drug Administration (FDA), Cryolife Inc. will resume distribution of donor tissue to medical facilities with new restrictions. In August, the FDA ordered Cryolife to recall distributed human tissue processed from October 3, 2001, to August 2002 after determining that the company could not ensure that the tissue was free from fungal and bacterial contaminants.
Under the new restrictions, warning labels will be placed on all tissue packaging, and infected tissue will be immediately destroyed. Cyrolife will also be required to obtain a physician's prescription before tissue is distributed. The temporary agreement will last 45 days, after which time federal regulators will reevaluate the company's donor tissue process.
-- Article Courtesy of InjuryBoard.com
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