ATLANTA - CryoLife, Incorporated has submitted to the Food and Drug Administration its plan to prevent contamination of the human tissue it distributes for implants. <br>
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The FDA in August ordered Kennesaw-based CryoLife to stop distributing cadaver tissue after its implants were linked to a death and several serious infections. <br>
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The FDA has since allowed CryoLife to resume limited distribution for urgent cases where no alternatives are available. <br>
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CryoLife says it continues to process cardiac and vascular tissues under its interim agreement with the FDA. Heart valves were not included in the FDA's orders. <br>
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CryoLife and other human-tissue processors have been under federal scrutiny since late last year. <br>
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A patient died from an infection after CryoLife tissue was implanted in his knee during a routine operation. The FDA is preparing rules to govern how tissues should be handled and stored. <br>
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The Centers for Disease Control and Prevention are surveying doctors to find out how many times patients have received infected tissue. The CDC has identified 54 such cases so far, including 25 from CryoLife.
