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FDA Steers Doctors From CryoLife

August 23, 2002

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ATLANTA (AP) _ The Food and Drug Administration has recommended that doctors consider suppliers other than CryoLife Inc. for human heart valves.

The Kennesaw-based tissue bank’s products have been linked to one death and numerous serious infections.

Last week, the FDA ordered CryoLife to recall all soft tissue processed since Oct. 3.

That order does not recall CryoLife’s cadaver heart valves. However, FDA inspectors are studying whether they also may pose a risk and the agency, in a posting on its Web site Tuesday, suggested surgeons investigate the reasons behind the recall of other CryoLife tissue before using the valves.

Among the FDA’s top charges is that CryoLife sent out tissue from a cadaver even after it had confirmed the presence of harmful germs in tissue samples from the same donor.

The FDA notice also said that surgeons considering a CryoLife valve tell their patients of the FDA’s concern and ``discuss the potentially higher risk for infection.″

``I can’t comment on what the FDA was thinking,″ said CryoLife Vice President David Fronk.

CryoLife, the nation’s largest supplier of living human tissue for implantation, is also being investigated by the federal Securities and Exchange Commission. The company said the SEC probe was related to its Aug. 14 disclosure that the FDA had ordered the tissue recall.




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