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Cadaver-Tissue Recall May Have Local Effect

Aug 16, 2002 | The Daily Press A recall of cadaver tissue used in surgery may affect hospitals in Hampton Roads, local officials said Thursday.

The FDA on Wednesday ordered a recall of cadaver tissue issued by CryoLife Corp. after a death and serious infections were linked to the company's supply.

While most tissue used by local doctors comes from LifeNet, a tissue bank based in Virginia Beach, CryoLife Corp. supplies a small amount.

Riverside Health System and Sentara Healthcare have placed orders with the company. Neither released details on exactly what kind of tissue was ordered or when it arrived, but officials said any affected patients would be notified directly.

The FDA ordered CryoLife to recall all soft tissue - such as cartilage and tendons - that it had processed since Oct. 3, a month before a 23-year-old Minnesota man died from a bacterial infection linked to CryoLife cartilage received during reconstructive knee surgery.

The Centers for Disease Control and Prevention in Atlanta has so far uncovered 54 infections associated with soft tissue grafts, 26 of them involving CryoLife tissue.

"Sentara has not been notified by the FDA or CryoLife about a recall," said Rod Hochman, chief medical officer for Sentara. "We don't know if any patient who's had surgery at a Sentara facility is affected. However, we are proactively taking steps to identify any potential patients who may be affected by the recall."

Riverside has made just one purchase from CryoLife since Oct. 3, said spokesman Peter Glagola.

As of late Thursday, Riverside officials didn't know whether that tissue was part of the recall, he said. The tissue was used immediately in a single patient.

"We're tracking what happened," Glagola said. "If some of the recalled tissue is inside someone, the doctor will contact the patient. If no symptoms are present, though, everything is probably OK."

LifeNet, the chief supplier for Riverside and Sentara, also provides tissue to Williamsburg Community Hospital and Obici Hospital in Suffolk. Mary Immaculate Hospital does not buy tissue.

Unlike CryoLife Corp., LifeNet is nonprofit and belongs to the American Association of Tissue Banks, which sets strict safety requirements for its members.

Those requirements include testing tissues before they are soaked in solutions that kill bacteria and fungi.

"We meet and exceed all of their safety measures," said Dena Reynolds, spokeswoman for LifeNet.

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