Cryolife Recall: Overview

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Modified on 2009/10/14 21:46 by admin
This provides information about recent actions taken by the Food and Drug Administration (FDA) against Cryolife, Inc. ("Cryolife") of Kennesaw, Georgia. The FDA has ordered Cryolife, a human tissue-processing firm, to recall all distributed human allograft tissues, except allograft heart valves, that have been processed by Cryolife since October 3, 2001. This FDA recall order was issued after FDA discovered regulatory violations related to the processing of human tissue by Cryolife, documented fungal and bacterial contamination of Cryolife tissues, and found that Cryolife had not fully implemented adequate corrective actions.

Allograft heart valves processed and supplied by Cryolife have not been included in the FDA recall order. This is because these devices are essential for the correction of congenital cardiac lesions in neonate and pediatric patients and no satisfactory alternative device exists. Under these circumstances, the benefit of these devices outweighs the risk associated with the current manufacturing deficiencies.

Even though the FDA has not included allograft heart valves in the FDA recall order for the reason stated above, the FDA still has serious concerns regarding the processing and handling of allograft heart valves by Cryolife because patients who receive these devices may be at increased risk for infection. Accordingly, the FDA recommends that you consider the following information when determining the appropriate treatment for your patients who have either already received any allograft tissues, including allograft heart valves, processed by Cryolife on or after October 3, 2001, or who have not yet received, but may need to receive an allograft heart valve.

Background
The FDA has ordered Cryolife to recall distributed human tissue, other than allograft heart valves, processed since October 3, 2001. Under the order, the firm also must withhold from the market all allograft tissue, other than allograft heart valves, processed since October 3, 2001. Tissue from a donor processed by Cryolife on and after October 3, 2001, has been associated with the November 7, 2001, death of a patient who received a soft tissue implant during reconstructive knee surgery. Additionally, in March 2002, the FDA learned that a patient who received a Cryolife allograft heart valve implanted in 2001 developed a fever within two months of the surgery. Cultures of the valve grew Candida Tropicalis and Candida Albicans. The FDA learned of a second event that occurred in March 2002 of a patient who also received a Cryolife valve who suffered a cerebrovascular accident and had positive blood cultures for Staphylococcus Epidermidis.

Current federal regulations for human tissue, like that subject to the FDA's recall order, require firms to prepare, validate, and follow written procedures for tissue processing to prevent infectious disease contamination or cross-contamination. Current federal regulations applicable to allograft heart valves also help ensure that appropriate procedures are validated and followed.

During inspections of Cryolife from March 25 through April 12, 2002, the FDA found numerous, significant violations of FDA regulations. The FDA issued a Warning Letter to Cryolife on June 17, 2002, after determining, among other things, that the firm did not adequately validate its processing and testing methods and did not adequately implement procedures recommended by the Centers for Disease Control and Prevention (CDC), or adequately implement any other appropriate procedures, to ensure that tissue processed by the firm is not contaminated.

If a bacterial or fungal infection were to occur following tissue implantation, the signs and symptoms usually appear within days to weeks after implantation. Therefore, it is unlikely that patients who have not recently received a tissue implant are likely to be at future risk. However, concerned patients are encouraged to contact their physicians.

See your doctor if you have experienced serious health problems due to contaminated Cryolife tissue. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.



See Also

  1. Human Tissue Donation: Overview
  2. Fungal Infections: Overview
  3. Infections
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