FDA Home Page | CDRH Home Page | Search | A-Z Index | ||
FDA Public Health Web Notification: Human Tissue Processed by Cryolife, Inc.August 21, 2002 (You are Encouraged to Copy and Distribute this Notification) This provides information about recent actions taken by the Food and Drug Administration (FDA) against Cryolife, Inc. ("Cryolife") of Kennesaw, Georgia. 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 FDA has not included allograft heart valves in the FDA recall order for the reason stated above, 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, 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. BackgroundFDA 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. This Web Notification is alerting you of FDA’s action and is also advising you of certain steps to consider when deciding whether to use Cryolife allograft heart valves. FDA has taken these actions because it has determined that Cryolife cannot ensure that the human tissue it processes for implantation is free from fungal and bacterial contaminants. 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, 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.
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. During inspections of Cryolife from March 25 through April 12, 2002, FDA found numerous, significant violations of FDA regulations. 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. After determining that Cryolife failed to take adequate corrective measures to address possible infectious disease contamination of tissue, and after reviewing information provided by the firm in response to FDA's warnings, FDA issued the present order for retention, recall and/or destruction of allograft tissues other than allograft heart valves, and is issuing this Web Notification to physicians regarding FDA's recommendations for both allograft heart valves and other allograft tissues. FDA's concerns described in the order relate specifically to bacterial and fungal contamination of soft tissues, such as cartilage and tendons. 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. FDA Recommendations
Reporting Adverse Events to FDAFDA has different adverse event reporting requirements for allograft heart valves and allograft tissues: FDA regulates allograft heart valves as medical devices while it regulates
other allograft products as tissues. Because FDA considers Cryolife allograft
heart valves to be medical devices, hospitals and other user facilities
are subject to the mandatory reporting requirements for reporting deaths
or serious injuries associated with these devices (see 21
Code of Federal Regulations part 803 for details on reporting certain
deaths and serious injuries). On the other hand, because FDA considers
the other allograft products subject to the recall order to be tissues,
hospitals and other user facilities are not subject to mandatory reporting
requirements for these products. If you become aware of an adverse event that reasonably suggests that a Cryolife allograft heart valve has or may have caused or contributed to a death or serious injury, you should follow the procedures established by your facility for mandatory reporting. Reports of any other adverse events or information about contaminated allograft tissues: While it is not mandatory to report such events to FDA, if you have reason to believe that you have received contaminated tissue from Cryolife, please be aware that MedWatch, the FDA’s voluntary reporting program, is open to receiving such reports. MedWatch reports are accepted four ways: online at http://www.accessdata.fda.gov/scripts/medwatch; by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857. Getting More InformationIf you have questions regarding the soft tissue products distributed by Cryolife, please use the Voice Information System – Direct access to a Consumer Safety Officer or Public Affairs Specialist (800-835-4709; 301-827-1800). You also may contact FDA by emailing your questions about biological products to OCTMA@CBER.FDA.GOV. If you have questions regarding allograft heart valves, please contact the Consumer Staff, Center for Devices and Radiological Health, at 301-827-3990 (Press 5 to speak with a staff member). All of the FDA medical device postmarket safety notifications can be found on the World Wide Web at http://www.fda.gov/cdrh/safety.html. Postmarket safety notifications can also be obtained through email on the day they are released by subscribing to our list server. You may subscribe at http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10. You may also subscribe by sending an email to listserv@list.nih.gov. In the body of the text, type "SUBSCRIBE DEV-ALERT firstname lastname". Updated 8/21/2002 |
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH