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Cryolife Heart Valve RecallThe FDA issued CryoLife human tissue recall on August 14, 2002. Below are the FDA press releases regarding the Cryolife soft tissue recallIf you have undergone a surgical procedure using soft tissue implant or heart valve implant, please contact us to learn more about your legal rights from a tissue implant attorney. The Cryolife soft tissue and Cryolife human heart valve recall may have implications for you. From the FDA
August 13, 2002 HAND DELIVERED Steven G. Anderson ORDER FOR RETENTION, RECALL, AND/OR DESTRUCTION Dear Mr. Anderson: The Food and Drug Administration's (FDA) inspection of your facility on March 25 through April 12, 2002, covering human tissue intended for transplantation which is subject to the requirements of Title 21, Code of Federal Regulations, Part 1270 (21 CFR 1270), and our review of the information and records examined during the inspection revealed that certain human tissue received and distributed by your firm may be in violation of 21 CFR 1270, as indicated below: * Your firm has not had validated procedures for the prevention of infectious disease contamination or cross-contamination by tissue during processing [21 CFR 1270.31 (d)] at least since October 3, 2001, as evidenced, in part, by tissues that were processed on and after October 3, 2001, and that tested positive for the same bacterial contaminant. One of these tissues has been associated with the death of a 23-year-old man. Pursuant to 21 CFR 1270.43, the above referenced tissue must be: * Recalled (if distributed), within five (5) working days of receipt
of this order, under the supervision of an authorized official of
the FDA, and/or CryoLife, Inc., its owners, employees, and agents shall not distribute or dispose of the tissue in any manner except to recall and destroy it consistent with the provisions of the Order. Any other arrangements for ensuring the proper disposition of the tissues must be agreed upon in writing by CryoLife and an authorized official of the FDA. Such arrangements may include assurance that the tissue has been recovered, processed, stored, and distributed in conformance with the attached regulations [21 CFR 1270]. In addition, FDA strongly recommends that CryoLife perform a retrospective review of all tissue in inventory that is not referenced in this Order to assure that it was recovered, processed, stored, and distributed in conformance with 21 CFR 1270. All actions taken pursuant to this Order, or otherwise related to the tissue subject to this Order, shall be taken under the supervision of an authorized official of the FDA. A joint inspection of your firm was conducted by FDA and the Centers for Disease Control and Prevention (CDC) from December 3-7, 2001. Subsequent to that inspection, your firm was notified on January 3, 2002, that additional tissue from the donor implicated in the death of a recipient had tested positive for the same bacterium, Clostridium sordellii. CDC also provided CryoLife with its recommendations to improve your tissue processing and testing procedures in this communication. Our inspection of March 25- April 12, 2002, revealed that your firm had not adequately investigated its validation of processing and testing methods nor implemented CDC's recommendations or any other procedures to ensure that tissue distributed by your firm was not contaminated. In addition, our investigators documented additional evidence of distribution of unsuitable tissue that resulted in infections in recipients. Your May 15, 2002, response to that inspection did not provide assurance that you would adequately correct these deficiencies in a timely manner, and address tissue in inventory or distribution. A warning letter was issued to your firm on June 17, 2002. Your latest response, dated June 25, 2002, did not provide assurance that you will adequately address these deficiencies in a timely manner, nor did it provide assurance that you would evaluate tissue in inventory or distribution. In addition, it has come to our attention that you were informed in March 2002, of a heart valve implicated in serious adverse reactions in a recipient, and finally acknowledged on July 6, 2002, that this heart valve, processed and tested using the same methods, is the likely source of this serious adverse event. Given these circumstances, it is our view that CryoLife has not promptly implemented appropriate corrective measures to address the serious deficiencies that have been brought to your attention. Within five (5) working days from the receipt of this Order, the recipient of the written Order or prior possessor of such tissue may appeal the Order to the District Director, Atlanta District, Food and Drug Administration, 60 8th Street, N.E, Atlanta, GA 30309 and request a hearing on the matter in accordance with 21 CFR Part 16 (copy enclosed). Such manner of appeal is described in section 1270.43(e) of the attached regulations. Failure to request a hearing within the specified time period constitutes a waiver of the right to a hearing. Please also be advised that the Center for Devices and Radiological Health is currently evaluating whether there are similar risks that may be posed by Cryolife's heart valves, and will take further regulatory action if appropriate. Please contact Serene A. Kimel, Compliance Officer, at 404-253-1296, to arrange for supervision of the disposition of the tissues. Sincerely, Barbara A. Wood August 14, 2002 The Food and Drug Administration (FDA) has ordered Cryolife, Inc. ("Cryolife") of Kennesaw, Ga., a human tissue-processing firm, to recall distributed human tissue processed from October 3, 2001, to the present. Under the order, the firm must also withhold from the market or destroy tissue processed after that date. FDA is taking this action because it has determined that Cryolife cannot ensure that the human tissue it processes for transplantation 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. "This order not only protects patients from the unacceptable level of risk associated with tissue processed by Cryolife, it sends a clear signal that FDA stands ready to take whatever action is necessary to ensure the safety of human tissue," said Dr. Lester M. Crawford, FDA Deputy Commissioner. During its inspection 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 had neither adequately investigated its validation of processing and testing methods, nor implemented recommendations from the Centers for Disease Control and Prevention (CDC), or any other procedures, to ensure that tissue processed by the firm is not contaminated. After determining that Cryolife had failed to take adequate corrective
measures to address possible infectious disease contamination of
tissue in inventory and distribution, and after reviewing information
provided by the firm in response to FDA's warnings, FDA issued the
present order. August 21, 2002 (You are Encouraged to Copy and Distribute this Notification) 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. Background 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. 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. Current federal regulations for human tissue, like that subject to 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, 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. Allograft tissues (except allograft heart valves) that are subject to the FDA Order for Retention, Recall, and/or Destruction: If you are a physician who is caring for a patient who was recently implanted with Cryolife processed tissue, FDA recommends that you:
If you are a surgeon who is considering using Cryolife processed tissue, FDA recommends that you:
Cryolife allograft heart valves: If you are a physician who is caring for a patient who was recently implanted with a Cryolife allograft heart valve, FDA recommends that you:
If you are a surgeon who is considering implanting a Cryolife allograft heart valve, FDA recommends that you:
Reporting Adverse Events to FDA FDA 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. Reports of Deaths or Serious Injuries associated with allograft heart valves: 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 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 Information If 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. All of the FDA medical device postmarket safety notifications can be found on the World Wide Web at 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://list.nih.gov/archives/dev-alert.html. 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".
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