FDA Tissue and Cell Pilot Project: A Special Collaboration With the Medical Product Safety Network (MedSun) Project
MedSun: Newsletter #9, November 2006
This month marks the 1-year anniversary of the FDA’s Tissue and Cell Pilot Project. Currently, 95 hospital staff members at 31 hospitals across the country have been trained to be on the lookout for and to report on adverse events involving biologics; 35 reports have been submitted.
CDC FAQs About Tissue Transplants
In a continuing effort to educate the public and to ensure the safety and well-being of cell and tissue implant patients, the Centers for Disease Control and Prevention (CDC) updated the online information on its “About Tissue Transplants” Web page on September 1, 2006. The following excerpted frequently asked questions (FAQs) provide recommendations on testing of individuals who received tissues from two companies named in indictments this year alleging illegal harvest, sale, and implantation of human tissues.
On October 26, 2005, the CDC and the U.S. Food and Drug Administration (FDA) recommended that recipients of tissues recovered by Biomedical Tissue Services (BTS) be tested for evidence of infection with HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis. (For more information about BTS, see “In Brief” on page 2.) On
August 30, 2006, CDC and FDA made the same recommendation for testing of recipients of tissues recovered by Donor Referral Services.
What tests should be performed and how often? There are no set guidelines on how this testing should be done for tissue recipients. CDC thus recommends that clinicians follow the postexposure followup testing recommendations that are used for occupational exposures to HIV, HBV, or HCV, as described in the Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis, available at http://www.cdc.gov/ncidod/dhqp/gl_occupational.html. The following recommendations can be used for all recipients who have normal immune systems. For those who have very weakened immune systems because of immune system suppressing medications, other tests might be indicated.
Patients who had tissue implanted more than 6 months ago should be offered the following tests: HIV antibody, antibody to hepatitis B core antigen, antibody to hepatitis C virus, a nontreponemal syphilis test (e.g., RPR or VDRL), and a treponemal syphilis test (TP-PA or any ELISA test). If all of these tests are negative, it is very unlikely that the recipient will contract any of these diseases from an implanted tissue that was potentially contaminated, and no further followup testing is necessary.
Patients who had tissue implanted less than 6 months ago can be offered the same series of tests as above immediately, but should also be retested 6 months after the tissue was implanted. If earlier diagnosis of HBV and HCV infection is desired, testing for hepatitis B surface antigen (HBsAg) and HCV RNA may be performed. If negative, testing for anti-HBc and anti-HCV should be performed at least 6 months after the tissue was implanted. Again, if all of these tests are negative 6 months after the tissue was implanted, it is very unlikely that the recipient will contract any of these diseases from an implanted tissue that was potentially contaminated, and no further followup testing is necessary.
How were these infectious diseases selected? HIV, hepatitis B and C, and syphilis are the infectious diseases for which potential tissue donors must be tested.
What if one of the screening tests is positive? It is important to remember that these initial tests are screening tests, and, hence, positive results do not always mean that the patient has been infected. Patients who have a positive result for any of these tests should undergo confirmatory or supplemental testing. Clinicians who have questions about confirmatory or supplemental testing should contact a clinician with expertise in infectious diseases.
CDC FAQs About Tissue Transplants
Recommendations for Postexposure Prophylaxis