FDA to step up tracking of human tissue transplants
Wary of potential transmission of HIV and hepatitis via transplanted human tissues, the Food and Drug Administration (FDA) expects to issue new regulations in the coming months outlining testing and tracking requirements for tissue banks and clinical centers.
The FDA does not regulate whole-organ human transplants, but has oversight on tissue procedures, including those involving bone, ligaments, tendons, fascia, cartilage, corneas, and skin. The agency issued interim rules on tissue screening in 1993 after investigating reports about the increasing sale of tissue originating from sources outside the United States. Donor information was often lacking about such tissues, including the cause of death, medical records, and the results of donor screening and testing, reports Kathryn C. Zoon, PhD, an FDA officer in the Center for Biologics Evaluation and Research, who outlined the action recently at a meeting of the American Association of Tissue Banks in Washington, DC.
"In one case, FDA investigators were provided with blood samples from a prospective donor-cadaver accompanied by documentation of previous infectious disease testing which was reportedly negative, including alleged testing for hepatitis B," Zoon said. "On retesting of the sample, FDA found that the sera was positive for hepatitis B."
While the agency knew this was not the predominant industry practice, such instances where infectious or potentially infectious tissue was offered for transplantation could not be permitted to continue, she said. The essential requirements imposed by the interim rule include infectious disease testing of donor blood for HIV and hepatitis; assessment of the donor for clinical signs of HIV and hepatitis; and written procedures to assure that testing and screening are adequate and consistently performed.
Final rule may require test results
"One of the major issues for the final rule concerns the steps to be followed when a human tissue is offered for import," Zoon said. "Under the interim rule, tissues without the results of infectious disease testing may be imported only under quarantine. As discussed in workshops and advisory committees, we are considering the requirement of test results prior to tissue importation. This step will help prevent the shipment of infectious tissues."
The interim rule requires that records be maintained to assist tracing in the event a tissue recipient is infected. The final regulation may expand that requirement, requiring a tissue log be kept by tissue banks, clinical facilities, and hospitals involved in tissue transplants. Each institution could be required to have an identification number on each tissue for tracking purposes, she said.
"We agree with comments that tracking is a crucial element to enable the tracing of donor information, should recipients develop evidence of disease transmission that could be attributed to transplantation," Zoon said. "All tissue establishments and tissue-receiving establishments could be required to maintain written procedures to investigate reports of infectious disease transmission."
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