NoBlood

Under porposed new FDA regulations, virtually all donated tissues and cells, including sperm and stem cells, must be screened for diseases from syphilis to SARS. Since 1993, the Food and Drug Administration has required that muscles, tendons, skin and eye tissue donations be tested for hepatitis B and C and for the AIDS virus. The new rule regulates reproductive tissue, hematopoietic stem cells derived from cord blood and peripheral blood sources, cellular therapies and other innovative products. The new rule also extends the scope of protection against communicable diseases that can be transmitted through transplanted tissues and cells, including Creutzfeldt-Jakob disease, syphilis and, for relevant tissues, human T-cell lymphotropic virus, and the bacteria that cause chlamydia and gonorrhea. The rule, which is open for comment, would also give FDA the option of imposing screening requirments for emerging new infections such as West NIle virus and Severe Acute Respiratory Syndrome. The rule, effective May 25, 2005, is available at www.fda.gov/cber/rules/suitdonor.pdf.