People who donate sperm, eggs and other commonly transplanted tissues will have to be screened for infectious diseases like blood donors are, under long-awaited federal rules announced Thursday.
Donated blood and organs have been strictly regulated for a long time. But less subject to oversight are other donated tissue such as skin for burn victims, ligaments for knee surgery, umbilical cord blood, and sperm and eggs.
Human tissues can carry diseases. So the way cells are handled can make the difference between a therapy that works or one that is wasted or, worse, dangerous when the cells die or are contaminated.
In 2002, a 23-year-old Minnesota man died after knee reconstruction surgery that used bacteria-laden cartilage.
Who is eligible?
The Food and Drug Administration had proposed new regulations in 1997 designed to prevent such contamination.
The agency on Thursday finalized one long-delayed but important part of those rules: Who is eligible to donate.
Before the use of most tissue or cell types, tissue banks must ask a living donor or relatives of a dead one about risk factors for infections, a practice similar to the screening that blood banks now perform.
That means, for example, that anyone who has used injected drugs in the past five years or men who have had sex with another man in the preceding five years could not donate sperm or any other tissue. Those are risk factors for the AIDS virus.
In addition to screening, tissue banks must test donors and/or the donated tissue for diseases that include HIV, hepatitis B and C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow disease.
The FDA said additional testing will be required for some tissue donations, such as the sexually transmitted diseases chlamydia and gonorrhea for reproductive tissue. The rules allow the agency to order checks for new diseases, such as West Nile virus or SARS, as it deems necessary.
Exceptions include cells or tissue removed from the patient and transplanted back into that person, or reproductive cells from a sexual partner, as is common with in vitro fertilization.