quality:correction
Safety

In the United States, tissue transplants are regulated by the US Food and Drug Administration (FDA) which sets strict regulations on the safety of the transplants, primarily aimed at the prevention of the spread of communicable disease. Regulations include criteria for donor screening and testing as well as strict regulations on the processing and distribution of tissue grafts. Organ transplants are not regulated by the FDA. It is essential that the HLA complexes of both the donor and recipient be as closely matched as possible to prevent graft rejection.

In November 2007, the CDC reported the first-ever case of HIV and Hepatitis C being simultaneously transferred through an organ transplant. The donor was a 38-year-old male, considered "high-risk" by donation organizations, and his organs transmitted HIV and Hepatitis C to four organ recipients. Experts say that the reason the diseases did not show up on screening tests is probably because they were contracted within three weeks before the donor's death, so antibodies would not have existed in high enough numbers to detect. The crisis has caused many to call for more sensitive screening tests, which could pick up antibodies sooner. Currently, the screens cannot detect the small number of antibodies produced in HIV infections within the last 90 days or Hepatitis C infections within the last 18–21 days before a donation is made.

Nucleic acid testing is now being done by many organ procurement organizations and is able to detect HIV and hepatitis C directly within seven to ten days of exposure to the virus.