Transplantation

Tissue Safety Measures

Specially trained personnel conduct serology (blood tests) on all tissue donors to determine if there is HIV, Hepatitis B/C, and other diseases. This is done at the time of recovery.

When screening tissue donors, the New York Organ Donor Network adheres to regulations from:

  • Food and Drug Administration (FDA)
  • New York State Department of Health (DOH)
  • American Association of Tissue Banks (AATB)

 

“FDA’s role in tissue-industry oversight began in 1993 with interim regulations, including limited donor-screening requirements. In 1997, FDA finalized the interim regulations and in 2004 and 2005, FDA made effective additional regulations to enhance tissue safety. CBER [Center for Biologics Evaluation and Research, one of six main centers for the FDA] is responsible for regulating many types of human tissues and cells, which are transplanted during various medical procedures to restore proper function to patients. …

During Financial Year 2009, CBER issued draft guidances for current good tissue practices to help prevent the introduction, transmission, or spread of communicable disease during the manufacturing process….”

Source: Food and Drug Administration FY 2011 Congressional Budget Request