Human Tissue Transplants : Good Tissue Practice

by Food and Drug Administration (FDA)

(Page 3 of 4)

The third rule addresses good tissue practice (GTP) and requires facilities to use specific methods and controls to prevent tissue from becoming contaminated. The GTP rule, finalized in November 2004, is effective on May 25, 2005.

The rule permits the FDA to inspect HCT/P manufacturers to ensure compliance with regulations and to order the recall or destruction of any tissue not meeting safety criteria.

"Where appropriate, information from FDA inspections can and will be used to take enforcement action," says Goodman. "However, it is preferable, wherever possible, to work with manufacturers to build quality into their procedures in an effort to prevent safety problems."

Quality controls begin with the recovery of tissues and extend through processing, storage, labeling, packaging, and distribution. Tissue recovery teams at Donor Alliance work in the sterile conditions of an operating room to protect the tissue from contamination, says Mansfield. "The donor is prepped as if having surgery and spends about five to six hours on the operating table."

Once tissues are recovered, they are sent to a processing facility where the donor's blood is tested for communicable diseases and the tissues are tested multiple times for possible bacterial or fungal contamination. The tissue is sterilized or disinfected and then packaged and labeled so it can be quickly tracked to its source if any questions arise about its safety. "We have a tracking system for every piece of tissue that allows us to track it from the donor to ultimate distribution to the hospital or surgical facility," says P. Robert Rigney Jr., the AATB's chief executive officer.

An important part of the GTP rule is a requirement for tissue transplant facilities to report to the FDA certain adverse reactions and product deviations. The tissue safety team, a group of medical experts within the FDA, then follows up on these events with the tissue bank and hospital or other facility involved. The agency may enlist the help of the CDC, the HRSA, or health department of the state where the event took place to investigate the source of infection.

Self-Regulation and Cooperation

Even before the FDA began regulating tissues in 1993, large segments of the domestic human tissue industry voluntarily complied with industry standards to regulate the quality and safety of their products. Trade groups such as the AATB and the Eye Bank Association of America (EBAA) sponsor voluntary accreditation programs requiring tissue and eye banks to adhere to standards and to pass periodic inspections. These standard-setting and accrediting organizations also certify tissue and eye bank personnel who have passed a rigorous exam.

The AATB estimates that 80 percent to 90 percent of tissue transplanted in the United States comes from a bank that it has accredited. The EBAA estimates that it has accredited 95 percent of the eye banks in the country.

In addition to federal government and industry standards, several state governments set their own tissue requirements. "Anyone who ships tissues into or out of New York or Florida has to comply with their departments of health," says Mansfield. "We have four primary auditing agencies. With the best practices we have in place, we are always prepared for an inspection."

Both the AATB and the EBAA require their member organizations to report adverse events. Their accreditation bodies investigate and take corrective and preventive actions if necessary.

Tissue safety depends on the cooperative and collaborative efforts of many entities, including the FDA, the CDC, state health departments, and the tissue industry. The FDA works with the CDC to investigate reported adverse events. The agency also works with states to resolve any potential conflicts of federal and state rules regarding tissue recovery and use. The FDA updates tissue banks on federal requirements through liaisons with AATB and EBAA committees. And the industry assists the FDA, says Solomon. "AATB and EBAA help us to leverage our resources," she says, "by writing draft guidance to help industry comply with our rules."

Meeting the Demand

There is a critical shortage of donor organs, but donor tissues are more available. "There are about four times as many tissue donors as cadaveric organ donors," says Rigney.

Unlike the half dozen organs that one person can donate, that same person can supply up to about 60 tissue grafts, and the window of time for tissue recovery is longer. For organs to be usable for transplant, a donor must be brain dead and on life support, meaning brain function has stopped permanently and the person cannot breathe on his or her own. Tissue may be used from a person who either is brain dead or has suffered cardiac death — the heart stops beating and breathing stops. "The tissue can be retrieved up to 24 hours later," says Rigney. Organs, which deteriorate more quickly than tissues, must be harvested sooner.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.