New FDA regulations heighten oversight of tissue banks

Physicians are supportive of the government's closer scrutiny of the rapidly growing industry of tissue donation and procurement.

By Victoria Stagg Elliott, AMNews staff. Feb. 5, 2001.

Reconstructive surgeons use skin, cartilage and bone from donor cadavers to repair damage from burns or congenital defects. Ophthalmologists use corneas to restore sight. Cardiologists, faced with a scarce supply of whole hearts, are sometimes able to use more readily available heart valves, which can be harvested up to 24 hours after the end of life.

"We think of these as vital resources," said Russell Kridel, MD, president of the American Academy of Facial, Plastic and Reconstructive Surgery.

But unlike the heavily regulated organ donor and procurement system, the tissue banking industry has been largely unpoliced -- a condition that had increasingly raised concerns. Some tissue banking entities are for-profit. Many have rarely, if ever, been inspected. And no one even has a list of all the tissue banks in the United States.

In order to remedy this situation, the Food and Drug Administration will require all tissue banks and their products to be registered within the next two years, according to final regulations issued in January. The step will help FDA fill the knowledge gaps regarding the existence and location of tissue banks -- those that handle eyes, bone, heart valves and skin -- which have fallen under the federal agency's purview since 1993. The January regulation also will expand the agency's reach to include organizations that handle reproductive tissue and stem cells.

"This rule will give the FDA the information it needs to implement the agency's risk-based approach to tissue-regulation," FDA Commissioner Jane E. Henney, MD, said in an agency statement. [...]