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, amednews 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.

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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.

The FDA also proposed two related regulations. The first would require banks to use standardized screening and testing measures to ensure that tissues are free from disease and remain free from disease during their handling. In addition, it proposed mandating implementation of "good tissue practices" regarding record-keeping, labeling, quality control and handling of material. These proposed measures are open to comment and expected to be finalized within the next two years.

Addressing concerns

The agency has been working since 1997 to address the rapidly expanding tissue bank industry amid growing concerns of possible profiteering, lack of respect for donated tissue, contamination of materials, and alleged biases in favor of cosmetic rather than therapeutic uses of donated tissues.

The latest FDA action came on the heels of two reports issued last month by the Dept. of Health and Human Services Office of Inspector General. Both documents offered findings that were critical of consent procedures used to obtain tissue and the lack of oversight from the FDA, the industry's umbrella organization and individual states.

The American Assn. of Tissue Banks inspects and accredits their members, but many tissue banks do not belong to the organization. The FDA had been mandated to inspect the banks, but had never been funded to do so. Only two states -- New York and Florida -- require banks to be licensed and inspected.

"It's becoming more formalized, and that's good because it forces the tissue banks who might be marginal to go through the whole process," said ophthalmologist Ronald E. Smith, MD, medical director of the Doheny Eye and Tissue Transplant Bank in Los Angeles.

While the FDA regulations do not address consent issues, the OIG report, "Informed Consent on Tissue Donation," was critical about how tissues are procured and how banks obtain consent from grieving families.

According to the report, consent is often acquired by phone and by people who are often not employed by the tissue bank, and therefore may not be properly trained or held accountable. Little written material is provided at the time of donation. The report acknowledged that families usually receive a request for donation within 24 hours of a death and may not be able to deal with the information at such a sensitive time. However, the document recommended that written materials be provided to the donor family to read later.

The OIG also reported that families felt that items derived from donated tissue were not treated with as much respect as donated organs.

"That 'screw' is not a screw to me -- it came from somebody's loved one," said the report, quoting the mother of a tissue donor.

The FDA will now require that products derived from tissue will be clearly marked that they are from "donated" human tissue in order to engender more respect.

The OIG report also suggested that there might be problems with the availability of some donated tissues, particularly skin.

The American Burn Assn. said that 32% of burn centers responding to a recent survey reported having delayed or altered treatment and that half had difficulty obtaining allograft skin. Some mainstream media reports have asserted that this situation is due to a bias that favors using such tissues for cosmetic purposes. However, the OIG report was unable to substantiate that allegation.

Physicians were generally supportive of the OIG reports and the FDA regulations.

"It's very important to have high standards for tissue banks to protect patients," said Dr. Kridel.

He took issue, however, with the suggestion that physicians may not have the same respect for something derived from donated tissue that they have for a donated organ.

"Most of us are so appreciative of the donation," said Dr Kridel. "Because those are the best tissues to use and much better than artificial."

Many also felt that the concern about the for-profit aspect of the industry was unwarranted. "Even if it's part of a commercial venture, it's final use is to help someone," said Dr. Kridel. "Doctors can't process this material. There's no state-run processing company."

The industry was generally supportive of the stepped-up government interest, but there were reservations, particularly regarding the additional record-keeping that might eventually be required. The Eye Bank Assn., for instance, warned that the record-keeping burden might put some smaller banks out of business.

There was also concern that the FDA's actions were an overreaction. Although the OIG report found examples of banks that accepted tissue without records and tissues that were contaminated during processing, adverse reactions from donated tissue are low. The system, as haphazard as it may be, appears to be working.

ADDITIONAL INFORMATION:

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FDA proposed rule on "Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement," in pdf format (http://www.fda.gov/cber/rules/gtp010801pr.pdf)

HHS OIG report on "Informed Consent in Tissue Donation, Expectations and Realities," in pdf format (http://www.hhs.gov/oig/oei/reports/a500.pdf)

HHS OIG report on "Oversight of Tissue Banking," in pdf format (http://www.hhs.gov/oig/oei/reports/a501.pdf)