While people are familiar with the concept of organ donation, tissue donation is not well understood by most Americans. Yet the tissue industry is very diverse and is growing rapidly. In fact, tissue donations now make possible about 750,000 transplants per year.
The recovery and medical use of tissue, including skin, bone, cartilage, tendons, ligaments, and heart valves, are unlike organ transplants because the tissue is usually not transplanted ``as-is'''' from the donor''s body into that of the recipient. Rather, donated tissue frequently undergoes considerable processing before it can be used. Bone from a donor''s femur, for example, can be reshaped into a component designed to give support to a recipient''s spine.
The organizations that make up the tissue industry are collectively referred to as tissue banks. Some are engaged in tissue recovery, while others process, store, and distribute human tissue.
Tissue donation is a generous, selfless act that improves the lives of many Americans. Just one donor, in fact, can help a large number of people in various ways. Skin donations, for instance, can be used to heal burn victims or aid in reconstructive surgical procedures. Ligaments and tendons can be used to repair worn-out knees. Bone donations can be used in hip replacements or spinal surgery enabling recipients to regain mobility. Donated arteries and veins can restore circulation, and heart valves can be transplanted to save lives.
The phenomenal growth and increasing competitiveness of the industry in its search for new sources of donated tissue, however, have resulted in some problems. Unsafe tissue obtained from unsuitable donors has been allowed to enter the American tissue supply, raising serious doubts about the adequacy of federal regulations. Other concerns involve whether or not the practices of some tissue banks are sufficient to reduce the danger of spreading such illnesses as the human variant of mad cow disease. Because communicable diseases such as HIV and hepatitis, among others, can also be transmitted through tissues, it is vital that potential donors be screened for suitability and tissue be tested effectively, to make sure it is safe.
The Food and Drug Administration (FDA) has failed to provide proper oversight of the human tissue industry, and in doing so, may have failed to prevent at least one death and dozens of other serious infections. The FDA''s failure to act in this area that affects public health and safety is simply inexcusable. It is a case of bureaucratic inertia at its worst.
The FDA, as far back as 1997, examined the public health issues posed by human tissue transplantation and concluded that the existing regulatory framework was insufficient and needed to be strengthened. Yet more than five years later, the agency has still not implemented critical regulatory changes, including requirements for better screening of potential donors and for safe tissue handling practices.
As Chairman of the United States Senate Permanent Subcommittee on Investigations, I led an investigation into the growing safety concerns involving tissue banks. My investigation concluded that serious gaps remained in the FDA''s regulations. The CBS News television program, "60 Minutes II," recently highlighted these findings further by tracing the tainted tissue that led to the death of a 23-year-old man.
In an effort to prevent any further tragedies, I have introduced legislation to require the FDA to issue the much needed regulations. My legislation would explicitly authorize the FDA to regulate any entity that engages in the recovery, screening, testing, processing, storage, or distribution of human tissue, or human tissue-based products. All tissue banks would be required to adhere to the standards that the FDA has identified as necessary for ensuring public safety. This provision would remove any doubt about the FDA''s authority to regulate tissue banks.
Tissue banks would also be required to report adverse incidents, including the detection of an infection, within fifteen days. Currently, tissue banks are not required to report adverse incidents to the federal government, making it difficult for public health experts to identify problem tissue banks.
Finally, the bill requires the Secretary of Health and Human Services to develop a database to store the adverse incident reports. That central repository of information would be very useful to the CDC.
The vast majority of tissue banks operate in a safe, professional manner, but there are exceptions. We are now very fortunate that advances in technology allow tissue to be used in ways that truly enhance lives for thousands of Americans. My legislation will ensure that the transplantation of human tissue saves lives, not ends them.