Provides that tissue or non-transplant organs from cadaveric donors shall be procured only in a hospital, morgue or other licensed facility

Section 2. The public health law is amended by adding a new section 4311 that requires tissue or nontransplant organs to be procured only in a hospital, morgue or other facility licensed for the purposes of tissue or organ procurement.

Section 3. Effective Date.

Existing law

None.

Justification

In response to major medical breakthroughs in healing burn victims, fixing athletic knee injuries and easing back pain, the tissue bank industry has boomed in recent years. According to the Food Drug Administration (FDA), the number of musculosketal tissue transplants done in the United States has more than doubled over the past dozen years - from 350,000 in 1990 to 800,000 in 2002.

While the proper harvesting of tissue makes medical miracles possible to achieve, there is a certain risk of disease transmission associated with tissue transplantation. The risk is believed to be low, but when the transmission of a disease has occurred the results have been tragic. In 2001, for example, a 23-year-old Minnesota man died four days after receiving a transplant of bone and cartilage to reconstruct his knee. He had acquired a deadly infection from toxic bacteria in the tissue. In 2002, five tissue recipients in the United States were believed to be infected by hepatitis C from a single donor's tissues. And in 2003, contaminated corneas resulted in infections and vision loss in two people.

In order to mitigate the probability of obtaining a dangerous disease through a tissue transplantation, the procurement of tissue should only occur in a hospital or morgue where it is certain that such activities take place in clean and sanitary conditions. This ensures that Human Tissue and Cellular and Tissue Based Products are processed in a way that prevents communicable disease contamination and cross-contamination. When other facilities, such as funeral homes, are allowed to harvest tissue, very real medical risks are created that will have tragic results.

Unfortunately, both the New York State Health Department Rules and Regulations and Article 43-B of New York's Public Health Law, which govern the harvesting of human tissue, do not adequately protect the public from the risks associated with disease transmission because they allow for the procurement of tissue to take place in unsanitary locations. Consequently, this legislation ensures the proper harvesting of human tissue by requiring tissue or non-transplant organs to be procured only in a hospital or morgue and by mandating that a person be licensed in accordance with Article 43-B of the public health law to procure a specified tissue or non-transplant organ.

Legislative history

2005-2006: S.7268-A - Passed Senate; 2007-2008 - Passed Senate

Fiscal implications

None.

Effective date

This act shall take effect on the one hundred eightieth day after it shall have become a law; provided, however, that effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized and directed to be made and completed on or before such effective date.