BILL NUMBER: S545
TITLE OF BILL :
An act to amend the public health law, in relation to the procurement
of tissue or non-transplant organs from cadaveric donors
This legislation ensures the proper harvesting of human tissue by
requiring tissue or nontransplant 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.
SUMMARY OF LEGISLATION :
Section 1. Subdivision 5 of section 4364 of the public health law, as
added by chapter 589 of the laws of 1990, is amended to only allow
persons licensed in accordance with Article 43-B of the public health
law to harvest tissue, and eliminates a clause that would allow
persons to harvest tissue if asked by a licensed bank or storage
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 :
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
LEGISLATIVE HISTORY :
2005-2006: S.7268-A - Passed Senate; 2007-2008 - Passed Senate
FISCAL IMPLICATIONS :
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.
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