What is a tissue bank?
A tissue bank is an organization that provides donor screening, recovery,
processing, storage, and/or distribution of allograft tissue. (Allograft is
tissue or organ transplanted from one person to another.) Transplantation
specialists recover and process donated tissues. These specialists are well
trained and most have passed a rigorous examination certifying them for their
knowledge tissue banking including decontamination techniques, quality
assurance, quality control, product testing, labeling, and record keeping.
However, not all tissue banks follow the same high standards. The industry is
not closely regulated.
there any donor screening process for tissue transplants?
In the best of circumstances, yes; donor eligibility is determined through donor
screening and donor testing. Donor screening involves reviewing all relevant
medical records, physically assessing the donor and questioning the donor's
next-of-kin to determine risk factors or clinical evidence of infectious or
communicable diseases. Donor testing involves testing samples of the donor's
blood taken pre- or post-mortem. Relevant communicable diseases for which the
donor is tested are HIV-1 and 2, hepatitis B virus, hepatitis C virus and
syphilis. A donor is determined eligible to donate tissues only if the results
of donor screening and donor testing indicate freedom from communicable diseases
or communicable disease risks.
Why are tissue banks so
unregulated? Unlike the tightly monitored organ donation network, tissue
banks are less rigorously regulated. This is in part because, unlike organs that
must be transplanted within hours of the donor's death, tissue can be removed
over a longer period, stored, and then in many cases processed. Human tissue is
a $900 million to $1 billion industry involving both mom-and-pop and large
companies. While most of the companies are non-profits about 20 percent are for
profit including LifeCell Corp. of Branchburg, New Jersey, one of the current
five tissue banks that the FDA pinpointed as having received questionable tissue
from Biomedical Tissue Services.
Biomedical Tissue Services registered with the FDA? Since 1993 the FDA
has required tissue banks to be registered. The FDA conducts periodic
inspections not based on a time schedule but as needed according to the risks
posed by their operations. Biomedical Tissue Services was registered with the
FDA but they have not revealed when or if they inspected it.
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