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Female Speaking: Okay, our next question is coming from
Steve of KCM Biomedical. Please state your question:
Participants: Steve and James Vander Wyk |
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Steve:
Hi. Thanks for taking my question. I was a little confused though
about what you said about the companion tissue. Are you saying
that if tissue from a donor is found to be contaminated that
the company routinely discards the other tissues or it does
not? It does sampling on each tissue. |
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JVW:
This is a confusing issue because there are different thought
processes in the industry with regulatory agencies and general
practices. The ATB has made some pronouncements and, so, it's
easy to become confused by this. What generally is done in my
understanding is that when tissue is procured from a donor,
it may involve varying sites of the body. For example, left
knee, right knee, heart and say vascular tissue. It is CryoLife's
standard operating procedure to test for each type of tissue
from each site that it is recovered from. For example, if they
were tendons from the left knee and a meniscus from the left
knee, that would involve two separate microbiological tests.
If there were additional tissue of different types from other
sites, the number of tests simply multiply. It is CryoLife's
policy that when tissue has a test that proves positive for
any growth of any type, the tissue from that site associated
with that test is discarded, regardless, as I said of the type
of tissue that it is. So, if there was a positive for a left
knee tissue all that knee tissue would be discarded. Right knee
carved out would not be. The data does not support that it is
necessary to do that. |
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| The other issue comes up is when there is a report of an infection
from the field. For example, if someone where to claim that
they had an infection from an implanted tendon from the left
knee, CryoLife would review the reports. If the reports appear
to be reasonably associated with an infection that could have
come from a tissue, companion tissue from that donor from the
left knee would be discarded. There is. . . the heart valves
or tissue from the other knee would need to be discarded. Matter
of fact, I would clearly remind you that in the case of the
patient in Minnesota who received that tissue and subsequently
did die, there were nine (9) other patients who received tissue
from that donor who had no such infection. The data did not
mean that it is necessary to act against all the other tissue.
CryoLife feels strongly, along with the rest of the industry,
that it has an obligation to extend the benefits of allograft
tissue to as many people as they can and tissue is hard to recover,
there's a loss of donors or rather there's not enough donors
to go around and it might be arbitrary in discarding for which
there is no data to act against it. |
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Steve:
Thank you. |
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| FDA
audit report from 14 February 2003 |
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| Back to Other Cases |
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