Cryolife Litigation: Other Cases

CryoLife Admits to Using Contaminated Tissue (25 June 2002)

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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
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.
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.
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.
Thank you.
FDA audit report from 14 February 2003
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