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academies
International Surgery and Ortho Conference
October 25-26, 2017 | Toronto, Canada
Case Rep Surg Invasive Proced 2017 | Volume 1 Issue 3
Ensuring the safety of allograft tissues (Iranian Tissue Bank & Research Center experience)
Mitra Mahdavi-Mazdeh
Tehran University of Medical Sciences, Iran
W
e witness over 2 million human tissue transplantation
annually worldwide. These tissues are used in different
surgeries from lifesaving orthopedic or early excision grafts for
severe burns to reconstructive or ophthalmologic ones. These
are shared between countries with different protocols and
regulatory systems to look for different viral or microbial agents
whichmay be a real concern for infection transmission. It seems
necessary to have not only a national legislative framework
with mandatory requirements and a regulatory system to
authorize cell &tissue establishments but also a reporting
system for allograft-associated complications by clinicians to
prevent errors or donation from the same donor or same batch.
(1, 2) The US Navy Tissue Bank, launched in 1949, was the
first standard setter for the world community of tissue banks
and established many of the standards that are still followed.
Processing, immunological principles of tissue transplantation
and sterilization by irradiation were developed in half a century
by Navy scientists. (3) There are reports of transmission of
infections or malignancies to recipients of not only solid organs
but tissues andeye grafts.(2, 4) Infectious pathogens can include
viruses, bacteria, parasites and prions. The risk may amplify due
to the high number of tissues which can be recovered from
a single donor. However, the overall risk of infectious disease
transmission in tissue and cell recipients thanks to more than
50 years of experience in the field is much less than solid
organ recipients which is less than 1%. (1) Furthermore, bone
banking procedures have improved significantly during the last
three decades. The balance between safety and availability
and cost has long been a concern but cannot be an excuse to
jeopardize the patient to the risk of disease transmission. We
need to follow strict evidence- based algorithm to prevent even
the very limited risk and allograft safety is dependent seriously
on effective sterilization. In a retrospective review of allograft
recall data from January 1994 to June 30, 2007 it was found
that 59,476 (96.5%) of recalled allograft tissues by FDA were
musculoskeletal. However, interestingly the percentage of
different errors has been changed through years. From 1994to
1998, insufficient or improper donor evaluation plus positive
serology accounted for 96.4% of musculoskeletal recalls
which decreased to 67.2% in the period of 1999 to 2007.(5)
So the importance of retrieval phase is evident. Any biologic-
based products is expected to carry such a risk due to intrinsic
characteristics. It should be claimed that the risk of transmission
can be eliminated. All the efforts are taking place to achieve the
lowest possible risk of disease transmission. There are three
stages from donor tissue retrieval, tissue processing in clean
room and sterilization before storage and packaging to provide
safe tissues appropriate for patient transplantation. Each needs
supervision of quality control and assurance protocols.
Speaker Biography
Mitra Mahdavi-Mazdeh is working as a Professor in the Division of Nephrology at
Tehran University of Medical Sciences. She was the Director of Management Center
of Transplantation and Special Diseases in Moh for two years (2005-2007). She has
been the Director of Iranian Tissue Bank Research Center since 2007. Her major
research interests lie in the epidemiologic features of RRT especially transplantation
in developing countries.
e:
mmahdavi@tums.ac.ir