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Patient safety is our highest priority.
While the options for surgical musculoskeletal repair
continue to expand, a growing number of surgeons worldwide
choose bone and soft tissue allografts as a safe, effective
and convenient surgical option. Allografts bearing the
SteriGraft™ label fulfill the discriminating surgeon's
desire to extend extraordinary patient care. Our superior
level of allograft processing begins with rigorous Donor
Screening and meticulous Donor Recovery Procedures,
Certified Laboratory Testing, validated Tissue Cleansing,
Sterile Packaging, and a meticulous Quality Assurance
& Documentation system that ranks second to none.
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These combine to form the proprietary,
GraftShield™ allograft processing system, designed
to set an entirely new standard in allograft sterilization.
This system offers scientifically validated tissue
sterilization (validated to SAL 10-6 in accordance
with ISO 11137-2 Method 1) which virtually eliminates
the risk of bacterial disease transmission. |
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To learn more about the various certifications
of Bone Bank Allografts and Texas Human Biologics,
please click here.
To download a PDF file of our catalog pages which
discuss our GraftShield™ human tissue processing
systems, please click
here.
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Donor Screening & Processing |
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A meticulous donor
screening system has been developed to assure
that only uniform, high quality tissues will be
recovered and processed.
- Donor Screening and Review
- An extensive donor screening process is
conducted to review medical / social history.
Only those donors that meet our standards
and screening requirements are qualified to
be accepted for donation. This rigorous screening
process is performed in an effort to eliminate
potential donors with risk factors, which
may contribute to the transmission of infectious
disease.
- Donor Recovery and Processing
- Our donor recovery partners and their staff
are held to the high standards implemented
by the American Association of Tissue Banks
(AATB). Specific policies and procedures are
followed to ensure that donor tissue is recovered
appropriately and aseptically.
Click here to learn more about our donor
screening and processing standards.
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In accordance with FDA regulations
and AATB Standards, donor tissues are tested by
laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) and carefully
analyzed using the latest technology in order
to confirm that the donor is free from the following
infectious diseases:
Click
here to learn more about our laboratory
testing process for donated tissues.
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The Graftshield™ process
makes improvements at multiple steps in the tissue
processing system. Our processing partner, Texas
Human Biologics utilizes a state of the art processing
facility which makes the following steps possible.
- Tissue Cleansing
- To prepare for processing, tissues are sanitized
using GraftCleanse™. This proprietary blend
of cleansing compounds significantly reduces
bio-burden and allows for an aesthetic, white
appearance.
- Sterilization
- GraftShield™ utilizes a low dose radiation
sterilization method that is validated in accordance
with ISO 11137-2 Method 1. Terminal sterilization
is achieved with allografts in their final packaging.
- Custom Processing Machines
- We have designed and built custom equipment
that enables individual equipment sterilization
between cases, thus eliminating the risk of
cross contamination - a significant advance
in the safety of processing human tissue allografts.
- Allograft Performance
- Each allograft is evaluated at the time of
processing, packaging, labeling, and again just
prior to release to ensure that high quality
tissue is being made available for transplantation.
Click
here to learn more about our allograft
tissue processing approaches.
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SteriGraft™ Allograft Tissues from
Bone Bank Allografts are sterilized in their
final packaging to ensure the highest patient
safety. Our packaging processes ensure allografts
arrive in the surgery in the best possible
condition to facilitate a successful transplantation.
Click
here to learn more about our sterile
allograft packaging.
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To comply with the standards
set out by the American Association of Tissue
Banks (AATB) and the U.S. Food and Drug
Administration's (FDA), Good Tissue Practices,
Bone Bank Allografts, its processing partner
(THB), and the various donor processing
organizations we work with all are subjected
to an extensive quality process.
Click
here to learn more about our quality
assurance programs.
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The proprietary GraftShield
process was design to set a new standard in allograft
processing, sterility, and patient safety. Thank you
for looking into this process. If you have further questions,
please feel free to contact us at 1-800-397-0088 or
at sales@bonebank.com.
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