Tutoplast®
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Facts About Tutoplast
The Tutoplast® process is a unique processing methodology developed by Tutogen to sterilize and preserve
tissue for implantation, while preserving the biomechanical and structural integrity of the graft. The process
has been in use for over 30 years with over one and a half (1.5) million grafts implanted without a
single documented case of disease transmission attributed to the graft.
Donor selection – Prior to beginning the Tutoplast® process, all grafts go through a comprehensive
donor-screening regimen to assure graft safety and eliminate the potential of using high-risk donors. The
screening includes a medical/social history review, a detailed interview with next of kin and an extensive
donor physical evaluation.
Serological testing – Comprehensive serological testing is performed by third-party CLIA (Clinical
Laboratory Improvement Amendment) certified laboratories, using FDA approved test methodology. Tutogen’s
exclusionary criteria are substantive and surpass FDA regulations and AATB standards. Following a thorough
quality assurance data review and acceptance by a licensed physician, donor grafts are released for
Tutoplast® processing. The serological screening includes testing for transmissible diseases as required
by FDA & AATB standards.
This blood sample screening is a significant step in reducing potential disease transmission by eliminating
any donor that may have had a prior medical condition or been involved in high-risk behavior. Tutogen’s
medical director, a Board certified physician, oversees the implementation of our screening guidelines by
tissue recovery agencies and releases the grafts for processing.
Donor grafts are additionally tested for microbial growth prior to the commencement of the preservation
and sterilization process. This step determines the level of bacterial loading in the graft. Any grafts that
exhibit unacceptably high levels of specific contaminants or highly pathogenic microbes is eliminated
from processing.
Grafts that pass this rigorous screening and testing process already present a very remote risk to the
patient. The Tutoplast® process further reduces the contamination risk of transplanted grafts until it is
virtually eliminated, by subjecting it to additional processing steps that destroy, remove or inactivate
disease causing agents.
Sterilization – After Tutoplast processing, the grafts are cut to shape and size and placed in double
barrier packaging, then terminally sterilized using low dose gamma irradiation. This step eliminates any
ancillary microbial contamination that may result from post-Tutoplast process handling and packaging and yields
a Sterility Assurance Level (SAL) of 10-6. This final step, alone, reduces the chance of viable microorganisms
on Tutogen products to one (1) in one (1) million.3
References
1. Mould, et al. Scrapie in Mice. (1965). Vet Sci.
2. Viral Inactivation Study During the Tutoplast Allografts Manufacturing Process. (1994). Institut Pasteur Texcel. Paris, France. On file at Tutogen Medical, Inc.
3. 10-6 SAL radiation dose validation study on file at Tutogen Medical, Inc.
Selected Publications
1. Mould, et al. Scrapie in Mice. (1965). Vet Sci.
2. Viral Inactivation Study During the Tutoplast Allografts Manufacturing Process. (1994). Institut Pasteur Texcel. Paris, France. On file at Tutogen Medical, Inc.
3. Brown P et al. (1986). Newer data on the inactivation of scrapie virus or Creutzfeldt-Jacob disease virus in brain tissue. J Infect Dis. Jun;153(6)
4. Conto A. (1994). Determination of the clearance factor for unconventional slow viruses during the processing of dura mater. Istituto Di Ricerche Biomediche Antoine Marxer Rome, Italy On file at Tutogen Medical, Inc.
5. University of Erlangen, Germany. (1992). On file at Tutogen Medical Inc.
6. Hathaway JK and Choe JM. (2002). Intact genetic material is present in commercially processed cadaver allografts used for pubovaginal slings.” J of Urology. Sept.
7. WHO Guidelines on Transmissible Spongiform Encephalopathies in relation to Biological and Pharmaceutical Products (2003).
www.who.int/biologicals/publications/en/whotse2003.pdf
8. Diringer H, Braig HR. (1989). Infectivity of unconventional viruses in dura mater. Lancet, Feb 25, 1(8635):439-40.
9. Stoess H and Pesch HJ. (1988). Dura Transplantation: Multisequential Implants of Solvent Dehydrated Dura Mater. Animal experiments to study sensitization. Biomed Technik.
10. Hinton R et al. (1992) A Biomechanical Analysis of Solvent-Dehydrated and Freeze-Dried Human Fascia Lata Allografts. Am J of Sports Medicine. 20(5).
11. Thull R et al. (1992). Mechanical Properties of Native and Prepared Cancellous Bone. Pesch HJ, Osteologie. No. 5.
12. Sclafani AP et al. (2002). Biophysical and microscopic analysis of homologous dermal and fascial materials for facial anesthetic and reconstructive uses. Arch Facial Plast Surg. Jul-Sep; 4(3): 164-71.
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