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Safety and Quality Systems

Quality Systems

                         Large tissue sample of clean bone

Large tissue sample of clean bone

 

 

 

 

 
Ground bone sample
 

Ground bone sample

 

Mount Sinai Allograft Technologies ensures excellence in allograft tissue by performing rigid testing through its strict adherence to quality control procedures. Each tissue is monitored from recovery through transplantation to prevent the introduction, transmission and spread of communicable disease. 

Key highlights are:

  • Proven track record for producing safe allograft tissue;
  • Medical review of a comprehensive questionnaire, including social and medical history on each donor;
  • Trained medical doctors in recovery procedures to ensure a thorough post-mortem physical exam was performed correctly on each donor;
  • Utilization of an established and transparent quality assurance program integrated with the quality standards of Mount Sinai Hospital;  
  • Established donor suitability standards created by an advisory panel consisting of pathologists, microbiologists and surgeons;
  • Serological testing that has been validated to meet regulatory standards;
  • Each donor tissue has been reviewed and deemed suitable by a medical doctor and quality assurance personnel.  
     
Additional Quality Control Measures
    • Heath Canada Registered
    • Canadian Standards Association Compliant
    • American Association of Tissue Banks Accredited
    • Ontario Laboratory Accredited
    • College of American Pathologist Accredited
    • Clinical Laboratory Improvement Amendments Accredited
 
Quality Systems Adopted
    • FDA — Good Manufacturing Practices
    • FDA — Good Tissue Practices
    • ISO 9001 Adopted Practices
       
Donor Testing & Sterilization Techniques

The Mount Sinai Allograft Technologies requirement for donor testing meets and surpasses established regulatory standards. Only validated and approved Health Canada testing kits are used to test donor samples.

Each donor is required to pass the following serological tests:

    • West Nile virus Nucleic Acid Test (WNV RNA)
    • Hepatitis B Nucleic Acid Test (HBV DNA)
    • Hepatitis C Nucleic Acid Test (HCV RNA)
    • HIV Nucleic Acid Test (HIV RNA)
    • Hepatitis B surface antigen (HBsAg)
    • Hepatitis B core Antibody (HBcAb)
    • Hepatitis C Antibody (HCV Ab)
    • HTLV 1&2 Ab (HTLV Ab)
    • HIV 1& 2 Ab (HIV Ab)
    • Syphilis (RPR)
    • CMV IgG Ab

Sterilization Technique

Mount Sinai Allograft Technologies utilizes gamma irradiation as a sterilization technique. A dose of 25kGy is certified by Steris Isomedix Corporation. This technique effectively eliminates bacteria and is designed to provide bactericidal and virucidal properties. At the selected dose, our tissues are able to maintain biomechanical strength and biochemical properties necessary for clinical use.