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Safety and Quality

Mount Sinai Allograft Technologies (MSAT), a department of Mount Sinai Hospital, has been a leader in advanced tissue innovation since 1972. We are committed to providing the highest quality of bone and tissue allograft products – as well as continued innovation in the development of allograft implants for transplantation. We are dedicated to exceeding surgical needs and to exceed all client expectations. We work closely with the Trillium Gift of Life Network to promote their mission of increasing donor awareness and to ensure that the wished of Ontario donor families’ are carried out with the utmost care and respect. Our allograft implants are 100% Ontario produced, human allograft tissues.

Industry Leading Processing Techniques

To produce the safest and highest quality Canadian produced allograft implants, MSAT leverages the expertise of a variety of medical experts, state-of-the-art laboratory testing, proven bio-processing techniques, tested irradiation methods and preferred packaging system.

Quality Systems

MSAT 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
  • 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

Donor Testing & Sterilization Techniques

MSAT 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

MSAT utilizes gamma irradiation as a sterilization technique. This technique effectively eliminates bacteria and is designed to provide bactericidal and veridical properties. At the selected dose, our tissues are able to maintain biomechanical strength and biochemical properties necessary for clinical use.