Allograft

MSAT is both Health Canada Certified and American Association of Tissue Banks (AATB) Accredited.

An allograft is when tissue from a donor is transplanted in another person. These tissue transplants can be used in medical procedures such as spinal or orthopaedic (bone) surgery.  

Safety and quality

At Mount Sinai Allograft Technologies, we are committed to providing the highest quality of bone and tissue allograft products. We work closely with the Trillium Gift of Life Network to ensure that the wishes of Ontario donor families are carried out with the utmost care and respect. Our allograft implants are 100 per cent Ontario-produced, human allograft tissues.

Industry-leading processing techniques

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

Quality systems

We ensure excellence in allograft tissue by performing rigid testing and through 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 of our quality systems include the following:

• A proven track record for producing safe allograft tissue
• A medical review of each donor through a comprehensive questionnaire, which includes social and medical history
• An established and transparent quality assurance program that is integrated with the quality standards of Sinai Health
• Donor suitability standards created by an advisory panel consisting of pathologists, microbiologists and surgeons
• Serological testing that has been validated to meet regulatory standards
• Review of each donor tissue for suitability by a medical doctor and quality assurance personnel

How to order allograft products

Health-care facilities and surgeons are approved to order allograft tissues from Mount Sinai Allograft Technologies. Only licensed surgeons and clinical professionals are permitted to transplant allografts.

To place an order, please email [email protected] or phone 416-586-8870.

Special orders

Tissue can be ordered 24 hours a day, seven days a week and 365 days a year. Emergency orders can be fulfilled on short notice. In many cases, orders can be shipped on the same day or within 24 hours.

Please phone 416-586-8870 for more information on rush orders. If phoning outside of office hours, please call the hospital locating at 416-586-5133 and ask to speak with the person on call for the bone bank department.

Consignment services

We can work with you to create customized solutions to meet your needs. For additional details regarding consignment services, please email [email protected] or phone 416-586-8870.

Return policy

We are pleased to accept returns of unused items subject to this return policy.  

Note that the transplant facility is responsible for obtaining a return authorization number (RAN) from Mount Sinai Allograft Technologies before returning any unused allograft implant.

The following applies for all allograft implants to be returned:

• Integrity of allograft package must be intact
• Allograft implants must be shipped back in the original validated box
• The Return Authorization Number (RAN) must be obtained prior to shipping back the allograft implant
• Frozen allograft implants must be received by Mount Sinai Allograft Technologies during regular business hours Monday to Friday 8 a.m. to 4 p.m.
• Outside of business hours, the coordinator on call must be paged by phoning hospital locating at 416-586-5133.

Frozen tissue return timelines

If frozen allograft implants have not been opened from their original shipping container, they can be returned within the expiration date and time indicated on the shipping box.

Lyophilized tissue return timelines

The integrity of the allograft implant packaging must be intact and in the original display box. Allograft implants must be returned within five days of shipment.

If return timelines have been exceeded, Mount Sinai Allograft Technologies may issue a credit for the following reasons:  

1. Unacceptability of the allograft as the result of an error for which the hospital or surgeon is not at fault.
2. If the hospital or surgeon questions the quality or clinical effectiveness of the allograft, we may authorize the return of the allograft for evaluation purposes. If, upon evaluation, the determination is made to replace the allograft implant, we will pay for shipping charges.

Payment

Account statements are sent on a monthly basis and payment is due within 30 days of the issue date, unless stated otherwise. Payments can be made via corporate cheque and mailed to:

Mount Sinai Allograft Technologies 
138.03 - 600 University Avenue 
Toronto, Ontario, Canada, M5G 1X5

Donor testing and sterilization techniques

Our 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)

Sterilization technique

We use gamma irradiation for sterilization. This technique effectively eliminates bacteria and provides bactericidal and veridical properties. At the selected dose, our tissues are able to maintain biomechanical strength and biochemical properties necessary for clinical use.

Accreditation

We have received the following accreditations.

• American Association of Tissue Banks 
• Health Canada CTO Registration 
• Canadian Standards Association 
• Food and Drug Administration (FDA) registration (FEI: 1000291168)

We have taken the following quality control measures:

• Ontario Accredited Laboratories testing (ISO 15189)
• Serology testing using Health Canada-approved serology kits
• Follow the FDA's Good Manufacturing Practices and Good Tissue Practices quality systems