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Fact Sheet

RegenMed is a not-for-profit organization that operates solely on a cost-recovery model. RegenMed is a designated tissue bank that is Health Canada compliant and is in the process of initial accreditation with the AATB, hopefully to be completed in fall of 2015.

Currently, RegenMed distributes tissue from the following tissue banks:

-          RegenMed

-          Hema Quebec

-          Community Tissue Services (CTS)

-          Tissue Bank Manitoba (processed by MTF)

 

Tissue is recovered from carefully screened and consented deceased donors. After careful validation, we have decided to utilize a detergent (non-ionic surfactant), hydrogen peroxide for no longer than one hour and isopropyl alcohol. Since the use of antibiotics is controversial, an antibiotic soak has not been included in the processing methodology. These chemical methods will be employed with pulse-lavage, centrifugation and sonication at a temperature of 15-60°C, this is followed by a thorough rinsing to remove residual solutions and then the tissue graft is packaged for aseptic presentation and either frozen or freeze dried for storage. The allograft is subsequently exposed to a controlled irradiation dose to effectively sterilize the tissue graft. This should result in a clean, sterile tissue graft that is clinically effective. Non-irradiated tissue, checked to be micro-organism free by multiple rounds of quality control samples, is processed aseptically and not labeled as sterile.

 

Type of Irradiation:  Cobalt (60Co) Gamma Irradition

Irradiation Facility:  Steris IsoMedix, Whitby, Ontario

  • ISO 13485 registered
  • Compliant with FDA 21 CFR part 820 requirements, AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006

Specified Dose Range:  15 -25 kGy

Justification of Dose: 

Gamma irradiation is an established method for the sterilization of tissue grafts.  Ideally, tissue grafts should be irradiated at the lowest dose that will ensure sterilization and at a low temperature to avoid as much damage as possible to the graft.  Levels of irradiation greater than 25 kGy have been shown to adversely affect the mechanical and biological properties of bone in a dose-dependent manner.  Biomechanical and histological data has suggested that irradiation at a dose of 15 kGy does not compromise the natural course of allogeneic cortical bone graft incorporation. Additionally, a low dose of gamma irradiation (18-22 kGy) did not affect the mechanical strength or modulus of elasticity for bone grafts and soft tissue grafts.  It has been recommended that a dose of above 15 and below 25 kGy is an ideal and effective range for sterilizing tissue grafts while avoiding potential damage.  In actual practice, the irradiation dosage is often ___________.

 

 

Included with each tissue graft is a package insert that should be consulted when looking for detailed information pertinent to the graft. General information is provided below:

 

Graft Type

Graft Storage

Graft Reconstitution

Freeze Dried

Ground Bone, Crushed Bone, Soft tissue

Store freeze dried grafts at ambient temperature in a clean, dry location

Place graft in sterile basin and cover with sterile saline or isotonic solution for 30-45 minutes

Struts, Wedges, Segments, Blocks, Shafts

Place graft in sterile basin and cover with sterile saline or isotonic solution for 30-60 minutes

Tissue should be used as soon as possible following reconstitution. Reconstituted tissue may be refrigerated in a sterile container after 2 hours and stored for no longer than 24 hours at 1-10°C.

Frozen

All Musculoskeletal tissue

May be stored at -20°C to -40°C if used within 6 months, otherwise store at or below -40°C

Place graft in a sterile basin and cover with sterile saline or isotonic solution until graft is thawed (approx. 30-60 minutes)

Tissue should be used as soon as possible following reconstitution. Reconstituted tissue may be refrigerated in a sterile container after 2 hours and stored for no longer than 24 hours at 1-10°C.

 

Most grafts are packaged in two or three peel packs allowing for the innermost package to remain sterile.  There are a few freeze dried grafts and most dental grafts that are packaged in sterile glass vials and must be opened using aseptic technique.  Remove seal, wipe entire stopper area with betadine or alcohol.  Deliver reconstitution solution into container by puncturing stopper with a needle attached to a syringe.  The solution should be drawn into the bottle by the vacuum inside the container.   Remove rubber stopper with sterile clamp.  Deposit contents of bottle into sterile container on operative field.  If gauze is present, remove and discard.

 

More detailed information can be found on the package inserts included with every graft.

 

To place an order, please contact:

regenmed%23ca|orders

Direct: 807-346-2265

Toll Free: 877-554-2205

Fax: 807-683-0710

For additional information, visit us at:

 www.regenmed.ca