Information to the grafted patient:
The grafting surgeon informs his patient about the use of a product of human origin before surgery.
Traceability of the grafts:
The human nature of the graft requires a strict traceability management in compliance with regulations.
Two documents drawn up by BIOBank are placed inside the box:
- The “graft ID form” certified by BIOBank, for the attention of the surgeon. It details the information required for traceability (origin, characteristics, result of the serological screening, preparation conditions, etc.); this form must be filed in the patient’s medical file.
- The “implantation form”, to be completed on the conditions of use and signed by the grafting surgeon. This form must be returned to BIOBank or your local distributor by post, fax or email. They will then manage the tissue traceability.
Graft use rules:
Bone graft tissue must be rehydrated in order to restore its natural elasticity. Rehydration enables the graft to be shaped and optimally adapted to the graft site.
The different steps of this preparation must be executed with highly rigorous asepsis rules, in the following order:
- Opening of the double package and taking out with sterile pliers,
- Immersion in a sterile saline solution at ambient temperature, patient’s blood or autologous marrow, in order to bring growth factors,
- Potential addition of antibiotics if the patient does not have known allergies.
The rehydration time depends on the size of the graft. It must be:
- 15 minutes minimum for femoral heads and half-femoral heads
- 10 minutes minimum for bone blocks
- 10 minutes for granules
- 1 minute for powders
Special conditions of use:
- In high stress conditions, depending on the case, an osteosynthesis can be combined and the loading must be gradual and adapted to the primary stability of the reconstruction.
- The powder’s presentation in syringe allows aseptic transfer, with the luer-lock connector provided, of a sterile solution of sodium chloride or the patient’s blood previously taken aseptically.
- The granule’s presentation in syringe allows the aspiration of a sterile sodium chloride solution, patient’s blood or bone marrow.
- For oral and maxillofacial surgery, the adjustment of the cortico-cancellous or cortical bone plates in terms of height, length and thickness, may be done using a rapid-rotation bone burr under irrigation.