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Quality and safety

Austrian Tissue Bank

As a certified Austrian tissue bank, surgebright meets the highest quality standards. Regular audits carried out by authorities, our partners and by surgebright itself ensure that all regulatory requirements are met. Through our collaboration with major international tissue banks such as DIZG, we are able to supply hospitals, orthopedic and trauma facilities with human tendons, cancellous bone chips, bone screws, but also human skin, amnion and fascia latavers.

Supply with bone replacement material

surgebright specializes in providing hospitals with human bone graft substitutes (allogeneic bone graft substitutes). Whether cancellous bone chips, femoral heads, skin, amnion, fascia lata or bone screws, surgebright only delivers bone substitute material from allogeneic, i.e. human bone. We at surgebright are convinced that sterile allogeneic bone without additives such as antibiotics is the method of choice for filling bone defects, cysts.

The augmentation of bone defects with bone substitute materials

Common materials for filling / augmentation of bone defects are: Allografts from allogeneic bone as well as grafts from autologous bone from the iliac crest or calcaneus. The great advantage of using allogeneic bone for the augmentation of bone defects is the time saved due to the elimination of bone harvesting and also that no harvesting morbidity occurs. When selecting the right allograft, there is a lot to consider in terms of manufacturer, grain and pack size, as well as shelf life and sterilization procedure.

Allogeneic bone

When using allogeneic bone, it is bone substitute material where donor and recipient are different. However, it is important that both have the same species. Allogeneic bone substitutes, for example, are from human to human. Allogeneic bone donations can come from living or deceased donors. Thus, people who receive a new artificial hip joint have the opportunity to donate their femoral head, which would otherwise be discarded during surgery.

Autologous bone

In autologous bone replacement, the donor of the bone and the recipient of the bone are the same. The advantage of autologous bone replacement is that the graft obtained contains the body’s own cells. The major disadvantage is that the removal of the autologous bone material can often lead to pain for the patient postoperatively.

The donor process

Human tissue grafts (allografts) are made of bone or soft tissue. They are taken from the donor and transplanted to another person. Each potential donor of our transplants is thoroughly screened and reviewed to rule out any risks (transmission of pathogens) with the utmost security. For maximum safety, a so-called “three-pillar model” is applied.

Pillar I

Anamnestian & Serological Screening

Anamnestic screening is assessed based on the donor’s medical history. This is done according to strict, internationally standardized exclusion criteria. In addition to antibody testing, serological screening also uses NAT methods that allow direct detection for viruses and even exceed EU requirements. Principle: “Screening is performed as if there were no sterilization.” If risks or diseases are identified by the history, tests and serological screening, the tissue donation will NOT be released for clinical use.

Pillar II

sterilization

The allogeneic grafts are sterilized and freeze-dried in a sterilization & inactivation process. The sterilization kills all known pathogens and prevents the transmission of diseases. Principle: “Sterilization is performed as if there were no screening.” If an infection would not have been detected by history or screening, a sterilization procedure kills these pathogens.

Pillar III

Traceability

All transplants are provided with an identification number and can be traced back from the donor to the end user(hospital) and thus to the patient. In the event of a suspected quality defect, all transplants of the affected batch can thus be recalled.

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