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Quality & Safety Services
As a certified Austrian tissue bank , surgebright meets the highest quality standards. Regular audits by AGES, our partners and surgebright itself ensure that all regulatory requirements are met. Through our cooperation with large international tissue banks such as the DIZG , we can supply hospitals, orthopedic and trauma surgery facilities with human tendons , spongiosa chips , bone screws and also human skin .
Surgebright has specialized in supplying clinics with human bone replacement material ( allogeneic bone replacement ). Whether spongiosa chips , femoral heads or bone screws , surgebright only supplies bone replacement material made from allogeneic , i.e. human, bone . At surgebright, we are convinced that sterile allogeneic bone without additives such as antibiotics is the method of choice for filling bone defects and cysts .
The augmentation of bone defects with bone substitute materials
Common materials for filling / augmentation of bone defects are: Allogeneic bone allografts and autologous bone transplants from the iliac crest or heel bone. The great advantage of using allogeneic bone for the augmentation of bone defects is the time saved by eliminating the need for bone harvesting and also that there is no harvesting morbidity. When choosing the right allograft, there are a few things to consider in terms of manufacturer, grain and packaging size, storage life and sterilization process.
Allogeneic Bone
When using allogeneic bone , it is a bone replacement material where donor and recipient are different. But it is important that both have the same species. For example, allogeneic bone replacement is human-to-human. Allogeneic bone donations can be from living or deceased donors. In this way, people who receive a new artificial hip joint have the opportunity to donate their femoral head , which would otherwise be discarded during the operation.
Autologous bone
In autologous bone replacement , bone donor and bone recipient are the same. The advantage of autologous bone replacement : the transplant obtained contains the body`s own cells. The big disadvantage: The removal of the autologous bone material can often lead to pain in the patient postoperatively.
Human tissue transplants (allografts) are of bone or soft tissue . They are taken from the donor and transplanted to another person. Every potential donor of our transplants is thoroughly examined and checked in order to be able to rule out any risks (transmission of pathogens) with the greatest possible certainty. For maximum security of supply, there is the so-called "three pillar model".
Anamnestic screening is assessed on the basis of anamnesis and the donor`s medical history, donor suitability. This is done according to strict internationally standardized exclusion criteria. In addition to antibody tests, NAT methods are also used in the serological screening, which enable direct determination of viruses and even exceed the requirements of the EU. Principle: "The screening is carried out as if sterilization did not exist." If the anamnesis, the tests and the serological screening identify risks or diseases, the tissue donation will NOT be released for clinical use.
The allogeneic transplants are sterilized and freeze-dried in a sterilization & inactivation process. Sterilization kills all known pathogens and prevents disease transmission. Principle: “Sterilization proceeds as if there were no screening.” So if a disease had not been detected by history or screening, a sterilization procedure would kill those diseases.
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 . If there is a suspicion of disease transmission and the sterile reference samples are checked positively, all transplants can be recalled from the respective donor.