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Quality and safety

As a certified Austrian tissue bank, surgebright meets the highest quality standards. Regular audits carried out by authorities, our partner and by surgebright itself ensure that all regulatory requirements are met. The constant further development of our TÜV certified quality management system is at the center to ensure maximum security for patients.

The donor process

Human tissue grafts 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 in order to exclude any risk (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: “The screening is done as if there was no sterilization.”

Pillar II
sterilization

The grafts are sterilized in a sterilization & inactivation procedure and freeze-dried. No gamma irradiation is used. The sterilization kills all known pathogens and prevents the transmission of diseases. Principle: “The sterilization is done as if there was no screening.”

Pillar III
Traceability

All transplants carry an ID number and are traceable to the end user (hospital) and thus to the patient. In case of suspicion of disease transmission and positive verification of the sterile retained samples, all transplants can be recalled.

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