Osteograft origin & safety
THE DIZG - GERMAN INSTITUTE FOR CELL AND TISSUE SUPPLY -
was founded in 1993 by medical scientists and scientists based on the expertise of the tissue banks of the University of Leipzig and the University Hospital Charité Berlin. The institute sees itself as a mediator between donor and patient. It wants to provide the gift of tissue donation to the community of medics.
With the safety and quality system, they have already delivered about 150,000 human transplants to doctors and clinics in Germany and abroad.
SAFETY AND QUALITY
In Germany, allogeneic cell and tissue transplants are regulated as drugs and subject to authorization, meaning the manufacturer, the biological safety and the clinical application are subject to the constant control of the German authorities. The products have 10 drug approvals for human tissue transplants.
The DIZG Biological Safety System for Tissue Transplants consists of extensive donor selection criteria, a comprehensive serological donor screening that includes EUV 23/2004, including 4 virus genome studies, and the use of a validated procedure for donor selection Removal / inactivation of viruses, bacteria and fungi and in-process and final controls on the graft.
The ARGON is certified according to DIN EN ISO 13485 and follows the Ethical Code and the quality standards of the European Association of Tissue Banks (EATB).
The application of OsteoGraft grafts is subject to documentation according to the Transplantation Act (TPG). For each package labels for the patient record are attached. All dimensions are approximate and minimum. They are subject to a preparation and tissue-related dispersion. Explanations and instructions for the application of the transplants can be found in the user and specialist information enclosed with each packaging.
In principle, all requests for delivery can be met by appointment on a specific date. The costs incurred by ARGON will be charged in full.
FREEZE DRYING (GT)
The preparations marked with GT are freeze-dried (exception: dried Amnion) and in unopened packaging when stored below 25 ° C for five years from the date of manufacture. Human amnion, dried and DBM pasty are ready for immediate use without rehydration, all other transplants should be at least 30 min in a suitable sterile physiological medium (eg, isotonic infusion solution) to rehydrate.
DEEP FREEZE (TK)
The preparations labeled with TK are freeze-preserved. In unopened packaging the shelf life when stored below -40 ° C is two years from the date of manufacture. Before use, freeze-preserved preparations should be thawed by placing them in a suitable sterile, physiological medium (eg isotonic infusion solution).
Tissue transplantation is one of the great achievements of modern medicine. Although less well known in the public as organ transplantation, human donor tissue treatments help more than 1 million people a year in Europe. Physicians use donated tissue of the human musculoskeletal system to replace bones, tendons, and ligaments that have been damaged by tumors, accidents, joint diseases (e.g., arthritis), or other causes. In order to make these transplants accessible on the basis of legal and ethical foundations as well as in compliance with the strictest quality and safety requirements, also users in the oral, maxillofacial and facial area in Germany and Europe, Argon Medical cooperates with the non-profit German Institute for Cell and Tissue replacement (DIZG) in Berlin, a foundation of doctors and scientists of the Universities of Berlin (Charité) and Erlangen.
In Germany, allogeneic tissue grafts are regulated as drugs and subject to authorization, meaning the production and thus the biological quality and safety are subject to the supervision and constant control of the German authorities. The transplants offered via the argon are processed by the DIZG in Germany and are approved as drugs in Germany. The system for ensuring the biological safety of the tissue grafts of the DIZG is among others:
- extensive criteria for donor selection,
- an elaborate, serological donor screening exceeding legal requirements, including four virus genome examinations,
- the application of a validated method for the inactivation of viruses, bacteria and fungi and
- documented in-process and final controls on the graft.
The DIZG and the Argon Medical are certified according to DIN EN ISO 13485 and the DIZG follows the ethical code and quality standards of the European Association of Tissue Banks (EATB). The DIZG is a partner of many non-profit institutions in Germany that deal with tissue donation. The grafts are sterilized by the peracetic acid method (PES). In a comprehensive review published in 2002, Pruss and co-workers report over 20 years of experience with allogeneic tissue transplants treated with the PES procedure. So far, over 130,000 such grafts have been successfully deployed for clinical use. In no case have clinical complications, e.g. the transmission of infectious diseases or rejection reactions, observed. Benefits and strengths Findings from animal experimental and clinical studies have led to the conclusion that allogeneic bone grafts are very well biocompatible and have osteoneogenetic potential, which can positively influence the formation of new bone in augmentation and defect fillings. Advantage: Users can now access the most simple way, according to their needs, quality drugs manufactured and approved in Germany. Clinical Approach DBM pastös is ready for immediate use. All other materials are rehydrated before use with a suitable sterile physiological medium (eg, isotonic infusion solution). The bone defects are filled up with the bone matrix. The material is easy to model and can also be used very well together with other bone substitute materials.