Orthoss® and Chondro-Gide® are CE-marked medical devices
Orthoss® and Chondro-Gide® are amongst the leading products for bone and cartilage regeneration in orthopaedic surgery with a long-standing record of highly successful clinical use throughout the world.
Geistlich Pharma is a quality-driven company that endeavours to provide patients with clinically proven and effective products.
As medical devices Orthoss® and Chondro-Gide® are covered by national regulatory frameworks which require thorough documentation as prerequisite for market approval.
The directive 2003/32/EC, an extension of the medical device directive 93/42/EEC, requires that manufacturers of medical devices derived from animal tissues justify the use of such products with regard to the clinical benefit for the patient within the framework of a risk management procedure and taking into account the available alternatives.
The normative requirements for the evaluation are specified in the guideline series ISO 22442.
Both Orthoss® and Chondro-Gide® have CE-marking certification as medical devices assuring their conformity with mandatory safety regulations and confirming that risk-benefit evaluation was performed in compliance with the norms.
The manufacturing processes, adherence to the strict control measures and clinical documentation are in accordance with a quality assurance system based on international standards (ISO 13485 and ISO 9001), and subject to continuous inspection by the competent authorities and regulatory bodies.
Animal tissues as raw materials for clinically proven and effective products
The natural structures of animal tissues from which our products are derived have specific properties that are uniquely beneficial to patients and enable Geistlich medical devices to be clinically successful.
A range of published data provides compelling evidence for the outstanding clinical performance and the leading role of Geistlich medical devices in the field of orthopaedic and maxillofacial surgery.
Transmission of zoonotic agents represents a potential risk when using animal tissues as raw materials for medical products. Specific and efficient concerted measures need to be implemented to assure the safety of animal tissue-derived products in humans.
The raw materials we use are sourced exclusively from animals that have undergone official veterinary inspection and certified as fit for human consumption, and from certified and officially inspected slaughterhouses.
Orthoss® is derived from bovine bone sourced in Australia, and the porcine tissue for the production of the collagen matrix Chondro-Gide® is sourced in Switzerland.
To safely, reproducibly and reliably inactivate and remove pathogenic bacteria, viruses, fungi, spores and parasites, all animal tissues used in our products as raw material are subjected to controlled and validated chemical and physical treatments. Before clearance all products are sterilised with a validated gamma-irradiation process.
Specific measures to protect against infectious agents
Geistlich Pharma has a Risk Management System in place including an annual post-marketing safety evaluation to ascertain the collection, documentation and notification of safety complaints, a regular update of the clinical data evaluation regarding safety and clinical performance and an annual surveillance of safety towards new and upcoming zoonoses. The adherence to all measures is controlled by regular on-site audits by the appropriate authorities.
As Orthoss® is produced from bovine bone, specific precautions in regard to prion transmission have been implemented. The first measure is a careful geographical selection of all source animals solely from Australia. Australia is and has always been free of by Bovine Spongiform Encephalopathies (BSE) and has put in place one of the strictest programs in the world of preventive measures, control and traceability, to assure that this status remains valid.
As a result, in official geographical BSE-risk classifications, Australia has always been ranked in the safest category. According to Resolution No. 17 passed at the 79th General Session (May 2011) of the OIE (World Organization for Animal Health), in terms of chapter 11.5 of the OIE Terrestrial Animal Health Code, Australia continues to belong to the lowest risk class of 'Negligible BSE risk' (OIE, 2011).
Obligatory inspections by official veterinarians certify that the animals are healthy and all raw materials meet the requirements of fitness for human consumption.
Bovine bone is tissue in which prion infectivity has never been detected so that bone tissue has consistently been assigned to Table IC of the WHO tissue infectivity classification (WHO 2003, 2006, 2010), which corresponds to the lowest category of risk of ‘undetected infectivity’.
Orthoss® is devoid of detectable protein and other organic matter. The absence of detectable protein is one of the criteria which need to be met before a production batch is released. The concerted measures were evaluated by experts in the field as efficient to reduce the risk of BSE-agents transmission following implantation of Orthoss® in patients.
The natural bone mineral of Orthoss® was one of the first medical device substances to receive a certificate of suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM). It confirms that the risk-minimising measures taken by Geistlich Pharma meet the requirements of the European Pharmacopoeia regarding Transmissible Spongiform Encephalopathies (TSEs), as outlined in the general monograph 5.2.8.
Eligibility for blood and organ donation after treatment with Orthoss® or Chondro-Gide®
The evaluation of conformity and the subsequent market approval of the products signify that the competent regulatory bodies rate Orthoss® and Chondro-Gide® as suitable and reliable for use in patients.
Many blood transfusion services around the world confirm that there are no scientific grounds that justify deferral of blood donors who have received Geistlich products and have set up their criteria for donor selection and deferral accordingly.