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.