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ePaper created 2017-12-06, 11:14:19 | version 1.38.0
sation for Animal Health (OIE). Afterwards, complex purification steps including both chemical and phys- ical methods are applied for a complete purification. However, those methods are occasionally discussed because of possible rejection reactions or a transfer of pathogens while applying bone grafting materi- als. In this context, the temperature treatment for the purification plays a major role. Bio-Oss™ is pro- cessed at temperatures of approximately 300 °C, while the bone substitute material cerabone® is purified by notably higher temperatures of up to 1,250 °C.1, 2 This difference in temperature seems to be of significant importance for the safe application of xenogeneic bone substitutes. temperature than a result of the treatment with highly concentrated sodium hydroxide (NaOH). While this chemical process was described as effi- cient by Wenz et al.,4 the reliability and sensitivity of the used tests were questioned by Kim et al.3 In this review, the authors describe that prions will only be effectively destroyed by heating up to 1,000 °C for five minutes. Furthermore, the according EU-guide- lines for medical devices utilising animal tissues and their derivatives (Part 1: Application of risk manage- ment, EN ISO 22442-1), point out that a treatment at temperatures above 800 °C is reducing the risk of the transmission of Transmissible Spongiform Encepha- lopathies (TSEs) to an acceptable minimum. The purification process of bovine bone tissue was evaluated in a recent review by Kim et al.3 Interest- ingly, the authors concluded that the inactivation of prions in Bio-Oss™ is rather based on the applied To assure a maximum level of safety, cerabone® is heated to temperatures above 1,200 °C during pro- cessing. Thus, organic parts like cells and proteins are removed and even potentially contained prions and industry | Fig. 4: Schematic illustration of the correlation between cellular and inflammatory processes caused by most of the applied bone grafting materials, the process of implant bed vascularisation and the process of bone tissue regeneration (based on a previous publication by Barbeck et al.9). Fig. 5: The cerabone® product family—naturally, safe and pure. implants 3 2017 35