A Sogal1, A J Tofe. 1. CeraMed Dental, LLC, Lakewood, CO 80228, USA.
Abstract
BACKGROUND: Several commercial products are currently available for clinical application as bone graft substitutes. These products can be broadly classified into two categories: synthetic and natural. Bovine bone is a popular source for several of the natural bone substitutes. The availability of bovine derived xenogenic bone substitutes has made it possible to avoid traumatic and expensive secondary surgery to obtain autogenous bone once thought essential for effective bone replacement. While autogenous bone still remains the undisputed "gold standard" in bone grafting, the realization that bone requirement in several clinical applications is as effectively met by xenografts has lead to their widespread use. But the convenience of using xenografts is tempered by the possibility of disease transmission from cattle to humans. The recent incidents of bovine spongiform encephalopathies (BSE) in humans have underscored this likelihood. In this paper, we report a risk analysis performed to assess the possibility of such disease transmission from a commercially available bone graft substitute (BGS) that is popularly used in clinical dentistry. METHODS: An extensive review of current literature on the status of risk assessment of BSE transmission was conducted, and two risk assessment models were identified as applicable to the present study. Risk assessment models developed by the German Federal Ministry of Health and by the Pharmaceutical Research and Manufacturers Association of America were applied to BGS. RESULTS: Results from the analyses conducted using both models showed that the risk of disease (BSE) transmission from BGS was negligible and could be attributed to the stringent protocols followed in sourcing and processing of the raw bovine bone used in the commercial product. CONCLUSIONS: Based on the risk analysis, it is evident that the risk of BSE infection from BGS is several orders of magnitude less than that posed by the risk of death related to, lightning, tornadoes, or similar remote events. However, this low risk can only be maintained as long as an effective and active risk management program is implemented in operations that involve processing xenogenic tissue for human use.
BACKGROUND: Several commercial products are currently available for clinical application as bone graft substitutes. These products can be broadly classified into two categories: synthetic and natural. Bovine bone is a popular source for several of the natural bone substitutes. The availability of bovine derived xenogenic bone substitutes has made it possible to avoid traumatic and expensive secondary surgery to obtain autogenous bone once thought essential for effective bone replacement. While autogenous bone still remains the undisputed "gold standard" in bone grafting, the realization that bone requirement in several clinical applications is as effectively met by xenografts has lead to their widespread use. But the convenience of using xenografts is tempered by the possibility of disease transmission from cattle to humans. The recent incidents of bovine spongiform encephalopathies (BSE) in humans have underscored this likelihood. In this paper, we report a risk analysis performed to assess the possibility of such disease transmission from a commercially available bone graft substitute (BGS) that is popularly used in clinical dentistry. METHODS: An extensive review of current literature on the status of risk assessment of BSE transmission was conducted, and two risk assessment models were identified as applicable to the present study. Risk assessment models developed by the German Federal Ministry of Health and by the Pharmaceutical Research and Manufacturers Association of America were applied to BGS. RESULTS: Results from the analyses conducted using both models showed that the risk of disease (BSE) transmission from BGS was negligible and could be attributed to the stringent protocols followed in sourcing and processing of the raw bovine bone used in the commercial product. CONCLUSIONS: Based on the risk analysis, it is evident that the risk of BSE infection from BGS is several orders of magnitude less than that posed by the risk of death related to, lightning, tornadoes, or similar remote events. However, this low risk can only be maintained as long as an effective and active risk management program is implemented in operations that involve processing xenogenic tissue for human use.
Authors: Alexander C Kübler; Jörg Neugebauer; Viktor Karapetian; Jung-Hwan Oh; Martin Scheer; Joachim E Zöller Journal: Mund Kiefer Gesichtschir Date: 2004-05-01