Pathogen Inactivation Making Decisions About New Technologies关于新技术的病原体灭活决策.pptVIP

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Pathogen Inactivation Making Decisions About New Technologies关于新技术的病原体灭活决策.ppt

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Pathogen Inactivation Making Decisions About New Technologies关于新技术的病原体灭活决策

M.A. Blajchman, MD, FRCP(C) McMaster University Canadian Blood Services WHAT IS PATHOGEN INACTIVATION? REDUCING THE RISK OF TRANSFUSION-TRANSMITTED INFECTIONS Donor history Donor examination Donor testing Diversion of initial aliquot Leukoreduction Post donation information Donor deferral registries Limit donor exposure CURRENT DONOR TESTING FOR INFECTIOUS DISEASE Syphilis (1938) ● HBsAg Anti-HIV ● Anti-CMV Anti-HTLV ● Anti-HCV HIV p24 Antigen ● HIV and HCV NAT WNV NAT ● Bacteria (2004) Anti-HBc ● Chagas Disease (2009) DONOR TESTING FOR INFECTIOUS DISEASE IN THE U.S. ONGOING AND UNTESTEDRISKS TO THE BLOOD SUPPLY Any agent known to cause disease in man and that has a viremic or bacteremic phase during its clinical course. RISKS OF TRANSFUSION-TRANSMITTED INFECTIONS IN THE UNITED STATES(1984-2005) RISK OF TA-BACTERIAL SEPSIS Data from 2001 Canadian data published in 2007 ARC data published in 2007 Passport data reported in 2008 Murphy W et al. data published in 2008 ● “It is unthinkable that a manufacturer of other intravenous medications could eschew reasonable methods to eradicate possible contamination on the basis that only organisms of questionable clinical significance persisted in the preparations infused.” ● “It is also unthinkable that end users of intravenous agents would be asked to check sterility before use, …….” ● “It is apparent to us that bacterial testing, whether early or late, lacks sufficient robustness …… as the method of choice once a method of eradication of adequate proven safety and utility is available.” W.G. Murphy et al Vox Sanguinis 2008 95:13-19 TAS RISK - SUMMARY Current methods for the bacterial screening of platelets are clearly inadequate. Considerable TAS risk remains, particularly for recipients of platelets, as ~1 in 1500 PC units may not be identified as containing bacteria. PI has shown efficacy in killing bacteria that may be present in PCs. FRACTIONATED PLASMA PROTEINS It is particularly relevant that there has been no re