医政地発0320第3号 薬食安発0320第4号 平成27年3月20日 都 道
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1. 1 FD A ERCP ERCP ERCP 22. o Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 ERCP lt EROP p n o
3. ERCP FDA
4. ERCP buius p Hie di rita 50 ERCP
5. o FDA o o AER o
6. FDA lt CDC EPA lt CDC o 3 FDA FDA MDR FDA
7. FDA 2013 1 2014 12 FDA 75 MDR 135 FDA MDR CDC EROP o FDA
8. 25 7 http www kankyokansen org other syoukaki_guide pdf http www jgets jp CD_MSguide20130710 pdf http www pmda go jp safety reports hcp pmd act 0003 html Hs F DA UKER ES ERCP FDA 2015 2 19 2015 2 23 2015 3 4 ERCP ERCP Figure 1 ERCP FDA ERP
9. o MedWatch FDA lt ERCP ERCP ERCP ERCP ERCP ERCP FDA FDA CDC
10. FDA MDR ERCP MedWatch FDA American Society for Gastrointestinal Endoscopy Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 Society of Gastroenterology Nurses and Associates Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes FDA Reprocessing of Reusable Medical Devices FDA Preventing Cross Contamination in Endoscope Processing FDA Safety Communication Alrabaa SF Nguyen P Sanderson R et al June 2013 Early Identification and Control of Carbapenemase Producing Klebsiella Pneumoniae
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13. 0 3 20 3 0 3 2 0 4 2 7 3 20 US R E Hl A rn ERCP ma FDA 11 1
14. 510 k ERCP FDA FDA ERCP ERCP 510 k FDA 50 ERCP FDA 3 510 k FDA FDA o
15. Originating from Contaminated Endoscopic Equipment Retrieved from http www ncbi nlm nih gov pubmed 23171594 Aumeran C Poincloux L Souweine B et al November 2010 Multidrug Resistant Klebsiella Pneumoniae Outbreak After Endoscopic Retrograde Cholangiopancreatography Retrieved from http www ncbi nIm nih gov pubmed 20725887 Epstein L Hunter JC Arwady MA et al October 2014 New Delhi Metallo 8 Lactamase Producing Carbapenem Resistant Escherichia Coli Associated with Exposure to Duodenoscopes Retrieved from http jama jamanetwork com article aspx articleid 1911326 Rutala WA and Weber DJ October 2014 Gastrointestinal Endoscopes A Need to Shift From Disinfection to Sterilization Retrieved from http jama jamanetwork com article aspx articleid 1911309 Verfaillie C Bruno M Poley JW et al Withdrawal of a Duodenoscope Stops Outbreak by A Vim 2 Pseudomonas Aeruginosa Abstract Retrieved from http www icaaconl ine com php icaac2014abstracts data papers 2014 K 1 685 htm the Division of Industry and Consumer Education DICE E DICE FDA HHS GOV 800 638 2041 301 796 7100 2015 3 4 TJF Q180V
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