薬食安発 0320第ー号
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1. 1 FD A ERCP ERCP ERCP 2 32. o Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 ERCP f ERCP
3. ERCP FDA
4. 4 5 CR 35 145 68 10 2 lt gt 25 7 http www ka
5. o FDA o AER c
6. FDA CDC EPA CDC 3 FDA FDA MDR FDA
7. ERCP 50 ERCP
8. 0320 3 0 3 2 0 4 47 3 2 0 OE B HR ERCP FDA 11 1
9. MedWatch FDA ERCP ERCP ERCP ERCP ERCP ERCP FDA FDA CDC
10. FDA 2013 1 2014 12 FDA 75 MDR 135 FDA MDR CDC ERCP o F D A
11. ERCP FDA FDA ERCP ERCP 510 k FDA 50 ERCP FDA 3 510 k FDA FDA o
12. 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 Originating from Contaminated Endoscopic Equipment Retrieved
13. 0320 1 27 3 20 R E Hm K FDA 27 3 20 0320 3 0320 4
14. o o o ERCP o ERCP FA ER Aw OE o MedWatch FDA
15. from http www ncbi nim nih gov pubmed 23171594 Aumeran 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 Metal lo 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 510 k
16. nkyokansen org other syoukaki_guide pdf http www jgets jp CD_MSguide20130710 pdf http www pmda go jp safety reports hcp pmd act 0003 html SU F DA 35 ERCP FDA 2015 2 19 2015 2 23 2015 3 4 ERCP ERCP ae i di Figure 1 FDA ERCP
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