十二指腸内視鏡の洗浄及び滅菌又は消毒方法の遵守について
Contents
1. ERCP FDA2. FDA 2013 1 2014 12 FDA 75 MDR 135 FDA
3. 0320 3 0 3 2 0 4 2 7 3 2 0 E a H b 4 ERCP FDA
4. FDA Reprocessing Medical Devices in Health Care Settings Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff http www fda gov downloads MedicalDevices DeviceRegulationandGuidanc e GuidanceDocument s UCM253010 pdf 1 HOY A Jk 73 0320 3 274 3 H 20 H 2 E 28 R a
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12. FDA FDA MDR FDA FDA MDR ERCP MedWatch FDA American Society for Gastrointestinal Endoscopy Multisociety Guideline on Reprocessing Flexible
13. 35 145 68 RO 10 2 gt 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 ERCP FDA 2015 2 19 2015 2 23 2015 3 4 ERCP
14. FDA o o AER o o Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 ERCP lt EROP
15. MDR CDC EROP o FDA o
16. 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 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 nlm 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 icaac2014abstra
17. cts 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 ERCP FDA FDA ERCP ERCP 510 k FDA 50 ERCP
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