医政地発0320第3号、薬食安発0320第4
Contents
1. FDA o o AER o2. 1 F DA ERCP ERCP V Ce ERCP 2 3
3. o Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 ARR EAURC RT d c E PL AIO3Ug MOI00 ERCP e ERCP ues e o
4. ERCP FDA
5. 4 5 CR E 35 145 68 10 2 lt gt 25 7 http www kankyokansen org other
6. MDR ERCP MedWatch FDA e American Society for Gastrointestinal Endoscopy Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 o Society of Gastroenterology Nurses and Associates Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes o FDA Reprocessing of Reusable Medical Devices o 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 nim nih gov pubmed 23171594 Aumeran C Poinclou
7. ERCP 50 ERCP
8. SAO FDA CDC EPA CDC 3 FDA FDA MDR FDA FDA
9. FDA 2013 1 2014 12 FDA at 75 MDR 135 FDA MDR CDC ERCP E c F DA
10. MedWatch FDA ERCP Eo ERCP ERCP ERCP ERCP ERCP Hiz RRA FDA FDA CDC
11. o o ERCP o ERCP ee MedWatch FDA 0
12. FDA FDA ERCP ERCP 510 k FDA 50 ERCP FDA 3 510 k FDA FDA o o
13. 0320 3 03 20845 2 7 3 20 s s Um E m C XA E 9 mmm ERCP FDA 11 1
14. syoukaki_ guide pdf http www igets jp CD M 5guide20130710 pdf http www pmda go jp safet y reports hcp pmd ac t 0003 btm lt BR gt F DA bp PLE ROSE CT HERB A Sa ERCP FDA 2015 2 19 2015 2 23 2015 3 4 ERCP KL CW SBS ERCP Figure 1 ERCP FDA ERCP
15. x 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 artioleidz1911309 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 ERCP
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