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平成 27 年4月 17 日 各保健福祉事務所長 殿 各保健福祉

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1. ERCP FDA
2. FDA 2013 1 2014 12 FDA 75 MDR 135 FDA
3. 11 1 c 1 F DA ERCP
4. 6 5 5 MedWatch FDA lt ERCP ERCP ERCP ERCP
5. MedWatch FDA o o m 5X X d 27 3 6 UR CRE FDA http www fda gov Medicallevices Safoty AlertsandNoticos ucu4348T1 htm 119 1
6. FDA FDA MDR FDA FDA MDR ERCP MedWatch FDA American Society for Gas
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16. o FDA o o AER o o Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes 2011 ERCP EROP
17. t Retrieved from http www icaaconline 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 FDA FDA ERCP ERCP 510 k FDA 50
18. trointestinal 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 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 Abstrac

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