federal_register: 2015-00755

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-00755 Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes." FDA has received reports of blood and stool traveling through colonoscope irrigation channels and into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place. This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. This draft guidance is not final nor is it in effect at this time. 2015-01-20 2015 1 https://www.federalregister.gov/documents/2015/01/20/2015-00755/mitigating-the-risk-of-cross-contamination-from-valves-and-accessories-used-for-irrigation-through https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/2015-00755.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes." FDA has...  

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