{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.\" FDA has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 This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with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 This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/01/20/2015-00755.html","cfr_references":[],"citation":"80 FR 2711","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 20, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-2153"],"dockets":[],"document_number":"2015-00755","effective_on":null,"end_page":2712,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/01/20/2015-00755.xml","html_url":"https://www.federalregister.gov/documents/2015/01/20/2015-00755/mitigating-the-risk-of-cross-contamination-from-valves-and-accessories-used-for-irrigation-through","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-00755?publication_date=2015-01-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-01-20/2015-00755/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":226,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/2015-00755.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-00755.pdf?1421437835","publication_date":"2015-01-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/01/20/2015-00755.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-2153","supporting_documents_count":0,"docket_id":"FDA-2014-D-2153","regulation_id_number":null,"title":"Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes","checked_regulationsdotgov_at":"2015-04-21T05:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2711,"subtype":null,"title":"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","toc_doc":"Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}