United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2018-02-16 article Notices D09002ee1c7f80866 D09002ee1c7f808e2 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes."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 This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with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 This draft guidance is not final nor is it in effect at this time. 80 FR 2711 https://www.govinfo.gov/app/details/FR-2015-01-20/2015-00755 2015-00755 fr20ja15-53 4164-01-P Docket No. FDA-2014-D-2153 https://www.govinfo.gov/app/details/FR-2015-01-20/2015-00755 https://www.govinfo.gov/content/pkg/FR-2015-01-20/html/2015-00755.htm https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/2015-00755.pdf 2 p. 2711 2712 80 FR 2711 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of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 80, Issue NOTICE 2015-00755 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-2153 4164-01-P 2015-00755 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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes."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.

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. Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. Guidance: Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes , CDRH-Guidance@fda.hhs.gov http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 80, no. 12 Office of the Federal Register, National Archives and Records Administration 2015-01-20 continuing daily deposited born digital 230 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-01-20 P0b002ee1987a7e61 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20ja15 https://www.govinfo.gov/app/details/FR-2015-01-20 https://www.govinfo.gov/content/pkg/FR-2015-01-20/pdf/FR-2015-01-20.pdf https://www.govinfo.gov/content/pkg/FR-2015-01-20/xml/FR-2015-01-20.xml fdlp 2591 2811 DGPO 2018-02-16 2024-06-02 FR-2015-01-20 machine generated eng FR FR-2015-01-20 80 12