[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2711-2712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00755]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2153]


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Endoscopes; Draft Guidance for Industry and Food and Drug 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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availability of the draft guidance entitled ``Mitigating the Risk of 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draft guidance document, when finalized, will highlight the cross-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

[[Page 2712]]

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 This draft guidance is not final 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.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 20, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Mitigating the Risk of Cross-Contamination From Valves and 
Accessories Used for Irrigation Through Flexible Gastrointestinal 
Endoscopes'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    During colonoscopy or esophagogastroduodenoscopy, clinicians often 
use a water bottle to supply irrigation for the procedure. Clinicians 
typically use a single water bottle for multiple patients without 
reprocessing the water bottle between patients. This practice raises 
the risk of cross-contamination between patients, because the water 
bottle and associated tubing/connectors can become contaminated with 
blood or stool that travels up through the endoscope channels and 
tubing (a phenomenon referred to as ``backflow''). FDA has received 
reports of backflow from colonoscope irrigation channels 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: (1) Highlight 
the cross-contamination risk associated with specific types of 
irrigation valves and accessories when used with flexible 
gastrointestinal endoscopes; (2) clarify terminology used to describe 
these devices; and (3) and outline strategies to mitigate the risk of 
cross-contamination between patients. These strategies will include 
recommendations on device design and appropriate labeling.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on mitigating 
the risk of cross-contamination from valves and accessories used for 
irrigation through flexible gastrointestinal endoscopes. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Mitigating the Risk of 
Cross-Contamination from Valves and Accessories Used for Irrigation 
Through Flexible Gastrointestinal Endoscopes'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1400054 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in 21 CFR part 801 
and 809 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00755 Filed 1-16-15; 8:45 am]
BILLING CODE 4164-01-P