[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]
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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Endoscopes; Draft Guidance for Industry and Food and Drug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.
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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availability of the draft guidance entitled ``Mitigating the Risk of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draft guidance document, when finalized, will highlight the cross-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 This draft guidance is not final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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 20, 2015.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requests for a single hard copy of the draft guidance document entitled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]
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