The FDA is now soliciting stakeholders and the public to comment on its just-published draft guidance document entitled:

Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes” — click here.

The FDA issued this draft document on January 20, 2015.

3-part series of articles

Last year Dr. Muscarella wrote a comprehensive 3-part series of independent articles discussing disposable irrigation tubing used during gastrointestinal (GI) endoscopy.

His recommendations are provided in these articles:

  1. Part 1:  “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” — click here.
  2. Part 2:  “Product Review: ‘Disposable’ Irrigation Tubing Used During Gastrointestinal Endoscopy” — click here.
  3. Part 3:  “Guidance for the Safe Use of “Disposable” Irrigation Tubing Used During GI Endoscopy” — click here.


The following recommendations are provided for the reader’s consideration.

  1. Review the FDA’s guidance document provided here for completeness.
  2. Review Dr. Muscarella’s 3-part series of articles listed above.
  3. Decide what practices and recommendations are optimal and safe when using disposable irrigation tubing during GI endoscopy.
  4. Provide the FDA with your comments (see below).

Related articles

A review of several of Dr. Muscarella’s related articles is also recommended. These articles include:

  • “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” – click here;
  • “How to Reprocess the MAJ-855 Water Tube and the GI Endoscope’s Auxiliary Water Channel” – click here; and
  • “Factors Affecting the Risk of Infection Associated with an Endoscope Reprocessing Error” – click here.

FDA instructions for the public’s submission of comments

In its draft guidance document the FDA provides the following information for submitting comments:

  • Submit electronic comments by clicking here.
  • Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
  • Note: Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.


Questions regarding the FDA’s draft guidance document may be directed to: The Division of Reproductive, Gastro-renal, and Urological Devices (301-796-7030) and Shanil Haugen, Ph.D. at 301-796-0301; email:

Article by: Lawrence F Muscarella; posted: 1/23/2015, Rev A.

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