The FDA is now soliciting stakeholders and the public to comment on its just-published draft guidance document entitled: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:
- Part 1: “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” — click here.
- Part 2: “Product Review: ‘Disposable’ Irrigation Tubing Used During Gastrointestinal Endoscopy” — click here.
- 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.
- Review the FDA’s guidance document provided here for completeness.
- Review Dr. Muscarella’s 3-part series of articles listed above.
- Decide what practices and recommendations are optimal and safe when using disposable irrigation tubing during GI endoscopy.
- Provide the FDA with your comments (see below).
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In its draft guidance document the FDA provides the following information for submitting comments: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Questions regarding the FDA’s draft guidance document may be directed to: The Division of Reproductive, Gastro-renal, and Urological Devices (301-796-7030) and Shanil Haugen, Ph.D. at 301-796-0301; email: firstname.lastname@example.org
Article by: Lawrence F Muscarella; posted: 1/23/2015, Rev A.