Category: Single-Use Disposable Devices

Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

Sept. 25, 2017 (Monday; 11:47am) — The FDA announced last week that it has “cleared the first duodenoscope with a disposable distal cap” for use in U.S. hospitals, calling this a “new feature.”…

Guidance for the Safe Use of “Disposable” Irrigation Tubing Used During GI Endoscopy

October 17, 2013 — This is the third and final article in a series discussing disposable tubing used for irrigation during gastrointestinal (GI) endoscopy. This is the most complete set…