FDA Archives - Discussions in Infection Control

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

Mar 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm) — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

DEC Duodenoscope Duodenoscopes Duodenoscopes Olympus TJF-160F Pentax ED-3490TK Pentax ED34-i10T Pentax ED34-i10T2 Single-Use Disposable Devices

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.

Sep 25, 2017 Lawrence F Muscarella PhD

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.”…

Automated Endoscope Reprocessors Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Postmarket surveillance studies

FDA Orders Endoscope Manufacturers to Perform Safety Studies

Oct 6, 2015 Lawrence F Muscarella PhD

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies. …

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

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.

FDA Orders Endoscope Manufacturers to Perform Safety Studies

You missed

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract

Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying

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FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

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.

FDA Orders Endoscope Manufacturers to Perform Safety Studies

You missed

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract

Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying