A Colonoscope is Linked to Two Infections of the Nightmarish ‘CRE’ Superbug. Colonoscopy could now also be a risk factor for infection, in addition to ERCP and bronchoscopy.

January 10, 2019 — Infections caused by a nightmarish superbug have been identified following exposure to a colonoscope, according to two related regulatory reports filed last month. On December 7th, a manufacturer notified the FDA that two U.S. patients developed an infection Read More …

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

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 2015, according to individualized warning letters the FDA sent each Read More …

A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug. In January, the FDA had issued a safety alert reporting a "design issue" with the endoscope "that could increase the risk of patient infection."

December 8, 2017 (2:46 pm) — A duodenoscope has been linked, possibly for the first time, to the “probable transmission” of a uniquely resistant type of superbug, I have learned. This incident is disclosed in an otherwise unknown regulatory report that the duodenoscope’s Read More …