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 …

Senator Murray’s ‘Superbug’ Report

BREAKING NEWS — Senator’s Murray’s anticipated report just published:  “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients“ — January 13, 2016. Patients should be able to trust that the devices they need for treatment are safe Read More …

FDA Investigation of ‘Superbug’ Outbreaks Now Includes Automated Endoscope Reprocessors

September 16, 2015 — The Food and Drug Administration is now publicly acknowledging that its investigation of the causes of more than a dozen deadly “superbug” outbreaks linked to contaminated duodenoscopes in the U.S. since 2012 includes automated endoscope reprocessors...

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