Duodenoscope Contamination Rates Higher Than Expected, FDA Reports

A medical device tied to deadly bacterial infections continues to contain high pathogen levels even after rigorous sanitization protocols are followed, according to the US Food & Drug Administration. In an April 12, 2019 Safety Communication, FDA experts again rang alarm bells over the duodenoscope, a reusable medical device found to transmit bacterial pathogens from [...]

By |2019-04-18T10:25:56-04:00April 18th, 2019|Duodenoscopes|0 Comments

Duodenoscopes & 3 New Strategies To Kill Superbugs

A series of threatening superbug outbreaks in medical centers has brought the use of duodenoscopes to light, indicating that the medical product may serve as a hidden breeding ground for deadly microbes. Several patients who have experienced severe infections after undergoing medical procedures involving duodenoscopes are now filing lawsuits against the product’s manufacturers. What Is A [...]

By |2019-04-03T09:08:51-04:00April 3rd, 2019|Duodenoscopes|0 Comments

FDA Slams Duodenoscope Manufacturers Over Postmarket Studies

The US Food & Drug Administration has issued official warnings to three duodenoscope manufacturers, saying the companies have failed to conduct federally-mandated studies on the real-world feasibility of cleaning the reusable medical devices. Olympus, Fujifilm Warned Over Insufficient Data In 2015, officials at the FDA ordered Olympus, Fujifilm and Pentax to perform their own postmarket [...]

By |2018-03-20T12:02:07-04:00March 20th, 2018|Duodenoscopes|0 Comments