The FDA says current duodenoscope designs cannot be adequately cleaned, and are calling for hospitals to shift to designs that are disposable or have disposable components.
Some medical experts are calling for duodenoscopes to be removed from the market, due to problems sterilizing them and the risk of patient infections.
The FDA received more than 200 adverse event reports linked to duodenoscopes since October, including 45 incidents of patient infections.
The FDA warns that duodenoscopes are still showing higher-than-expected infection rates despite updated cleaning instructions and design changes.
The FDA has cleared Custom Ultrasonics AERs for the cleaning of some duodenoscopes, which have been linked to hospital infection outbreaks.
The FDA has issued warning letters to the three manufacturers of duodenoscopes, warning that they have fallen behind on required postmarketing studies imposed after a number of infection outbreaks were…
The FDA has issued new voluntary protocols for hospitals to help ensure that duodenoscopes are properly cleaned and sanitized following a number of deadly hospital infection outbreaks in recent years.
The FDA has approved design and label changes announced in a Pentax duodenoscope recall, designed to make the device less likely to spread infectious material to patients.
The FDA has approved a new type of Pentax duodenoscope with disposable parts that are designed to prevent the spread of hospital infections.
Fujifilm has recalled one of its duodenoscopes to update certain parts and its operating manual to allow better cleaning to prevent the spread of "superbug" infections that resist antibiotic treatment,…
