More Than 200 Duodenoscope Problems Reported to FDA Since October, But Number is Declining
The FDA received more than 200 adverse event reports linked to duodenoscopes since October, including 45 incidents of patient infections.…
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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 linked to the endoscopy scopes.…
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, which have been linked to these types of devices.…
The FDA warns that cracks and gaps in the Pentax ED-3490TK duodenoscope can make them more difficult to clean, potentially increasing the risk of hospital-acquired infections.…
Fujifilm is recalling some older model duodenoscopes to replace them with those which have updated cleaning instructions for avoiding hospital-acquired infections.…