Out with the Old, FDA Recommends Use of Duodenoscopes with Innovative Designs
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Tag Archives: Duodenoscopes
CDRH Director Jeff Shuren Emphasizes Duodenoscope Contamination Risk
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
Olympus, Fujifilm and Pentax Warned by FDA for Compliance Failures
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Pentax Medical Recalls Certain Duodenoscopes
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
Consent Decree, Oh My!
With the consent decree, the risk of financial death is very real.
Why Duodenoscopes Are So Tough to Clean
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
FDA Touts Record PMA Approval, Ebola Response and Fighting Duodenoscope Issue
The acting commissioner reflects on the agency’s achievements in the last year.
Endoscopes, Too Little and Too Late
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
Following Duodenoscope Debacle, FDA Releases Safety Communication
After an FDA expert panel held earlier this year, the agency is offering supplemental reprocessing measures.
After an FDA expert panel held earlier this year, the agency is offering supplemental reprocessing measures.
