Easier-To-Clean Duodenoscope Gets US FDA Clearance
Executive Summary
The device from Pentax features a disposable distal cap, thus cutting the risk of infection transmission between patients. An earlier Pentax duodenoscope model was the subject of an infection-related safety alert in January.
You may also be interested in...
New Duodenoscope Protocols Released
US FDA, CDC and medical groups joined forces to develop safer handling standards for the endoscope equipment, which has been tied to infection outbreaks.
Cracks, Gaps In Pentax Duodenoscopes Prompt Company, US FDA Safety Communications
Pentax Corp. sent out a field correction on Jan. 16, and FDA followed up with a safety communication the next day, warning that cracks and gaps in the company's ED-3490TK duodenosopes could increase risks of patient microbial infections, unless appropriate reprocessing instructions are followed closely.
FDA Advisors Call For New Cleaning Methods, Sterilization For Duodenoscopes
Current reprocessing methods for duodenoscopes provide no reasonable assurance of safety and effectiveness, and manual cleaning steps need improvement, an FDA panel said. Most panelists called for upgrading manual cleaning, followed by lengthy sterilization of the products until they can be redesigned.