FDA Advisors Call For New Cleaning Methods, Sterilization For Duodenoscopes
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
The trial was the first related to outbreaks of antibiotic-resistant “superbugs” that were linked to improperly cleaned duodenoscopes.
Prompted by reports from a European hospital of a microbial outbreak last year linked to an Olympus TJF-Q180V duodenoscope, causing one death and five infections, Sen. Patty Murray requested that the company send her "any and all reports" about the product's safety. The outbreak was not forwarded to FDA's adverse events database until early February.