FDA News

FDA releases updated information on ERCP duodenoscopes

The FDA has released updated information for health care providers regarding the safety of endoscopic retrograde cholangiopancreatography, or ERCP, duodenoscopes.

In response to inquiries from health care providers about whether they should cancel ERCP procedures due to news that the Olympus TJF-Q180V — one specific model of duodenoscope manufactured by the company — does not currently have 510(k) clearance, the FDA said it does not recommend that these procedures be canceled for patients who need them, according to the update.

Olympus continues to market this device while its 510(k) application is being reviewed, and the FDA does not plan to take action against the company. “We believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year,” the update said.

Furthermore, according to the update, infections have reportedly been association with duodenoscopes from other manufacturers as well, and there is no evidence that Olympus’ lack of a 510(k) clearance was associated with the infections.

This update follows ongoing communication from the FDA regarding the challenges for effective cleaning and disinfection caused by the complex design of ERCP duodenoscopes, which was linked to a recent outbreak of carbapenem-resistant Enterobacteriaceae at Ronald Reagan UCLA Medical Center.

The FDA has released updated information for health care providers regarding the safety of endoscopic retrograde cholangiopancreatography, or ERCP, duodenoscopes.

In response to inquiries from health care providers about whether they should cancel ERCP procedures due to news that the Olympus TJF-Q180V — one specific model of duodenoscope manufactured by the company — does not currently have 510(k) clearance, the FDA said it does not recommend that these procedures be canceled for patients who need them, according to the update.

Olympus continues to market this device while its 510(k) application is being reviewed, and the FDA does not plan to take action against the company. “We believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year,” the update said.

Furthermore, according to the update, infections have reportedly been association with duodenoscopes from other manufacturers as well, and there is no evidence that Olympus’ lack of a 510(k) clearance was associated with the infections.

This update follows ongoing communication from the FDA regarding the challenges for effective cleaning and disinfection caused by the complex design of ERCP duodenoscopes, which was linked to a recent outbreak of carbapenem-resistant Enterobacteriaceae at Ronald Reagan UCLA Medical Center.