Despite the outbreak of multidrug-resistant bacterial infections linked to duodenoscopes, healthcare providers should not cancel endoscopic retrograde cholangiopancreatography (ERCP) procedures for their patients who need them, the US Food and Drug Administration (FDA) advised March 4 in an updated safety communication.
The agency notes that they have received inquiries from healthcare providers about whether they should cancel ERCP procedures, "based on the fact that one specific model duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance." The answer, for now, is no.
The 510(k) application for this device is pending, and the company continues to market it while the application is under review. "FDA is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the Agency, we believe that 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 FDA said.
Further, the FDA said their analysis shows that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers (Olympus, Fujifilm Holdings Corp, and Pentax). "At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections," the agency said.
On February 18, the University of California, Los Angeles, Health System reported that close to 200 patients may have been infected with multidrug-resistant bacterial infections including carbapenem-resistant Enterobacteriaceae during endoscopic procedures that took place between October 2014 and January 2015. There are also reports this week of drug-resistant infections linked to duodenoscopes at two other US hospitals.
In their initial safety communication on February 19, the FDA warned that the complex design of duodenoscopes used during ERCP may impede effective cleaning, even when manufacturer protocol is followed.
To help reduce the risk for infection, the FDA continues to recommend the following actions:
Thoroughly clean and disinfect duodenoscopes between uses, pursuant to the manufacturers' instructions.
Have a comprehensive quality program in place for reprocessing duodenoscopes.
Take a duodenoscope suspected of being associated with a patient infection after ERCP out of service and meticulously disinfect it until it is verified to be free of pathogens.
Inform patients of the benefits and risks associated with ERCP procedures.
Discuss with patients what they should expect after the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
Submit a report to the manufacturer and to the FDA via MedWatch if you suspect that problems with reprocessing a duodenoscope have led to patient infections.
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Cite this: Don't Cancel ERCP Procedures for Patients in Need, FDA Says - Medscape - Mar 05, 2015.