The Food and Drug Administration (FDA) has released updated information for healthcare providers regarding endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) following recent adverse event reports of multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes.
After receiving inquiries from healthcare providers regarding canceling ERCP procedures based on one specific duodenoscope model manufactured by Olympus (the TJF-Q180V) not currently having a 510(k) clearance, the Agency is not recommending the cancellation of these procedures for patients who need them. Olympus has a pending 510(k) application for the device and is continuing to market the product while the application is under review. No action will be taken against Olympus because the Agency believes that removing the device from the market could lead to an insufficient number of available duodenoscopes based on clinical demand.
The reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers and there is no evidence at this time that the lack of 510(k) clearance is linked to the infections.
The FDA recommends the following for healthcare providers:
- Thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers’ instructions.
- Have a comprehensive quality program in place for reprocessing duodenoscopes.
- If you suspect that a duodenoscope may be associated with a patient infection, take it out of service and meticulously clean and disinfect it until it is verified to be free of pathogens.
- Inform patients of the benefits and risks associated with ERCP procedures, including the risk of possible infection.
- Discuss with your patients what they should expect following 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 problems have led to patient infections.
For more information visit FDA.gov.