PENTAX, the manufacturer of the ED-3490TK video duodenoscope, has issued updated validated manual reprocessing instructions to replace those provided in the original device labeling in response to a Food and Drug Administration Safety Communication released last February concerning the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and the risk of multidrug-resistant bacterial infections.
The FDA has reviewed these updated reprocessing instructions and recommends that staff be trained to implement them as soon as possible. Several changes have been made to the protocol for precleaning, manual cleaning, and high-level disinfection that the FDA found to be adequate.
Olympus, the manufacturer of the TJF-Q180V duodenoscope has also issued updated manual reprocessing instructions.
In February 2015, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP with duodenoscopes that had been cleaned and disinfected properly (according to manufacturer instructions) and determined that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”
Since then, the FDA has been working with duodenoscope manufacturers to revise their manual reprocessing instructions to devise standard procedures to eliminate the risk of spreading infection between patients and better survey any contamination of the duodenoscopes.
The American Gastroenterological Association's Center for GI Innovation and Technology has been working closely with the FDA and device manufacturers to develop a path forward with zero device-associated infections.
Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.
