The U.S. Food and Drug Administration (FDA) announced that the three manufacturers of duodenoscopes marketed in the U.S. will be required to conduct postmarketing surveillance studies to examine how these medical devices are reprocessed (a scope cleaning and disinfecting process that allows multiple patient use) in real-world medical settings.
Duodenoscope manufacturers Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) will have 30 days to submit their postmarket surveillance study plans to the FDA that will evaluate for example, how well health care personnel follow instructions for disinfecting duodenoscopes between patients and to better uderstand the rate of duodenoscope contamination.
FDA Cautions: Multidrug-Resistant Bacterial Infections are Associated with Some Reprocessed ERCP Duodenoscopes
In a Safety Communication dated February 19, 2015, the U.S. Food and Drug Administration (FDA) cautioned that the design of certain ERCP duodenoscopes may interfere with the ability to sterilize these reusable medical devices, putting patients at risk for infection with potentially deadly multidrug-resistant bacteria. Referred to as Carbapenem-Resistant Enterobacteriaceae (CRE), these drug-resistant bacteria include E. coli and Klebsiella species and have been linked to infections following duodenoscope procedures, even when the manufacturer’s cleaning instructions are followed.
Duendoscope Cleaning Problems
Duodenoscopes may be used in procedures to drain fluids from blocked pancreatic and biliary ducts, inject contrast dyes, obtain tissue samples for biopsy, or to treat certain medical conditions. The flexible scope is passed through the mouth, throat, and stomach, into the top of the small intestine ( known as the duodenum). At the tip of the scope is a movable “elevator” mechanism that allows gastroenterologists to change the angle of instruments passed through the scope during these procedures. According to the FDA, this movable feature can add to the challenge of cleaning and disinfecting these reusable devices.
For more information visit our Duodenoscope Infections page.
Manufacturers will Study the Real-World Application of their Duodenoscope
Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division), the three duodenoscope manufacturers, will have to submit their plans for postmarket surveillance to the FDA in 30 days. According to William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, “These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”
Dr. Maisel continues, “This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used.”
Specifically, the manufacturers’ studies are required to answer three important surveillance questions:
The FDA has not recommended that these devices be pulled from the market or recalled because there are no alternative products that can perform endoscopic retrograde cholangiopancreatography.
OBTAIN A FREE DUODENOSCOPE LAWSUIT EVALUATION
The Weinberg Law Firm is currently accepting Duodenoscope-linked infection personal injury cases nationwide. If you or someone you know has suffered a CRE infection (also called a “Superbug Infection”) after undergoing ERCP with a reprocessed duodenoscope, please contact our firm toll free at 1-877-934-6274 for a free legal case evaluation or visit our Medical Device Lawsuit page.
