The makers of medical scopes that are used to evaluate and to treat problems in the bile and pancreatic ducts turned down invitations to speak at a medical device safety panel discussion that the U.S. Food and Drug Administration held May 14. Meanwhile, the FDA continues to investigate the link between the use of these reprocessed devices, known as duodenoscopes, and the emergence of potentially fatal superbugs.
The FDA's Gastroenterology and Urology Devices Panel called the meeting, which was held in the Maryland suburbs of the nation's capital, to discuss effective ways to clean and to disinfect or sterilize duodenoscopes for reuse.
These re-useable flexible lighted tubes are used in a procedure called Endoscopic Retrograde Cholangiopancreatography, which is abbreviated ERCP. During this procedure, the patient, according to the FDA, is lying on his or her back or side as the duodenoscope is passed through the esophagus and stomach to the duodenum. Preparing this device for reuse can be a problem. Federal officials have known this for some time.
The FDA, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs issued a safety communication in 2009 explaining that "flexible endoscopes are fundamentally difficult to clean and disinfect or sterilize." In 2011, the FDA participated in a pair of workshops centered on the challenges of following the complex reprocessing instructions. In September 2013, the inevitable happened: The CDC alerted the FDA of an apparent association between the use of duodenoscopes and the development of "multi-drug resistant organisms." The FDA promptly began an investigation and issued updated safety communications and guidance on making certain that the devices remain clean and sterile.
U.S. physicians performed more than 668,000 ERCPs in 2014, according to FDA documents. The executive summary for the May 14 meeting gets to the heart of the matter, explaining, "Duodenoscopes contain many small working parts with hidden, often difficult to reach, crevices. Therefore, if the duodenoscope is not meticulously reprocessed, living microbes harboring in residual tissue or fluid from a prior procedure can be transmitted via the scope to a subsequent patient. In rare cases, this can lead to patient-to-patient transmission of infection."
The FDA examined reports of health problems related to this medical device that occurred from Jan. 8, 1997, through Feb. 17, 2015.
"Overall, a total of 433 endoscope reports related to a patient infection, exposure or device contamination were received during the timeframe described above," the FDA reported, noting that the FDA does not receive all of the reports of injury or death - and there were 13 deaths. "Of these endoscope reports, 146 were associated with ERCP devices (duodenoscopes). Of these 146 reports, 142 were received since 2010."
There are three U.S. duodenoscope manufacturers: Fujifilm, Olympus, and Pentax. Olympus dominates the market.
Banning a device appears to be a solution that creates a problem. For instance, the FDA learned in March that an Olympus model was on the market without the required "premarket notification" to the FDA. Nevertheless, according to an FDA report, "While duodenoscope-associated infections have been reported in patients who have had procedures with the Olympus TJF-Q180V, the Agency believes 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."
There may be reasons that reprocessing these scopes can be so problematic. The problem could be related to the nature of the design or to the sterilization methods. Maybe it's both. The FDA said in its executive summary that everything is on the table, writing, "It is important to note that FDA is taking a thorough and comprehensive approach to reducing infections post ERCP that result from ineffective reprocessing of duodenoscopes. Therefore, in addition to discussing duodenoscope design features and the manual reprocessing steps as instructed by the duodenoscope manufacturers, the committee will also discuss the role of Automated Endoscope Reprocessor (AER) devices for cleaning, high level disinfection or liquid chemical sterilization as performed at many institutions."
What about the patients who contracted serious and potentially deadly infections? They have options. Duodenoscope lawsuits are beginning to be filed. Anyone who was diagnosed with an infection following an ERCP may want to contact an attorney to determine whether there is an entitlement to compensation.
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