Our use of proven equipment and sterilization procedures provides patients the highest level of confidence.
You may have seen news reports this spring about a number of hospital patients in California who were infected with a powerful bacterium between October 2014 and January 2015. As many as 179 patients may have been exposed to Carbapenem-Resistant Enterobacteriaceae—an infection resistant to most antibiotics— after undergoing a complex procedure called endoscopic retrograde cholangiopancreatography (ERCP), at the University of California at Los Angeles’ Ronald Reagan Medical Center. Seven of those patients developed infections, and two died.
As a result of that outbreak, the U.S. Food and Drug Administration issued a warning to health providers this past February regarding the use of medical endoscopes for complex endoscopic procedures such as ERCP. The warning stated that the complicated design of duodenoscopes, the type of endoscope used in ERCP, might impede effective reprocessing—that is, the ability to effectively “clean, disinfect and sterilize reusable devices.”
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” the warning stated. “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.”
Should Premier’s GI patients be concerned about this? “Not at all,” says Dr. Sunil K. Khurana, co- CEO of Premier Medical Group. “The risk of infections such as this at our outpatient center is zero.”
The reason for Dr. Khurana’s high level of confidence is that Premier does not utilize duodenoscopes at the center. “Those scopes are used only for highly specialized and complex procedures that are performed exclusively in a hospital setting,” he says. “They are very different from the regular scopes that we use on a day-today basis.”
The usual range of endoscopes have straight channels through which medical and surgical instruments are inserted for visualization and to obtain tissue samples or inject contrast dyes for imaging studies. Duodenoscopes, on the other hand, are more complicated instruments. They are angular, flexible tubes that are threaded through the mouth and into the top of the duodenum.
Unlike most other endoscopes, duodenoscopes also have a movable “elevator” mechanism at the tip, which allows the physician to change the angle of the accessory exiting the accessory channel. This affords the instrument better access to the pancreatic and biliary ducts that may be blocked by cancerous tumors, gallstones, or other conditions.
With this design efficiency, however, comes challenges for cleaning and disinfection. “Because the scope channel is angular and curved, we think that, even when protocols are being correctly followed, the cleaning agents may not get to all of the areas of the scope,” Dr. Khurana says.
Safe Scopes, Rigorous Measures
The endoscopes normally used at Premier’s outpatient center go through a multiple-cycle wash in an autoclave, a pressure chamber that uses high-pressure, high-temperature saturated steam, for 40 minutes. Joy Jones, Premier’s technician in charge of sterilization efforts, follows gold-standard protocols. “She undergoes yearly competency testing and is up-to-date on all the newest sterilization procedures,” Dr. Khurana says. “That is her total focus—sterilizing our instruments and doing it right.”