AGA Issues New Endoscope Safety Recommendations

Janis C. Kelly

April 02, 2015

After recent outbreaks of drug-resistant and sometimes fatal infections after endoscopic retrograde cholangiopancreatography (ERCP), the US Food and Drug Administration (FDA) and device manufacturers have issued warnings and updated instructions on cleaning the equipment. Now, the American Gastroenterological Association (AGA) has published best-practice recommendations for physicians using endoscopes.

Investigations showed that the infections occurred even after medical staff followed the manufacturers' original recommendations for disinfecting the instruments, suggesting a design flaw in the reusable elevator-channel endoscopes. While companies and regulators work on a safer redesign, clinicians need to continue to use the existing, if imperfect, endoscopes.

That means clinicians need to do all they can to ensure the equipment is sterile and to reassure patients that the procedures have a very low associated risk, AGA President John I. Allen, MD, told Medscape Medical News.

"The need for ERCP or endoscopic ultrasound must be firmly established, and it is often discussed in a life-threatening situation," he said. "The use of these scopes has revolutionized our approach to patients with biliary or pancreatic disorders. We used to have to operate on patients with gallstones in their common bile duct. Now stones are routinely removed by ERCP, a much safer alternative. The number of infections detected so far is less than 200 compared to over more than 1 million procedures performed, so this needs to be put in perspective. Bottom line: if a patient needs an ERCP, this is still a safe procedure, and we, as the physician and gastroenterology community, are dedicated to further reducing risk. The [AGA] has named this effort 'Getting to Zero,' and that is what we will accomplish."

AGA Recommendations for Physicians Using Endoscopes

In the new recommendations, published online March 23, the AGA recommends physicians:

  • treat all elevator-channel endoscopes the same, including both fine-needle aspiration echoendoscopes (endoscopic ultrasound) and duodenoscopes;

  • continue to follow the recently enhanced manufacturer reprocessing guidelines;

  • track elevator-channel endoscopes by patient and by device serial number to facilitate retrospective identification in case of infection;

  • use a two-phase infection surveillance program that tracks all patients who have had a procedure with an elevator-channel endoscope and periodically collect culture surveillance of all elevator-channel endoscopes — a positive culture should trigger a review of reprocessing techniques;

  • use a standard device reprocessing training program and require reprocessing staff to demonstrate competency every 6 months; and

  • immediately contact the Centers for Disease Control and Prevention to aid in investigation of any suspected breach or infection.

Elevator Design Difficult to Clean

Duodenoscopes contain a hollow channel for the injection of contrast medium or insertion of other instruments. Unlike most other endoscopes, they also have a movable elevator mechanism that can be used to change the angle of the accessory instrument to improve access to the pancreatic or biliary ducts. That is key to the devices' usefulness in draining fluids from ducts blocked by tumors, gallstones, or other conditions.

However, this complex design created unexpected cleaning and high-level disinfection challenges. According to a February 19 US Food and Drug Administration (FDA) safety warning, "Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections."

Brushing, Flushing, Culturing Recommended for Endoscopes

Procedures for reprocessing the devices have been intensified, with an additional focus on cleaning out pathogens and bodily fluids from the movable elevator mechanism at the tip of the duodenoscope, higher-level sterilization using ethylene-oxide, and quarantining each device before reuse until it is proven sterile. These steps are expected to add considerably to costs, as more of the $40,000 to $80,000 devices will be needed to replace the ones undergoing cleaning or quarantine .

Dr Allen, who is also clinical chief of digestive diseases at Yale University School of Medicine, New Haven, Connecticut, said, "There is heightened awareness about the risk of transmitted infections specifically to endoscopes that have an extra elevator' channel. This includes duodenoscopes used for ERCP and some endoscopes used for endoscopic ultrasound. There is not a risk for the endoscopes used for screening colonoscopy and standard upper [gastrointestinal] endoscopy. Additionally, these infections appear to be specific for several types of bacteria, especially those that form mucus or biofilms. This includes the [carbapenem-resistant Enterobacteriaceae] bacteria and pseudomonas."

According to Dr Allen, gastroenterologists and infectious disease experts have changed their practices to confront this problem. He said that most now routinely culture duodenoscopes to detect bacteria of high concern (such as Klebsiella species and Escherichia coli), that patients who are to undergo or have undergone procedures with the elevator channel scopes are monitored for infections with the organisms of high concern, and that special cleaning techniques are being developed and implemented.

For example, on March 26, the FDA reported that Olympus had issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope involved in several outbreaks of carbapenem-resistant Enterobacteriaceae. Validation by FDA standards requires soiling the device with bacteria to simulate use in a procedure, and then showing that following the reprocessing instructions would result in a six-log reduction in bacterial counts at each of several locations on the device.

On March 27, Olympus issued a 13-page letter that included supplemental reprocessing instructions developed during the validation studies. These include raising and lowering the elevator during a precleaning step of immersion in water, additional brushing of the forceps elevator recess area with two brushes (including a very small one the manufacturer expected to ship to facilities by May 8, 2015), additional flushing of the forceps elevator recess area, and additional raising and lowering of the forceps elevator. This manual cleaning is to be followed by manual high-level disinfection, including more manual flushing and increased flushing volume of each endoscope channel and the elevator recess area, and by additional raising and lowering of the forceps elevator. The FDA recommended immediate implementation of the new manual cleaning and high-level disinfection procedure.

How Should a Redesigned Duodenoscope Look?

Dr Allen said the expected redesign of elevator-channel endoscopes has generated a surge of clinical questions: "Should the elevator channels be designed in an 'open' or sealed configuration? Should the tip of the endoscope (the most common site to harbor infections) be removable for better cleaning, or even be single-use? Should seals in the small crevices of the endoscope be made with more durable and impermeable material? Should different brushes [for cleaning] be developed?"

All these issues are being looked at by device engineers and will be further explored in a planned May 14 to 15, 2015, FDA Medical Devices Advisory Committee meeting about the reprocessing of duodenoscopes and other endoscopes and the use of automated endoscope reprocessors for duodenoscope reprocessing. The meeting is expected to produce recommendations on the effectiveness of cleaning, high-level disinfection, and sterilization methods; amount and type of premarket validation data needed to support labeling claims and technical instructions; use of other risk mitigations, such as surveillance cultures; guidelines for reprocessing duodenoscopes and endoscopes at user facilities; and approaches for ensuring patient safety during ERCP, including appropriate patient selection.

Dr Allen said other important unanswered questions are whether more infections of this type are still going undetected, whether the sensitivity for culturing scopes is sufficient to detect all infected scopes, what failure points in the endoscopes are most prone to harboring infections, and what needs to be redesigned in endoscopes to avoid transmitting infections.''

Dr Allen has consulted for Olympus and Pentax.


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