FDA: Inform patients about CRE infection risk during intricate “ERCP” endoscopy

February 27th, 2015

ERCP (Endoscopic retrograde cholangiopancreatography) — an upper endoscopy procedure performed on some half million U.S. patients annually – poses a risk of transmission of practically untreatable carbapenem-resistant Enterobacteriaceae (CRE), outbreak investigators are finding.

After a series of outbreaks over the last few years, the Food and Drug Administration issued a Feb. 19th alert saying patients should be advised of the benefits and risks associated with ERCP procedures, which typically involve the use of intricately designed duodenoscopes on the pancreas, biliary tract and liver. Patients should report back to their providers after an ERCP procedure if they have symptoms such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, and black or tarry stools, the FDA advised.

The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including CRE resistant strains of Klebsiella species and Escherichia coli. In total, from January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) totaling some 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.

The UCLA Health System in Los Angeles recently announced it has notified more than 100 patients that they may have been exposed to CRE during complex endoscopic procedures that took place between October 2014 and January 2015. The patients were being offered free home testing kits that will be analyzed at UCLA.

The endoscopes used at Ronald Reagan Medical Center were sterilized according to the standards stipulated by the manufacturer, but an internal investigation determined that CRE "may have been transmitted during a procedure that uses this specialized scope to diagnose and treat [pancreas and biliary tract] diseases and may have been a contributing factor in the death of two patients," UCLA stated. "A total of seven patients were infected. The two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond manufacturer and national standards."

A similar outbreak occurred in 2013 at Advocate Lutheran General Hospital in Park Ridge, IL, which halted transmission by going beyond standard practices to gas sterilize scopes used for ERCP with ethylene oxide.1 A recurrent theme is that no breaks in cleaning and reprocessing protocols are identified, yet CRE may persist in the intricately designed duodenoscopes used in the procedures. The infection rate for ERCP is typically 1% or less, but the emergence of CRE threatens to change that calculus. Previous studies have shown an association between ERCP endoscopes and transmission of multidrug-resistant bacteria, as the complex design of the endoscopes may make them difficult to clean.2,3

Virginia Mason Medical Health System in Seattle recently reported that it had "discovered and addressed a potential connection between endoscopes used in ERCP procedures and patients infected with a drug resistant bacteria in 2012 and 2013." Published reports said at least 32 patients were exposed or infected, including 11 who died.4 However, the patient deaths were not definitively linked to the infections, at least some of which were caused by CRE.

Virginia Mason has now gone to a stringent system of withholding scopes from procedures until they test negative for bacterial pathogens. Virginia Mason posted information on its website that an internal review "determined the manufacturer's recommended guidelines for processing the scopes were less than optimal so we developed and implemented a much more rigorous cleaning process. By testing and holding all scopes until a negative culture is confirmed, we believe we are using an infection control/safety approach that goes above and beyond what most or all other hospitals are doing."

Though citing something similar to that approach as an additional measure to consider, the FDA essentially recommended continued adherence to general endoscope reprocessing and consensus guidelines such as the "Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011." While some of the affected hospitals have clearly gone beyond the manufacturer's guidelines to stop transmission, the FDA said "it is important to follow specific reprocessing instructions in the manufacturer's labeling for each device. Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer's reprocessing instructions will minimize the risk of infection. Deviations from the manufacturer's instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer's instructions, such as channel flushing aids, brushes, and cleaning agents, is not known."

According to the FDA, additional general best practices include:

• Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor. Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.

• Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.

• Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.

• Submit a report to the manufacturer and to the FDA if you suspect that problems with reprocessing a duodenoscope have led to patient infections.

References

1. Centers for Disease Control and Prevention. Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013. MMWR 2014; 62(51):1051-1051.

2. Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957–959.

3. Alrabaa SF, Nguyen P, Sanderson R, et al. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control 2013;41:562–564.

4. Aleccia J. Undisclosed superbug sickened dozens at Virginia Mason. Seattle Times Jan. 26, 2015: http://bit.ly/1L252Ug

Endoscope Illustration: CDC