CDC Statement: Los Angeles County/UCLA investigation of CRE transmission and duodenoscopes
Currently, CDC is providing consultation to the Los Angeles County Health Department as it investigates, in collaboration with the University of California, Los Angeles (UCLA) Medical Center, a cluster of carbapenem-resistant Enterobacteriaceae (CRE) cases. In this investigation, exposure to duodenoscopes—a device inserted down the throat and used in a lifesaving procedure called endoscopic retrograde cholangiopancreatography (ERCP)—was associated with transmission of CRE.
The duodenoscope is different than the endoscope used for routine upper gastrointestinal endoscopy or colonoscopy. The duodenoscope is more intricate than other endoscopes and can be difficult to clean and disinfect.
Infections caused by CRE are generally found in hospitalized patients or residents in long-term-care facilities. ERCP is an important and potentially lifesaving medical procedure that allows doctors to evaluate and remove blockages from the channels (bile and pancreatic ducts) that drain a patient’s liver. Use of this device can potentially avoid the need for more invasive procedures such as surgery.
- Interim Duodenoscope Surveillance Protocol
- Interim Duodenoscope Sampling Method
- Interim Duodenoscope Culture Method
- FAQs on the Interim Duodenoscope Surveillance Protocol
- NDM-Producing CRE Associated with ERCP
- NDM-Producing CRE Associated With Duodenoscope
- See CRE homepage
U.S. Food and Drug Administration
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaningexternal icon
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling pdf icon[PDF – 1.3 MB]external icon
- Notice of Meeting: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committeeexternal icon
Investigators of previous outbreaks of CRE related to duodenoscopes have identified recognized breaches of approved cleaning protocols. In other outbreaksexternal icon, including this cluster, investigators reported finding no breach in duodenoscope reprocessing and no evidence of defects in the duodenoscope.
This investigation highlights the challenging and complicated nature of duodenoscope reprocessing and the potential for CRE transmission. Today, the Food and Drug Administration (FDA) released a safety communication about duodenoscopes: http://www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/ucm434871.htmexternal icon. The FDA is aware of and closely monitoring the association between reprocessed endoscopes and multidrug-resistant bacterial infections caused by CRE, such as Klebsiella species and Escherichia coli.
CDC continues to investigate and work with FDA and others on the optimal protocols for endoscope reprocessing. At this time, CDC recommends facilities reprocess endoscopes as directed by the manufacturer, typically high-level disinfection. Although sterilization is the definitive mechanism to eradicate all microorganisms during reprocessing, several issues potentially limit its widespread use, including longer processing and aeration time than with disinfection, toxicity of some sterilizing agents, and potential incompatibility with some duodenoscope devices. Until more is known, it is important for facilities to be aware of the potential risk of CRE transmission and that they adhere strictly to the recommended reprocessing practices, particularly manual cleaning and drying.
CDC is working with partners including FDA, the device manufacturers, specialty societies, subject matter experts, and state and local health departments to further understand and address the possibility of CRE transmission related to duodenoscopes in the following ways:
- investigate potential CRE transmission
- determine which duodenoscope models are potentially impacted;
- evaluate duodenoscope cleaning, drying, and disinfection;
- assess the feasibility of using microbiologic sampling cultures to evaluate a facility’s duodenoscope cleaning methods and identify if bacterial contamination remains after cleaning; and
The risk to patients of CRE infection following ERCP is low and, for most patients, the benefits of this potentially lifesaving procedure outweigh the risks.
Combating antibiotic-resistant infections is a top priority of the Administration. The President’s FY 2016 Budget nearly doubles the amount of federal funding for combating and preventing antibiotic resistance to more than $1.2 billion. In September 2014, President Obama signed Executive Order 13676 launching Federal efforts to combat the rise in antibiotic-resistant bacteria. The Administration has also issued its National Strategy on Combating Antibiotic-Resistant Bacteria, which outlines steps the U.S. government will take to improve prevention, detection, and control of resistant pathogens.
This outbreak also highlights the importance of CDC and state health departments working collaboratively to identify and stop outbreaks of antibiotic resistant pathogens. In the FY 16 budget, CDC has requested funding to support State Antibiotic Resistance Prevention Programs in all 50 states and 10 large cities and a regional lab network to help identify and to respond faster to these outbreaks. This funding would provide critical national infrastructure to prevent the growing threat of CRE and other drug-resistant pathogens.