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May 1, 2015

Endoscopy-Related CRE Outbreak Necessitates Improving Prevention Protocols

Multiple news stories related to the superbug Carbapenem-resistant Enterobacteriaceae

Preventing and controlling infections is a challenge that many hospitals face. It's bad enough that patients may come down with secondary infections brought on by an original illness, but given the use of invasive procedures involving catheters and other deviceseven when hospitals follow best practicesunintended healthcare-associated infections (HAIs) do occur.

HAIs that occur in hospitals impose significant economic consequences. About 4% of US hospital patients experience at least one HAI annuallyapproximately 722,000 people.[1] The overall direct cost of HAIs to hospitals is in the $40 billion range.

Endoscopy-Related Infections
There have been multiple news stories recently regarding patients who underwent endoscopy-related procedures and also contracted infections related to the superbug Carbapenem-resistant Enterobacteriaceae (CRE). CRE is a family of bacteria that are difficult to treat because they have high levels of resistance to antibiotics. Healthy people usually do not get CRE infections. This type of infection most often occurs with patients in hospitals, nursing homes and other healthcare settings.

Specifically, the recent infections occurred after patients underwent endoscopic retrograde cholangiopancreatography (ERCP), which combines endoscopy and fluoroscopy in order to diagnose and treat problems of the biliary or pancreatic ductal systems. The test examines the tubes that drain the liver, gallbladder, and pancreas.

Awareness Efforts are Lacking
Hospitals are starting to monitor their HAI infection rates, but there are few educational programs in place to ensure awareness among staff of prevention and precautions for infection events. Typically, staff members are oriented once when they start working at a facility. After an initial orientation, personnel are notified of any new prevention protocols and statistics by email or during staff meetings. For the most part, there is no required competency to ensure that staff members understand and follow protocols on a daily basis.

This situation must improve for hospitals to successfully address and control HAI infection rates including those involving CRE. Moreover, certain personnel should be certified in infection prevention and should be aware of the latest information and prevention efforts in the field, such as those available through the Certification Board of Infection Control and Epidemiology (CBIC).

New FDA Guidelines
Preventing CRE contaminations and other HAIs involves controlling exposure to bacteria and viruses by ensuring hospital rooms and equipment are properly sanitized for each individual patient. In March 2015, the Food and Drug Administration (FDA) released new guidelines for how reusable medical devices, such as scopes and catheters, should be cleaned. Just following manufacturer cleaning instructions may not guarantee that a device is contaminant-free.[2] Devices must be thoroughly cleaned, and sanitation should be validated by proper infection prevention personnel.

The CDC also released new guidelines in March 2015 to assist hospitals that want to validate the effectiveness of endoscope cleaning by culturing, at a minimum, both the instrument channel and the elevator after reprocessing is complete. Culturing can be done on a weekly or monthly basis.

Documentation is a key process to ensure that hospitals can demonstrate their proactive steps to prevent HAIs. Staff training and competency should be documented on a regular schedule, no less than yearly. Training and competency should also be conducted/documented any time that changes are made into a protocol. Cleaning and reprocessing procedures must be written and displayed prominently. Endoscope logs should document the patient, cleaning personnel, AER cycles and culture results for each use. In the event of an HAI, it is imperative that the possible causes can be identified and removed from use until a remedy is found.

Little missteps can result in big problems for both patients and hospitals. These include errors in device cleaning protocols. In addition, some CRE bacteria have become resistant to most available antibiotics. They are very difficult to treat and can be deadly.

Government Assistance
The CDC is funding some testing that covers the use of its "Detect and Protect" strategies to find and prevent the spread of germs causing HAIs. These strategies include the following:

  • Tracking CRE, including use of the National Healthcare Safety Network
  • Prevention activities, such as those found in CDC guidelines and HAI prevention toolkits

According to the CDC, controlling the transmission of CRE in healthcare facilities involves the following steps:

  • Recognizing these organisms as epidemiologically important
  • Understanding their prevalence
  • Identifying colonized and infected patients present in a facility
  • Implementing regional and facility-based interventions to stop the transmission of these organisms

The CDC indicates that there are eight core measures that facilities should follow to control CRE.

  • Hand Hygiene: Facilities should ensure that healthcare personnel are familiar with proper hand hygiene techniques and their rationales.
  • Contact Precautions: Systems should be in place to identify patients with a history of CRE colonization or infection at admission so that they can be placed on contact precautions if not free of colonization.
  • Education: Healthcare personnel who care for patients with CRE should be educated about preventing transmission of these organisms.
  • Use of Devices: Minimizing device use in all healthcare settings should be part of the effort to decrease the prevalence of CRE.
  • Patient Cohorting: When available, patients colonized or infected with CRE should be housed in single-patient rooms, and, if not available, these patients should be cohorted together.
  • Laboratory Notification: Laboratories should have protocols in place that facilitate the rapid notification of appropriate clinical and infection prevention staff whenever CRE are identified from specimens to ensure timely implementation of control measures.
  • Antimicrobial Stewardship: Facilities should work to ensure that antimicrobials are used for appropriate indications and duration, and that the narrowest spectrum antimicrobial appropriate for the specific clinical scenario is used.
  • CRE Screening: CRE screening of epidemiologically-linked patients is a primary prevention strategy for all healthcare facilities.[3]

Next Steps
Infection control efforts often work well in conjunction with quality assurance initiatives to limit or eliminate facility risk, as well as patient, caregiver, visitor and staff exposure. Third parties can assist facilities with ongoing regulatory agency readiness and recommendations for key operational practices including active surveillance and prevention activities.  

If you would like the assistance of a third party when dealing with the prevention of HAIs or other infection-related issues, Soyring Consulting can help. We specialize in many areas of quality, safety and risk management consulting including quality assurance and infection control assessments and implementation.

Contact us today to learn more.



  1. Centers for Disease Control and Prevention (CDC), Healthcare-Associated Infections Data and Statistics.  
  2. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf.
  3. Healthcare-associated Infections (HAIs). CDC. http://www.cdc.gov/hai/organisms/cre/cre-toolkit/f-level-prevention.html#facility-strategies.

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