What’s New in the Patient Safety World

April 2015

Duodenoscopes and CRE

 

 

There has been considerable media attention recently to the transmission of CRE (carbapenem-resistant Enterobacteriaceae) to patients via contaminated duodenoscopes, resulting in some fatalities (Briggs 2015, Lowes 2015). The problem has now occurred in multiple hospitals in multiple states so one should assume that the risk is likely present anywhere duodenoscopes are used.

 

As a result, new guidelines for appropriate cleaning and reprocessing and validation of sterility have been issued by multiple sources, including the FDA, CDC, ECRI Institute, American Gastroenterological Association, and a device manufacturer.

 

The ECRI Institute recommendations note that they suspect the problem applies to all duodenoscopes, not just those from one manufacturer. Hence it is important to ensure that your processes comply with the manufacturer’s recommendations. But ECRI Institute considers the key step is culturing the duodenoscopes after they have gone through your reprocessing procedures and waiting to release the scopes only after negative cultures are received. They note that those facilities with lesser resources might consider weekly culturing rather than culturing each scope after each reprocessing cycle. We think we will avoid those facilities with “lesser resources”!

 

The new procedures seem to especially focus on the forceps elevator recess. We refer you to the above sites for details. However, we suspect that the guidelines are still evolving and we are likely to hear more down the line.

 

 

References:

 

 

Briggs B, Blankstein A. UCLA Warns Nearly 180 Patients about Dangerous 'Superbug' Exposure. NBC News. February 19, 2015

http://www.nbcnews.com/health/health-news/ucla-warns-nearly-180-patients-about-dangerous-superbug-exposure-n308626

 

 

Lowes R. Infection-Prone Duodenoscopes to Stay on Market, FDA Says. Medscape Medical News March 12, 2015

http://www.medscape.com/viewarticle/841394?src=wnl_edit_tpal&uac=14695HV

 

 

FDA (US Food and  Drug Administration). Center for Devices and Radiological Health. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. FDA March 17, 2015

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf

 

 

CDC (Centers for Disease Control and Prevention). Interim Duodenoscope Surveillance Protocol. Interim Protocol for Healthcare Facilities. Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. CDC March 12, 2015

http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html

 

 

ECRI Institute. High Priority Hazard Report. ECRI Institute Recommends Culturing

Duodenoscopes as a Key Step to Reducing CRE Infections. ECRI Institute 2015; March 3, 2015

https://www.ecri.org/Resources/Superbug/Culturing_Duodenoscopes_Key_Step_to_Reducing_CRE_Infections.pdf

 

 

American Gastroenterological Association (AGA). How to Stop Duodenoscope Infections. March 23, 2015

http://www.gastro.org/news/articles/2015/03/23/how-to-stop-duodenoscope-infections

 

 

Infection Control Today. Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes. Infection Control Today. March 31, 2015

http://www.infectioncontroltoday.com/news/2015/03/olympus-validates-new-reprocessing-instructions-for-model-tjfq180v-duodenoscopes.aspx

 

 

 

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