Endoscopic Devices Found to be Source of Deadly Infections

In February of 2015, the FDA issued a safety communication warning regarding the use of the medical devices known as ERCP endoscopes (also called duodenoscopes). The device is used as a less invasive alternative to surgery to open and drain fluids from blocked pancreatic and biliary ducts.

Blockages can be due to gallstones, cancerous tumors, and other conditions. The device is inserted through the mouth and threaded through the esophagus, stomach and into the small intestine (duodenum) to reach the blocked area. The design includes an elevator tip that can change the angle of the tip when exiting the accessory channel. The tip has a hollow channel that injects a contrast dye and allows the use of other instruments for biopsy or treatment of other abnormalities.

The issue is the cleaning instructions by the manufacturers have been found to be deficient. Parts of the endoscope have such microscopic crevices, they cannot be reached by the brush used during manufacturer recommended cleaning. It has been found that body fluids and organic debris can remain in the crevices after cleaning. These residual fluids can contain contaminations that have led to outbreaks of the drug-resistant Escherichia coli (E. coli) and Carbapenem-Resistant Enterobacteriaceae (CRE).

Seattle Virginia Mason Medical Center reported that 32 patients were infected with a strain of antibiotic-resistant E. coli after use of contaminated endoscopes. The hospital followed the manufacturer’s cleaning protocol. It is estimated that 3 in 10 infected patients died; seven deaths occurred in the hospital. This outbreak occurred between November of 2012 and August 2013.

A Chicago hospital reported another outbreak of E. coli infections from exposure through endoscopic use in 39 patients in 2013. Recently, the University of California, Los Angeles, Health System alerted the public that seven patients had been infected with CRE after undergoing procedures with this type of endoscope. It is reported that 2 of the patients died, and CRE may have contributed to their deaths. An additional 179 patients were notified that they might have been exposed.

The less than adequate manufacturer’s cleaning protocol were reported as early as November 2010, when doctors in Clermont-Ferrand, France reported in the journal Endoscopy that the devices “can act as a reservoir for bacteria.“ They reported that 16 patients developed infections after use of the endoscopes between December of 2008 and August 2009. After investigation, it was found the cleaning procedure was “insufficient.”

Initially, the FDA advised medical professionals to follow manufacturer cleaning protocols, as well as general endoscopic cleaning guidelines. The LA hospital that reported the CRE outbreak mandated extra measures for cleaning the endoscopes. These included manual cleaning and a 48-hour quarantine. Three percent of the scopes were reportedly still contaminated.

The FDA updated the February Advisory to include that the endoscopes not be used until they are confirmed to be free of the infectious material. In March, the FDA updated its advisory again to mandate that manufacturers prove the endoscopes can be adequately cleaned before being placed back onto the market. Olympus, one of the manufacturers of the endoscope, also found mechanical defects in 7 of 8 devices they reviewed.

To date, it is reported that more than 500,000 endoscopic procedures are performed each year in the United States. The FDA acknowledges that the extent of infection in individuals after an endoscopic procedure is not known due to the possibility of unreported cases.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.

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