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Endoscope Infection Risk Highlighted in FDA Warning

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December 19, 2014 — Karl Storz Endovision, Inc., one of the largest manufacturers of endoscopes, has received a warning letter after the FDA received complaints about cleaning brushes not fitting inside properly.

The FDA was specifically concerned about the Flex-X2 Ureteroscope, which is a long tube that is passed through the urethra, bladder, and then into the upper urinary tract.

The device consists of a long, thin tube that has a light and a camera on the end. It is used to find the cause of urinary problems, such as kidney stones or cancer.

Because endoscopes are used in highly-contaminated areas of the body, they must be thoroughly cleaned and disinfected between uses to prevent transmission of diseases, such as HIV and Hepatitis C. Unfortunately, cleaning endoscopes is labor-intensive and difficult.

The first step is physically scrubbing the endoscope to remove debris, which requires a properly-fitting brush. After this step, the endoscope is disinfected with an enzymatic cleaner and a high-level disinfectant.

Even after cleaning, it is not uncommon for endoscopes to remain contaminated. In October, the Chicago Sun Times reported that a hospital in Illinois was hit with a lawsuit after an outbreak of infections.

The woman claims she was one of 44 people who developed the same bacterial infection after endoscopies and other procedures. She blames her infection on an endoscope that was contaminated with NDM producing CRE, a common pathogen found in hospitals.

In 2011, a hospital in New Orleans was hit with a class action after hundreds of patients were exposed to diseases when an endoscope was not sanitized between October 8 and December 1, 2010.

 

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