FDA Warning Highlights Endoscope Cleaning Problems

December 19, 2014 — The FDA has issued a warning letter to Karl Storz Endovision, Inc. after receiving complaints that the cleaning brush for an endoscope may not fit properly.

The warning cited the Flex-X2 Ureteroscope, which is a device that consists of a long tube with a light and video camera on the end, which is inserted through a patient’s urethra to look inside the bladder or upper urinary tract.

Endoscopes are used in highly-contaminated ares of the body, such as the intestines, but cleaning is difficult and labor-intensive. After an endoscope is used, a technician must scrub it with a cleaning brush that fits precisely inside the tube to remove gross contamination and debris.

Without this step, the endoscope cannot be effectively disinfected. Then, the technician must use an enzymatic cleaner and soak it in a high-level disinfectant.

Unfortunately, residual contamination of endoscopes is a persistent problem. In 2009, the FDA warned:

“Flexible endoscopes are fundamentally difficult to clean and disinfect or sterilize. Because of this, it is essential that facilities establish a quality system program that covers all aspects of endoscopy procedure management.”

Two months ago, the Chicago Sun Times reported that a lawsuit was filed by a woman who claimed that she and 43 other patients developed the same bacterial infection after undergoing endoscopies and other procedures at Advocate Lutheran General Hospital in Park Ridge, Illinois.

According to the lawsuit, the endoscope was not properly cleaned and it was “colonized” by NDM producing CRE, a disease-causing bacteria that is commonly found in hospitals.

Another class action was filed on behalf of hundreds of patients in New Orleans who were exposed to Hepatitis B, Hepatitis C, HIV, and other diseases because the endoscope was not cleaned between October 8 and December 1, 2010.