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Study on Endoscope Sterilization Produces Disturbing Results

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According to a paper presented at the annual conference for the Association for Professionals in Infection Control and Epidemiology (APIC) last month, a study conducted at five hospitals across the country found that three out of twenty flexible gastrointestinal (GI) endoscopes used for screening were found to harbor unacceptable levels of “bio dirt” – cells and matter from a patient’s body that could pose potential infection risk.

 

Endoscopes are instruments inserted to visually examine interior organs, such as the colon and stomach, to identify polyps or cancer. Duodenoscopes, gastroscopes and colonoscopes examine the duodenum (the first section of the small intestine), the stomach, and the colon. Each year, between 15 and 20 million endoscopy procedures are conducted with reusable endoscope devices to screen various components of a patient’s GI tract.

 

After a procedure has been performed, the endoscope is sent for cleaning before being reused on another patient. This reprocessing involves two steps: first, manual cleaning with an enzymatic cleaner and flushing by a hospital technician and second, soaking the device in a high-level disinfectant. The first step is vital to ensure that the disinfection process is effective. After manual cleaning is completed, the technician visually inspects the instrument to ensure cleanliness. But the results of this study found that contamination can remain on the device and may be invisible to the naked eye.

 

Reports of incidents of improperly cleaned endoscopes have increased over the past few years. In 2008 and 2009, eleven thousand veterans were notified that they may have been exposed to contaminated blood during colonoscopy procedures at several Veterans Affairs hospitals, after it was discovered that the staff was not properly cleaning the endoscope equipment. Just last year, Air Force veteran Robert Metzler was awarded $1.25 million after suing the VA for contracting hepatitis C from allegedly contaminated endoscopy tools.

 

According to the Centers for Disease Control and Prevention (CDCP), more healthcare-associated outbreaks have been linked to contaminated endoscopes than to any other medical device.  And the ECRI Institute, an independent organization that researches patient safety and quality, has identified cross-contamination from flexible endoscopes as a leading health hazard.

 

“The cleaning protocols for flexible endoscopes need improvement, such as guidelines tailored to the type of scope or identifying if there is a critical step missing in the manual cleaning process, and documented quality control measures. These types of improvements could have a positive impact on patient safety,” said Dr. Marco Bommarito, the lead researcher in the project.