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Health Officials Mull Better Sterilizing Techniques for Duodenoscopes After Outbreaks of Antibiotic-Resistant Infections Emerge

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Health Officials Mull Better Sterilizing Techniques for Duodenoscopes

Health Officials Mull Better Sterilizing Techniques for Duodenoscopes


A U.S. Food and Drug Administration (FDA) never reviewed data from manufacturers concerning the procedures needed to clean duodenoscopes that infected seven patients with multidrug-resistant bacteria, and the agency has yet to offer any guidance.

Duodenoscopes are long, flexible tubes with a tiny camera at the tip. The devices are inserted into the throats of patients to examine the small ducts that drain the liver or gallbladder. The bacteria spread even after clinicians followed manufacturers’ concise instructions for disinfecting the duodenoscopes. Makers of the scopes have defended their recommended cleaning techniques, but the scopes are notoriously difficult to sanitize. The inner tubing is intricate and difficult to clean, and can allow for the growth of up to 10 billion individual bacteria, William A. Rutala, an infection control specialist at University of North Carolina Hospitals, told The New York Times (The Times.)

Duodenoscopes have been blamed for an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) at Advocate Lutheran General Hospital in Park Ridge, Illinois, in 2013; at Virginia Mason Hospital in Seattle, Washington, between November 2012 and early 2014, and most recently at Ronald Reagan UCLA Medical Center in Los Angeles, California, where seven people were sickened. Eleven CRE patients from Virginia Mason hospital died, The Times reported.

The standard cleaning procedure for duodenoscopes involves workers using tiny brushes to clean out the crevices. Workers then hook the device to a machine that cleans difficult hard-to-reach parts with a disinfecting chemical. The process takes about an hour. The U.S. Centers for Disease Control and Prevention (CDC) found that even with no recognized lapses in the cleaning process, duodenoscopes remained contaminated with CRE, The Times reported.

“When we clean devices for health care, we do it in such a way that even if we don’t clean it perfectly, it’s still clean,” Dr. Srinivasan said. But with the duodenoscope, cleaning must be “perfect every single time.”

The FDA is looking into adding additional cleaning methods, such as using toxic gases to sterilize duodenoscopes, or sampling them for microbiological cultures every so often. UCLA Medical Center and Advocate Lutheran General Hospital are now using ethylene oxide gas to sterilize the scopes, and no further cases have emerged, according to The Times.

The CDC is working on protocols for hospitals to use to screen cultures taken from duodenoscopes. Workers at Virginia Mason Hospital clean the scopes according to the manufacturers’ instructions, then test them for pathogens and quarantine them until they are deemed safe. The University of North Carolina hospitals are considering manually brushing duodenoscopes with high-level disinfectants, then using gas sterilization. Health experts, however, have not provided additional instructions to prevent the spread of superbugs caused by the scopes, The Times reported.

breakinglawsuitnews.com disclaimer: This article: Health Officials Mull Better Sterilizing Techniques for Duodenoscopes After Outbreaks of Antibiotic-Resistant Infections Emerge was posted on Friday, February 27th, 2015 at 1:55 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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