3/2/15

CRE Infections From Inadequately Reprocessed Endoscopes


By on 8:32 AM

Endoscopy refers to a variety of gastrointestinal (GI)-related invasive procedures using an illuminated flexible or rigid instrument to visualize the interior of a hollow organ or body part. Examples of endoscopic procedures include upper endoscopy (sometimes referred to as gastroscopy) and a colonoscopy, referring to visualization of the lower GI tract including the colon.

In addition to these procedures, an endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that combines the use of an endoscope as well as a fluoroscope to specifically diagnose and treat problems associated with the gall bladder and pancreas, including the ducts related to these organs.

Almost half a million ERCP procedures are performed annually nationwide. The challenge related to these procedures is the design of the duodenoscope, which includes a movable "elevator" mechanism at the tip. This elevator mechanism contains crevices that are hard to reach with a brush used to clean endoscopes.

The U.S. Food and Drug Administration (FDA) is aware of the complexities related to manual cleaning and high-level disinfection of endoscopes, particularly the duodenoscope. From January 2013 through December 2014, FDA received approximately 75 medical device reports related to possible transmission of organisms from reprocessed duodenoscopes in 135 patients.

On February 19, exposure to a highly resistant class of organisms known as carbapenem-resistant Enterobacteriaceae (CRE) was reported by Ronald Reagan UCLA Medical Center, with more than 170 patients possibly exposed. At least seven patients have been infected, and two of those patients died from the highly fatal CRE.  Reports have suggested that the transmission occurred through two contaminated duodenoscopes with "embedded" organisms, despite cleaning of the scopes following manufacturer's instructions.

FDA issued an advisory warning to doctors that even when a manufacturer's cleaning instructions are followed, germs may linger. The device's complex design and tiny parts make complete disinfection extremely difficult, the advisory said. The manufacturers of the scopes are working with the FDA on additional cleaning measures as well as the overall infection problem.

Phenelle Segal, RN, CIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.

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