Superbug concerns, questions spread nationwide

It may sound like something out of a science fiction movie: a drug-resistant superbug bacteria claiming the lives of patients who were infected while undergoing medical procedures at an established hospital. Unfortunately, this alarming news is all too real.

News media recently reported that two patients have died and five others were infected after being exposed to CRE, a drug-resistant bacteria, at UCLA Ronald Reagan Medical Center. Last week, Carolinas HealthCare System announced increased efforts to prevent the spread of CRE after two Charlotte-area residents died in recent months after being infected by the superbug.

Killing up to 40 percent of the people it infects, Carbapenem-Resistant Enterobacteriaceae, or CRE, is resistant to almost all antibiotics and is more deadly than the more widely known superbug MRSA. The bacteria is being transmitted by ERCP endoscopes (also called duodenoscopes), a flexible, lighted tube threaded down a patient’s throat during the ERCP endoscopic procedures. ERCP refers to endoscopic retrograde cholangiopancreatography, a gastrointestinal procedure primarily used to treat problems of the bile and pancreatic ducts. We perform ERCPs in the hospital facility, NOT in our surgery centers.

According to a USA Today investigation published in January 2015, a deadly pattern of infections from the duodenoscope began to emerge in 2012 at hospitals in Seattle, Pittsburgh and Chicago. The report found that infection was being passed from patient to patient because of accumulating bacteria in the duodenoscope. The device has small maneuvering levers in the instrument tip and microscopic crevices that can be extremely difficult to access and clean.

On Thursday, the FDA announced new warnings designed to raise awareness among health care professionals about potential infection problems associated with the duodenoscope:

… Unlike most other endoscopes, duodenoscopes also have a movable “elevator” mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage.

Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.

At Gastrointestinal Associates, we take infection control measures very seriously. We have performed more than 100,000 procedures over the past five years without any reported transmission of any type of infection. In fact, we have never experienced a single infection in our centers as a result of an endoscopic procedure since we began the very first gastrointestinal ambulatory surgery center in 1986. That is a remarkable record, and we are quite proud of it.

We do have a duodenoscope, which was used nine times in 2014 to enhance viewing of the duodenal area – but not for ERCP. It is rarely used and is cleaned STRICTLY according to manufacturer’s guidelines by specially trained staff.

Patient safety remains our top priority, and we make every effort to ensure our patients receive the highest quality of care before, during and after their procedure. We are constantly reviewing our cleaning processes and training our employees on manufacturer-recommended best practices.