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A medical device linked to an outbreak of drug-resistant superbugs at a UCLA hospital is particularly hard to clean, the Food and Drug Administration said Thursday.
UCLA has contacted 179 people who may have been treated using a contaminated endoscope. Seven people were infected with a drug-resistant bacteria called CRE and two of them died after being treated using the devices.
The scopes — flexible tubes that carry a camera and other equipment into the body through the mouth — are specifically designed for procedures called endoscopic retrograde cholangiopancreatography (ERCP).
“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the FDA said in a notice to medical professionals.
One mechanism at the tip has microscopic crevices that a brush cannot get into. "Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection," the FDA said.
"Effective cleaning of all areas of the duodenoscope may not be possible."
“The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices.”
The problem is clearly not limited to UCLA, the FDA says.
“The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli,” the agency says.
FDA says it’s heard of at least 75 cases of possible infection from the devices involving 135 patients. “It is possible that not all cases have been reported to the FDA,” it added.
“For most patients, the benefits of ERCP outweigh the risks of infection."
ERCP is used to treat a range of problems with the pancreas and bile ducts, including gallstones, tumors, infections and inflammation of the pancreas. The alternative to using an endoscope is surgically cutting open a patient.
“For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed,” the FDA said.
“The FDA is actively engaged with other government agencies, including CDC, and the manufacturers of duodenoscopes used in the United States to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.”