February 19, 2015 — The FDA has warned doctors and hospitals that ERCP endoscopes have a design flaw that “may facilitate the spread of deadly bacteria.”
The warnings were issued after a drug-resistant “superbug” on contaminated endoscopes caused a deadly outbreak of infection at UCLA’s Ronald Reagan Medical Center. At least 179 patients were exposed, seven infections have been confirmed, and two people have died.
The patients were infected with Carbapenem-resistant Enterobacteriaceae (CRE), which are antibiotic-resistant germs. CRE infections are very difficult to treat and deadly in up to 50% of patients, according to the Centers for Disease Control (CDC).
The FDA blamed duodenoscopes, which is a type of endoscope (flexible tube) that is threaded into a patient’s mouth, throat, stomach, and intestine. The unique feature is a movable “elevator” channel that bends the scope in tight places. It is used to treat cancer, gallstones, and other digestive-tract diseases.
Unfortunately, this unique mechanism is also very difficult to sterilize between uses and experts suspect that bacteria can build up inside tight spaces.
The FDA warns that cleaning the scope is “a detailed, multi-step process,” but even if the manufacturer’s instructions are followed exactly, “[disinfecting] should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The Los Angeles Times reported that UCLA discovered the outbreak late last month while running tests on a patient. According to the Times:
“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety. Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”
Meanwhile, Olympus Corp., the manufacture of the endoscope, admitted that it has been under investigation by the Justice Department since 2011. The company may have violated the law by making improper payments to doctors and other customers.