February 19, 2015 — After an outbreak of antibiotic-resistant infections was traced to ERCP endoscopes, the FDA has issued a warning that design flaws “may facilitate the spread of deadly bacteria.”
The Los Angeles Times reports the outbreak began last month at UCLA Ronald Reagan Medical Center.
Approximately 179 patients were exposed, seven were infected, and two have died. They were all treated with a medical scope that has a unique “elevator channel” that is very difficult to clean.
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.”
According to the FDA, cleaning the scope is a “a detailed, multi-step process,” and “[disinfecting] should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The device is a duodenoscope, which is a long, flexible tube that is threaded down a patient’s mouth, throat, stomach, and intestines to treat gastrointestinal diseases like gallstones and cancer.
All of the patients were infected with Carbapenem-resistant Enterobacteriaceae (CRE), which is a family of antibiotic-resistant germs that can cause deadly infections in 40-50% of victims.
The manufacturer of the scope, Olympus Corp., also reported that the Justice Department has been investigating them since 2011 for making improper payments to doctors and customers.