That finding highlighted a U.S. Food and Drug Administration safety communication issued earlier in the day about how the complex design of the endoscopes “causes challenges for cleaning and high-level disinfection.”
That FDA advisory was designed to raise awareness among health care professionals.
An internal review at the Ronald Reagan UCLA Medical Center found that the cleaning protocols set by the FDA and scope manufacturers still didn’t remove the superbug from the devices.
In fact, the superbug was “embedded” in the scopes even after cleaning, said Dr. Robert Cherry, chief medical and quality officer of the UCLA Health System.
Since that internal January 28 finding, the hospital is now using an additional new sterilization procedure that involves applying a gas to the scopes, hospital officials told reporters.
“There’s no risk,” Cherry added.
Changing national discussion
The hospital review found no deficiencies in its cleaning process of the scopes, said Dr. Zachary Rubin, medical director of clinical epidemiology and infection prevention at the UCLA hospital.
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The ERCP procedure involves a duodenoscope, a flexible, lighted tube that is threaded through the mouth, throat, stomach and into the top of the small intestine (the duodenum), the FDA said.
The device contains a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities. The device also has a movable “elevator” mechanism at the tip, the agency said.
Even meticulously cleaning the devices before high-level disinfection “may not entirely eliminate” the risk of transmitting infection, the FDA said.
“Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly,” the FDA said.
“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,” the FDA said.
From @CDCgov, risk of CRE infections #KindredCIS: pic.twitter.com/HQfhMgtSf0
CNN’s Debra Goldschmidt and John Bonifield contributed to this report.
