The "superbug" outbreaks at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center have raised questions about the most effective way to decontaminate a particular type of medical device, called the duodenoscope.
It's a flexible, lighted tube that's threaded through the mouth, throat, and stomach, and into the small intestine. It's used in more than 500,000 endoscopic procedures every year. The procedure, known as ERCP, allows doctors to diagnose and treat problems in the bile and pancreatic ducts.
Do you have an ERCP surgery scheduled? If so, don't be alarmed.
These are critical, life-saving procedures, and the infectious complication rate of these procedures is only about one percent, according to the American Gastroenterological Association.
Still, following the highly publicized cases of antibiotic-resistant bacteria - known as Carbapenem-resistant Enterobacteriaceae, or CRE - at UCLA and Cedars, patient safety experts say there are a couple of steps that patients can take to ensure their surgery is as safe as possible.
"The patient needs to be educated, needs to know what questions to ask," says Larry Muscarella, a hospital safety expert and president of LFM Healthcare Solutions LLC. "If the patient doesn't ask the question, no one's going to answer them."
If your physician recommends the ERCP procedure, Lisa McGiffert, director of the Safe Patient Project at Consumers Union, says the first question to ask is: "Do I really need that?" In other words, is the procedure elective or can it be postponed until some of the concerns with the scopes are cleared up?
If the surgery is necessary, that's OK. But, Muscarella says, "I would ask the patient to talk with their physician about what assurances the hospital might be making to confirm that the instrument is safe, that it’s not contaminated with any of these pathogenic organisms."
Muscarella suggests asking pointed questions like: How is the facility cleaning and disinfecting the scopes? He says the cleaning procedure recommended by the device maker may not be sufficient.
McGiffert puts it even more bluntly: "If your doctor says, 'we follow the manufacturer's cleaning procedures,' that's the wrong answer," she says. "As a patient, you should say, 'what else are you doing?'"
The FDA is still recommending the ERCP procedure for people who need it. It recommends cleaning and disinfecting the scopes according to the manufacturer's instructions, and having a "comprehensive quality program in place for reprocessing duodenoscopes."
Still, in a recent letter to gastroenterologists and other medical professionals, the agency warned: "Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."
Above and beyond
Some hospitals are going beyond the manufacturer's recommending cleaning procedures: Some have started sterilizing the devices with a gas called ethylene oxide, Muscarella says. Others, he says, are cleaning and disinfecting the devices, and then biologically sampling them, to confirm that no bacteria are hiding in the device's nooks and crannies.
"It would be safe to proceed with the procedure if the hospital is practicing either of those mitigations," Muscarella says.
Both UCLA and Cedars say they have taken steps beyond the manufacturers' guidelines since learning of the links between the scopes and the superbug infection.
One more thing
If you're undergoing an ERCP procedure, Muscarella says you should ask at least one more question.
Before the surgery, you'll likely sign an informed consent form. During this process, he says, a patient can make requests of the hospital. For example, he says, if you're harmed during the procedure and an outbreak of CRE were to be discovered at a later date and the contaminated instrument was used during your procedure, you can request to be be notified.
The bottom line? He says, "undergo ERCP, but introduce some important checks and balances."