ERCP – or endoscopic retrograde cholangiopancreatography – is a complex medical procedure used to diagnose and treat diseases and problems in the digestive system including the liver, pancreas, and gallbladder.
What Happens During an ERCP?
During an ERCP procedure, a gastroenterologist inserts a long flexible medical device called a duodenoscope into the patients mouth. The device is then directed through the back of the throat, down the esophagus and stomach, and into the duodenum. From there the duodenoscope sends digital video images back to the gastroenterologist to help him or her diagnose problems or perform therapies – such as removing stones in bile ducts or relieving obstructions.
The procedure is uncomfortable, but not painful, and is performed under intravenous sedation, typically without general anesthetic. Over 500,000 ERCP procedures are performed each year in the hospitals all over the United States, and there are typically a very low incidence of complications.
However, over the last year, ERCP procedures have been linked to multiple outbreaks of deadly CRE bacterial infections. CRE – or carbapenum-resistant Enterobacteriaceae – has been labeled as a “nightmare superbug” and can be fatal in up to 50 percent of those infected. In fact, outbreaks have killed over a dozen people in Seattle and Los Angeles alone.
How Would CRE Bacteria Be Transmitted During ERCP?
Because the instrument used in ERCP procedures – the duodenoscope – is not disposable, it is used on multiple patients. That means that after one procedure is performed the duodenoscope is sterilized (in a process called reprocessing) and then used again on another patient.
If the sterilization process is successful and all the bacteria is killed, this would not be a problem. However, sometimes – especially with Olympus duodenoscopes – residual body fluids and other organic debris remain in crevices. If these fluids and debris contain CRE bacterial contamination, the next patient that undergoes an ERCP procedure with that endoscope will be exposed to a CRE superbug infection.
How Often does this Happen?
Right now, it’s very difficult to tell exactly how many CRE superbug infections are transmitted during ERCP procedures. The reason is that CRE outbreaks have not been thoroughly kept track of. There is no reliable national data on the scope of the CRE problem, let alone on how often infections are a result of ERCP procedures. The CDC is urging states to track and report cases, but even when they do, methodologies and accuracy vary making it almost impossible to get a clear view of the problem.
However, more and more recent CRE outbreaks are being attributed to ERCP procedures.
In February of 2015, over 180 patients were exposed to CRE superbug bacteria after undergoing ERCP procedures at the Ronald Reagan UCLA Medical Center.
But ERCP superbug outbreaks are not limited to UCLA. 64 patients were exposed at Cedars Sinai Medical Center, five people where infected in Wisconsin in 2013, and 32 people were infected at Virgina Mason Medical Center in Seattle.
Who is responsible for these ERCP CRE Infections?
In a word, the manufacturer. The recent ERCP superbug outbreaks have all been linked to Olympus TJF-Q180V duodenoscope. In these recent cases, the hospital and doctors were performing necessary medical procedures and following sterilization guidelines that were provided to them by Olympus.
What should I do if I have had an ERCP or am scheduled to have one?
First of all, if you are scheduled to have an ERCP you should NOT cancel it. More than likely you have a serious problem or disease that needs to be treated and an ERCP can be lifesaving. However, you should arm yourself with knowledge and ask the right questions.
Find out what manufacturer makes the duodenoscope that will be used in your procedure. If it is an Olympus TJF-Q180V (this is the model linked to the most recent outbreaks), find out how they are cleaned and if they are taking any extra precautions with them.
Show your doctor the FDA advisory recommending additional cleaning practices (although if your gastroenterologist hasn’t seen this advisory you may consider finding a new one).
If you have already had an ERCP, contact your doctor or the hospital where you underwent the procedure. More than likely, any hospitals that have seen a CRE outbreak have reviewed patient records and contacted those who have been exposed. However, new cases are coming to light almost every week.
If you think you may have been exposed to or infected by CRE bacteria after an ERCP procedure at any hospital in the United States, contact us to seek legal advice and medical help. People have died from CRE infection after this procedure, don’t delay. Your life may depend on it.