Intestinal Scopes Linked to Deadly Infection

Las Vegas, NVIn February 2015, officials at UCLA Ronald Reagan Medical Center reported that seven patients at the hospital were infected and two died after being infected with a deadly superbug embedded in a type of medical device known as a duodenoscope (or ERCP endoscope) used to investigate patients with gastrointestinal complaints.

The superbug, carbapenem-resistant enterobacteriaceae, or CRE, is extremely resistant to all types of antibiotics. CRE is commonly found in hospitals and spreads easily to immune-compromised patients; however, it can also be deadly in healthy patients as well.

Known as the new superbug, CRE is easily transferred to patients through non-disinfected surfaces, medical cabinets and portable medical equipment such as x-ray machines, or through improper sterilization of medical devices like endoscopes.

According to the literature, 50 percent of those who contract CRE will die.

The duodenoscopes are extremely complex devices with thin tubes that are inserted through the mouth to the liver and small intestine.

Several lawsuits have already been filed against Olympus, the maker of the Q180V duodenoscope, the main supplier of the device in the United States. Lawyer Kevin Boyle, from the firm of Panish, Shea & Boyle believes this is just the tip of the iceberg.

“We have three cases that we are working on right now,” Boyle told lawyers at the Consumer Attorneys Association of Los Angeles (CAALA) in Las Vegas in September 2015. “We have the case of a 14-year-old boy who went into the hospital and was scoped in a routine investigation for pancreatitis. He ended up with a CRE infection and spent eight months in the hospital. He almost died.

“We also have two deaths related to duodenoscope CRE infections. One was an 11-year-old boy and the other was a 41-year-old wife and mother who had a scope for a clogged bile duct,” added Boyle.

The suits against Olympus allege that the design of the scope was changed but the company failed to advise users that it required a new, highly specialized type of sterilization protocol between uses. It is alleged that, as a result, CRE remained embedded in the complex, multipart scopes and was transferred to some patients.

In the spring of 2015, following the UCLA Ronald Reagan Medical Center revelations that CRE infections had been tracked back to its Olympus Q108V scopes, the company issued new instructions for cleaning the scopes.

The FDA is currently tracking cases of CRE especially with respect to any connection to Olympus duodenoscopes. In a February 2015 Safety Communication, the FDA wrote, “The complex design of the ERCP endoscopes may impede effective reprocessing.”

Reprocessing means a detailed sterilization method.

The communication went on to say, “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.”

Olympus has issued a number of statements regarding problems with the Q180V scope. The company points out that 500,000 ERCP scopes are done annually in the US with few reported problems. Olympus also maintains it followed necessary information procedures to the best of its ability and has expressed sympathy to those that may have been affected by CRE.

Two other companies, Fujifilm and Pentax, sell similar scopes in the United States. The focus of the investigation remains on Olympus.