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ERCP Duodenoscopes

ERCP Duodenoscopes are a type of endoscope made by Olympus Corp., Pentax Medical and Fujifilm. Some patients have undergone duoendoscope procedures that resulted in serious illness or death.

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ERCP Duodenoscopes and Endoscopy

Duodenoscopes are often used during gastrointestinal endoscopy procedures.

Endoscopic Retrograde Cholangiopancreatography (ERCP), or side-viewing, duodenoscopes are reusable, nonrigid, illuminated tubes designed to be inserted into a patient’s mouth and sent down into the stomach to provide visualization of the duodenum, which is located on top of the intestines. 1

An ERCP duodenoscope is a type of endoscope used during an ERCP gastrointestinal endoscopy procedure. As with other endoscopes, the tube of an ERCP duodenoscope is hollow.

This permits contrast dye to be injected once the scope arrives at the duodenum, if the doctor performing the procedure feels dye is necessary for better visualization. It also allows other instruments to be carried within the tube, making it possible to perform biopsies or treat disease conditions.

However, unlike most other endoscopes, the ERCP duodenoscope contains a movable “elevator” mechanism at its tip. The purpose of the elevator is to adjust the tip positioning of the instruments carried through the tube.

This serves to make the ERCP duodenoscope a more versatile tool. For example, the elevator makes it possible to access ducts within the intestines in such a way as to facilitate treatment of problems that require drainage of fluids.

Use of ERCP Duodenoscopes

Procedures using ERCP duodenoscopes are performed approximately 500,000 times per year in the U.S. ERCP duodenoscopes allow doctors to perform several gastrointestinal procedures without the need for surgery. These procedures include fluid drainage from pancreatic and biliary ducts. Fluid can build up in these ducts as a result of cancer and gallstones.

These conditions can cause the ducts to become blocked. During an ERCP procedure these ducts can be drained and opened.

ERCP has evolved from a diagnostic procedure intended to detect gallstones, stenoses (a product of tumors), lesions, and other abnormalities in the ducts to, mainly, a procedure intended to treat those abnormalities. These ducts include common bile, cystic, hepatic and pancreatic.

Complexity of ERCP Duodenoscopes

ERCP duodenoscopes are complex reusable devices. This complexity and reusability are both benefits and serious drawbacks.

Because of this apparent inability to sufficiently clean the devices even after following manufacturer instructions, and the fact that these devices are designed to be reused, the potential to transmit bacteria from patient to patient is extremely problematic.

The complexity is a benefit because it allows ERCP procedures to be performed in an efficient manner. The reusability allows for hospitals to keep costs lower than they would be if a separate device had to be purchased for each patient. The complexity of these devices is a serious drawback because it apparently can prevent the device from being fully cleaned and disinfected or sterilized prior to reuse. The complex design appears to limit access to all surfaces that need cleaning and disinfecting or sterilizing.

Because of this apparent inability to sufficiently clean the devices even after following manufacturer instructions, and the fact that these devices are designed to be reused, the potential to transmit bacteria from patient to patient is extremely problematic.

For example, the manufacturer’s cleaning instructions direct that, as an initial cleaning step, the elevator area should be brushed. Unfortunately, the reach of a cleaning brush may be impeded because of the elevator mechanism’s moving parts. Consequently, the microscopic crevices in the device may be beyond the reach of the brush, causing the potential spread of bacteria from one patient to the next.

It is possible for these crevices to trap residual body fluids and organic debris that defy removal or eradication, even when following manufacturer cleaning instructions. If bacteria are present in the fluids or materials left behind, the device becomes contaminated, leaving subsequent patients vulnerable to risk of serious infections. In a recently issued Safety Communication, the U.S. Food and Drug Administration (FDA) attributed this shortcoming to what it characterizes as product design issues.

ERCP has evolved from a diagnostic procedure intended to detect gallstones, stenoses (a product of tumors), lesions, and other abnormalities in the ducts to, mainly, a procedure intended to treat those abnormalities.

510(k) Approval Process and Scopes

The ERCP duodenoscopes currently on the market are Class II medical devices and subject to the FDA’s 510(k) clearance program.

The 510(k) program allows a device to enter the market without first having undergone clinical trials if its manufacturer can prove it is substantially equivalent to another device already approved for use.

The program is intended to let medical device manufacturers quickly and economically bring to market a product similar to one that has been previously tested through clinical trials.

Unfortunately, this process carries inherent risks to consumers. For example, if the device already on the market suffers from a design flaw, it is likely the substantially similar newcomer contains that same design flaw or, possibly, one that is even worse.

If the device already on the market is flawed, it is possible no one will discover the shortcoming until post-market injuries start to occur, since long-term clinical trials are seldom conducted.

Importantly, what qualifies as substantial equivalence is a matter of potentially broad interpretation.
Therefore a product entering the market through the 510(k) program may not actually be like a predicate. As a result, the new device may contain design flaws not previously encountered.

Olympus’s ERCP Duodenoscopes

The dominant manufacturer of ERCP duodenoscopes is Olympus Corp. The company makes a family of these devices, including the EVIS EXERA II series.

The newest addition to the EVIS EXERA II line is the TJF-Q180V. In a March 4, 2015 Updated Information for Healthcare Providers Regarding Duodenoscopes, the FDA notes that the TJF-Q180V still has a 510(k) application pending for review although it is already being marketed by Olympus.

The other two manufacturers who sell ERCP duodenoscopes on the US market are Pentax Medical and Fujifilm.

Signs of CRE

However, doctors may suspect CRE if they see:

  • High fever

  • Sepsis

  • Septic shock

  • Pneumonia

  • Urinary tract infection

  • No response to antibiotics

ERCP Duodenoscope Complications

ERCP duodenoscopes are capable of harboring a potentially deadly strain of a rare antibiotic-resistant “superbug” bacterium, as well as other infections.

The especially deadly bacteria, known as carbapenem-resistant Enterobacteriaceae (CRE), can cause serious illness or death. CRE bacteria are resistant to the antibiotic carbapenem. 2

CRE is often grouped with E. coli and Klebsiella pneumonia because they share very similar genetic traits and, as a result, cause similar problems for patients.

Symptoms of CRE infections tend to be nonspecific and can appear weeks after initial infection, which can make diagnosis a challenge for physicians. CRE kills about half of those who become infected, once the bacteria enter the bloodstream or bladder.

Contamination and Infection from ERCP Scopes

On February 19, 2015, the FDA issued a Medical Devices Safety Alerts and Notices statement. In it, the agency disclosed findings of an engineering assessment it conducted into ERCP duodenoscopes. The FDA said it had “identified design issues” affecting these devices.

As a result of these design issues, the CRE superbug and other bacteria are believed to be surviving the manufacturer’s recommended cleaning and disinfecting or sanitizing processes. It is feared that these microorganisms are being spread from one patient to the next each time the ERCP duodenoscopes are reused.

Based on an examination of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which collects adverse event information and other data from healthcare providers, consumers and manufacturers, the FDA first received reports of potential contamination and infection traceable to ERCP duodenoscopes and sanitization problems in 2012.

Deaths and Serious Illnesses

In January 2015, seven patients who had undergone ERCP duodenoscope procedures at the UCLA Ronald Reagan Medical Center in Los Angeles developed symptoms of CRE.

Two of those patients died from their infections, according to news reports.

The CRE outbreak in Los Angeles was only the latest in a series of similar occurrences around the country. Other locations where CRE outbreaks linked to ERCP duodenoscopes occurred include Washington, Illinois and Pennsylvania.

Since 2012, as many as 150 patients were stricken by the CRE superbug following ERCP duodenoscope procedures.

On March 4, 2015 several news reports discussed a subsequent outbreak of CRE at Cedars-Sinai Medical Center in Los Angeles, in which at least four patients were infected and 67 others may have been exposed. An increase in infection rates of another drug-resistant “superbug” known as Beta-lactamase E. coli (ESBL) following ERCP procedures was also reported at Hartford Hospital in Connecticut.

FDA Actions

On February 19, 2015, the FDA issued a Medical Devices Safety Alert entitled “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication.”

This alert was intended to reach gastroenterologists, gastrointestinal surgeons, endoscopy nurses, endoscopy reprocessing unit staff, infection control practitioners, and patients considering ERCP procedures.

By issuing the alert, the FDA hoped to raise awareness of the problems in effectively reprocessing ERCP duodenoscopes because of their design issues. Meanwhile, the FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of CRE.

Between January 2013 and December 2014, the FDA received 75 Medical Device Reports relating to possible microbial transmission from reprocessed duodenoscopes. Because reporting is voluntary for healthcare professionals and consumers (though not medical device manufacturers) it is likely that not all cases have been reported to the FDA.

On March 4, 2015 the FDA issued Updated Information for Healthcare Providers Regarding Duodenoscopes in which the agency recommends informing patients of the possible risk of infection accompanying ERCP procedures and symptoms of infection that “should prompt additional follow-up” after an ERCP procedure.

The agency is continuing to evaluate information about documented and potential infections from multiple sources, including Medical Device Reports, journal articles and other medical literature, healthcare providers, professional medical societies, and the Centers for Disease Control and Prevention.

Scope Recalls and Lawsuits

As of March 1, 2015, no recalls of ERCP duodenoscopes have been initiated, either voluntarily by manufacturers or by government order.

An unknown number of lawsuits loom for the manufacturers of ERCP duodenoscopes.

As of February 26, 2015, two lawsuits had been filed against Olympus by patients infected with CRE after undergoing procedures in which the corporation’s ERCP duodenoscope was used.

  1. U.S. Food and Drug Administration, “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication,” Feb. 19, 2015, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm. Accessed March 2, 2015. 

  2. Medicinenet.com, “CRE Bacteria Infection (Carbapenem-Resistant Enterobacteriaceae),” http://www.medicinenet.com/cre_infection/article.htm. Accessed on March 2, 2015.