Endoscopic retrograde cholangiopancreatography procedures and the duodenoscopes used in them are considered to be a safe, cost-effective alternative to surgery on the digestive system. But officials have recently determined the difficult-to-clean scopes are the cause of several deadly outbreaks of antibiotic-resistant infections.
A duodenoscope is a medical tool used to noninvasively examine the duodenum, or small intestine. The scope is a flexible tube with a light and camera on the end. Duodenoscopes are commonly used in procedures called endoscopic retrograde cholangiopancreatography or ERCP, a pancreatobiliary — pancreas, bile duct and gall bladder — procedure doctors began using 40 years ago. Duodenoscopes were first invented in the late 1960s and are used in an excess of 700,000 ERCP procedures each year.
To use the scope, a doctor must thread the device through a patient’s mouth, throat and stomach to reach the duodenum — the first part of the small intestine. The light and camera on the end of the scope allow the doctor to see inside a patient, and the hollow scope gives them the ability to insert other medical tools such as catheters. Used in conjunction with X-rays and other noninvasive scans, doctors can remove gallstones, heal pancreatitis, drain bile ducts and treat other conditions during an ERCP.
Each duodenoscope costs between $40,000 – $80,000. According to one study of a hospital ERCP unit, each ERCP procedure costs an average of $743, varying more or less depending on if the procedure is diagnostic or therapeutic. The average insurance reimbursement to the hospital was $221 per procedure.
Controversy surrounded duodenoscopes beginning in 2010 when scientists linked the outbreak of rare and often deadly antibiotic-resistant infections or “superbugs” to the scopes. Independent studies revealed device design continued to blood and tissue getting trapped in microscopic, difficult-to-clean crevices causing the patient-to-patient spread of infection.
There are three main manufacturers of duodenoscopes:
- Olympus America, Inc., with U.S. headquarters in Center Valley, PA
- Hoya Corp., the parent of Pentax Life Care Division, with Pentax endoscope headquarters in Montvale, NJ
- Fujifilm Medical Systems, USA, Inc., with headquarters in Stamford, CT
Many ERCP patients and their loved ones have sued these manufacturers — particularly Olympus, which manufactures 85 percent of the duodenoscopes in America — for defective product design and negligence in failing to provide hospitals with comprehensive cleaning guides.
ERCP Test Procedure
Endoscopic retrograde cholangiopancreatography is used to access the duodenum, or upper part of the small intestine, which in turn provides access to the pancreas, liver and gallbladder. Several drainage tubes called ducts connect the duodenum with these organs. When the body is functioning normally, these ducts drain fluid into the bowel, but certain conditions can obstruct this function. Doctors typically use endoscopic ultrasound, CT scans or other scans to identify problems in the pancreatobiliary system before determining whether an ERCP is necessary. Certain symptoms or conditions may indicate a need for an ERCP.
Some ERCP indications include:
- Choledocholithiasis, or gallstones
- Acute pancreatitis, or sudden inflammation of the pancreas
- Chronic pancreatitis, or long-term inflammation of the pancreas
- Pancreatic divisum, when the pancreatic duct exists as two ducts rather than one
- Pancreatic or biliary cancer
ERCP is the most noninvasive method to diagnose or treat these indications, which is why both doctors and patients prefer the procedure over painful, lengthy, expensive and possibly dangerous surgery. ERCP during pregnancy is very popular, for example, because it allows doctors to treat common conditions such as acute pancreatitis that are associated with pregnancy without endangering the fetus.
|Common Duodenoscopes By Manufacturer and Model|
|Olympus||EVIS EXERA: TJF-160F|
|EVIS EXERA: TJF-160VF|
|EVIS EXERA II: TJF-Q180V|
What to Expect During an ERCP
An ERCP involves two pieces of equipment — a duodenoscope and an X-ray machine. For this reason, doctors perform ERCPs while the patient lies on an X-ray table. The specially trained doctors who perform these procedures are called gastrointestinal endoscopists.
Before the procedure, patients are required to fast for at least six hours so the stomach is empty. Patients are sedated for an ERCP, both intravenously and locally at the back of the throat to dull the gag reflex. Most ERCPs take one hour to complete, and patients are monitored for an additional one or two hours at the hospital before they are allowed to go home.
During an ERCP, the doctor will pass a duodenoscope through the patient’s mouth, esophagus and stomach into the duodenum. Once the duodenoscope is in place, the doctor inserts a catheter through the scope and injects dye. An X-ray identifies the obstruction of the pancreatic or biliary ducts.
At this time, the doctor may insert another tool through the scope to:
- Perform a biopsy, or take a tissue sample
- Remove a gallstone
- Insert a stent
ERCP Complications and Risks
Although ERCP is generally less risky than gastrointestinal surgery, the procedure still carries risks of complication. Most of these complications are not life-threatening, but some can be if left untreated.
Complications of ERCP include:
- Perforation of the duodenum
- Failure to retrieve the gallstone
- Allergic reaction to the sedatives
- Stent occlusion, or blockage
- Formation of pseudocysts
- Pancreatic duct obstruction
If a patient feels ill immediately after their ERCP — anywhere from one day to two weeks after the procedure — the patient should contact their doctor right away. They may have experienced a complication from the procedure that could require further treatment.
Symptoms of ERCP complications include:
- Abdominal pain
- Rectal bleeding
Serious Infections Caused by ERCP Duodenoscopes
Of all the possible side effects from ERCP, infection can be the most dangerous. While an ordinary infection can threaten a person’s life if it spreads through the bloodstream, doctors can use antibiotics to treat that infection with almost universal success. However, in recent years duodenoscopes have been linked to the spread of antibiotic-resistant infections that have remarkably high mortality rates. These infections are commonly called “superbugs” because the bacteria have evolved to resist drugs that normally would destroy them.
A recent string of superbug infections began popping up across America in 2012, infecting and killing patients in Washington, Pennsylvania, Illinois, Florida and California. The U.S. Centers for Disease Control and Prevention first notified the U.S. Food and Drug Administration of a potential correlation between these superbugs and duodenoscopes in 2013.
|Superbug Outbreaks Related to Duodenoscopes|
|Date||Location||Number of patients infected||Number of patients who died|
|2008||Highlands County, Florida||70||22|
|2012||Charlotte County, Florida||22||7|
|Dec. 2012||University of Pittsburgh Medical Center, Pennsylvania||18|
|Nov. 2013||Virginia Mason Medical Center, Washington||32||11|
|Jan. 2014||Advocate Lutheran General Hospital, Illinois||44|
|Oct. 2014||University of California Los Angeles Ronald Reagan Medical Center, California||7||2|
|March 2015||Cedars-Sinai Medical Center, California||4||1|
|Aug. 2015||Huntington Memorial Hospital, California||3|
Independently ordered investigations of duodenoscopes revealed a movable piece of the device near the tip called the elevator mechanism is nearly impossible to clean, allowing for blood and infected tissue to spread from patient to patient.
Examples of superbugs spread through the use of duodenoscopes are:
- Carbapenem-resistant enterobacteriaceae
- Acinetobacter baumannii
- Klebsiella pneumoniae
- Pseudomonas aeruginosa
In January 2016, during the height of government investigation of the issue, the FDA had received 319 reports of infection or other problems related to use of the duodenoscopes. Of those complaints, 273 were from procedures involving Olympus scopes, 42 were from procedures using Pentax scopes and four were linked to Fujifilm scopes.
CRE are a category of antibiotic-resistant bacteria, which are also commonly called superbugs. CRE are notoriously difficult to treat and kill nearly 50 percent of those infected. CRE are typically spread in healthcare facilities such as hospitals — what medical professionals call nosocomial infections.
The a. baumannii is a nosocomial bacteria. A. baumannii can cause pneumonia, bloodstream infections, meningitis, wound infections and urinary tract infections. Roughly 63 percent of acinetobacter strains are considered to be superbugs because they are antibiotic resistant. Doctors can only treat a. baumannii after running drug susceptibility tests. Contaminated duodenoscopes have been linked to the spread of NDM-1 carbapenemase-producing a. baumannii.
K. pneumoniae is a bacteria that normally lives in the human intestines where it does not cause infection. If spread to other areas of the body, k. pneumoniae can cause pneumonia, meningitis, urinary tract infections, wound infections and bloodstream infections. This bacteria is nosocomial. Antibiotic-resistant klebsiella pneumoniae, technically called carbapenem-resistant klebsiella, can only be treated using a combination of strong antibiotics. Each year, this bacteria infects nearly 8,000 people in the United States and causes more than 500 deaths. Strains linked to contaminated duodenoscopes include ESBL-producing k. pneumoniae and VIM-producing k. pneumoniae.
P. aeruginosa is a bacteria that can cause bloodstream infections, pneumonia, urinary tract infections and surgical wounds infections. It’s a nosocomial infection, but a person can also be infected after drinking contaminated water. Carbapenem-resistant p. aeruginosa causes about 400 deaths in the U.S. each year. The superbug strain of the bacteria linked to duodenoscopes is KPC-producing p. aeruginosa.
ERCP Infection Symptoms
Although ERCP patients can contract a variety of conditions from contaminated duodenoscopes, they all lead to similar infections and therefore similar symptoms. However, with superbug strains an infection is not as harmless as it may appear, as these infections are notoriously difficult to treat.
Symptoms of superbug infections include:
- Body aches
- Decreased urination
- Nausea and vomiting
- Rapid pulse
- Dizziness or lightheadedness
- Cough, sometimes with yellow, green or bloody mucus
- Painful urination
- Bloody urine
- Inflamed wound sites
Infection Diagnosis and Treatment
Superbugs are incredibly difficult to treat because the bacteria has mutated to resist antibiotics. There are a limited number of antibiotics that work on on superbugs, and even when combined with other “last resort” antibiotics, these measures don’t always save a patient’s life.
Some drugs used to treat superbugs are:
FDA Warnings and Recalls
Since it was first informed of a possible link between the superbug outbreaks and duodenoscopes, the FDA has been heavily involved in reviewing and reforming duodenoscope design and cleaning practices.
In 2014, following the UCLA outbreaks, the FDA issued a safety communication explaining thorough disinfecting of duodenoscopes still may not eliminate the risk of spreading infections between patients. It did not recommend hospitals discontinue use of the devices, however.
Following the outbreak, investigative news reports revealed that one Olympus duodenoscope linked to the superbug outbreaks was never approved by the FDA in the first place. The company told the Philadelphia Inquirer it never sought approval from the FDA for its 2010 remodeled scope because the design was not significantly different from the previous FDA-approved model.
In March 2014, the FDA notified Olympus it had to submit the model — TJF-Q180V — for additional clearance, which it did not do until seven months later. In March 2015, the FDA issued a safety communication with updated cleaning instructions for the devices. Meanwhile, in October of that year, the agency ordered all three manufacturers to conduct “postmarket surveillance studies to better understand how the devices are reprocesses in real-world settings.”
In January 2016, the FDA cleared the Olympus TJF-Q180V with design modifications, at which point Olympus initiated a recall to replace the difficult-to-clean elevator channel. Pentax never recalled its scopes, but rather resubmitted new FDA-approved cleaning instructions to medical professionals in February 2016. Fujifilm also never recalled its devices, but similarly submitted FDA-approved cleaning instructions to medical professionals in December 2015.
The antibiotic-resistant infection outbreaks have affected many American families — thousands were potentially exposed to the infection, hundreds contracted infections and dozens died as a result of contaminated duodenoscopes. As a result, many have sought justice against the duodenoscope manufacturing companies for wrongful death, negligence and for knowingly marketing a defective product. As these cases make their way through the courts, attorneys are continually accepting new superbug cases.
One family is suing Olympus after their son died following an ERCP at UCLA’s Ronald Reagan Medical Center. Jeffrey Hughes, 11, developed a CRE after undergoing a procedure using a duodenoscope during the Los Angeles outbreak. He had been fighting cancer for three years and his weakened immune system made him more susceptible to the infection. The case is ongoing in California federal courts.
Theresa Bigler is also suing Olympus for wrongful death. Her husband, Richard, was one of 11 who died after contracting a CRE following a procedure that used a duodenoscope at Virginia Mason Medical Center in Washington. Her complaint also alleges the hospital chose to not tell the family Bigler had contracted an infection from the contaminated scope, and if successful will force the hospital to inform the other 31 families affected.
In a third case, North Carolina widow Carla Warner is suing Olympus after the death of her husband, Bill, in 2013. He was treated with one of the company’s duodenoscopes and died of an infection. The federal court case alleges wrongful death.