Duodenoscopes are hollow, flexible, lighted tubes that provide doctors with access to the top of a patient’s small intestine, or duodenum, in what is called an endoscopic retrograde cholangiopancreatography (ERCP) procedure. The instruments are critical to the diagnosis and treatment of severe, often life-threatening, diseases in the pancreas and bile ducts.
According to the U.S. Food and Drug Administration (FDA), the ERCP procedure is also “the least invasive way of draining fluids from pancreatic and biliary ducts” in patients with blockages caused by cancerous tumors, gallstones or other conditions.
Duodenoscopes are used in more than 500,000 ERCP procedures performed in the United States each year. They are complex devices that contain many small working parts, including a movable “elevator” (lever with a hinge) mechanism at the tip. This design is effective in allowing doctors to angle the scope into the pancreatic or bile duct, but it also presents difficulty in cleaning and high-level disinfection for reuse.
In late 2013, the FDA determined that despite health care professionals’ efforts to follow proper manufacturer cleaning and disinfection or sterilization instructions, residual body fluids and tissue from one patient can remain present in duodenoscopes. These fluids and other debris can be passed to subsequent patients and in some instances, lead to serious bacterial infections.
In 2015, following a safety communication, the FDA issued warning letters to the three duodenoscope manufacturers, citing them for failure to report problems with the scopes. Two of the manufacturers were also faulted with not properly ensuring the adequacy of the device’s cleaning procedures.
In 2016, the FDA announced that Olympus, the leading manufacturer of duodenoscopes, would be voluntarily recalling its original model of the device to make needed repairs. One of the corrective actions the company agreed to take was updating its reprocessing manual to include a new warning, which required all users to conduct all duodenoscopy precleaning and manual cleaning steps.
The recall came at the same time as the publication of a United States Senate report by the Health, Education, Labor and Pensions Committee entitled Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.
The report pointed to numerous failures by duodenoscope manufacturers and the FDA, including:
- Lack of reporting and timeliness or accuracy in reporting adverse events
- Lack of public or medical community awareness of an investigation into the spread of infection via the devices
- Problems with the FDA’s “outmoded” (outdated) adverse event device database
The report also noted that two of the manufacturers failed to meet requirements under the current regulatory system in that they did not seek FDA clearance prior to selling the “closed-channel” duodenoscopes in the U.S.
An endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that looks at a patient’s bile and pancreatic ducts to diagnose and treat diseases of the gallbladder, bile system, pancreas and liver. The procedure is used to treat gallstones, tumors, or narrowed or blocked sections of the bile ducts.
These obstructions and/or complications can occur due to the following conditions:
- Gallstones (small masses that form in the gallbladder and can get stuck in the bile duct)
- Trauma or surgical complications in bile or pancreatic ducts
- Tumors or cancers of the bile ducts
- Acute pancreatitis (inflammation of the pancreas)
- Chronic pancreatitis
- Pancreatic pseudocysts (fluid-filled sac in the abdomen)
- Tumors or cancers of the pancreas
When Is An ERCP Procedure Used?
ERCP procedures can be used as diagnostic tools and/or for the treatment of various conditions of the pancreas or bile ducts. Bile ducts are small tubes that carry bile from one’s liver to his or her gallbladder and duodenum (the first part – top – of the small intestine). Bile is made up of toxins and wastes extracted from the body by the liver and stored in the gallbladder. Bile also assists in the digestion of fats and fat-soluble vitamins such as vitamins A, D, E and K.
If gallstones become stuck in the bile duct and block the flow of bile, it may cause swelling in the gallbladder. As a result, patients might experience sharp abdominal pains, vomiting and indigestion.
Pancreatic ducts carry bodily fluids from the pancreas to the duodenum. Smaller pancreatic ducts empty juices into the main pancreatic duct, and this duct joins the bile duct prior to emptying into the duodenum.
Typically, a patient undergoes other noninvasive tests for diagnosis prior to having an ERCP performed.
An ERCP procedure may be used to:
- Open the entry of the ducts into the bowel (intestines)
- Remove or dissolve gallstones
- Diagnose certain conditions, such as biliary cholangitis or sclerosing cholangitis
- Stretch narrowing segments (called strictures) of the bile duct
- Take tissue samples (biopsies) to diagnose tumors of the pancreas, bile ducts or gallbladder
- Drain obstructed sections of the ducts
What is Biliary Cholangitis?
Primary biliary cholangitis (PBC) (formerly known as primary biliary cirrhosis) is an autoimmune disease, meaning it is caused by antibodies or lymphocytes that attack the body’s naturally present substances. PBC causes the slow progression of the destruction of a patient’s bile ducts. The disease starts as an inflammation in the bile ducts that eventually causes scarring and hardening resulting in damage to the liver.
Symptoms experienced in the initial stages of the condition may include fatigue, itching, abdominal pain, muscle and joint pain, dry mouth and eyes, and skin darkening. As the disease progresses, patients may experience yellowing of the skin, swelling of the legs and feet, an enlarged abdomen from fluid accumulation, thinning of the bones, and internal bleeding in the upper stomach and esophagus due to enlarged veins.
There is no cure for PBC. However, treatments have been successful in slowing the progression of the disease and managing symptoms associated with the condition.
What is Sclerosing Cholangitis?
Sclerosing cholangitis is the swelling (inflammation), scarring and deterioration of the bile ducts inside and outside the liver. It is a chronic (long-term) condition that slowly results in irreversible damage of the bile ducts.
The cause of primary sclerosing cholangitis (PSC) is usually unknown. However, it is more common in patients with autoimmune disorders and those with an inflamed pancreas or inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis. It is also more commonly seen in people who have sarcoidosis, a disease that causes inflammation throughout the body.
PSC is common in patients with autoimmune disorders and those with an inflamed pancreas or inflammatory bowel diseases.
PSC may also be caused by gallstones in the bile duct or infections in the liver, gallbladder and bile ducts. As bile accumulates in the liver due to swelling and/or obstructions, it damages liver cells and results in scar tissue and hardening of the organ. The scar tissue then continues to block drainage of bile and can lead to more infections.
In the early stages of this disease, most patients do not experience symptoms. As the disease progresses, people may experience fatigue, itching of the skin and yellowing of the eyes and skin. Other symptoms can include an enlarged liver or spleen, loss of appetite and weight loss, and fever, chills and abdominal pain if the bile ducts become infected.
PSC can lead to cancer of the bile ducts. Ultimately, many patients need a liver transplant.
What To Expect During the ERCP Procedure
ERCP procedures are performed at a hospital or an outpatient center. The patient is sedated by a sedative provided through an intravenous (IV) needle. An anesthetic is applied to the back of the throat to numb it and keep the patient from gagging during the procedure. In some instances, the patient receives general anesthesia.
The patient receives a mouthpiece that is placed in the mouth to keep it open. A special type of endoscope called a duodenoscope is threaded through the mouth, throat and stomach into the duodenum (top of the small intestine). A small camera at the end of the scope sends video images to a monitor as air is pumped into the duodenum to make it easier to see.
Contrast dye can be injected into the pancreatic or biliary ducts to take X-rays. The dye allows for a better view of the ducts.
Tiny tools can also be passed through the endoscope to do the following:
- Open blocked or narrowed ducts
- Remove or dissolve stones
- Perform biopsies or remove tumors
- Insert stents (tiny tubes) to keep narrowed ducts open or to stop bile leaks following gallbladder surgeries
Recovering After the ERCP Procedure
Most ERCP procedures take between one and two hours. Following the procedure, patients can expect to stay at the hospital or outpatient center for another one to two hours while the sedation or anesthesia wears off. Some patients may be required to stay overnight.
Patients can expect to experience some bloating and/or nausea for a short time following the procedure. A sore throat is also a common side effect of an ERCP procedure, and can typically last for up to four days.
Since most patients are still be somewhat sleepy following the procedure, it is recommended that someone else drive them home and stay with them for up to 24 hours after the ERCP is performed.
Patients should seek emergency medical help if they experience any of the following symptoms within 72 hours of the procedure:
- Severe abdominal pain and/or severe bloating
- Bleeding from the rectum or black stools
- Trouble breathing
- Continuous coughing
- Chest Pain
- Nausea and/or vomiting, especially if there is blood in the vomit or it looks like coffee grounds
- Difficulty swallowing or throat pain that persists or gets worse
Risks and Complications of an ERCP Procedure
The ERCP procedure is a minimally invasive one, but it is not without risks and complications. Sedation and anesthesia come with their own set of risks, and ERCP procedures with the use of a duodenoscope can result in complications, some of which can be serious and/or life-threatening.
Some risks associated with the procedure include:
- Reaction to the anesthesia, dye or drugs used during the procedure, including respiratory and cardiac problems
- Excessive bleeding
- Tissue damage from X-ray exposure
- Perforation (hole) in the bile or pancreatic ducts, or in the duodenum
- Inflammation (swelling) of the pancreas (pancreatitis)
Duodenoscopes Versus Endoscopes
Endoscopes are medical devices consisting of a thin flexible tube with a light and camera attached to the end. It is an instrument used by doctors in minimally invasive procedures designed to allow them to look at a specific body cavity or organ without having to resort to an open-body surgery.
Endoscopes usually enter the body through a natural opening such as the mouth or rectum. A medical procedure requiring the use of any type of endoscope is called an endoscopy. Some different types of procedures utilizing an endoscope may also be named according to what part of the body is being examined. For example, a bronchoscopy is a procedure performed to view the airways and treat or diagnose certain lung conditions.
Other types of procedures using endoscopes include colonoscopies (to look at the inside of the colon, or large intestine), cystoscopies (to examine the bladder and urethra – the passage through which urine flows from the body), and laryngoscopies (to view the larynx, or voice box).
A duodenoscope is an instrument that is only used for an endoscopic retrograde cholangiopancreatogram (ERCP). This type of scope is slightly different from an endoscope in that it has a lever with a hinge (elevator mechanism). This added feature makes it possible for a doctor to angle a small tube called a cannula into the pancreatic or bile ducts during an ERCP procedure.
Three manufacturers —Olympus America, Inc., Hoya Corp. (Pentax Life Care Division) and Fujifilm Medical Systems, U.S.A., Inc. —market duodenoscopes sold in the United States; although Olympus is said to control about 85 percent of that market. Overall, duodenoscopes are used in more than 500,000 ERCPs performed in the U.S. each year.
An endoscope can provide access to the esophagus, stomach and duodenum via an endoscopy or a procedure called an esophagogastroduodenoscopy (EGD). But the endoscope lacks the elevator mechanism made of moving parts for better maneuvering.
However, the added hinge mechanism has been found to be difficult to clean. While these scopes were designed with the intent to seal off the device’s elevator wire channel from organic debris in the patient’s body, they instead proved to be too difficult to clean and sterilize efficiently. The movable part contains microscopic crevices that the FDA noted cannot be reached with a cleaning brush.
Even when following the guidelines issued by the manufacturer for appropriate cleaning and disinfection, the duodenoscope has been found to harbor bacteria sometimes contained in residual body fluids and organic debris from prior patients that is passed along to subsequent patients during reprocessing (reuse), resulting in infection.
FDA Warnings and Recalls
The FDA published a safety communication in February 2015, advising that the design of duodenoscopes used in ERCP procedures may cause difficulty in effective cleaning of the device. The FDA recommended that users closely follow all manufacturer instructions for cleaning and reprocessing.
Additionally, the FDA provided some “general best practices” for more efficient cleaning, such as raising and lowering the elevator throughout the manual cleaning process, as well as a recommendation to health care providers to inform patients of the benefits and risks associated with the use of the device in an ERCP procedure.
From January 2013 through December 2014, the agency had already received 75 Medical Device Reports (MDRs) involving 135 patients in the U.S. potentially affected by microbial transmission from reprocessed duodenoscopes. The FDA said in its communication that it “is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents.”
In August 2015, the FDA issued warning letters to each of the three manufacturers of duodenoscopes citing them for numerous violations, including two of the manufacturers (Fujifilm and Pentax) marketing and selling their devices without proper FDA clearance to do so. Olympus was previously cited for the same regulatory offense in March 2014.
FDA investigators found that Fujifilm’s methods used in manufacture, packing, storage and installation of its device were not in conformity with the current good manufacturing practice requirements. Pentax was charged with the same offense and both companies were also faulted for failing to establish and maintain design validation procedures.
Olympus was additionally cited for failing to report to the FDA no later than 30 days following the discovery of information that its device may have caused or contributed to a death or serious injury.
In October 2015, the FDA also ordered the three duodenoscope manufacturers to conduct post-market surveillance studies “to better understand how the devices are reprocessed in real-world settings.” The FDA noted that reprocessing is very detailed, labor-intensive and time-consuming, and that errors can occur due to several variables that impact the process.
The FDA pointed out that staff, availability of training, availability of equipment and access to the manufacturer’s instructions are some of the many challenges facing individual health care facilities that can impact the effectiveness of reprocessing reusable medical devices.
Recalls and Market Withdrawals
In March 2015, the FDA issued a safety communication to relay the validated instructions for cleaning and disinfecting Olympus’ duodenoscope model TJF-Q180V while the manufacturer’s pre-market application (submitted to demonstrate the safety and efficacy of the device) for a design modification was still under review.
In January 2016, Olympus initiated a voluntary recall of its original duodenoscope model TJF-Q180V to replace the elevator channel sealing mechanism after receiving clearance from the FDA. The FDA reported that the new mechanism “is designed to reduce the risk of fluid leakage into the elevator channel.”
The company estimated that the mechanism would be fixed in approximately 4,400 models used in health care facilities throughout the U.S. by August 2016. While waiting for the repairs, health care providers were advised by the FDA that they could continue to use the allegedly defective device, but that they should “meticulously follow the manufacturer’s reprocessing instructions.”
In January 2017, the FDA announced that Fujifilm was removing certain older duodenoscope models from clinical use, including its legacy 250/450 models, Fuji ED-250XLS, ED-250XT5, ED-450XL5 and ED-450XT5. The manufacturer explained in its customer notification letter that the older models would be replaced with the ED-530XT model.
No Duodenoscope Alternative
Despite clear design flaws, alleged regulatory violations and resulting CRE infections, the duodenoscope is the only device that currently exists in the U.S. market for use in ERCP procedures.
The CDC reported that ERCPs are important and potentially lifesaving medical procedures for most patients and that the use of duodenoscopes can potentially avoid the need for more invasive surgical procedures.
Since no alternative devices currently exist for use in ERCPs, the FDA stated that it “believes at this time that the continued availability of duodenoscopes is in the best interest of the public health.”
Flaws in Device Monitoring and Oversight
The United States Senate, Health, Education, Labor and Pensions Committee issued a report on January 13, 2016, titled Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.
The report’s executive summary immediately points out that while two hospitals in 2013 notified the manufacturers and the FDA that closed-channel duodenoscopes remained contaminated even after proper cleaning, it took the companies and the agency over a year to alert the health care community and the general public. Senate staff confirmed that at least 68 patients in seven different hospitals across the U.S. were infected during that time period.
The report also noted that at least 16 separate hospitals failed to report infections traced directly to duodenoscopes to federal regulators and device manufacturers. When adverse events were reported it was often done in an untimely manner, notification was given informally, and the reports were not inclusive of all necessary information required for the manufacturers to submit their own accurate and complete reports to the FDA.
Senate staff investigations found that Olympus had knowledge of two independent lab reports that showed the duodenoscope model to harbor and spread bacteria even after appropriate cleaning.
Senate staff investigations found that by early 2013, Olympus had knowledge of two independent lab reports that showed the potential for the closed-channel duodenoscope model to harbor and spread bacteria even after appropriate cleaning measures had been taken. The manufacturer never informed the FDA, and hospitals, physicians and patients were not made aware of the risk of infection until early 2015.
The report stated that the FDA “wasted valuable time” seeking cleaning data from manufacturers trying to conclusively determine that mistakes made by hospital staff in carrying out cleaning procedures were not the reason for the transfer of bacteria and resulting patient infections.
Senate staff concluded in its report, “The failure of FDA’s current device safety reporting system to rapidly identify duodenoscope-related, antibiotic-resistant infections, including superbug infections, should serve as warning that without a comprehensive postmarket device surveillance system that supplements self-reporting from hospitals and manufacturers, future device system issues are likely to go undetected for far too long and with life-threatening consequences.”
Senate’s report recommended that the FDA “quickly evaluate the design of closed-channel duodenoscopes and implement a phased recall to fix or modify the devices if necessary.”
It was also recommended that information of potential compromises to patient safety be distributed to the public in a timely manner, or when the agency first becomes aware of such information.
Olympus Warned Europe, Not U.S.
As far back as January 2013, Olympus knew the TJF-Q180V duodenoscope — the same model involved in the California superbug controversy — was difficult to clean. That month it sent out an “Important Safety Advice” notice to European hospitals in response to a “reported case of a contaminated Olympus Video-Duodenoscope TJFQ180V.”
The notice warns that the scopes have to “undergo detailed preparation and inspection before patient use.” Attached to the letter is a detailed quick reference for proper pre-cleaning and reprocessing of the scope.
In August 2014, Olympus sent another communication to European hospitals and urgent “field safety corrective action.” This letter addressed “a few complaints of residual debris in the distal end of the TJF Q180V duodenoscope” and “prevention of cross infection among patients.”
The company recommended an additional cleaning brush and cleaning around specific parts at the tip of the device, “around the forceps elevator.” It also updated the cleaning manual.
Olympus Corp., the manufacturer of the scrutinized endoscope, did not take action in the U.S. until after the February 2015 outbreak at UCLA and Cedars-Sinai medical centers. After seven patients were sickened and two died, the manufacturer issued alerts. By then, about 200 more patients may have also been infected at UCLA, and many more could have been infected in hospitals across the country.
Later, it learned an outbreak in October 2014 in Seattle was linked to the same model scope. This outbreak also occurred after Olympus’s European warnings.