A duodenoscope is a type of endoscope that is used to visualize the duodenum, the upper part of the small intestine. The duodenoscope has a long, flexible tube with a light and a camera at the end. It is inserted through the mouth and passed through the stomach and into the duodenum.
The camera allows the doctor to see the inside of the duodenum and take pictures or videos. The duodenoscope is also equipped with a tool that can be used to take biopsies (samples of tissue) or remove polyps (growths) from the duodenum.
Doctors use duodenoscopes to perform more than 500,000 procedures each year as a less invasive way to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other gastrointestinal conditions.
History of the Duodenoscope
The first duodenoscope was designed in the early 1900s and was known as the Röntgen-Welch duodenoscope. This early version of the duodenoscope was difficult to use and had a number of drawbacks.
In the 1960s, a new type of duodenoscope was developed that was easier to use and more effective. This new duodenoscope, known as the fiberoptic duodenoscope, revolutionized the field of gastroenterology. The fiberoptic duodenoscope allowed doctors to see inside the duodenum without having to make a large incision in the abdomen.
The fiberoptic duodenoscope quickly became the standard of care for diagnosing and treating disorders of the duodenum. Today, there are several different types of duodenoscopes on the market, but the fiberoptic duodenoscope remains the gold standard.
There are several companies that manufacture duodenoscopes, including Olympus, Pentax, Fujifilm, and Boston Scientific. Duodenoscopes are used in a procedure called endoscopic retrograde cholangiopancreatography (ERCP), which is used to diagnose and treat problems of the biliary system (the system that includes the gallbladder, bile ducts, and pancreas).
ERCP is a procedure that is performed using a duodenoscope. The doctor inserts the duodenoscope through the mouth and stomach into the duodenum. Then, the doctor injects a contrast dye into the bile ducts. The dye allows the doctor to see the biliary system on x-ray. The doctor can then diagnose and treat problems of the biliary system, such as blockages, gallstones, and pancreatitis.
What Was Behind the Recall of Duodenoscopes?
Starting in 2010, medical facilities began to report “superbug” infections of multi-drug resistant bacteria, most commonly carbapenem-resistant Enterobacteriae or CRE, which causes serious illness and a high risk of death.
A subsequent investigation led by The United States Senate Health, Education, Labor, and Pensions Committee (HELP) found that between 2010 and 2015, more than 400 patients were infected after undergoing treatment with duodenoscopes, with many more exposed, and several people dying.
Superbug breakouts occurred in 36 hospitals across the country, with most reporting CRE infections caused by duodenoscopes that were used for procedures that diagnose and treat diseases that affect the bile and pancreatic ducts.
Olympus sells about 80% of all duodenoscopes on the market, so the majority of lawsuits have focused on that brand, however, there have been other manufacturers being sued as well, such as Pentax and Fujifilm.
There have been several recalls of duodenoscopes in recent years. In 2013, Olympus issued a recall of its TJF-Q180V duodenoscopes after it was found that the devices could retain bacteria and transmit infections. In 2015, Pentax issued a recall of its ED-3490TX duodenoscopes after it was found that the devices could also retain bacteria and transmit infections. In 2016, Fujifilm issued a recall of its DU-145 and DU-150 duodenoscopes after it was found that the devices could also retain bacteria and transmit infections.
The FDA reported that from January 2013 to December 2014, it received 75 reports from medical facilities concerning about 135 patients who had suffered a possible infection from duodenoscopes. The FDA said it will continue to monitor the reported link between duodenoscopes and infections.
In 2013, the Food and Drug Administration (FDA) was alerted to a potential connection between drug-resistant bacteria and duodenoscopes. Despite confirmation that medical professionals were using the devices as intended and instructed, investigations showed it was clear that the cases of bacterial infection were occurring even though the devices were cleaned according to manufacturer’s instructions.
In the release of a new Safety Communication, the FDA alerted health care facilities that Pentax was issuing a voluntary recall of the Pentax ED-3490TX duodenoscope to make changes to the device’s design to help medical professionals better clean and disinfect devices. The manufacturer submitted design changes for the scope, building a new elevator channel sealing mechanism at the top of the scope.
The FDA cleared the changes for the Pentax model, with the design change intending to prevent the seepage of body fluids and bacteria into the small crevices of the device that make it difficult to clean properly. The design flaw was found to be a source of infection transmission between patients, as the devices are reused after cleaning.
The agency also worked with the company on its corrective action to remove the older model from health care facilities to make the necessary modifications to the scope’s design.
In February 2016, the FDA issued a Safety Communication and Pentax issued updated, validated manual reprocessing instructions for the ED-3490TK duodenoscope to replace those provided in the original device labeling.
In January 2017, the FDA updated the Safety Communication to warn that cracks and gaps in the adhesive that seals the ED-3490TK distal cap to its distal tip can occur, which can lead to microbial and fluid seepage. The recall and new device design cleared today are intended to address these safety issues.
March 2014 – Although their product was not approved for release to the market, the FDA notified Olympus that they needed to submit a premarket notification, called a 510(k), for their “closed” elevator channel model.
The FDA sent a letter to Olympus indicating that the design changes that resulted in a “closed” elevator channel were important to the safe use of the device. Olympus subsequently responded by submitting a 510(k) for their model TJF-Q180V with a newly designed mechanism that took into consideration the improved closed channel design, which the FDA approved.
March 2015 – The FDA issued another Safety Communication to put forth validated instructions for the cleaning and disinfection of the Olympus scope. The validated instructions for cleaning and reuse of duodenoscopes issued in 2015, while the Olympus 510(k) was still under review, remain the same instructions that are in place today.
On February 7, 2018, the FDA released the following statement:
Even after it was reported that people died as a result of contaminated scopes, the Los Angeles Times reported in 2015 that Olympus refused to replace the tainted medical scopes at UCLA’s Ronald Reagan Medical Center, and instead, offered to sell them 35 new scopes at a 28% price increase.
History of Lawsuits
There has been a recent spate of lawsuits filed against Olympus, the Japanese manufacturer of duodenoscopes. The lawsuits allege that the company’s duodenoscopes- which are used to treat pancreatic and biliary diseases- are defective and have caused patients to contract life-threatening infections.
One of the most prominent cases was that of Steven Johnson, who sued Olympus after he contracted a drug-resistant superbug known as CRE while undergoing a routine endoscopic procedure. Johnson’s lawsuit alleges that Olympus knew about the risks associated with their duodenoscopes, but failed to warn patients or properly disinfect the devices between uses.
Other lawsuits have been filed by patients who contracted hepatitis C or other serious infections after undergoing endoscopic procedures. Some of these patients have died as a result of their infections.
Olympus has denied any wrongdoing, and has blamed the infections on the hospitals where the procedures were performed. However, many experts say that the design of the duodenoscopes is to blame, as the devices are difficult to clean and disinfect properly.
The FDA has issued a warning about the potential risks associated with duodenoscopes, and has urged hospitals to take extra steps to ensure that the devices are properly cleaned and disinfected. However, many patients who have been infected with superbugs say that it is too late for them, and that they will never be able to trust Olympus or any other medical manufacturer again.
Settlements and Fines
In 2014, Antonia Torres Cerda was treated at Ronald Reagan UCLA Medical Center with an Olympus’ Q180V Scope that was purportedly contaminated with bacteria. A lawsuit filed by Armando Cerda against Olympus America, they contend Antonia contracted an infection and died as a result of a dirty scope.
The lawsuit claimed, “Defendant knew, or should have known, that if these residual fluids contain microbial contamination, multiple patients would be exposed to a serious risk of harm, including lethal infection. The suit also alleged, “Defendant’s reprocessing instructions did not prepare the Q180V Scope for safe re-use.”
In 2015, Theresa Bigler sued the hospital and Olympus alleging the company put patients’ lives at risk by failing to disclose design flaws in its duodenoscopes. At the time, her husband Richard Bigler was one of dozens of patients with so-called “superbug” infections connected to duodenoscopes. The infection was found to have contributed to Bigler’s death.
In 2017, a King County Superior Court jury in Washington state concluded that Olympus must pay $6.6 million to Virginia Mason Medical Center, where Richard Bigler died in 2013 after being infected from a contaminated duodenoscope. According to the award, the hospital was ordered to pay $1 million to Bigler’s family.
Olympus did address the lawsuit in its 2018 integrated report. It did not disclose the exact number of pending lawsuits, although in a later news release said, “As these lawsuits are still before the courts, Olympus will refrain from commenting on this matter.”
In a 2018 court ruling, a New Jersey judge fined Olympus $80 million and ordered $5 million in criminal forfeiture, in line with a plea agreement deal between Olympus and the DOJ. According to the judgment, Olympus must also abide by an agreement with the justice department that requires the company to undertake comprehensive compliance reforms.
The Japan Times reported in 2018 that Olympus was facing approximately 50 duodenoscope lawsuits in multiple courts. All of the lawsuits were seeking compensation for drug-resistant bacteria infections.
FDA Investigation Timeline on Infections Associated with Duodenoscopes.
“Ensuring the safety of reprocessed medical devices for use in multiple patients is a shared responsibility among the FDA and other federal agencies, public health systems, state and local health departments, medical device manufacturers, health care facilities, professional societies and others. The FDA is actively engaged with many of these stakeholder groups to better understand the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.”
Olympus offers customer guidance on the care and cleaning of their duodenoscopes.
FDA issues warning to duodenoscope manufacturers about failure to comply with postmarket surveillance studies to assess contamination risk. FDA clears design changes to Pentax duodenoscopes to improve cleaning and disinfection.