A duodenoscope is a type of endoscope used to visualize the duodenum, the upper part of the small intestine. The duodenoscope has a flexible, lighted tube and a video camera. The camera allows the doctor to see the inside of the duodenum on a video monitor.
In recent years, evidence has been uncovered suggesting that duodenoscopes carry a significant risk of infection transmission between patients. These revelations and subsequent recalls have sparked waves of lawsuits against device manufacturers. Join the Many is working to support those who believe they were harmed by this device, educating victims on their legal rights and making it as easy as possible to take action.
History of the Duodenoscope
The duodenoscope is a relatively new medical device. It was first used in the early 1970s. At that time, the duodenoscope was a simple, flexible tube with a light at the end. The first duodenoscopes were used to diagnose and treat disorders of the duodenum, such as ulcers.
In the 1980s, the duodenoscope was improved with the addition of a video camera. This allowed doctors to see the inside of the duodenum on a video monitor. The video camera also allowed doctors to record images of the duodenum for review or for teaching purposes.
Today, the duodenoscope is a sophisticated medical device used for a variety of purposes. It is used to diagnose and treat disorders of the duodenum, such as ulcers. The duodenoscope is also used to obtain biopsies (tissue samples) of the duodenum for laboratory analysis. In addition, the duodenoscope is used to perform a variety of therapeutic procedures, such as the removal of foreign bodies from the duodenum.
The duodenoscope is a safe and effective medical device. However, like all medical devices, it has potential risks. The most serious complication associated with the use of a duodenoscope is infection. Although infections associated with the use of a duodenoscope are rare, they can be serious, and even life-threatening.
Research Findings Leading to a Lawsuit
A new study has found that a common type of medical scope used in hospitals can harbor dangerous bacteria, even after being cleaned according to manufacturer’s instructions.
The study, published in the journal Infection Control and Hospital Epidemiology, tested 25 duodenoscopes after they had been used on patients and then cleaned according to the manufacturer’s instructions. Researchers found that all of the scopes tested positive for bacteria, and more than half of them tested positive for a potentially dangerous superbug.
The findings add to a growing body of evidence that duodenoscopes can be difficult to clean, putting patients at risk for serious infections. In recent years, there have been a number of high-profile outbreaks linked to contaminated duodenoscopes, including one at UCLA Medical Center that sickened seven patients and killed three.
The new study highlights the need for better cleaning methods for duodenoscopes, or for hospitals to switch to a different type of scope altogether. In the meantime, patients who are scheduled for a procedure using a duodenoscope should ask their doctor about the risks and what steps are being taken to minimize them.
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.
As medical devices go, duodenoscopes are relatively simple: a long, thin tube equipped with a tiny camera and light, used to peer inside the upper digestive tract. But they’re also notoriously difficult to clean, and over the last few years, they’ve been linked to outbreaks of deadly infections.
Now, a new study has found that many physicians feel ill-equipped to deal with the potential dangers posed by duodenoscopes.
The study, published in the journal Infection Control and Hospital Epidemiology, surveyed nearly 500 physicians who had used duodenoscopes in their practices. Nearly two-thirds of respondents said they were “somewhat” or “very” concerned about the safety of the devices, and less than half said they felt “very confident” in their ability to clean them properly.
“There’s a lot of anxiety out there about duodenoscopes,” said Dr. David Bromberg, lead author of the study and an infectious disease specialist at the University of Pennsylvania.
The unease is understandable. In 2015, the Food and Drug Administration linked duodenoscope-related infections to three patient deaths. Since then, there have been at least two dozen more outbreaks, involving hundreds of patients in the United States and Europe.
The vast majority of those infections have been caused by a particularly virulent strain of bacteria called Pseudomonas aeruginosa. The bacteria can cause severe respiratory illness and, in some cases, death.
Experts believe the outbreaks are the result of a “perfect storm” of factors, including the design of the duodenoscope itself, the way it’s used in procedures, and the way it’s cleaned afterward.
The devices are complex pieces of equipment, with nooks and crannies that are difficult to clean with conventional methods. And because they’re reused, they can harbor infectious bacteria even after they’ve been disinfected.
In response to the outbreaks, the FDA issued new guidance on the use and cleaning of duodenoscopes in 2016. The guidance includes recommendations for specialized cleaning procedures that should be done after each use.
But the new study suggests that many physicians are still struggling to implement the FDA’s recommendations.
Nearly 60 percent of respondents said they were “somewhat” or “very” familiar with the FDA’s guidance. But only 40 percent said they were “very confident” in their ability to follow the guidance.
What’s more, nearly one-third of respondents said their hospitals or clinics did not have the proper equipment or personnel to implement the recommended cleaning procedures.
The findings highlight the need for more education and training on the proper use and cleaning of duodenoscopes, Bromberg said.
“This is a complex problem, and it’s going to require a multifaceted solution,” he said.
A duodenoscope is a medical device that is used to examine the inside of the duodenum, the upper part of the small intestine. The duodenoscope has a long, flexible tube that is inserted through the mouth and down the throat. The scope has a light and a camera that allow the doctor to see the inside of the intestine.
The duodenoscope has been the subject of several lawsuits. In 2015, Olympus, a manufacturer of duodenoscopes, was sued by the families of three patients who died from a bacterial infection that was linked to the use of the scope. The lawsuit alleged that Olympus knew about the risk of infection but failed to warn patients and doctors.
In 2016, another lawsuit was filed against Olympus by the family of a patient who died from a bacterial infection. The lawsuit alleged that Olympus knew about the risk of infection but failed to warn patients and doctors.
In 2017, a class action lawsuit was filed against Olympus and another manufacturer of duodenoscopes, Pentax. The lawsuit alleged that the companies failed to warn patients and doctors about the risk of infection.
The duodenoscope has also been linked to a number of other infections, including a superbug outbreak at a hospital in Los Angeles. In response to the outbreak, the FDA issued a warning to hospitals and patients about the risk of infection from the use of the scope.
The Harvard Law Review recently published an article discussing the recent spate of lawsuits involving duodenoscopes. The article notes that while the devices have been linked to a number of infections, the lawsuits have been largely unsuccessful.
The article attributes this to a number of factors, including the fact that the FDA has not issued a recall of the devices and that many of the infections occurred in hospitals where proper cleaning procedures were not followed. The article also notes that the majority of the infections occurred in patients who were already critically ill, which made it difficult to prove that the duodenoscope was the cause of the infection.
The article concludes by noting that while the current lawsuits may not be successful, they could help to bring about changes in the way that duodenoscopes are manufactured and used, which could help to prevent future infections.
In 2019, the Los Angeles Times reported that the FDA approved the first fully disposable duodenoscope to address the continued problems medical facilities faced attempting to properly clean and sanitize reusable devices. An article that appeared in the Seattle Times in 2018 reported on a paper published in the American Journal of Infection Control in February of that year that found that 71 percent of reusable scopes that were deemed ready for use on patients were contaminated with bacteria.