A duodenoscope, categorized as an endoscope, serves the purpose of visualizing the duodenum, the upper section of the small intestine. This medical device features a flexible, illuminated tube and a video camera, enabling doctors to examine the interior of the duodenum on a video monitor.
Recent years have witnessed the emergence of evidence suggesting a significant risk of infection transmission between patients associated with duodenoscopes. These findings, coupled with subsequent recalls, have triggered a surge in lawsuits against medical scope manufacturers.
Entities like Join the Many are actively engaged in supporting those who believe they have suffered harm from this device. Their efforts involve educating victims about their legal rights, with a particular emphasis on the importance of proper disclosure of internal emails by device manufacturers.
Ongoing developments, including FDA clearances and interventions by the Justice Department requiring action from companies like Olympus, underscore the gravity of the situation. Reporting adverse events is a critical component of addressing these concerns, as highlighted by instances such as the infections at Erasmus Medical Center.
History of the Duodenoscope
The duodenoscope, a medical device first utilized in the early 1970s, initially featured a simple, flexible tube with an end-mounted light. Primarily designed for diagnosing and treating duodenal disorders, such as ulcers, it underwent significant advancements in the subsequent decades.
In the 1980s, a pivotal enhancement was made with the integration of a video camera into the duodenoscope. This innovation enabled doctors to visually inspect the duodenum on a video monitor, facilitating real-time observation and recording of images for educational and review purposes.
Today, the duodenoscope a sophisticated medical device, serves various purposes, including the diagnosis and treatment of duodenal disorders such as ulcers. Additionally, it is employed for acquiring duodenal biopsies for laboratory analysis and performing therapeutic procedures, such as the extraction of foreign bodies from the duodenum.
Manufactured by reputable medical device companies, the duodenoscope is generally considered safe and effective. However, like all medical devices, it is not without potential risks. The most severe complication linked to its use is infection, though such instances are rare. Nevertheless, infections associated with the duodenoscope can be serious, even life-threatening.
Instances of misbranded medical devices, as exemplified by reports at Virginia Mason Medical Center and Erasmus Medical Center, have raised concerns. Adverse event reports, including those involving antibiotic-resistant bacteria, highlight the importance of medical device manufacturers properly disclosing internal emails and adhering to regulatory standards. Legal actions, such as cases brought before the Newark Federal Court, emphasize the consequences of distributing misbranded medical devices and the responsibility of medical scope manufacturers in ensuring product safety.
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.
Recall History
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.
Pentax Recall
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.
Voluntary Recall
In a recent Safety Communication, the FDA notified healthcare facilities of a voluntary recall by Pentax for the Pentax ED-3490TX duodenoscope. This recall was initiated to implement design changes aimed at enhancing the device’s cleanability and disinfection. The manufacturer, Pentax, submitted modifications for the scope, introducing a new elevator channel sealing mechanism at the top of the device.
The FDA granted clearance for the changes to the Pentax model, focusing on preventing the seepage of body fluids and bacteria into small crevices that posed challenges for proper cleaning. The identified design flaw was recognized as a potential source of infection transmission between patients, especially considering the reuse of these devices after cleaning.
Collaborating with the company, the FDA oversaw corrective actions, including the removal of older models from healthcare facilities for necessary modifications to the scope’s design. Back in February 2016, the FDA issued a Safety Communication, and Pentax provided updated, validated manual reprocessing instructions for the ED-3490TK duodenoscope, replacing the original device labeling.
By January 2017, an additional update to the Safety Communication warned about cracks and gaps in the adhesive sealing the ED-3490TK distal cap to its distal tip, leading to potential microbial and fluid seepage. The current recall and the introduction of the redesigned medical scope aim to address these safety concerns.
This development aligns with increased scrutiny on medical device safety, with the FDA playing a crucial role in clearance processes. Instances of adverse events, as reported in compliance with regulations, underscore the significance of ongoing efforts by device manufacturers to ensure the safety and effectiveness of their products. The collaboration between regulatory bodies and companies, as seen in this case, reflects the commitment to implementing necessary reforms for enhanced patient safety.
It’s worth noting that this situation is specific to Pentax, and the keywords related to the Justice Department, Olympus Corp, and federal food compliance reforms aren’t explicitly addressed in this paragraph. If you want those incorporated, please provide more context or specific details, and I can adjust accordingly.
Olympus Recall
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.
Physician Sentiment
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.
Lawsuit History
A duodenoscope, a medical device designed for examining the inside of the duodenum, the upper part of the small intestine, utilizes a long, flexible tube inserted through the mouth and down the throat. Equipped with a light and camera, the scope enables doctors to visualize the interior of the intestine.
Several lawsuits have targeted duodenoscope manufacturers, with Olympus facing legal action in 2015. Families of three patients who succumbed to a bacterial infection linked to the scope filed a lawsuit. The allegations asserted that Olympus was aware of the infection risk but neglected to warn patients and doctors.
In 2016, another lawsuit was brought against Olympus by the family of a patient who died from a bacterial infection. Similar to the previous case, it contended that Olympus knew about the infection risk but failed to issue adequate warnings.
Further legal action unfolded in 2017 with a class action lawsuit targeting both Olympus and Pentax, another duodenoscope manufacturer. The lawsuit claimed that these companies failed in their duty to alert patients and doctors about the infection risk associated with their products.
Notably, the duodenoscope has been implicated in various infections, including a superbug outbreak at a Los Angeles hospital. Responding to the outbreak, the FDA issued a warning about potential safety issues linked to the use of the scope. As the legal landscape continues to evolve, instances like Shawver’s lawsuit and Yabe’s case highlight the ongoing concerns and the judicial responses, such as judge orders and required Medical Device Reports (MDRs), underscoring the gravity of carbapenem-resistant Enterobacteriaceae and other infectious risks associated with these medical devices.
More Information
The Harvard Law Review has recently addressed the surge in lawsuits pertaining to duodenoscopes. The article highlights that despite the association of these devices with various infections, the legal actions have seen limited success.
The Department of Justice’s involvement and the challenges posed by bacteria like Staphylococcus aureus are crucial elements in understanding the complexities of these cases. Additionally, the role of medical scope manufacturers is a focal point in examining the legal landscape surrounding duodenoscope-related litigations.
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.