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Duodenoscopes

The duodenoscope injury attorneys at the Drug Law Center are now reviewing information involving CRE infections that cause harm to patients following an endoscopic procedure.

What is the Duodenoscope?

Duodenoscope RecallsA duodenoscope is a lighted flexible tubing that doctors spread through the oral cavity, down the throat, and into the stomach to perform procedures on the duodenum (the top portion of the small intestine). More than 500 ERCP (endoscopic retrograde cholangiopancreatography) procedures are performed in America every year. The noninvasive procedures drained accumulating fluid from biliary and pancreas ducts that have been blocked by gallstones, tumors, or other serious condition.

Duodenoscopes are not the same devices as endoscopes used by doctors during colonoscopy and gastrointestinal endoscopic procedures. Because of the complexity of the device’s design, it is significantly more challenging to keep the product clean and disinfected.

What Is the Problem?

For years, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have been searching for better ways to clean and disinfect complex instruments including duodenoscope devices to reduce health risks and maximize the success of procedure outcomes.

However, in 2013, the CDC alerted the FDA concerning reports of potential “Superbug” contaminant problems associated with duodenoscopes. The CDC had received reports of duodenoscope-related multi-drug-resistant Carbapenem-resistant enterobateriaceae (CRE) bacterial infections. The potentially deadly infection can be exceedingly challenging to treat because of its resistance to most antibiotics.

Warnings by the FDA revealed specific safety hazards to patients undergoing endoscopic retrograde cholangiopancreatography procedures. The federal agency stated that:

“The moving parts of the elevator mechanism contain microscopic crevices that may not be reached with the brush… Residual body fluids and organic debris may remain in these premises after cleaning and distant action. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

To date, hospitals in Los Angeles, Florida, Chicago, Philadelphia, Seattle, North Carolina have experienced deadly outbreaks of the superbug that proved to be fatal in many cases.

What is a Superbug?

Anti-resistant superbugs are bacteria strains that have developed a high resistance to popular antibiotics. This means hospitals, doctors, nursing homes, and other healthcare providers might not be able to control the infection which can easily spread quickly throughout the healthcare environment. Carbapenem-resistant enterobateriaceae (CRE) is the most common superbug with a high fatality rate of 50 percent of all patients suffering from the infection.

Many individuals die every year of an infection because their immune system is unable to fight back against deadly bacteria. This is because superbugs are highly resistant and can easily pass between patients in a hospital environment when procedures, protocols and cleaning methods allow the bacteria to spread in numerous ways.

Decades of Underestimating the Risks

for more than 20 years, doctors have provided patients reassurance that ERCP (endoscopic retrograde cholangiopancreatography) procedures are not only effective but safe. Many of these doctors have used outdated historical 1993 statistics showing that the risk of infection caused by an endoscopic procedure is less than one out of every million procedures. In fact, that number has always been inaccurate.

A published article by the American Journal of Infection Control stated that the risk estimate reported decades ago is “inaccurate, outdated and based on flawed methodology.” Finding out the exact number of individuals who suffered serious life-threatening superbug infections caused by an improperly cleaned duodenoscope is unknown.

CRE Outbreaks

In 2015, seven incidents of CRE infections were reported by the UCLA Medical Center where the deadly bacteria claimed the life of two patients. The hospital had determined that the source of the deadly infection was two Olympus facility-use duodenoscopes that were originally used at the hospital for five months to perform endoscopic procedures.

In January 2016, a published investigation report by the U.S. Senate alerted the public of 25 outbreaks of CRE that had been attributed to improperly sterilize duodenoscopes. The investigation determined that cross-contamination between patients were the cause of infections associated with approximate 250 patients. However, the study indicated that there were likely many more cases that had yet to be reported.

The report identified Olympus, Pentax, and Fujifilm as the duodenoscope makers that were involved in the CRE outbreaks, concluding that the closed channel device had a design flaw. This included the Olympus TJF-Q180V Duodenoscope The Senate alleged that these companies failed to inform doctors and hospitals that a potential cross-contamination could occur between patient use. The investigative statement detailed criticism of government regulatory agencies and hospitals for failing to report known incidents of Carbapenem-resistant enterobateriaceae (CRE) bacterial infections.

The investigative report established that the device manufacturer new the device had a design defect in 2012 but conceal the information. The company was cited for negligence and its failing to warn hospitals. A separate March 2015 investigation by CNN revealed that Olympus Corporation of the Americas started selling a defective duodenoscope before it had received clearance from the Food and Drug Administration. This was the same model that had been voluntarily recalled by Olympus.

Sen. Murray’s Investigation

In April 2017, U.S. Sen. Patty Murray, Democrat from Washington state, asked Olympus Corporation of the Americas to send data that proves their redesign duodenoscopes are safe for use in patients. Her letter was in response to current concerns about patients who have been infected by superbug outbreaks. The center reported that 19 out of the 25 incidences involving highly resistant Carbapenem-resistant enterobateriaceae bacterial infections were specifically linked to the use of the Olympus manufactured duodenoscope. Of the 19 cases, three patients died. Since the defect first became known, the device manufacturer has apparently “repaired” the duodenoscope, but only after the model had been recalled by the FDA due to the infections.

The investigation also revealed that between 2012 and 2015, officials conducting the investigation had revealed that at least “25 different incidents of antibiotic resistant infections that sickened at least 250 patients worldwide” were connected to closed channel duodenoscopes. The device manufacturer (Olympus) had known of two laboratory reports that uncovered the possibility of their devices spreading bacteria because of insufficient cleaning. A report published by the Dutch Health Ministry in 2013 also concluded that the device maker had insufficient data to show that their endoscopic procedure product works consistently, effectively, and safely.

Duodenoscope Recall

The Food and Drug Administration recalled the Olympus TJF-Q180V duodenoscope in January 2016 over concerns of the potential risk of infections due to a design flaw. Since then, the federal agency has cleared the company’s new design after a press release was announced that the company “modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.”

As a part of the recall, the device manufacturer will conduct annual inspections of every duodenoscope used in facilities worldwide to determine if wear and tear on the product have the potential of causing an infection. The company plans to replace every component that requires replacing should the new design not allow the device to function safely. All the necessary repairs made to recalled duodenoscope being used at approximately 4400 facilities was to be completed in August 2016.

Duodenoscopes in the News

The latest information concerning duodenoscope device recall infections from federal regulatory agencies include:

  • Newly Redesigned Olympus Duodenoscope Linked to Infection Breakout
    March 2017 – After the January 2016 recall of Olympus TJF-Q180V was redesigned due to its potential risk of infection, new incidents of a superbug outbreak has been reported by a foreign health facility. The newly modified device alteration design should ensure cross-contamination could no longer occur when the duodenoscope was used. However, five patients have been treated. Health officials indicate that the potentially deadly bacteria tested positive.
  • New Disposable Colonscopes May Solve Cross-Contamination Infection Problems
    February 2017 – U.S. regulators have approved two new disposable colonscopes. The new design has the potential of costing less money during surgical procedures and provide peace of mind of patients concerned about developing infections from traditional models that previously caused life-threatening contamination. Some positions are indicating that the newly designed disposable scopes could be an effective solution when used in simple procedures.
  • FDA Says Many Hospitals Are Failing to Disclose Duodenoscope Infection Problems
    November 2016 – A report released by the Food and Drug Administration indicate that 12 hospitals across the United States have failed to report defective device-related injuries and deaths. Device manufacturers and hospitals must inform the public and notified the federal agency any time a death occurs due to a problem associated with the medical device, including the Olympus Duodenoscope. In one incident, the Huntington Memorial Hospital in California failed to notify the FDA of a patient who had died after contracting the deadly CRE infection after undergoing a duodenoscope procedure.

Even though Olympus Corporation of the Americas new of the superbug outbreak that occurred throughout the United States in 2012, the company waited three years to notify the Food and Drug Administration that the infections had occurred.

The recent developments of CRE infection outbreaks and the lack of concern by device manufacturers will likely keep duodenoscope problems in the news for many more months to come. As a result, many attorneys are now formulating superbug litigation to protect the rights of their clients who have been injured by the device.

What to Do

Before undergoing any duodenoscope procedure, it is important to discuss all concerns with the doctor to ensure you protect yourself or loved ones from life-threatening infections associated with the device. However, for individuals who have undergone procedures using duodenoscope devices who did develop an infection, it is essential to seek out immediate legal assistance. An attorney working on your behalf can protect your rights and provide numerous legal options to hold the device manufacturer financially accountable.

Take Legal Action Now

The duodenoscope injury attorneys at the Drug Law Center are currently accepting CRE infection injury cases are reputable attorneys are devoted to providing the highest level of legal representation, counsel, and advice to our injured clients. We offer our services and compassionate advocacy to ensure that every client receives personal attention. We build our cases for trial litigation to present evidence and expert testimony in front of a jury. While many of our cases are settled out of court, we are ready to go to trial if the device manufacturer is not willing to pay the highest level of financial compensation our clients deserve.

Resolving your case remains our highest priority. Contact us today to assist you in pursuing a superbug infection lawsuit. Let us discuss your options through a complimentary, case evaluation and provide information on our legal strategy to resolve your case.

We are currently accepting all personal injury, wrongful death, medical malpractice, and product liability cases through contingency fee arrangements. This means you will receive immediate legal representation while we postpone accepting payment for our legal services until after we have won your case at trial or negotiated an acceptable financial out-of-court settlement on your behalf. We provide every client a “no win/no fee” guarantee.

Sources:

https://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol-faqs.html

https://www.help.senate.gov/ranking/newsroom/press/murray-presses-scope-manufacturer-linked-to-superbug-outbreak-at-virginia-mason-for-answers-accountability

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm

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