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Dangerous By Design?
Duodenoscopes are long, flexible tubes used to provide a color view of the “duodenum,” the first portion of the small intestine.
But they don’t just give us a picture of your insides. The device’s complex design allows surgeons to dislodge obstructions that are blocking tiny ducts to the pancreas and gallbladder. According to the US Food & Drug Administration, this unique design has “improved the efficiency and effectiveness” of endoscopic procedures.
But it’s also had an unintended, and often tragic, effect.
Made for use in multiple procedures, duodenoscopes are virtually impossible to clean completely. With tiny nooks and crannies, the instruments can become a breeding ground for dangerous microbes. Cleaning procedures exist, but Olympus has failed to demonstrate that its suggested process can kill enough bacteria to meet the FDA’s standards.
A growing number of critics are now calling the device’s intricate design an inherent flaw, one that allows tiny microorganisms with deadly potential to travel from one patient’s intestines to the next.
What Is Behind The Deadly Outbreaks?
It’s very likely.
In a recent public warning, the US Food & Drug Administration noted an “association between […] duodenoscopes and the transmission of infection agents.” After outbreaks in their own facilities, many hospitals have cautioned other medical establishments about the duodenoscope’s potential risks.
But the instruments’ risks came to light long before the recent superbug crisis.
Government Agencies Respond To Risks
After a pathogen spread by endoscopic instruments led to 8 French citizens contracting blood infections, the FDA released its first Safety Communication on duodenoscope risks.
That was almost 6 years ago, and the danger has only grown, with new antibiotic-resistant bacteria evolving at a frantic pace. But duodenoscopes remain in common use.
Spurred by a recent outbreak at UCLA, the US Department of Justice launched a formal investigation into Olympus’ duodenoscope business. In the company’s shareholder report for the first quarter of 2015, Olympus listed “Duodenoscopes” under its survey of potential “Business Risks,” noting that a subpoena had been issued by the federal government. In light of the recent superbug lawsuits, Olympus told its shareholders that the company’s “financial condition may be affected.”
On October 5, 2015, the FDA ordered the world’s three largest duodenoscope manufacturers to conduct “real-world” studies on how well, or poorly, their products are being cleaned after use.
A recent investigation led by CNN revealed that the Olympus endoscopes linked to UCLA’s superbug outbreak had never been approved by the FDA. Rather than seek clearance, the company simply started marketing and selling a potentially deadly product.
Risks Underestimated For 20 Years
For more than two decades, physicians have reassured their patients that the risk of infection related to endoscopy is as low as 1 in 1.8 million procedures. This statistic, first reached in 1993, has never been correct. According to researchers at the American Journal of Infection Control, the “1 out of 1.8 million” risk estimate was “inaccurate, outdated [and] based on flawed methodology” from the start.
So how high is the risk of contracting a superbug infection from an inadequately cleaned duodenoscope? No one knows. Even with public scrutiny pointed squarely at duodenoscope procedures, many infections that may be linked to the device go unreported.
Despite the dangers, Olympus Corp. reported a 14% jump in duodenoscope sales so far this year, according to the Los Angeles Times.
Can Superbug Victims File Lawsuits?
Antibiotic-resistant bacteria have been called the next “global pandemic” waiting to happen. But these microscopic organisms won’t have to travel across an ocean to reach our shores; they’re already here and being spread.
Duodenoscopes aren’t just a threat to individual patients; slowing the transmission of superbugs is critical to the safety of thousands.
For patients who have already been harmed, legal action may be possible. If you contracted a serious infection after undergoing an endoscopic procedure, contact the personal injury attorneys at Banville Law today.
Our lawyers can help you understand your rights and legal options. You may be entitled to significant financial compensation.
For more information complete our contact form. Your initial consultation is free and comes at no obligation.
Latest Duodenoscopes & Superbug Updates
By Laurence P. Banville
Following warnings about the likelihood between duodenoscopes and the transmission of infection agents, it is important to keep well informed. Below you will find regular updates about superbug infections and risks linked to duodenoscopes.
September 25, 2017 – New Endoscope Approved By The FDA
On September 20, the FDA announced their approval of the Pentax ED34-i0T model duodenoscope via a news release. This new model features a disposable cap designed to avoid superbug infections which have previously occurred due to difficulties in cleaning the devices in between patients. There are several different manufacturers of the medical devices and there have been several superbug outbreaks linked to the difficult-to-clean devices. After these duodenoscope related infections, the FDA determined that the instructions included which described how to clean the devices were inadequate. The FDA has stated that the newly improved model’s disposable cap “represents a major step towards lowering the risk of future infections associated with these devices” and encourages other companies to continue to pursue innovations that will reduce risks to patients.
August 29, 2017 – Fugifilm Recalls Duodenoscope Due To Infection Risk
On July 21 the FDA issued a safety communication announcing a recall of Fugifilm ED-530XT duodenoscopes due to the risk of infection. On the same day, Fugifilm issued an Urgent Medical Device Correction and Removal notice that certain parts of the medical device would be replaced to make cleaning between patients easier. This recall comes at a terrible time, as the safety of the medical devices are being questioned after superbug infection outbreaks occurred in various hospitals and medical centers linked to duodenoscopes, some even resulting in the deaths of patients. Lawsuits have been filed against Olympus, one of the manufacturers of the medical device which was linked to an outbreak in UCLA. As the FDA continues to monitor the situation, it is possible that Fugifilm could face similar lawsuits.
July 31, 2017 – Jury Orders Payment Of $6.6 Million In Lawsuit Over Superbug Infection
On Monday, July 26 Olympus was ordered to pay $6.6 million to Virginia Mason Medical Center in the lawsuit over superbug infection outbreaks linked to the company’s duodenoscope. $1 million of that amount will be paid to the family of the man who died in August of 2013 when he contracted a CRE infection which was linked to an Olympus duodenoscope. Similar infections occurred at the hospital after patients were exposed to the device prompting Virginia Mason to join the lawsuit. At least 39 patients were exposed to the medical device, and 18 deaths occurred which were linked to the superbug outbreak. The trial lasted 8 weeks and concluded that Olympus failed to adequately instruct and warn the hospital on how to properly clean the devices and the risks of infections.
June 26, 2017 – Lawsuit Filed Against Duodenoscope Manufacturer Goes To Trial
A lawsuit has been filed against Olympus Corp. by the widow of a man who passed away after allegedly contracting a deadly superbug infection from a duodenoscope used during one of his procedures. This is the first case to go to trial which stems from a series of superbug outbreaks linked to Olympus scopes. Over 25 complaints have been filed across the country against the company alleging fraud, negligence, or wrongful death in relation to the scope-linked superbug outbreaks. Documents show that Olympus received complaints as early as 2011 of the risk the scopes posed due to the difficulty of cleaning them properly. The 3 Olympus executives will not be present during the trial since they are all under criminal investigation. They all have pled the Fifth Amendment right in depositions in Tokyo last year.
May 30, 2017 – Approval Of High-Risk Medical Devices Defended In FDA Editorial
The New England Journal of Medicine published an editorial on April 6, in which FDA officials defended the controversial issue of allowing approval of certain medical devices to occur without using a randomized double-blind clinical trial. Several health experts and consumer watchdog groups have spoken against this new streamlined process, raising concerns that the FDA has made it too easy for untested medical devices to reach the U.S. market. In the editorial, FDA officials defend the agency’s new process saying that they aren’t abandoning their clinical trial but simply looking for more flexibility in approving new devices.
April 13, 2017 – Senator Requests Data Connected To New Olympus Scope And Recent Patient Infection
U.S. Senator Patty Murray (D-Wash) wrote a letter to Olympus requesting data from them that would prove the newly designed medical scope they manufacture is safe. This request was prompted after a new superbug outbreak occurred in Europe making 5 patients sick. The Senator is especially concerned after having already led an investigation last year into the safety of the duodenoscope. The investigation linked the scope to over 250 sick patients worldwide and at least 25 superbug outbreaks. 19 of the outbreaks were linked specifically to the Olympus manufactured scope which resulted in 3 patient deaths. Olympus has since “repaired” the device after recalling the model linked to the infection.
March 24, 2017 – Infection Outbreak Linked To Redesigned Olympus Scope
A foreign health facility recently had a superbug outbreak which doctors have linked to the newly modified Olympus scope. The scope had been modified last year in order to reduce the infection risk presented from bacteria being spread from patient to patient. Several outbreaks occurred in hospitals located in Southern California two years ago, connected to the scopes, which resulted in the deaths of numerous patients. Five patients affected in the foreign outbreak were treated with the redesigned scope and tested positive for the same potentially deadly bacteria according to the Food and Drug Administration.
February 22, 2017 – Disposable Scopes Being Tried Out In Hospitals
Two new colonscopes were approved by U.S. regulators which have been designed to be thrown away after one use. The new scopes would cost significantly less money than the reusable ones that have been in use and could offer patients more peace of mind that they will not fall ill from infection. Some smaller companies have also started promoting other similar devices in response to the recent superbug outbreaks across the country, many of which have been linked to contaminated scopes. Some doctors have stated the scopes may work well for simple procedures.
January 16, 2017 – Older Duodenoscope Models Being Removed From Clinical Use
According to a safety communication released by the FDA, Fujifilm Medical Systems Endoscopy Division is removing four older duodenoscope models from clinical use. The company states that there is only a limited number of these older models in use and they are not removing them due to a known safety risk. Rather, the company made a business decision to remove the devices so that all US users would be using the most recent model. Older models will be replaced with the ED-530XT, the company stated.
December 16, 2016 – New Business Launched To Help Control Threat Of Healthcare Acquired Infections
A new subsidiary of Sanovas, Inc. was launched this month with the purpose of fighting Hospital Acquired Infections (HAIs). SteriView, Inc. and the SteriView Instrument Inspection and Infection Control System will fight the global threat with direct visual inspection and cleaning of difficult to access spaces in medical devices and endoscopes. The company will assist hospitals with maintaining compliance of the new Infection Control Standards recently implemented. HAIs have become a growing concern as information has emerged estimating them to be the fourth leading cause of death in the U.S. and to possibly be a bigger threat than HIV or the flu in Europe. HAIs are on the rise, most especially those associated with the recent superbug outbreaks. SteriView aims to offer a cost effective method to medical device inspection and documentation to reduce the risk of HAIs.
November 14, 2016 – FDA Faults 12 Hospitals For Failing To Disclose Medical Device Problems
The FDA disclosed violations in inspections reports in which 12 hospitals, 3 in the Los Angeles area, failed to properly report injuries or deaths linked to medical devices. Federal law requires hospitals to report serious injuries possibly caused by medical devices to the manufacturer and to notify the FDA and manufacturer when a death occurs. Manufacturers then have 30 days to file a report to the FDA after being notified. According to FDA reports Huntington Memorial Hospital failed to report the death of a patient who contracted a multidrug-resistant infection following a procedure which involved a duodenoscope. The hospital spokesperson stated that steps were taken to ensure compliance going forward. The FDA indicated that these hospitals were most likely not unique and that a larger problem exists.
October 11, 2016 – FDA Urges Doctors Not To Use Custom Ultrasonic Reprocessors To Clean Duodenoscopes
The FDA released a safety communication in August which indicated that the System 83 Plus Automated Endoscope Reprocessors (and Custom Ultrasonics) should not be used for duodenoscopes because they can not guarantee they can effectively clean or reprocess the devices. The agency stated that the May 6 letter released by Custom Ultrasonics was considered a recall, but they later revised the earlier recall notice to allow the devices to stay on the market for other uses.
September 12, 2016 – Risk Of Infection May Be Increased With Use OF Gas Relief Drops In Medical Scopes
A new study conducted in Minnesota found that abdominal anti-gas drops for infants, which doctors regularly use by injecting them into medical scopes to reduce bubbles, may contribute to the contamination of the devices. The use of the medication may encourage the growth of bacteria which is difficult to remove, putting patients at serious risk for infection. The liquid medication contains silicone which doesn’t dissolve in water impeding the ability to properly clean the devices. While no infections have been linked to the anti-gas drops, the study suggests the possibility of contamination. New studies are being conducted to create simpler, easy to clean designs.
August 25, 2016 – Olympus Said No Warning Was Necessary Amid Superbug Outbreaks
Olympus Corp., the Japanese company which controls 85% of the U.S. market in gastrointestinal scopes, reportedly told U.S. executives that no broad warning was needed when questioned about the outbreak of superbug infections in a Pennsylvania hospital. Warnings, however, had been communicated to European users. Infections continued in several hospitals in the U.S. killing at least 35 people since 2013. Emails from Olympus reveal conflict internally over how to deal with the growing danger the devices posed to patients. Several American lawsuits have been filed claiming negligence by the manufacturers.
April 21, 2016- Congress Being Called Upon To Change The Law Governing Medical Devices
Outbreaks in Los Angeles and Seattle hospitals as well as elsewhere, due to antibiotic-resistant superbugs spread by tainted endoscopes, have led to one California congressman to call for a change in a law governing medical device makers. Because these devices used to look inside the body have recently sickened hundreds and even caused death in some cases, the congressman wants medical device makers to tell the Food and Drug Administration whenever a design change is made. According to the congressman, there are loopholes when it comes to how medical devices are regulated, that need to be closed.
March 31, 2016- Email Evidence Reveals Olympus Increased Duodenoscope Price Post CRE Outbreak
Email evidence has revealed that Olympus hiked up the price of duodenoscopes, even after there was knowledge of the deadly Carbapenem-resistant Enterobacteria outbreak at UCLA’s Ronald Reagan Medical Center. One of the emails shows that Olympus pushed the price of new duodenoscopes up by 28% from an earlier quoted price. The duodenoscopes sold by Olympus between October 2014 and January 2015, left seven people infected with CRE.
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