A series of threatening superbug outbreaks in medical centers has brought the use of duodenoscopes to light, indicating that the medical product may serve as a hidden breeding ground for deadly microbes. Several patients who have experienced severe infections after undergoing medical procedures involving duodenoscopes are now filing lawsuits against the product’s manufacturers.
Learn more about filing Duodenoscope lawsuits with our dedicated team of attorneys.
Duodenoscopes are illuminated, flexible tubes that can be run through the mouth, throat, and stomach into the upper area of the small intestine for a medical procedure called endoscopic retrograde cholangiopancreatography. Annually, they are utilized over 500,000 times across the United States.
By using duodenoscopes, physicians are able to drain fluids stuck in pancreatic and biliary ducts due to tumors, gallstones, or other issues in a much less invasive way. Because of the complexities of the duodenoscope instrument, however, it has been associated with bacterial infections.
In 2013, this issue was brought to the attention of the Food and Drug Administration (FDA), who began to speed up investigations on the subject by holding public meetings to discuss how to properly sterilize, clean and disinfect the medical devices. Additionally, the FDA reached out to the specific hospitals where duodenoscope infections had occurred in order to study the devices and hospital cleaning procedures. Lastly, they contacted the manufacturers of duodenoscopes to gather additional product information that could help combat the bacterial issues.
FDA statements note: “We have been actively working with federal partners, manufacturers, hospitals, medical professional societies, and other stakeholder to better understand the issues that contribute to these infections and what can be done to mitigate them.”
Hospitals in Philadelphia, North Carolina, Florida, Chicago, Los Angeles, and Seattle have watched helplessly as superbugs infect patients and spread rapidly. Most of these infections, 50% of which end up being fatal, are thought to be spread by duodenoscopes. Despite vigorous cleaning, these complex medical devices can harbor microscopic bacteria, and physicians using them can unknowingly pass it from patient to patient.
Collectively, there are three ideas concerning how to better avoid these superbug outbreaks and bacterial infections. These ways are: through the use of synthetic antibiotics, through the use of ultraviolet light and by finding more effective ways to completely clean duodenoscopes.
On October 5, 2015, federal regulators ordered several duodenoscope manufacturers to research how medical centers were disinfecting their products. The manufacturers Fujifilm Medical Systems, Hoya and Olympus America have been instructed to survey the procedures of healthcare personnel following instructions to clean their duodenoscopes in between each use. They have just 30 days to submit their plans for doing so to the FDA, and to therefore decide whether their device’s cleaning instructions are sufficient ones.
Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health, called these requirements “...a significant step in the effort to combat infections spread through duodenoscopes.” If the process is effective, it will create a much-welcome change. Many patients, however, have already suffered from serious health conditions or have died, allegedly due to the use of contaminated duodenoscopes. For these people, the solutions are too little too late.
There is a chance, as well, that there are no solutions to come of this process. The duodenoscopes have many tiny cracks and crevices, which quickly turn into breeding grounds where all sorts of dangerous bacteria can thrive. To date, manufacturers have been unable to demonstrate that the cleaning processes detailed in their instructions can actually kill enough of the bacteria for the FDA to deem the product safe.
Although the superbugs found on duodenoscopes have developed a high level of resistance to antibiotics, researchers are hopeful that synthetic antibiotics may be able to better attack the bacteria. Synthetic antibiotics are generally chemically related to natural antibiotics, and can help to inhibit bacterial growth. They work by mirroring substances produced by microorganisms that are designed to inhibit the growth of others. Effectively, physicians would work to attack superbugs with super drugs.
Science Daily reported that a new type of synthetic sugar could be the latest weapon used to fight superbugs. According to the report, published in July of 2015, a group of scientists from The University of Queensland and Alchemia, (a Queensland biotechnology company), have recently discovered what appears to be a new class of antibiotics that are inspired by the sugar molecules produced by bacteria. These new types of antibiotics are ones that bacteria are less likely to develop resistance to.
A recent study from Duke University School of Medicine has brought to light promising indications that a specific combination of chemicals and ultraviolet light can clean more deeply and cut the transmission of at least four major superbugs. This new study found that patient rooms which were cleaned with the chemical/UV light combination saw about a 30% reduction in superbugs.
Hospitals who participated in the study used 3 different methods to try to kill the super germs: irradiating the room with UV light after using a quaternary ammonium disinfectant, irradiating the room with UV light after using bleach, and replacing the quaternary ammonium disinfectant with bleach alone. Data collected showed that the most effective method was using a standard disinfectant quaternary ammonium disinfectant to clean followed by a cycle of 30-50 minutes of cleaning with a portable UV irradiating machine.
Ultraviolet light works to kill organisms by using reflective properties. Essentially, the light is able to disrupt the DNA of the germs and therefore kill them.
An additional specific subgroup was also studied. In this group, when the most effective cleaning method was used, it resulted in a cumulative reduction of almost one-third of the four main superbugs, as well as a reduction in the likelihood that patients would develop infections over the following 3 months.
Individuals who have undergone a medical procedure using a duodenoscope and who have subsequently developed a superbug are likely entitled to legal action. To ask questions or explore your rights surrounding this subject, contact the personal injury attorneys at Banville Law. They provide complimentary and confidential consultations to help victims look into their options. To get more information, simply call 877-671-6480 at your convenience.
Continue Reading: Duodenoscope Contamination Rates Higher Than Expected, FDA Reports