Superbug is a term sometimes used to refer to a strain of bacteria that resists most antibiotics. Becoming infected with a superbug can be very dangerous and even life-threatening. Hospitals are often the sites at which these infections occur, as patients are vulnerable to all kinds of infections. In the last couple of years a few outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE), a group of superbugs, made hundreds of people sick and caused fatalities.
One source of the infection was found to be a particular duodenoscope, a device inserted into the small intestine for imaging, made by Olympus. The device’s design did not allow it to be cleaned effectively, putting patients at risk of infection. At least two people died from these outbreaks and many more were made sick. Some of these people may now sue Olympus for its poorly designed scope.
CRE refers to family of bacteria, not just one type, that cause infections that are difficult to treat. This is because they resist many of the most commonly used antibiotics. In other words, they are superbugs and are tough to kill. E. Coli is an example of a CRE. This is a type of bacteria normally found in the gut, but which can cause serious infections when it spreads to any other part of the body.
Carbapenem is a group of antibiotics reserved for some of the most serious bacterial infections. CREs are so tough that they resist even these medications, used like a last line of defense against infection. It was first discovered around 2001 that CRE bacteria produce certain enzymes that breakdown carbapenem antibiotics, rendering them ineffective. Up to half of people infected with CRE die.
How CRE Infections Occur
Healthy people are unlikely to develop a CRE infection. Patients in hospitals who are ill are at the greatest risk. They can become contaminated and infected with a CRE by contact with bodily fluids or feces with the bacteria. The main way in which this happens is when a medical device has been contaminated or not cleaned well and then is inserted into the patient. This could occur with surgical tools, breathing tubes, imaging scopes and other devices.
Symptoms and Treatment
Most people with healthy immune systems are not likely to develop a CRE, but any patient in a hospital is vulnerable. The signs of a CRE infection include serious urinary tract infections, kidney infections and pain in the side and back, a fever, pneumonia, sepsis and septic shock. There may be other symptoms as well, depending on what part of the body has become infected by the CRE.
Although CREs resist many of the antibiotics that are most often used for severe infections, there are still a few medicines that may work. It is possible, but rare, for a CRE to resist all antibiotics. Older antibiotics and combinations of antibiotics are most often used to treat CRE infections. Not everyone will survive this type of infection. The bacteria spread quickly throughout the body, and because the patient is likely already sick with another illness, the infection may worsen that condition and contribute to the patient’s death.
CRE Infection and the Olympus Scope
A duodenoscope is a type of scope that is inserted in the mouth of a patient. From there it goes down the esophagus, through the stomach, and into the duodenum, the upper part of the small intestine. A small camera on the end of the scope allows a doctor to see inside the patient’s body to help remove a foreign object, perform a biopsy, or make a diagnosis.
Because the scope travels through the inside of the body, any bacteria on it can infect the patient and cause serious problems. Scopes need to be thoroughly cleaned and sterilized before being used to avoid this. The problem with the Olympus TJF-Q180V duodenoscope was that part of its design made it difficult to clean. Even following the manufacturer’s instructions for proper cleaning, many of the scopes carried bacteria from patient to patient.
Olympus makes 85 percent of all such scopes used in the U.S., which means a lot of patients were exposed to potentially life-threatening infections. The scope caused 25 outbreaks of bacterial infections across the country, which resulted in over 140 patients becoming infected and three dying. Many of the infections were attributed to CRE bacteria.
A Faulty Design
Multiple separate investigations found that the design of the Olympus scope meant it could not be completely disinfected. Other reports found that Olympus may have known about the problem long before it came to light to the public and to doctors. The design of the scope included an interior elevator channel that allowed fluids and tissue to seep inside it. This area of the scope was then impossible to clean thoroughly enough to completely sanitize it.
The Approval Process
Olympus was also found to be at fault because it marketed and sold the scope while its approval was still under review by the U.S. Food and Drug Administration (FDA). The FDA sent the company a warning letter in 2014 that stated their scope had not been cleared to be sold. Olympus had failed to complete a 510(k) approval process, the expedited process used for devices that are similar to those already on the market.
The FDA requested the submission for 510(k) approval because Olympus had made changes to an existing scope model. The changes were to the elevator channel, which ultimately proved to be at fault for the infection outbreaks. The FDA also sent out a safety announcement in 2015 to warn doctors and patients about the risks of using the Olympus duodenoscope.
In January of 2016 Olympus began a voluntary recall of the faulty scopes, which numbered in the thousands. The company also redesigned the scope so that the issue with cleaning would no longer be a problem. On January 15, the FDA cleared the new design, stating that the scopes were once again safe to use on patients. The elevator channel seal was redesigned to make it tighter and less prone to leakage.
If Olympus can be proven to be at fault in the illnesses and deaths of patients, lawsuits may be filed by those people or their surviving loved ones to get compensation. Reports indicate that Olympus might have known about the scope’s problem as early as 2012. Furthermore the company changed its product without submitting it for approval by the FDA and continued to market the scope while the FDA reviewed the problem. If you were made sick because of an endoscope and fought a battle with a CRE infection, you may be able to file a lawsuit and seek monetary damages.