Endoscope Lawsuits

Lawsuits have been filed against the makers of some endoscopes—used in endoscopic procedures—alleging the design of the devices is so complex that the endoscopes cannot be properly cleaned, putting patients at risk of developing a superbug. Some studies have found that not all endoscopes are being properly cleaned and the US Food and Drug Administration (FDA) has issued a warning concerning adequate sterilization of endoscopes and endoscopic devices after multiple deaths were linked to endoscopes.

An endoscope is a thin tube with a camera that sends images to a nearby screen attached to one end. It is inserted into the patient's body and used to diagnose or help treat a health issue. In some cases, additional tools are inserted into the body through the endoscope to assist with a procedure. Such tools might include flexible forceps, biopsy forceps, cytology brush, or suture removal forceps.

Endoscopes can be used for a variety of health problems, including those affecting the airways, the joints, the urinary tract and the abdomen. Among endoscope procedures:

• Arthroscopy (arthroscope)—Used on the patient's joints
• Bronchoscopy (bronchoscope)—Used to examine airways
• Colonoscopy (colonoscope)—Used to examine the entire length of the colon and large intestine
• Colposcopy (colposcope)—Used to examine the vagina and cervix (in this case, the camera is placed at the opening to the vagina)
• Cytoscopy (cytoscope)—Used to examine the bladder
• Esophagoscopy (esophagoscope)—Used to examine the esophagus
• Gastroscopy (gastroscope)—Used to examine the stomach and duodenum
• Laparoscopy (laparoscope)—Used to examine the stomach, liver, and other abdominal organs, including female reproductive organs
• Laryngoscopy (laryngoscope)—Used to examine the larynx
• Neuroendoscopy (neuroendoscope)—Used to examine parts of the brain
• Proctoscopy (Proctoscope)—Used to examine the rectum and sigmoid colon
• Sigmoidoscopy (sigmoidoscope)—Used to examine the sigmoid colon (bottom of colon)
• Thoracoscopy (thoracoscope)—Used to examine the pleura covering the lungs.

Some cancers, infections and other conditions such as arthritis can be diagnosed with an endoscopic procedure.

Of concern is the growing intricacy of endoscopes, which has led to issues with proper reprocessing—or cleaning—of the endoscopes. Improper cleaning can result in bacteria growing on the endoscope, putting anyone who comes into contact with it at risk of developing a severe infection from a superbug. Such infections can, in some cases, result in death. Lawsuits have been filed against device makers, alleging the device designs prevent proper sterilization from occurring, putting patients at risk of serious health problems.

Health problems arise when an endoscope picks up carbapenem-resistant enterobacteriaceae (CRE) from one patient and spreads it to other patients because it is not properly sterilized.

In February 2015, the US Food and Drug Administration (FDA) issued a warning about improper cleaning of endoscopes and specifically duodenoscopes, which are threaded through the patient's mouth into the throat, stomach and top of the small intestine. According to the FDA, the duodenoscopes have an "elevator" mechanism that allows the doctor to change the angle of the duodenoscope, but that elevator might prevent adequate sterilization of the device. The FDA warned that meticulously cleaning the devices prior to disinfection should reduce the risk of transmitting and infection, "but may not entirely eliminate it."

At the time the FDA noted that between January 2013 and December 2014, it had received 75 reports involving around 135 patients who may have become ill due to an improperly sterilized duodenoscope. Among the infectious agents that can be transmitted on an improperly cleaned endoscope are carbapenem-resistant enterobacteriaceae, also known as CRE.

According to reports, 11 patients died after 35 had developed infections linked to endoscope contamination at Virginia Mason Medical Center. Meanwhile, between October 2014 and January 2015, up to 200 patients at UCLA Medical Center might have been exposed to a superbug linked to two deaths and seven infections. Reports indicate that up to 40 percent of patients who develop CRE die from it.

Studies have been conducted concerning the possibility of developing a superbug due to improperly cleaned endoscope devices. One such study was published in BMJ (British Medical Journal). Authors of the study cited a 2013 study, which found that approximately 15 percent of endoscopes in US hospitals did not achieve an accepted standard of cleanliness after liquid reprocessing. Of the devices examined, duodenoscopes had a 30 percent contamination rate while colonoscopes had only a 3 percent contamination rate.

"The endoscopy itself is not dangerous, but the current cleaning process used between procedures leaves patients susceptible to infection and troubles many healthcare practitioners," the authors wrote.

Lawsuits have been filed against the makers of various endoscopes by patients who became ill following an endoscopic procedure and family members whose loved ones died after contracting a superbug.

Lawsuits have reportedly been filed against Olympus Corporation, maker or the endoscope linked to the UCLA CRE outbreak. The lawsuit was filed by an 18-year-old patient who was allegedly infected by use of the endoscope. In at least one case, a medical center has joined a lawsuit against an endoscope maker, alleging that even when the devices are cleaned according to manufacturer guidelines, patients are at risk of infection. In that case, UCLA joined a lawsuit against Olympus Corp., following an outbreak of drug-resistant bacteria.

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Last updated on Nov-28-16