Modern medicine offers more alternatives and procedures to help diagnose and treat medical conditions. The use of an endoscope (a flexible (or rigid) tube with a light and video camera attached to the end that is introduced into the body through an incision or existing opening that offers a minimally invasive diagnostic technique in which to view inside the body) is one of the marvels of high-tech medicine that has helped patients achieve their optimal health. A physician or technician guides the endoscope by viewing the image on a video screen. Surgical tools may be attached to the end of the endoscope to allow for the removal of tissue or foreign objects from inside the body for diagnostic testing (biopsy).
While endoscopes are an important tool for diagnostic and treatment procedures, it is imperative that the endoscopes, which are typically not disposable and are re-used on patients after cleaning and sterilization, are properly prepared before being used on the next patient. Manufacturers of the endoscopes and the surgical tools used during endoscopy provide detailed and specific instructions regarding the cleaning, sterilization, and preparation of their endoscopes before they are used for patient treatment. Hospitals and surgical centers often have established protocols and procedures that their employees are required to follow in order to avoid contamination and putting patients at risk for infection and other avoidable consequences of improperly or inadequately cleaned endoscopes. If the training of the personnel responsible for preparing endoscopes for use is inadequate, or the personnel fail to precisely following their training, the health of patients may be put at serious risk, sometimes resulting in death.
The most recently reported example of possible inadequate cleaning and sterilization of endoscopes, which allegedly led to two patient deaths, occurred at the Ronald Reagan UCLA Medical Center, where seven patients acquired CRE (Carbapenem-Resistant Enterobacteriaceae), a so-called “superbug” that is highly resistant to antibiotics and leads to death in up to one-half of patients infected with the bacteria, following routine endoscopies for bile duct, gall bladder, or pancreas treatments. An additional 179 patients who underwent ERCP (endoscopic retrograde cholangiopancreatography) between October 2014 and January 2015 at the UCLA Medical Center have been contacted and offered home screening tests for the bacterium.
The FDA warned on February 19, 2015 that the complex design of ERCP endoscopes may impede effective reprocessing (the detailed, multistep process used to clean and disinfect or sterilize reusable devices). Unlike most other endoscopes, duodenoscopes have a movable “elevator” mechanism at the tip that changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage.
The FDA warns that the complex design of duodenoscopes means that some parts of the scopes may be extremely difficult to access and effectively clean (the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush during cleaning, resulting in residual body fluids and organic debris remaining in the crevices after cleaning and disinfection; if the residual body fluids contain microbial contamination, subsequent patients may be exposed to serious infections).
The FDA recommends strict adherence to the manufacturer’s reprocessing instructions to minimize the risk of infection, warning that deviations from the manufacturer’s instructions for reprocessing may contribute to contamination.
The FDA received 75 Medical Device Reports (MDRs) involving approximately 135 patients in the United States related to possible microbial transmission from reprocessed duodenoscopes, from January 2013 through December 2014 (all such cases may not have been reported to the FDA). More than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually.
If you or a family member acquired a serious infection following an endoscopic procedure, you should promptly consult with a local medical malpractice lawyer in your U.S. state who may investigate your possible endoscopy claim for you and represent you in a claim for compensation due to the injuries you suffered following an endoscopy.
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