Duodenoscopes are used in more than 500,000 gastrointestinal endoscopic procedures each year. These devices are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can be used to drain fluid from bilary and pancreatic ducts that is blocked by tumors, gallstones, or other conditions affecting the gastrointestinal system.
Recently, evidence surfaced connecting the devices to the transmission of Carbapenem-resistant enterobacteriaceae (CRE), a form of antibiotic resistant infection. These infections are exceedingly difficult to treat and are often fatal.
Duodenoscopes Cause Outbreaks of CRE
In 2015, the Ronald Regan UCLA Medical Center reported 7 incidences of CRE infection in patients and two deaths related to the infection. The hospital found the source of the infection to be two duodenoscopes, both manufactured by Olympus Corporation of the Americas, that were used in routine endoscopic procedures in the five months leading up to the outbreak.
In January, 2016, the United States Senate published an investigation that attributed 25 outbreaks of antibiotic resistant infections, in the United States and Europe, to cross-contamination by improperly sterilized duodenoscopes. The infections were identified in nearly 250 patients, though many additional cases may not have been reported.
The Senate Report identifies the duodenoscope manufacturers, including Olympus, Fujifilm, and Pentax, failed to inform hospitals and physicians of design flaws that prevent their closed-channel duodenoscopes from being properly decontaminated between patient use. The investigation also criticized hospitals and government regulatory agencies for failing to report incidents of infection.
Alleged Manufacturer Negligence
The Senate Report also establishes that Olympus was aware of its duodenoscope device flaws as early as 2012, but failed to inform users or regulatory agencies. Olympus—the manufacturer and supplier of approximately 85% of the scopes used in United States hospitals—was specifically cited for its negligence in warning hospitals of the cross-contamination hazards. Further, a CNN investigation published in March, 2015, revealed that Olympus began selling its TJF-Q180V duodenoscope before receiving FDA clearance to do so.
On January 15th, 2016, Olympus issued a voluntary recall of the TJF-Q180V duodenoscope. The manufacturer is working to modify the device’s design and labeling design and labeling in order to reduce the risk of bacterial infection and cross-contamination. Olympus has also indicated that it plans to conduct annual inspections of each device in order to identify any wear on the re-designed sealing mechanism or the presence of attached debris at the scope’s tip—flaws that may require replacement of the parts.
Lawsuits Regarding Duodenoscope-Related CRE
Lawsuits are now being filed by patients, and their families, who contracted CRE and other antibiotic resistant infections after undergoing routine endoscopic procedures using a duodenoscope. If you or a loved one suffered from severe abdominal pain, gallstones, pancreatic cancer, or bilary or pancreatic duct obstructions between 2012 and 2015, and underwent an ECRP procedure using a duodenoscope, you may be able to seek legal redress. Contact the attorneys at Peter Angelos, P.C., for a no-cost legal consultation.