ERCP Infection Problems May Be Widespread
Over the past year, concerns have emerged about a potential risk of severe “superbug” infections from duodenoscopes used during endoscopic retrograde cholangiopancreatography procedures (ERCP), where the device may not be properly cleaned between patients. However, recent reports suggest that the ERCP infection problems may be much more widespread than previously believed.
Earlier this year a U.S. Senate report was released, titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” which found at least 25 separate instances of hospital infection outbreaks linked to duodenoscope cleaning problems since 2012. However, data that will likely be released by the FDA this week may indicate that the ERCP infection problems are even more widespread at hospitals nationwide.
Duodenoscopes are used during ERCP surgery, which combines the use of endoscopy and fluoroscopy to diagnose and treat certain problems involving the biliary or pancreatic duct systems. The device can be used during procedures involving complications with the:
- Bile Ducts
- Pancreatic Duct
- Leaks from Trauma and Surgery
- and Other Conditions
Problems with the design of the device suggest that hospitals may not be able to properly clean duodenoscopes between patients, even when instructions previously provided by manufacturers were followed. This may allow infectious tissue and blood hidden in the devices to remain on the ERCP duodenoscope, spreading infections from one patients to another.
Amid hospital infection outbreaks at facilities nationwide, the FDA has approved revised cleaning instructions for ERCP duodenoscopes made by Olympus, Pentax and Fujifilm, but it appears that these problems do not appear to be limited to a small group of facilities
The Senate report indicates that prior to these changes, at least 25 different outbreaks involving duodenoscope infections may have impacted 250 people worldwide, striking hospitals in 10 U.S. states and four different countries. However, the actual number of problems is likely to be much larger.
According to the report:
“Because some of the infections identified had unique markers that made the bacteria possible to track, and because the hospitals that have reported infections are primarily large, well-resourced research hospitals adept at spotting and addressing antibiotic-resistant infections, it is likely that there have been more incidents of infections linked to these devices that were never identified.”
In addition, the report only focused on infections that are antibiotic-resistant. It did not address more common and treatable, but still dangerous, infections that may have been spread by duodenoscopes.
Duodenoscope ERCP Infection Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for those who suffered an ERCP infection that may have been caused by problems with a duodenoscope used during their procedure. In many cases, these infections can be difficult to treat and may involve antibiotic-resistant pathogens and can lead to severe injury, illness or death.
Financial compensation may be available through an ERCP infection lawsuit due to the manufacturers failure to ensure that their device can be properly cleaned between patients and providing inadequate warnings for consumers and the medical community. To review whether you or a loved one may have a case, request a free consultation and claim evaluation.