Some patients suffered or died from “dirty” duodenescopes

FDA warns of duodenescopes housing deadly superbug

FDA warns of duodenescopes housing deadly superbug

Recently, I wrote about a jaw-dropping story about the carbapenem-resistant Enterobacteriaceae (CRE) “superbug” related deaths stemming from duodedenscope procedures done at Seattle’s Virginia Mason. The news was just surfacing as I wrote about it, as the public started to learn about the details. Shortly after the news hit the airwaves, victims and their family members contacted our law firm, Stritmatter Kessler Whelan, to hear their tragic stories. As we delve into their stories, it is unfortunately not a surprise to see that the FDA just issued a warning addressing those including gastroenterologists, gastrointestinal surgeon, endoscopy nurses, as well as patients considering endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The FDA’s purpose in issuing this February 19, 2015 warning:

The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it. [emphasis added]

The ERCP endoscopes or duodenescopes are apparently quite difficult to clean, despite the detailed reprocessing instructions. This detail, however, is little comfort to those who have lost a family member or who themselves have had to battle the CRE. At the UCLA Health System at least two deaths related to the “superbug” endoscopic procedure occurred at its facility.  Additionally, over 100 patients are thought to have likely been exposed to the “superbug” at the UCLA facility during endoscopic procedures between October 2014 and January 2015.

According to the AP,  an 18-year-old student now hangs on by a thread after he was infected by a “superbug” outbreak tied to contaminated medical instruments at the Ronald Reagan UCLA Medical Center.

Between the beginning of 2013 to the end of 2014, the FDA received 75 device-related reports relating to 135 patients linked to possible microbial transmission from reprocessed duodenoscopes. More troubling news is that the agency states that it’s possible more cases went unreported. The FDA it’s working with the Centers for Disease Control and Prevention and the manufacturers of the devices in order to find solutions to the problem.

Sadly, as certain as we will see more tragedies linked to this procedure, we will see more potential lawsuits against the manufacturer and lawsuits against various medical providers. Stay tuned…


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