Duodenoscope Lawsuit Lawyers
Drug resistant bacteria from duodenoscopes is suspected to have caused the deaths of two patients and could potentially affect hundreds more. The FDA has cautioned medical providers that endoscopes used for diagnosis and surgery may be difficult to clean properly and could cause grave concern for transmission of bacteriological infection(s). The agency called on medical providers to meticulously wash the devices, but also warned, “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” The superbug is known as CRE – carbapenem-resistant Enterobacteriaceae.
UPDATE: FDA issued warnings to duodenoscope makers on August 12, 2015.
Superbug Outbreak at UCLA
The Los Angeles Times broke the story – on Feb. 19, 2015 – of a superbug outbreak at UCLA. A spokeswoman for the agency said that the Centers for Disease Control and Prevention first alerted the FDA about a potential association between multidrug-resistant bacteria and duodenoscopes in the fall of 2013.
Spokeswoman Leslie Quander Wooldridge said, “The FDA has been actively working with federal partners, manufacturers, and other stakeholders to better understand the issues that contribute to the infections and what can be done to mitigate them.
“The agency now has enough of an understanding of the issues to communicate publicly and to provide recommendations to mitigate the risk associated with the transmission of infections by duodenoscopes.”
Two Deaths from Tainted Endoscopes
L.A. County health officials lead the investigation into the deadly outbreak at UCLA, which has affected more than 180 patients. Five UCLA patients have already been infected with CRE bacteria from tainted endoscopes, and the hospital said the outbreak was a contributing factor in the deaths of two additional patients.
The hospital is notifying 179 other patients who may have been exposed to the bacteria from October 2014 to late January during a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP.
Superbug at UCLA: Some 200 People exposed
Half a Million Endoscope Procedures
The Times reports that roughly half a million patients each year undergo ERCP procedures; doctors thread a specialized endoscope down a patient’s throat to view and treat cancer, gallstones, other digestive system issues.
Drug Resistant Bacteria
CRE – carbapenem-resistant Enterobacteriaceae – are germs resistant to most antibiotics. According to the CDC, CRE can kill half of the people it infects.
UCLA told the LA Times that it changed decontamination protocol procedures for the endoscopes involved after discovering CRE in a patient in late January, when UCLA also alerted county and state health authorities.
After the outbreak, UCLA switched to using gas sterilization for duodenoscopes, but experts say the gas used can be highly toxic to hospital employees and patients.
Endoscope Design Questions
Many doctors and hospitals question the design of the scopes, which make them difficult to disinfect. Device makers report they are working with FDA and medical groups to address these safety concerns.
A CDC medical officer, Dr. Alex Kallen, is assisting the county in its UCLA investigation. Kallen said that parts of the scopes are “incredibly intricate,” making them difficult to clean and completely rid of bacteria.
Matthews & Associates is evaluating endoscope injuries for potential litigation. If you or someone you love was injured by a drug resistant bacteria as the result of an endoscope, contact our law firm for a free legal consultation regarding a potential endoscope lawsuit. Please view our testimonials to see how we have helped others in medical device cases.