Olympus Corporation, the manufacturer of endoscopes at the center of an antibiotic-resistant infection outbreak at UCLA that has already killed at least two people, will soon face a product liability lawsuit brought by one of seven other patients who have contracted the “nightmare bacteria”.
An unidentified 18-year-old patient is planning to filed a lawsuit that alleges there design problems with a type of endoscope, known as a duodenoscope, which make it difficulty to clean.
Following an outbreak of carbapenem-resistant enterobacteriaceae (CRE) infections at UCLA Ronald Reagan Medical Center, which is believed to have caused at least seven illnesses and two deaths, the FDA issued warnings last week that suggested that blood and other contaminants can become trapped, even when the endoscope is cleaned according to manufacturer instructions.
At least 179 patients who underwent surgery at UCLA Medical Center between October 2014 and January 2015 have been warned that they may have been exposed to a deadly endoscopy infection risk.
Not only does carbapenem-resistant enterobacteriaceae (CRE) resist treatments by antibiotics, but it kills about half of those it infects, leading the U.S. Centers for Disease Control and Prevention (CDC) to refer to it as a “nightmare bacteria”.
The endoscopy infection lawsuit is expected to be filed by a teen who is still struggling to recover from the infection, according to a report by NBC News.
The case may be the first of many product liability lawsuits filed against Olympus and other endoscope manufacturers, after reports suggest that sevearl infection outbreaks may be linked to improperly cleaned duoendoscopes, which are used during a procedure known as an endoscopic retrograde cholangiopancreatography (ERCP).
According to the FDA safety communication issued last week, duodenoscopes may have designs that make them difficult to clean properly even when doctors and health care professionals follow the recommended steps for cleaning it. Many of the devices include a movable “elevator” at the tip, which may trap pathogens and blood even when recommended cleaning techniques are used.
Duodenoscopes are flexible, lit tubes that are inserted down the throat to the top of the small intestines for gastrointestinal procedures. They allow contrast dye to be injected and can be used with other medical instruments to retrieve biopsy samples. The FDA estimates that more than 500,000 ERCP duodenoscope procedures occur each year in the U.S.
The FDA reports that from January 2013 through December 2014, it received at least 75 reports of infections that affected about 135 patients linked to the use of the devices. However, the problems may go back even further.
In 2009, the FDA issued an advisory to health care professionals following an infection outbreak that affected 16 patients in France following duodenoscope procedures. In 2012, duodenoscope use was linked to an outbreak at the Moffitt Cancer Center in Tampa, Florida, where four patients were infected with drug-resistant pathogens.
Some health care experts say that the FDA needs to create new guidance on the cleaning of the instruments, or force manufacturers to correct the design issues that make then difficult to clean properly.
The FDA says it is currently working with the manufacturers and the CDC to identify the causes and risk factors linked to the devices and continues to actively monitor the situation.
Olymups Corp. of America, a subsidiary of Japan-based Olympus Corp., has announced that it has sent new cleaning instructions to hospitals that carry its devices and is working with the FDA to address the problems.