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superbug outbreak 8 articles

Olympus communications regarding contaminated duodenoscopes could play key role in lawsuits

In June 2012, an investigator hired by medical device company Olympus and a Netherlands hospital concluded in a report that the design of the company’s specialized endoscope called a duodenoscope could trap blood and tissue that was difficult to remove under standardized cleaning and disinfecting, allowing the device to spread bacteria from patient to patient. The independent expert recommended that Olympus conduct a worldwide investigation and recall all its duodenoscopes if outbreaks of patient infections should arise. At the time, Olympus executives were aware of three outbreaks of superbug infections in patients who had undergone procedures with its duodenoscopes – affecting about ... Read More

Health officials say Huntington Hospital broke state law by not reporting superbug outbreak linked to duodenoscopes

Huntington Hospital in Pasadena, Calif., broke state law by waiting too long to report an outbreak of a deadly drug-resistant bacterial infection, city health officials claim. The accusation comes after an investigation into the outbreak at the hospital during which 16 people were infected, 11 of whom died. The outbreak was later traced to specialized endoscopes that had been cleaned and disinfected but still contained traces of bacteria that spread from patient to patient when reused. Only one death lists the drug-resistant bacterial infection as the cause of death. But attorneys for other infected patients claim that the illnesses occurred ... Read More

Olympus agrees to pay $646 million for kickback scheme

Medical device maker Olympus Corp., has agreed to pay $646 million to settle criminal and civil charges linked to a “greed-fueled kickback scheme” designed to sway hospitals into buying their products and steal market share from competitors. The agreement does not affect the current federal investigation into superbug outbreaks linked to the company’s specialized endoscopes, called duodenoscopes. The settlement is the largest on record for violations to the U.S. Anti-Kickback Statute, federal prosecutors said. Nearly $23 million of the $646 million will resolve similar allegations in Latin America. Prosecutors said Olympus promised doctors at prominent hospitals research grants, consulting deals, ... Read More

FDA updates safety communication about Olympus duodenoscopes

The Food and Drug Administration (FDA) is issuing an update to a March 26, 2015, Safety Communication regarding one of Olympus Corporation’s duodenoscopes. The specialized endoscopes have come under scrutiny in recent months when they were linked to the spread of drug-resistant superbugs at more than a dozen hospitals across the country. Duodenoscopes are surgical tools that are fed down patients’ throats in order to diagnose or treat conditions affecting the pancreas and bile duct. Researchers found that small crevasses in the scope could harbor bacteria even after the devices have been cleaned and disinfected. The bacteria can then be ... Read More

Medical device washing machine claims to kill deadly superbugs

Upstart company Langford IC Systems claims its specialized washing machine can wash away deadly superbugs from medical equipment better that other cleaning and sterilizing processes currently in practice, and is the only system that meets Food and Drug Administration (FDA) standards for reprocessed medical devices. Ronald Reagan UCLA Medical Center in Los Angeles has stepped in to be the machine’s first buyer, testing the company’s claims on controversial duodenoscopes, a specialized endoscope that is fed down a person’s throat to treat or diagnose conditions affecting the duodenum. The devices have been blamed for spreading life-threatening CRE infections from patient to patient ... Read More

CDC, White House work to stop spread of superbugs

Drug-resistant bacteria sickens about 2 million people and kills 23,000 each year, which has prompted the Centers for Disease Control and Prevention (CDC) to warn travelers about their hygiene and the White House to launch an aggressive initiative at stopping the spread of these bacteria. So-called superbugs, bacteria powerful enough to survive drugs such as antibiotics, have become an increasing concern in recent months. First, specialized endoscopes known as duodenoscopes were found to be the culprit in the spread of the deadly CRE bacteria among patients who had undergone gastrointestinal procedures using the devices. The latest concern is the diarrhea-causing ... Read More

Olympus issues new cleaning instructions for duodenoscopes

Olympus, makers of the specialized endoscopes called duodenoscopes targeted by lawsuits tied to the superbug outbreak at UCLA Ronald Reagan Medical Center, has issued new manual reprocessing instructions for medical facilities charged with cleaning and disinfecting the duodenoscopes in an effort to curb the number of patient-to-patient infections caused by the devices. The new, validated manual reprocessing instructions are specifically for the TJF-Q180V duodenoscope and are designed to replace those provided in the original labeling. The Food and Drug Administration (FDA) has reviewed the new reprocessing instructions and validated data as part of its ongoing review of the device. Any facilities using ... Read More

Endoscope at center of superbug outbreak was never FDA approved

The manufacturer of the specialized endoscope at the center of the deadly drug-resistant bacteria outbreak at UCLA never obtained approval from drug and medical device regulators to sell the surgical tool in the United States, CNN has learned. Olympus began selling its TJF-Q180V duodenoscope in 2010. The Food and Drug Administration (FDA), didn’t realize until late 2013 or early 2014 that Olympus had never filed for FDA approval on the device. Duodenoscopes are a type of flexible endoscope fitted with a camera that is put down throats of patients to treat a variety of gastrointestinal conditions. A half million duodenoscope ... Read More