A lawsuit filed against Olympus Corp claims that nearly two years before the CRE outbreaks at UCLA and Cedars-Sinai, the company was warning hospitals in Europe about the risk of infection caused by their gastrointestinal scopes. However, no alarms were sounded until after the massive outbreak in February, when seven patients fell ill, and two died.
The health risk comes from cleansing the device. The scopes are apparently hard to clean, requiring a special brush to prevent contamination. In January 2013, Olympus Corp issued a safety warning to European hospitals, recommending a specific cleaning brush, yet in August 2014, another alert was sent out after receiving complaints of debris on scopes ever after they were disinfected. These safety alerts were considered so important, that European hospitals were required to fill out and return a form stating that they had informed relevant staff. The same alerts to United States hospitals were only issued about a month ago.
The U.S. Food and Drug Administration apparently had knowledge of the European safety alerts last summer, yet failed to take action to warn U.S. hospitals. A spokesperson for the FDA claims steps were not taken, because they were already working with Olympus to make sure the cleaning protocols worked. When the cleaning protocols were sent for approval in October 2014, they were rejected by the FDA, because the company did not provide enough data.
As the largest supplier of gastrointestinal scopes in the world, it is estimated that the company has a market share of 70%. The scopes are used in ERCP (endoscopic retrograde cholangiopancreatography) procedures, where they are inserted down a patient’s throat to diagnose and treat digestive diseases, gallstones, and cancer. If not properly cleaned, bacteria can build up in small crevices along the scope, and infect patients with CRE (carbapenem-resistant Enterobacteriaceae), a bacteria that is highly resistant to antibiotics, causing a 50% death rate in those infected.
“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions.” Los Angeles Representative Ted Lieu commented.
If you or a loved one have suffered from diseases contracted from faulty and improperly cleaned medical equipment, the law firm of Hodes Milman Liebeck can provide you with the assistance you need. Contact us today online at hmlm.com or call 866-730-1976 for a complimentary case evaluation.