The LA Times reports a new congressional investigation has revealed that the number of potentially deadly “superbug” infections from improperly cleaned and contaminated medical scopes is significantly higher than previous federal estimates. [Read more…]
During the deadly “Superbug” CRE infection outbreak from contaminated medical scopes, three UCLA patients died and five more fell ill to the lethal bacterial spread. When doctors at UCLA’s Ronald Reagan Medical Center inquired about replacing the tainted medical scopes, medical device maker Olympus Corp. offered to sell the hospital 35 new scopes for $1.2 million — a 28% increase in price for the defective products, compared to the pricing just months earlier. [Read more…]
Olympus, the manufacturer of some allegedly defective medical scopes that have been linked to deadly superbug CRE infections worldwide, announced that it will voluntarily recall and redesign its affected medical scope products. Japan-based Olympus Corporation holds 70% of the share of gastrointestinal endoscopes on the global market.
FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities
In the wake of widespread reports of dangerous and sometimes deadly infections occuring from repeated use of the devices, on October 5, 2015, the FDA ordered the three medical duodenoscope manufacturers in the U.S. to begin conducting surveillance studies to increase understanding of precisely how the devices are cleaned (reprocessed) in the real world. [Read more…]
Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the adult children of Renate Winkler as administrators of her estate have filed a wrongful death lawsuit against Pentax Medical, a division of Pentax of America, Inc., and Advocate Lutheran General Hospital, which is located in the Chicago suburb of Park Ridge, Illinois. Ms. Winkler died on December 7, 2013 from carbapenem-resistant Enterobacteriaceae or CRE, a bacteria that is highly resistant to antibiotics, following Endoscopic Retrograde Cholangiopancreatography or ERCP at Advocate Lutheran General Hospital. For the procedure, the hospital used a duodenoscope manufactured and sold by Pentax Medical.
–Husband Suffered “Excruciating Pain and Horrific Injuries” and Ultimately Died from Superbug Bacterial Infection Spread by Contaminated Medical Scope
Washington, D.C. – May 15, 2015 – Carla Warner of Statesville, North Carolina, yesterday provided emotionally powerful testimony to a U.S. Food and Drug Administration Advisory Panel on the devastating impact of carbapenem-resistant Enterobacteriaceae (CRE) on her husband, Willie “Bill” Warner. The Panel was convened to examine the safety of certain medical scopes, called duodenoscopes, which have been linked to the outbreak of superbug infections at hospitals nationwide.
Over the last few months, news outlets have reported on outbreaks of antibiotic-resistant “superbug” infections at hospitals across the United States, infections alleged to have been caused by insufficiently cleaned and/or defectively designed medical scopes (duodenoscopes). The list of states with hospitals reporting superbug infection outbreaks includes California, Connecticut, Florida, North Carolina, Pennsylvania, and Washington.