In an attempt to reduce the spread of bacteria between patients, Olympus redesigned and modified its duodenoscope medical devices last year. However, the U.S. Food and Drug Administration (FDA) now reports that five patients were infected with deadly bacteria after being treated with the updated devices, which were approved by the FDA in early 2016. [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.
Contaminated medical scopes may have sickened more Americans than federal investigators had originally determined, according to the results of a U.S. Senate investigation released today. The Seattle Times reports the Senate investigation indicates that from 2012 to 2015, antibiotic-resistant illnesses linked to specialized duodenoscopes sickened at least 250 people – most at U.S. hospitals. That number is nearly double the statistic previously identified by the U.S. Food and Drug Administration (FDA) for cases since 2010. [Read more…]
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…]
Across the nation, from Seattle to Pittsburgh to North Carolina and Florida, hospital officials have revealed that patients have tested positive for drug-resistant “superbug” bacteria after being examined with a special kind of endoscope, called a duodenoscope. At the same time, some of these same officials assert that they have no evidence the medical scopes at their facility actually transmitted the infections.