The industry leader finds itself at the center of superbug outbreaks at U.S. hospitals, including UCLA, where two patients have died and nearly 180 more people may have been exposed to deadly bacteria on contaminated Olympus scopes.
From LA Times: Olympus Corp. said Friday that it would voluntarily recall and redesign a troubled medical scope that has been linked to deadly patient infections around the world. The company, which sells about 85% of the duodenoscopes used in the United States, said it would revamp an internal mechanism inside the reusable device that [...]
“New and safer approaches to the diagnosis of esophageal cancer have been developed and perfected over the past twenty years, but their utilization has been stymied by special interests. CSE was created in order to break the conspiracy of silence and insure that patients know that there are better diagnostic tools available to them, ones that pose a much less significant threat to their health and longevity.”
Scores of hospital patients treated with medical scopes were infected with potentially deadly bacteria because of repeated failures by manufacturers, regulators and hospitals to report outbreaks, according to a U.S. Senate investigation released Wednesday.
This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable1 medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices.
From The Seattle Times: A retired Navy chief petty officer treated at the Seattle Veterans Affairs hospital may have been the victim of a deadly infection tied to dirty medical scopes — and to scope-washing machines ordered recalled last week by U.S. regulators because of increased risk to patients. That’s according to an amended lawsuit [...]
American Society for Microbiology: Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy
Most contemporary flexible endoscopes cannot be heat sterilized and are designed with multiple channels, which are difficult to clean and disinfect.
A relatively new antibiotic-resistant bacteria called CRE is making inroads in some major American cities, U.S. health officials report.
It started with a chance discovery, a lucky break that revealed an unlucky situation.
Unsedated transnasal endoscopy was shown to be a safe, well-tolerated and lower-cost alternative to esophagogastroduodenoscopy for evaluating pediatric eosinophilic esophagitis, according to recent study data.