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 [...]
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.
Unsedated transnasal endoscopy (TNE) is a safe, low-cost procedure that can help physicians evaluate paediatric patients with potentially chronic problems in their oesophagus, according to a study published in the journal Gastrointestinal Endoscopy.
Melissa Rivers says that her mother Joan Rivers' death could have been avoided.
Reprocessing has taken center stage in the medical device industry over the past two months, thanks to several high-profile “superbug” outbreaks that were linked to the use of contaminated duodenoscopes (type of endoscope) at two prominent U.S. hospitals.
The deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh, Chicago. In each case, the culprit was a bacteria known as CRE, perhaps the most feared of superbugs, because it resists even "last defense" antibiotics — and kills up to 40% of the people it infects.
From Forbes: A deadly strain of antibiotic-resistant bacteria, dubbed “nightmare bacteria” by the head of theCenters for Disease Control and Prevention (CDC), has struck again. This time two people died and 179 were exposed to [...]
While Joan Rivers lay sedated in a Manhattan clinic, her doctors performed unauthorized medical procedures, snapped a selfie with the comedian and failed to act as her vital signs deteriorated, according to a malpractice lawsuit filed Monday by her daughter, Melissa.