FDA Cracking Down on Dirty Duodenoscopes
The federal government is cracking down on dirty duodenoscopes. In a publicly issued safety notice from the U.S. Food & Drug Administration, or FDA, the federal agency outlines some dangers of these reusable medical devices. Duodenoscopes are incredibly valuable medical devices, used in a common procedure to diagnose and … [Read more...] about FDA Cracking Down on Dirty Duodenoscopes
Lawmakers Want Better Reporting for Medical Device Injuries
Medical Device Injuries Better Reporting. In light of medical devices that have raised concerns in recent years, regulators and lawmakers are both looking to improve the way medical device injuries and deaths are reported. Specifically, there has been criticism over the delayed awareness of power morcellators, devices that … [Read more...] about Lawmakers Want Better Reporting for Medical Device Injuries
Tainted Medical Scopes Allegedly Cause Superbug Infections
The Olympus Corporation, based in Japan, was allegedly aware of superbug outbreaks in three countries as early as 2013 and did not alert American hospitals about possibly deadly infections from contaminated medical scopes known as duodenoscopes. After two-dozen infections were reported in Dutch and French hospitals, Olympus warned … [Read more...] about Tainted Medical Scopes Allegedly Cause Superbug Infections
Olympus Fails to Warn Duodenoscopes Infection in Hospitals
Risk Of Infection with Duodenoscopes Still A Problem In The U.S. The duodenoscope debacle continues to grow, as an LA Times investigation reveals that scope maker Olympus failed to warn US hospitals about the risk of infection with its TJF-Q180V duodenoscope. According to LA Times, Olympus became aware of potential infections in … [Read more...] about Olympus Fails to Warn Duodenoscopes Infection in Hospitals
FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes
The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being issued due to “continued violations of federal law and a consent … [Read more...] about FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes
Lawsuit Filed Over Death of Patient Who Contracted Fatal Superbug
Patient Contracted Fatal Superbug Due To Pentax Scope. A wrongful death lawsuit has been filed in connection with the superbug outbreaks linked to contaminated duodenoscopes. The suit, which was filed on August 31, 2015 in state court in Cook County, Illinois, alleges that Pentax Medical, a division of Pentax of America, Inc. and … [Read more...] about Lawsuit Filed Over Death of Patient Who Contracted Fatal Superbug
In Light of Superbug Outbreak, FDA Requires Manufacturers to Show Duodenoscopes Can be Sterilized
Following a superbug outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is requiring device makers to submit data showing that new usable devices can be cleaned effectively. Up until now, manufacturers did not have to provide any evidence that their cleaning instructions were sufficient, LA … [Read more...] about In Light of Superbug Outbreak, FDA Requires Manufacturers to Show Duodenoscopes Can be Sterilized
FDA Steps Up Oversight of Endoscopes Linked to “Superbug” Outbreaks
The Food and Drug Administration (FDA) has stepped up its oversight of the medical scopes linked to potentially fatal "superbug" outbreaks. In the last month, two Los Angeles hospitals have reported multi-drug resistant infections in patients following a duodenoscope procedure, despite following manufacturer's cleaning guidelines. … [Read more...] about FDA Steps Up Oversight of Endoscopes Linked to “Superbug” Outbreaks
