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...]
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...]
FDA Never Approved Scopes Implicated in Superbug Outbreak
The U.S. Food and Drug Administration (FDA) never approved the model of duodenoscope implicated in the recent superbug outbreak at Ronald Reagan UCLA Medical Center, CNN reports. Between October to January, the scopes spread the superbug carbapenem-resistant Enterobacteriaceae (CRE) to seven patients, two of whom died. According … [Read more...]
FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes
The Food and Drug Administration (FDA) has issued a safety communication to raise awareness that the design of ERCP endoscopes (also called duodenoscopes) may impede effective disinfection of the reusable devices. The FDA says recent reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP … [Read more...]
