Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope
A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an antibiotic-resistant infection after undergoing a routine Endoscopic Retrograde … [Read more...] about Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope
Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers
The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The makers of the specialized gastrointestinal scopes, which are … [Read more...] about Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers
Deadly Superbug Outbreaks Result in FDA Warning Letters for Duodenoscope Manufacturers
Warning Letters For Duodenoscope. A series of superbug outbreaks in hospitals across the country has resulted in FDA warning letters to Olympus Medical Systems, Pentax Medical, and Fujifilm from the Food and Drug Administration (FDA). In the letters, the FDA cited failure to report infections in a timely manner and problems with … [Read more...] about Deadly Superbug Outbreaks Result in FDA Warning Letters for Duodenoscope Manufacturers
Superbug Outbreaks Result in FDA Warning Letters
Duodenoscopes Have Been Linked To Outbreaks. A series of superbug outbreaks in hospitals across the country has resulted in FDA warning letters to Olympus Medical Systems, Pentax Medical, and Fujifilm from the Food and Drug Administration (FDA). In the letters, the FDA cited failure to report infections in a timely manner and … [Read more...] about Superbug Outbreaks Result in FDA Warning Letters
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...] about FDA Never Approved Scopes Implicated in Superbug Outbreak
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...] about FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes
Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures
In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven … [Read more...] about Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures
