Medtronic Infuse Recipients Receive $8.45 Million in Settlements
The University of California, Los Angeles has agreed to pay a combined $8.45 million to two patients who received Medtronic's controversial Infuse bone graft product. These individuals filed lawsuits alleging that the product caused unwanted bone growth. They also claimed that the implanting surgeon had a conflict of interest because … [Read more...] about Medtronic Infuse Recipients Receive $8.45 Million in Settlements
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
FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act
Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements. The latest outbreak involving duodenoscopes may have exposed 179 patients at UCLA's Ronald Reagan Medical … [Read more...] about FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act
Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug
One hundred seventy-nine patients at UCLA Ronald Reagan Medical Center have been told they may have been exposed to a drug-resistant "superbug" during endoscopy procedures that infected seven patients and may have contributed to two deaths. Patients who may have been infected by the carbapenem-resistant Enterobacteriaceae (CRE) … [Read more...] about Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug
UCLA Surgeon Didn’t Report Industry Payments
UCLA Surgeon Fails To Dislose Industry Payments. The relationships and finances exchanged between Industry and researchers have long been making the news and point to a bias in which patients are often not the prime concern. In a growing trend of reports of physicians and researchers failing to disclose Industry payments, … [Read more...] about UCLA Surgeon Didn’t Report Industry Payments
