Senate Report Critical of Medical Device Makers’ Failure to Report Infections
A Senate report released on January 13, 2016 finds that superbug infections linked to poorly cleaned medical devices have been more widespread than previously known. The reports places blame on hospitals, device makers, and the Food and Drug Administration (FDA). Senator Patty Murray of Washington state began the yearlong … [Read more...] about Senate Report Critical of Medical Device Makers’ Failure to Report Infections
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
Medical Scope Makers Warned in the Wake of Superbug Outbreaks
Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in some instances, failed to ensure the … [Read more...] about Medical Scope Makers Warned in the Wake of Superbug Outbreaks
Gastrointestinal Scope Makers Receive FDA Warning Letters
The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals. In the spring, the FDA conducted inspections of the manufacturing plants for Olympus Medical Systems Corp., Fujifilm Corp. and Pentax … [Read more...] about Gastrointestinal Scope Makers Receive FDA Warning Letters
Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time
Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012. The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning letters to Olympus and two other scope manufacturers. … [Read more...] about Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time
Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago
The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked numerous drug-resistant infections in Florida hospital patients (and to … [Read more...] about Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago
FDA Increases Oversight of Endoscopes Linked to ‘Superbug’ Infections
Endoscopes Associated With Infections. The Food and Drug Administration (FDA) is increasing oversight of endoscopes associated with a number of "superbug" infection outbreaks. The FDA has released stricter guidelines for manufacturers of reusable medical instruments, including specialized endoscopes – duodenoscopes – … [Read more...] about FDA Increases Oversight of Endoscopes Linked to ‘Superbug’ Infections
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
Drug-Resistant MRSA Superbug Found in Gay Men
MRSA Superbug is Resisting Even More Drugs And Affecting Gay Communities. A highly drug-resistant MRSA super bug is resisting even more drugs than other strains of the bacteria and affecting gay communities in San Francisco. Sexually active gay men are 13 times more likely to develop this new strain—called USA300. San Francisco’s … [Read more...] about Drug-Resistant MRSA Superbug Found in Gay Men
MRSA Hospitalizations Surge, as Drug Resistant
MRSA Hospitalizations Have Doubled. MRSA hospitalizations have doubled since 1999, a new study says, another indication that the drug-resistant "superbug" is becoming an urgent public health issue. The study, which appears in the December issue of the journal Emerging Infectious Diseases, is the first to examine the recent … [Read more...] about MRSA Hospitalizations Surge, as Drug Resistant
MRSA, Antibiotic Resistant Staph ‘Superbug’ Plaguing Schools
MRSA, Short for Methicillin-Resistant Staphlococcus Aureas, has been Ravaging Schools Across the Country this Year. MRSA, short for methicillin-resistant Staphlococcus aureas, has been ravaging schools across the country this year. The drug resistant infection has been reported in schools in at least a half dozen states, and has … [Read more...] about MRSA, Antibiotic Resistant Staph ‘Superbug’ Plaguing Schools
Patients Ill With ‘Superbug’ Often Given the Wrong Drugs
Patients With MRSA Skin Infections Given The Wrong Drugs. The drug-resistant "superbug" formally known as methicillin-resistant Staphylococcus aureus, or MRSA is now the most common cause of skin and soft-tissue infections treated in 11 US hospitals, found a study published in the New England Journal of Medicine. Although rates … [Read more...] about Patients Ill With ‘Superbug’ Often Given the Wrong Drugs
