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 patients with drug-resistant bacteria at Ronald Reagan UCLA Medical Center.
A duodenoscope is a long, flexible tube with a tiny camera attached at the end. It is inserted through the throat to help diagnose gastrointestinal tract disorders. According to NYT, these devices have been linked to serious infections at several other hospitals. In 2013, 39 patients at Advocate Lutheran General Hospital in Chicago were infected with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing procedures with duodenoscopes. This is the same bacteria that caused recent infections in Los Angles. In January, Virginia Mason Hospital in Seattle said that from November 2012 to early 2014, 32 patients were infected with CRE through the scopes. Eleven of these patients ultimately died, but it is unknown whether the infections were to blame because they were already critically ill. Continue reading
HeartWare International is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System controllers distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012.
The company has written to clinicians and patients to inform them that the affected clinical trial controllers are more susceptible to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or death, according to HeartWare’s news release. HeartWare has improved the design of newer controllers to improve immunity to ESD. The recall does not affect the newer controllers. Continue reading
Lenovo users may be getting more than they bargained for with their new laptops. Mashable reports that some Lenovo products come preinstalled with adware called Superfish, which breaks secure website connections and makes sensitive user information vulnerable to security threats.
Superfish breaks HTTPS, which is meant to provide a secure connection over the internet, in order to better scout for ads. The adware also looks at user data on connections that would not normally be visible. Mashable reports that according to experts, Superfish disrupts encrypted connections in a way that leaves users vulnerable to more malicious hackers; sensitive data, such as banking information, can potentially be stolen. Continue reading
A Philadelphia jury hit a Johnson & Johnson unit with $2.5 million in damages in a case accusing the drug maker of failing the parents and doctors of an autistic boy about risks associated with the antipsychotic drug Risperdal.
During the trial in the Philadelphia County Court of Common Pleas, the jury heard testimony that Janssen Pharmaceuticals Inc. had worked for years to hide evidence that the drug was linked to abnormal growth of female breast tissue — gynecomastia — in adolescent boys, Law360 reports. The lawsuit was filed in 2012 by the family of a boy who grew large breasts after taking Risperdal for nearly five years, beginning in 2002, when he was seven. Continue reading
Earlier this month, GE Healthcare recalled 12,968 MRI systems due to a disabled Magnet Rundown Unit (MRU) in India. When this unit is disabled, it can slow the removal of a magnetic object from the scanner. This can lead to life-threatening consequences, prompting a Class I recall.
Class I recalls are reserved for issues that can lead to serious injuries or death. They are the U.S. Food and Drug Administration’s (FDA’s) most serious type of recall. Continue reading
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 Center in Los Angeles to drug-resistant bacteria and contributed to two deaths, Reuters reports. This is not the first time the sometimes-fatal infections have been traced to the devices, which are inserted down the throat to diagnose and treat pancreatic and bile duct diseases. Duodenoscopes are manufactured by the medical divisions of Olympus Corp, Pentax, and Fujifilm. The UCLA hospital uses an Olympus model. Continue reading
A Class I recall has been issued for more than 12,000 MRI systems manufactured by General Electric, Modern Healthcare reports. The recall was issued because of a potentially life-threatening problem that can occur when parts are not connected properly. Many GE MRI brands, including Signa and Discovery, are affected by the recall.
Class I recalls are the FDA’s most serious recall status, and are reserved for situations where serious injury or death can occur. In this case, the problem was that the magnet rundown units may not be connected properly. “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the FDA said in its recall notice, issued Feb. 18. The recall affects a total of 12,968 machines; 5,708 are in the United States and the rest are in other countries. Continue reading
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) are being offered home testing kits that would be analyzed by the hospital, UCLA officials said. The exposures occurred between October 2014 and January 2015 during which a specialized endoscope is inserted down the throat to diagnose and treat pancreatic and bile duct diseases, Reuters reports. The Food and Drug Administration (FDA) warned that the design of the endoscopes may hinder proper cleaning and disinfection, the FDA warned on Thursday. Continue reading
A new study has found that drinking at least one can of soda per day may significantly increase the risk of cancer. Research conducted by the Johns Hopkins Bloomberg School of Public Health found that some caramel colorings in soda can produce 4-methylimidazole (4-MEI), a potential carcinogen.
The study, published online in the Public Library of Science journal PLOS One, noted that 44-58 percent of American adults typically consume at least one can of soda daily; these individuals have a higher risk of 4-MEI from soft drinks. In 2014, Consumers Reports published an analysis of 4-MEI concentrations among 110 different soft drinks. This study builds on that analysis, and researchers say that the risk of cancer may increase greatly with lifetime exposure to the substance.
“Soft drink consumers are being exposed to an avoidable and unnecessary cancer risk from an ingredient that is being added to these beverages simply for aesthetic purposes,” said Keeve Nachman, senior author of the study and director of the Food Production and Public Health Program at the CLF, according to Newsmax Health. “This unnecessary exposure poses a threat to public health and raises questions about the continued use of caramel coloring in soda. Continue reading