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Pittsburgh 30 articles

Endoscope at center of superbug outbreak was never FDA approved


The manufacturer of the specialized endoscope at the center of the deadly drug-resistant bacteria outbreak at UCLA never obtained approval from drug and medical device regulators to sell the surgical tool in the United States, CNN has learned. Olympus began selling its TJF-Q180V duodenoscope in 2010. The Food and Drug Administration (FDA), didn’t realize until late 2013 or early 2014 that Olympus had never filed for FDA approval on the device. Duodenoscopes are a type of flexible endoscope fitted with a camera that is put down throats of patients to treat a variety of gastrointestinal conditions. A half million duodenoscope ... Read More

Patient files first lawsuit in deadly superbug outbreak


An 18-year-old boy who became infected with a deadly superbug after undergoing a procedure using a specialized endoscope at UCLA’s Ronald Reagan Medical Center has filed a lawsuit against the manufacturer of the surgical tool. The patient, high school student Aaron Young, remains hospitalized with carbapenem-resistant enterobacteriaceae, or CRE, a highly antibiotic-resistant bacteria that kills up to 50 percent of infected patients. The lawsuit names Olympus Corp. of Americans, manufacturers of the specialized endoscope, known as a duodenoscope. UCLA and the University of California regents may also be added as defendants following more investigations into the matter. Duodenoscopes are flexible fiber-optic ... Read More

Three superbug cases, one possible related death at NC hospital


One person has died in a North Carolina hospital after becoming infected with the same superbug bacteria blamed for two recent deaths in Los Angeles. According to the Carolinas HealthCare System in Charlotte, N.C., 15 patients admitted to the hospital carried carbapenem-resistant Enterobacteriaceae (CRE) upon admission. Three patients contracted a CRE infection in the hospital, and one of the patients died. The North Carolina hospital has not said how three of its patients contracted the infection, and it is not yet clear whether the reported death was caused by a CRE infection. The CRE bacteria are from a family of ... Read More

Family of teen infected by superbug at UCLA may sue endocope maker


A California teenager is in “grave condition” with an antibiotic resistant superbug infection months after undergoing an endoscopic procedure at Ronald Reagan UCLA Medical Center in Los Angeles, stoking fears that the design of specialized duodenoscopes used on about a half a million patients a year makes them difficult to thoroughly sanitize. Duodenoscopes are flexible fiber-optic tubes fitted with a light and camera that that are inserted down the throat, enabling physicians to examine an organ. Regulators and medical professionals are now learning the devices are can be extremely difficult to disinfect, a potential design flaw that could open the ... Read More

FDA endoscopy warning insufficient for patient safety


Federal drug regulators knew for at least five years that specialized endoscopes could spread deadly drug-resistant bacterial infections but offered no recommendations other than issuing a Safety Communication about the risk to patients and suggesting more stringent cleaning of the nooks and crannies of the surgical tools, medical experts said. This week, the Food and Drug Administration (FDA) issued the warning about the reusable devices, known as duodenoscopes, which are inserted down the throat to treat gallbladder disease, cancer and other gastrointestinal problems. An estimated 500,000 duedenoscope procedures are performed each year in the United States. Hundreds of patients who have undergone ... Read More

Endoscopes linked to deadly superbug bacteria


A specialized endoscope, put down about a half million throats each year to treat gallstones, cancers and other digestive system problems, have infected hundreds of people with serious drug resistant bacteria and may be a contributing factor in at least a dozen patient deaths, the Food and Drug Administration (FDA) warned in a recent Safety Communication. “The complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices,” the agency reported. “Recent medical publications and adverse event reports associate drug-resistant bacterial infections in patients who ... Read More

West Virginia pipeline explosion blasts fireball hundreds of feet into air; fourth major pipeline disaster this month

pipeline explosion W Va - image by WTRF

A gas pipeline owned by a Houston, Texas-based petroleum corporation exploded Monday morning in Brooke County, W. Va., just across the Ohio River from Steubenville, Ohio, and about an hour from Pittsburgh, Penn. The pipeline explosion and subsequent fuel leak was the fourth major pipeline disaster to occur in the U.S. this month. Enterprise Products Partners, which owns the pipeline involved in Monday’s explosion, said it is investigating the incident. There were no reports of injuries, but witnesses reported a massive fireball that shot hundreds of feet in the air, damaging a nearby house and power lines. Reports so far ... Read More

Outbreak of drug-resistant superbug linked to specialized endoscopes


A specialized endoscope, put into the throats of a half-million people each year to treat gallstones, cancers, and other digestive system problems, has been identified as the source of a deadly bacterial infection in patients who have undergone procedures using the devices. It was found that conventional methods of cleaning the specialized endoscopes, known as duodenoscopes, do not always remove the so-called superbug. If the bacteria is not thoroughly removed from the scopes, the devices can spread infections from patient to patient. The superbug, known as CRE, is highly resistant to numerous antibiotics and kills as many as 40 to 50 ... Read More

Whistleblower lawsuit says the Art Institutes corporation is duping veterans


Education Management Corporation (EDMC), a for-profit chain of colleges, manipulated student job placement data to attract as many students as possible and to maximize the amount of taxpayer-subsidized federal student loan money, a whistleblower lawsuit unsealed in federal court last week alleges. The lawsuit is the third whistleblower case to be filed against the EDMC, which owns the giant Art Institutes chain comprised of more than 50 campuses throughout North America. The U.S. Justice Department and four states intervened in another whistleblower complaint brought against EDMC in 2007 alleging the college corporation defrauded the government by paying recruiters based on ... Read More

Bus drivers may be charged for causing Pittsburgh Port Authority bus crash

bus crash Pittsburg Port Authority - WTAE News image

Two Pittsburgh Port Authority bus drivers are will likely face criminal charges for causing a bus crash last month that destroyed one the of the vehicles and left one driver critically injured. The Port Authority of Allegheny County bus drivers were allegedly “goofing off” and speeding alongside each other on Interstate 279 Sept. 22 before one the vehicles bumped the other one, sending it through a guardrail. The bus tumbled down a steep embankment onto a residential street below. A Port Authority spokesman said that video surveillance from one of the buses showed the drivers gesturing to each other playfully as ... Read More