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Pittsburgh 61 articles

Risk of infection remains with Pentax specialized endoscope


Tiny cracks and gaps in the adhesive seals used on Pentax Ed-3490K duodenoscopes, a specialized endoscope used to diagnose and treat certain gastrointestinal conditions, can trap bacteria and make thorough cleaning and high-level disinfecting difficult, which can increase the risk of infection transmission between patients, the Food and Drug Administration (FDA) warned in a Safety Communication. The issue is related to an issue with the design and manufacturing of the ED-3490K duodenoscope. Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, “which can lead to microbial and fluid ingress,” according to the ... Read More

GNC agrees to pay $2.25 M, strengthen practices to ensure quality, safety of products

dietary supplements - pills, probiotics

Pittsburgh-based health and nutrition company GNC Holdings Inc., has agreed to pay $2.25 million and “take a number of actions” to ensure the dietary supplements and other products it sells do not contain unlawful and potentially harmful ingredients. The announcement comes on the heels of a federal investigation into how a GNC vendor’s falsely labeled and branded dietary supplement imported from China made it to GNC’s retail sites nationwide. The issue arose when GNC sold Oxy Elite Pro Advanced Formula, a product manufactured by Dallas-based USP Labs, which was indicted in November 2015 for allegedly conspiring to import the tainted ... Read More

GNC dietary supplements recalled due to undeclared major allergen


Nutra Manufacturing, Inc., is recalling one lot of GNC Women’s Ultra Mega Time Release dietary supplements because they may contain an undeclared major food allergen, milk. People who have an allergy or severe sensitivity to milk are at risk of having a serious or life-threatening allergic reaction if they consume this product. The recall affects the supplements sold in 180-count containers with the UPC 048107158910, the lot number 3044FQ2024, and an expiration date of June 2018. The lot number can be found on the bottom of the product box and the side panel of the product label. The affected dietary ... Read More

Study: Trauma Patients Do Not Benefit from IVC Filter Use

IVC filter

Inferior vena cava (IVC) filters that were used in trauma patients to prevent pulmonary embolism proved to be unnecessary, according to a single-center study at Boston Medical Center. Trauma patients who survived at least 24 hours after the time of their injury didn’t show a decreased death rate associated with an IVC filter insertion. The trend didn’t change at either six months or 1 year after the discharge date. Among the patients who received an IVC filter, only 8 percent of the filters were removed over a 3.8-year average follow-up. IVC filters are usually placed in patients that cannot tolerate anticoagulation medication, but the high failure rates ... Read More

PA Doc Pays Nearly $1 Million To Resolve FCA Lawsuit Alleging Medicare Fraud

Pills - Stethoscope on Money

A Western Pennsylvania doctor and a health care company he operated in five states will pay the U.S. government nearly $1 million to settle a False Claims Act lawsuit alleging he and the companies defrauded the Medicare program. David J. Hickton, U.S. Attorney for the Western District of Pennsylvania, said Tuesday that Dr. John Balko and Dr. John Balko & Associates Inc., doing business as Senior Healthcare Associates, have agreed to settle the False Claims Act case for $930,000. The False Claims lawsuit alleged Medicare fraud due to Dr. Balko and his clinics submitting claims to Medicare for a range of ... Read More

Pennsylvania Farmers Sue Insurer In Wake of Gas Explosion


A  Southwest Pennsylvania couple whose cattle farm was partially destroyed by a natural gas explosion likely caused by corroded underground pipes are suing their insurance company in federal court, alleging it is holding out on paying them their full policy limit until it gets paid by pipeline owner and utility Spectra Energy Corp. Randy and Wendy Gillis, whose family-owned farm has produced crops and pastured cows for nearly a century, sued State Automobile Mutual Insurance Co. of Columbus, Ohio, alleging the insurer is compounding the suffering they’ve already experienced in the aftermath of the April 29 blast. The gas explosion ... Read More

Public Indoor Vaping: Should It Be Banned?

e-cigarette vaping - photo by the-best-electronic-cigarette-review dot com

A public hearing was held last week by the Allegheny County Board of Health in Pittsburgh, Penn., regarding the banning of e-cigarette smoking indoors at public places because it “normalizes” the act of smoking. But many showed up to fight the proposed vaping ban. The county law being proposed would ban the smoking of e-cigarettes indoors in public places, just like regular cigarettes, as suggested by the Clean Indoor Air Act. The ban would restrict use at establishments that serve food and drink, and places with children present younger than 18. “Exercise became possible. I lost 100 pounds,” said 21-year-old Ryan Huntermark, speaking ... Read More

Child Thrown From Roller Coaster Airlifted To Pittsburgh Hospital

roller coaster injury, Pennsylvania - image by WPIX Chopper 11

A 3-year old child was airlifted to a Pennsylvania hospital Thursday after being thrown from a roller coaster at an amusement park near Pittsburgh. The accident occurred at the Idlewild & Soak Zone in Ligonier, a Southwestern Pennsylvania town about 50 miles east of Pittsburgh. Initial reports said the child fell from the park’s “Rollo Coaster,” one of the two roller coasters in an amusement park featuring mostly children’s rides and attractions. The child was flown to the University of Pittsburgh Medical Center’s Children’s Hospital of Pittsburgh. The extent of the child’s injuries was not made public Thursday afternoon. According ... Read More

University of Pittsburgh Medical Center Pays $2.5 Million To Settle Whistleblower Claims

Pills - Stethoscope on Money

The University of Pittsburgh Medical Center (UPMC) and three related entities will pay the U.S. more than $2.5 million to partially settle a False Claims Act lawsuit brought by whistleblowers who alleged the defendants were submitting false and inflated bills to Medicare for their neurology services. U.S. Attorney David J. Hickton of the Western District of Pennsylvania announced the settlement Wednesday. The University of Pittsburgh Physicians, UPMC Community Medicine, Inc., and Tri-State Neurosurgical Associates-UPMC, Inc. are the other defendants named in the whistleblower suit. The complaint alleged that certain UPMC neurosurgeons submitted claims for assisting with or supervising surgical procedures ... Read More

Olympus communications regarding contaminated duodenoscopes could play key role in lawsuits


In June 2012, an investigator hired by medical device company Olympus and a Netherlands hospital concluded in a report that the design of the company’s specialized endoscope called a duodenoscope could trap blood and tissue that was difficult to remove under standardized cleaning and disinfecting, allowing the device to spread bacteria from patient to patient. The independent expert recommended that Olympus conduct a worldwide investigation and recall all its duodenoscopes if outbreaks of patient infections should arise. At the time, Olympus executives were aware of three outbreaks of superbug infections in patients who had undergone procedures with its duodenoscopes – affecting about ... Read More