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Consumer Advocate Blames both Manufacturer and FDA for Dragging their Heels

Consumer Advocate Blames both Manufacturer and FDA for Dragging their Heels November 23, 2017. By Gordon Gibb.
Washington, DC: Public Citizen is an internationally-recognized consumer advocacy group founded by perhaps the original consumer advocate, Ralph Nader. He’s the guy who railed over the safety of cars, and advocated for seat belts. And today, the organization he founded holds, amongst other things, the feet of the pharmaceutical and medical device industries to the fire over safety and efficacy. Whenever an endoscope lawsuit, for example, appears on a court docket you have to know that Public Citizen is watching in the wings. They have even launched lawsuits themselves, taking both manufacturers and the federal regulator to task.
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Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States

Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States October 31, 2017. By Lucy Campbell.
Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.
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Will Duodenoscope Redesign Prove Sufficient to Stem Endoscope Infection?

Will Duodenoscope Redesign Prove Sufficient to Stem Endoscope Infection? October 22, 2017. By Gordon Gibb.
Washington, DC: Many an endoscope lawsuit have alleged injury, or even death when a reusable endoscope or duodenoscope has passed potentially harmful infections between patients due to an inability to be thoroughly cleaned and sterilized. Plaintiffs have alleged everything from defective design, to a lack of training and inadequate cleaning procedures inherent with optimum disinfection protocols.
Read [ Will Duodenoscope Redesign Prove Sufficient to Stem Endoscope Infection? ]

Olympus Tagged with Partial Liability in Endoscope Lawsuit

Olympus Tagged with Partial Liability in Endoscope Lawsuit September 19, 2017. By Gordon Gibb.
Seattle, WA: One of the world’s leading manufacturers of endoscopes, and a target of a wrongful death trial in an endoscope lawsuit, escaped liability for a patient’s fatal infection but was nonetheless compelled to pay almost $6.6 million to the hospital involved for failing to adequately instruct hospital staff.
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Scoping the Landscape of Endoscope Infection

Scoping the Landscape of Endoscope Infection August 20, 2017. By Gordon Gibb.
Pittsburgh, PA: There is little doubt that endoscopes, duodenoscopes and other intricate scopes designed for ‘internal diagnostics’ are a godsend for patients and used hundreds of times a day, says Dr. Raymond Pontzer of Pittsburgh-based UPMC. “The benefit far outweighs the risks,” the director of infection prevention for the nonprofit said in comments published in the Pittsburgh Post-Gazette (07/04/17). However, the risks cannot be discounted, as many an endoscope infection lawsuit has shown.
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ED-530XT Duodenoscopes Recalled

ED-530XT Duodenoscopes Recalled July 21, 2017. By Lucy Campbell.
Santa Clara, CA: An urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria.
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Improvements in Cleaning Endoscopes Still not Universally Implemented: Study

Improvements in Cleaning Endoscopes Still not Universally Implemented: Study July 21, 2017. By Gordon Gibb.
Pittsburgh, PA: A recent study last month has shown that risks of infection stemming from use of endoscopes and duodenoscopes is continuing generally in the healthcare field in spite of guideline updates and other examples of tightening compliance aimed at improving, or even eliminating infection from the reusable devices. It’s the kind of infection passed along from one patient to another that has previously, and continues to fuel many an endoscope lawsuit.
Read [ Improvements in Cleaning Endoscopes Still not Universally Implemented: Study ]

Power Morcellation Cancer Warning One Year Too Late for Doctor

Power Morcellation Cancer Warning One Year Too Late for Doctor July 10, 2017. By Jane Mundy.
:Washington, DC: Dr. Amy Reed, a physician and mother of six had surgery for uterine fibroids with a power morcelletor one year before the FDA first warned about the risk of power morcellators spreading cancer. Dr. Reed died from cancer in May—she was 44 years old.
Read [ Power Morcellation Cancer Warning One Year Too Late for Doctor ]

Are Recalled Duodenoscopes Any Safer?

Are Recalled Duodenoscopes Any Safer? June 21, 2017. By Gordon Gibb.
Washington, DC: Any medical device plaintiff fighting an endoscope infection lawsuit appears to have a friend in Senator Patty Murray (D-Wash). The Democratic lawmaker noted back in April that she had become alarmed in the face of a superbug outbreak in Europe late last year, and thus had issued a request to medical device manufacturer Olympus Corp. (Olympus) for data that would demonstrate a redesigned medical device was safe.
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Olympus Settles Four Power Morcellator Lawsuits

Olympus Settles Four Power Morcellator Lawsuits June 18, 2017. By Deb Hipp.
Upper Saucon Township, PA: Olympus Corp. of the Americas has settled four lawsuits for injuries and one death allegedly related to the company's power morcellator surgical device, according to The Morning Call.
Read [ Olympus Settles Four Power Morcellator Lawsuits ]

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