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Endoscope Infection Articles
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.Read [ Consumer Advocate Blames both Manufacturer and FDA for Dragging their Heels ]
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.Read [ Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States ]
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? ]
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.Read [ Olympus Tagged with Partial Liability in Endoscope Lawsuit ]
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.Read [ Scoping the Landscape of Endoscope Infection ]
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.Read [ ED-530XT Duodenoscopes Recalled ]
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 ]
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 ]
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.Read [ Are Recalled Duodenoscopes Any Safer? ]
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 ]
- Ongoing Efforts to Improve Endoscope Disinfection May not be Enough By Gordon Gibb (May-21-17)
- Ovarian Cancer Survivor Blames Power Morcellator By Jane Mundy (May-9-17)
- Recent Study Suggests Endoscope Infection Escapes Even Rigorous Cleaning By Gordon Gibb (Apr-20-17)
- Power Morcellation Suits Wrap Up but Doctors Still Like Procedure By Brenda Craig (Apr-18-17)
- Power Morcellators Fast-Tracked Through FDA 510(k) Clearance By Gordon Gibb (Apr-16-17)
- Pentax targeted by FDA Safety Update in January By Gordon Gibb (Mar-21-17)
- Regulatory Concern Mounting Over Power Morcellators, Adverse Events Reports By Gordon Gibb (Feb-21-17)
- Endoscope Disinfection Problems Extend Beyond Devices Themselves By Gordon Gibb (Feb-14-17)
- Damning Report on FDA Approval of Power Morcellators Released By Lucy Campbell (Feb-9-17)
- In the Midst of Concern Over Endoscope Infection, a New Threat Looms By Gordon Gibb (Jan-19-17)
- Power Morcellator Patient Advocate Dies By Heidi Turner (Jan-19-17)
- Older Model Duodenoscopes Pulled from Market By Lucy Campbell (Jan-13-17)
- Will FDA Guidance Help Stem Endoscope Lawsuits Going Forward? By Gordon Gibb (Dec-26-16)
- Olympus America Attempts a Power Morcellation Comeback By Gordon Gibb (Dec-19-16)
- Hospitals, Medical Centers Caught Up in Endoscope Infection Turmoil By Heidi Turner (Nov-28-16)
- Power Morcellators May Be Doing More Harm than Good By Heidi Turner (Nov-15-16)
- Olympus Duodenoscopes: Failure to Warn “Disturbing” By Gordon Gibb (Oct-23-16)
- Laparoscopic Uterine Surgery for Women Morcellation Lawsuits Continue By Gordon Gibb (Oct-8-16)
- Should Women Still Undergo Power Morcellation? By Heidi Turner (Sep-27-16)
- FDA Solidly on the Fence with Regard to Troubled Endoscope Reprocessor By Gordon Gibb (Sep-8-16)
- Continued Fallout from Three-Year Delay to Recall Problematic Endoscopes By Gordon Gibb (Aug-12-16)
- Proposed Government Bill Aims to Increase Reporting of Defective Medical Devices By Gordon Gibb (Aug-9-16)
- Olympus Failed to Warn US Hospital of Duodenoscope Infections By Lucy Campbell (Jul-26-16)
- Problems with Power Morcellators Lead to Government Action By Heidi Turner (Jul-8-16)
- New Study Shows Just How Difficult Endoscope Disinfection Is By Heidi Turner (Jul-6-16)
- FDA Solidly on the Fence over Laparoscopic Uterine Surgery By Gordon Gibb (Jun-8-16)
- The Curious FDA Reversal over Allegedly Flawed Endoscope Washers By Gordon Gibb (Jun-5-16)
- FDA Reportedly Reverses Decision on Endoscope Recall By Heidi Turner (May-9-16)
- FDA Approves New Power Morcellation Device By Heidi Turner (May-8-16)
- Massachusetts Hospital Slammed with Endoscopy Infection Lawsuits By Gordon Gibb (Apr-11-16)
- Laparoscopic Power Morcellation amongst Most Dangerous Medical Procedures By Gordon Gibb (Apr-3-16)
- Olympus Corp On the Hook for $646 Million, Endoscope Infections Still a Concern By Gordon Gibb (Mar-6-16)
- Laparoscopic Power Morcellation Lawsuits Expected to Keep Growing By Gordon Gibb (Mar-3-16)
- Officials Ask How FDA Was So Wrong on Risks of Power Morcellation By Heidi Turner (Feb-8-16)
- Voluntary Recall of Olympus Duodenoscope Announced While Regulators Slam Device Makers By Heidi Turner (Feb-7-16)
- Dirty Duodenoscopes Needlessly Infected Dozens, Investigation Finds By Lucy Campbell (Jan-13-16)
- Power Morcellation Can Free a Hidden Enemy By Gordon Gibb (Jan-11-16)
- Lawsuits Allege Olympus Withheld Reports of Endoscopy Infections from US Hospitals By Gordon Gibb (Dec-30-15)
- Power Morcellator Lawsuits Consolidated; More Lawsuits Filed By Heidi Turner (Dec-15-15)
- Officials Announce Power Morcellation Investigation By Heidi Turner (Nov-12-15)