Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints
Repeated problems with duodenoscopes and the risk of patient infections have led to industry-wide changes in their design.
Tag Archives: Endoscope
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Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds
Standard duodenoscopes were three times as likely to have persistent microbial contamination when compared to duodenoscopes with disposable elevator caps
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Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements
FDA indicates Olympus failed to report complaints over endoscope products in a timely manner, which is necessary to help regulators monitor infections or reprocessing failures associated with the devices.
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FDA Calls For Full Transition To Disposable Duodenoscopes Due to Infection Risks
The FDA found 6.6% of reusable duodenoscopes carried high-concern organisms after cleaning, while only 0.5% of those with disposable parts carried infection risks.
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Karl Storz Endoscope Recall Issued Over Inadequate Sterilization Process
Healthcare professionals are being warned not to follow instructions for high-level disinfection methods, due to the risk of exposing patients to infectious materials and bloodborne diseases.
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Infections Linked To Reprocessed Urological Endoscopes Under Investigation, FDA Announces
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Cross Contamination, Infection Risk From Arthroscopy Pump Tubing Sets Results in FDA Guidance
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Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA
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First Fully Disposable Duodenoscope Approved By FDA
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FDA Hopes Duodenoscope With Disposable Elevator Will Solve Sterilization Problems
