Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints
The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.
Tag Archives: ERCP
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Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds
A new study appears to confirm the effectiveness of disposable elevator caps in preventing duodenoscopes from passing infections from one patient to another.
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Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements
The FDA has issued warning letters to Olympus over a failure to meet quality control requirements, including reporting of complaints, involving its endoscope products.
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FDA Calls For Full Transition To Disposable Duodenoscopes Due to Infection Risks
The FDA says disposable duodenoscopes should be adopted by every hospital in the U.S. to cut down on infection risks linked to the endoscopic devices.
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Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA
The FDA urges hospitals to start using duodenoscopes that are fully disposable or use disposable parts to protect their patients from potential infections.
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First Fully Disposable Duodenoscope Approved By FDA
The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.
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FDA Hopes Duodenoscope With Disposable Elevator Will Solve Sterilization Problems
The FDA has approved the first duodenoscope with a disposable elevator tip, which should reduce infection risks.
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FDA Calls For Duodenoscope Manufacturers To Create New Easier-To-Sterilize Designs
The FDA says current duodenoscope designs cannot be adequately cleaned, and are calling for hospitals to shift to designs that are disposable or have disposable components.
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Duodenoscopes May Be Impossible To Sterilize Safely and Need to be Recalled, Experts Tell NYT
Some medical experts are calling for duodenoscopes to be removed from the market, due to problems sterilizing them and the risk of patient infections.
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More Than 200 Duodenoscope Problems Reported to FDA Since October, But Number is Declining
The FDA received more than 200 adverse event reports linked to duodenoscopes since October, including 45 incidents of patient infections.
