FDA Issues Back-To-Back Warnings To Major Endoscope Maker Amid Device Reporting And Quality Systems Concerns
The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.
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FDA Slaps Olympus With Another Endoscope Warning
The US FDA recently rebuked Tokyo-based medical device firm Olympus for failing to adhere to good manufacturing practices for its endoscopes and for not investigating complaints related to the devices.
Switch To Disposable Duodenoscopes To Reduce Infections, FDA Advises
The US FDA says medical facilities should transition to duodenoscopes with disposable endcaps or fully disposable ones to limit device contamination and patient-to-patient infection.
Updated Endoscope Cleaning Guidance Urges Move From Manual Cleansing To Sterilization
ANSI/AAMI ST91:2021 offers best practices for cleansing the notoriously difficult-to-clean devices and strongly recommends health care providers transition from manual, sink-based cleaning to sterilization.