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.
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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.
Study: FDA Data Shows Endoscope-Related Adverse Events Continue To Rise
A new review of adverse event data found reports tied to each of six endoscope categories rose significantly between 2014 and 2021. For gastroscopes, the rise was an eye-popping 8,630%.
FDA Recommends Broader Use Of Single-Use Bronchoscopes
The single-use scopes should be used in lieu of reprocessed devices when a significant infection risk exists, the US agency says.