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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During MD&M East in New York, Robert Austring, vice president of sales and marketing at Precision Optics, described the opportunities and challenges of marketing either reusable or single-use endoscopic devices.
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.
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%.