Safety

FDA, Olympus issue new cleaning rules

Hospital Safety Insider, June 25, 2015

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 In light of an outbreak of deadly healthcare-acquired infections in U.S. healthcare facilities during February and March caused by improperly disinfected duodenoscopes, federal regulators have issued warnings that led the nation’s largest supplier of medical scopes to issue urgent updates on how the devices should be cleaned.

 
Pennsylvania-based Olympus Corp. issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope in a 13-page letter to customers in March after the FDA and CDC warned that it may be impossible to properly clean and disinfect the complicated instruments. In May, the company began shipping customers new small-bristle cleaning brushes designed to clean inside the duodenoscopes’ tiny channels.
 
The move was made after customers began questioning whether procedures should be stopped. To prevent a potential health hazard for the patients who need the potentially lifesaving procedures—duodenoscopes are used to peer deep into a patient's digestive tract with high-resolution cameras and surgical tools—Olympus was under pressure to issue new guidelines.
 
This is an excerpt from an article in Briefings on Hospital Safety. Visit here to log in or subscribe.



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