Posts Tagged 'hoya corp'

FDA Orders Duodenoscope Makers to Surveil Devices in Hospitals

fda orders new standards on duodenoscopesThe U.S. Food and Drug Administration (FDA) recently ordered all three duodenoscope manufacturers marketing in the United States to conduct postmarket surveillance studies to assess how their devices are reprocessed (or cleaned) in “real-world settings.”

Duodenoscopes, a type of reusable medical device used in endoscopic procedures, have received a great deal of attention recently after being linked to several deaths and hundreds of infections at two L.A. medical centers. ...

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