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FDA: Unapproved Duodenoscope OK to Use
HealthLeaders Media

Although one of the duodenal endoscopes implicated in recent “superbug” infections was never cleared by the FDA, the agency said Wednesday that physicians should continue to use it because otherwise there wouldn’t be enough devices available to meet patient needs.

Also, the FDA pointed out that infections have occurred with other duodenoscopes that had been approved, reiterating that the designs of all these devices made them hard to disinfect thoroughly after use.