The FDA Nov. 13 said it has ordered Custom Ultrasonics to pull all its automated endoscope reprocessors (AERs) from health-care facilities because of concerns that the devices can’t adequately wash and disinfect endoscopes.
Using the AERs could result in an increased risk of infection, the agency said in a Nov. 13 press release.
AERs are devices that wash and disinfect endoscopes. Endoscopes are tubes inserted into the body that enable doctors to visualize internal organs, and they are used in many areas, including the digestive, respiratory and urinary tracts.
Inadequate cleaning of endoscopes and related devices has been linked to ...
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