The Food and Drug Administration has ordered the recall of roughly 2,800 Custom Ultrasonics automated endoscope reprocessors (AERs) from hospitals and other healthcare facilities, claiming the company cannot prove that the devices properly clean and disinfect endoscopes.
The Warminster, Pennsylvnia-basedcompany "has a history of violating federal rules for manufacturing and quality control," the AP reported. The FDA ordered the recall under a 2007 consent decree with Custom Ultrasonics.
The recall is "necessary to protect the public health," William Maisel, the FDA's deputy director for medical devices, said in the agency's recall announcement.
It was unclear whether any of Custom Ultrasonics' AERs were part of a superbug outbreak that killed and sickened patients in hospitals nationwide after they underwent endoscopic procedures. The drug-resistant bacteria Carbapenem-resistant Enterobacteriaceae (CRE) was passed from patient to patient; CRE infections in the bloodstream have a 50 percent fatality rate.
The FDA warned at the time that duodenocope manufacturers' sterilization protocols might be inadequate, as FierceHealthcare reported, and later issued new guidelines.
Last week ECRI Institute named inadequate cleaning of devices as the top health hazard for 2016.
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