Amid rising concerns about superbug outbreaks linked to contaminated medical scopes, federal regulators are demanding more rigorous testing of the machines used to clean the devices — and cracking down on manufacturers that don’t meet government standards.
The steps are part of a Food and Drug Administration effort to ensure the effectiveness of Automated Endoscope Reprocessors, or AERs, which are akin to high-tech dishwashers used to clean medical scopes between uses. The measures focus specifically on checking the reprocessors’ efficacy in cleaning and disinfecting duodenoscopes, which have been found in some cases to spread antibiotic-resistant bacteria from patient to patient.
