FDA tells scope cleaners to ramp up testing; cites one manufacturer

Federal regulators want a tougher testing process for the machines used to clean medical scopes after contaminated endoscopes led to a series of superbug outbreaks, according to USA Today. The Food and Drug Administration (FDA) has directed manufacturers of Automated Endoscope Reprocessors (AERs) to develop more rigorous validation protocols, and the agency will also actively inspect some manufacturing facilities for quality controls. At least one manufacturer has been cited thus far, according to the article. "The agency considers this an urgent public health matter of great importance, so it is our expectation that all (AER) firms … will respond quickly to our inquiries," William Maisel, deputy director at the FDA's Center for Devices and Radiological Health, told USA Today. "We did ask each of the AER firms to conduct additional testing … [and] to make the testing more challenging." Article

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