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FDA issues final rules on endoscopes, other devices
Modern Healthcare

Federal regulators Thursday issued final rules regarding the cleaning and disinfecting of reusable medical devices such as the endoscopes that have been responsible for outbreaks of drug-resistant bacteria at a number of hospitals.

Product makers will be required, under the new guidance, to validate that the disinfecting instructions for their medical devices are effective before they can get Food and Drug Administration approval.

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