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FDA Lays Down Strict Disinfection Guidance In Wake Of Scope Incidents

The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.

Makers of bronchoscopes, biopsy forceps, duodenoscopes and other reusable devices must submit data as part of their premarket submissions on the effectiveness of their cleaning and disinfection protocols and meet tighter sterilization standards, a March 12 reprocessing guidance from FDA says.

The final guidance, addressed to companies submitting a 510(k), PMA, humanitarian device exemption or investigational device exemption for certain reusable devices, also calls on manufacturers to think carefully about the...

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