FDA Lays Down Strict Disinfection Guidance In Wake Of Scope Incidents
This article was originally published in The Gray Sheet
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.
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The single-use scopes should be used in lieu of reprocessed devices when a significant infection risk exists, the US agency says.
FDA has found that validation test data for three automated endoscope reprocessors – including Medivators’ Advantage Plus and DSD Edge, and Steris’ System 1E Liquid Chemical Sterilant Processing System – are adequate.
FDA says that additional pre-cleaning, cleaning and high-level disinfection steps spelled out in Fujifilm Medical Systems’ updated reprocessing rules for the firm's ED-530XT duodenoscopes can effectively disinfect the scopes and may reduce risk of infection.