FDA Endorses New Fujifilm Duodenoscope Reprocessing Instructions
This article was originally published in The Gray Sheet
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.
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Prompted by reports from a European hospital of a microbial outbreak last year linked to an Olympus TJF-Q180V duodenoscope, causing one death and five infections, Sen. Patty Murray requested that the company send her "any and all reports" about the product's safety. The outbreak was not forwarded to FDA's adverse events database until early February.
Fujifilm is removing its legacy 250/450 duodenoscope models from clinical use and replacing them with the ED-530XT model, telling customers that they will receive new scopes and cleaning accessories at no cost. Some older models were involved in antimicrobial drug-resistant contamination outbreaks.
FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.