In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Endorses New Fujifilm Duodenoscope Reprocessing Instructions

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



Outbreak Triggers Senator's Renewed Probe Of Olympus Duodenoscope

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 Asks Customers To Turn In Older Duodenoscopes

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.

Latest FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT034560

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel