Duodenoscope Maker Updates and Validates Reprocessing Protocol

Marie Thibault

FUJIFILM Medical Systems, USA has released revised reprocessing instructions for one of its duodenoscope models.

After a long year of negative headlines about duodenoscopes, one scope maker had an early holiday gift for its customers. FUJIFILM Medical Systems, USA (Fuji) sent a letter to customers last week detailing revised reprocessing instructions for one of its duodenoscope models as well as a box of new brushes to use with the protocol. 

In a December 23 Safety Communication, FDA said it had reviewed and accepted Fuji's revised reprocessing instructions and validation data on its ED-530XT duodenoscope. The scope maker also offers other duodenoscope models, including the ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5. These other scopes are undergoing validation testing but meanwhile, according to Fuji and FDA, the revised 530XT reprocessing instructions should be used to clean these scopes as well.  

"FDA believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust because of additional pre-cleaning, cleaning and high-level disinfection steps and, for that reason, should increase the safety margin of the 250 and 450 duodenoscope models," the agency wrote in the safety notice.

After a series of high-profile cases of carbapenem-resistant enterobacteriaceae (CRE) infections at U.S. hospitals were linked to duodenoscopes, the devices came under heavy scrutiny. Duodenoscopes are a type of endoscope used to diagnose and treat diseases of the liver, bile duct, and pancreas. Their design, which includes a tight, small space around the "elevator" mechanism, means they can be especially hard to clean completely.

FDA released its final guidance on medical device reprocessing in March, giving manufacturers guidelines for disinfecting reusable devices that are reprocessed in the health care setting.

In the recent safety communication, FDA notes that Fuji started validation testing of its updated reprocessing instruction in May and submitted validation reports to the agency in July. After clarification and confirmation, FDA ok'd the validation data and helped Fuji revamp its instructions for use. 

Included in the new reprocessing instructions is the use of a new disposable brush, Model WB1318DE, for cleaning the scope's distal end. Fuji's customers received 20 of these brushes with the updated reprocessing instructions and will also receive up to a six month supply. 

In October, FDA told the scope manufacturers that it wants to see postmarket studies conducted on whether reprocessing and cleaning instructions can be followed, how often cleaned scopes are still contaminated, and what is needed to address such post-reprocessing contamination.   

FDA wrote in the recent safety notice that earlier this year, it required Fuji to submit a new 510(k) for changes made to the ED-530XT model. The company submitted the 510(k) in August and that is being reviewed by the agency.

Fuji's changes to the manual reprocessing steps are similar to the steps added by another manufacturer, Olympus America Inc., when it released its new, validated reprocessing procedures in March. Here are the details from Fuji's letter to customers: 

Pre-Cleaning

Manual Cleaning

Manual High-Level Disinfection

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of FUJIFILM Medical Systems, USA]