Medical Device Safety and Recalls: FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication

A new Safety Communication has been posted titled, "FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes." 

As noted in FDA’s February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

In May 2015, Fuji initiated testing to validate the revised reprocessing instructions and provided the cleaning validation reports to FDA in July 2015. Between July and October 2015, the Agency continued to work with Fuji to clarify and ultimately confirm that their cleaning and high-level disinfection instructions met the Agency’s expectations. In October 2015, the FDA notified Fuji that the validation data for the ED-530XT duodenoscope were acceptable and worked with the company as they developed revised instructions for use.

The revised instructions include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures. They also incorporate the use of an additional disposable brush (Model WB1318DE) to manually clean the distal end of the scope. The agency reviewed the validation data and believes that when followed, the revised, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of the Fuji ED-530XT duodenoscope.