January 04, 2016
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FDA approves revised, validated duodenoscope reprocessing instructions

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The FDA has determined Fujifilm Medical Systems’ revised, validated manual reprocessing instructions for its ED-530XT duodenoscope meet the agency’s expectations and should be implemented as soon as possible, according to an FDA press release.

Following the FDA’s initial safety communication issued in February 2015, the agency “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 duodenoscopes,” according to the press release.

Fuji began testing to validate its revised instructions in May 2015 and submitted validation reports to the FDA in July, at which point “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.” The FDA told Fuji its validation data for the ED-530XT duodenoscope were acceptable in October, and continued working with the company as it developed its revised reprocessing instructions.

Key changes to the reprocessing procedure include more rigorous protocols for pre-cleaning, manual cleaning and high-level disinfection. During pre-cleaning, the forceps elevator should be moved back and forth and the detergent solution should be aspirated while the forceps elevator is raised and lowered.

Manual cleaning protocols now recommend additional brushing of the scope’s distal tip, forceps elevator and elevator recess with the disposable Model WB1318DE brush following brushing with the existing Model WB11002FW2 valve cylinder cleaning brush. Manual high-level disinfection protocols also recommend additional and more robust flushing procedures.

“While formal validation testing with the revised reprocessing instructions is ongoing for Fuji’s 250 and 450 duodenoscope models, FDA encourages health care facilities to apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the 250 and 450 duodenoscope models,” according to the press release. “FDA believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust because of additional precleaning, cleaning and high-level disinfection steps and, for that reason, should increase the safety margin of the 250 and 450 duodenoscope models. We recommend implementing the revised reprocessing instructions as soon as possible.”

The FDA continues to work with duodenoscope manufacturers to validate reprocessing instructions, and with the health care community to continue investigating the risks of infection associated with these devices, according to the press release.

Reference:

FDA. Fujifilm Medical Systems U.S.A., Inc. validates revised reprocessing instructions for model ED-530XT duodenoscopes: FDA safety communication. Accessed January 4, 2016. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm478290.htm.

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