AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing
ISSUE: FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency’s expectations. FDA recommends that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible.
BACKGROUND: 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.
RECOMMENDATION: 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. FDA recommends that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible. See the FDA Safety Communication for details of the key changes to the reprocessing procedure for Fuji's ED-530XT duodenoscope.
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. 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. FDA recommends implementing the revised reprocessing instructions as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[12/23/2015 - Safety Communication - FDA]