Monday, 08 February 2016 08:51

Ed-530xt Duodenoscopes By Fujifilm Medical Systems – Validated Reprocessing Instructions

This is to notify you of important safety information for ED-530XT Duodenoscopes manufactured by Fujifilm Medical Systems, U.S.A. Duodenoscopes are lighted flexible tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used for endoscopy – an invasive diagnostic medical procedure used to assess the interior surfaces of an organ by inserting a tube into the body. As a result of its sensitivity, the device is to be regularly cleaned and disinfected or sterilized by a multistep process known as reprocessing.

Fujifilm Medical Systems Inc. re-evaluated and validated the manual reprocessing instructions of the device to replace those provided in the original device labeling. Upon assessment by the FDA, investigations showed that the validated reprocessing instructions when adhered to properly demonstrated more consistent and reliable cleaning and a high level of disinfection of the ED-530XT duodenoscopes.

Although the validated reprocessing instructions  includes a more rigorous protocol for pre-cleaning compared to the manual process; they however enhance the safety margin of the device and show a high degree of assurance of disinfection.

Healthcare Provider’s Action

  • Healthcare Providers should be aware of the validated reprocessing instructions and ensure that all device operators are intimated on it and adopt the procedure.
  • While formal validation testing is being conducted on reprocessing instructions for Fujifilm’s 250 and 450 duodenoscope models, healthcare providers are encouraged to apply the reprocessing instructions for ED-530XT duodenoscope to reprocess the 250 and 450 duodenoscope models.
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543 – Toll free from all network) or via individual case safety report forms or via email : This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC… Safeguarding the health of the Nation!

Read 16516 times Last modified on Wednesday, 18 May 2016 14:21



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