New Duodenoscope Cleaning Instructions Issued for Reprocessing Procedure

New Duodenoscope Cleaning Instructions Issued for Reprocessing Procedure
New Duodenoscope Cleaning Instructions Issued for Reprocessing Procedure

The Food and Drug Administration (FDA) has announced that new, validated manual reprocessing instructions have been issued by Olympus for the TJF-Q180V endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) after reports of multi-drug resistant bacterial infections in patients in patients who have undergone ERCP with reprocessed duodenoscopes, even when the manufacturer reprocessing instructions are correctly followed.

The FDA issued recommendations for healthcare professionals in February 2015 on the complex design of ERCP duodenoscopes that may create challenges in cleaning and high-level disinfection. Residual body fluids and organic debris may remain in these crevices following cleaning and disinfection, which may expose patients to serious infections if the fluids contain microbial contamination. In September 2014, Olympus initiated testing to validate new reprocessing instructions and submitted new high level disinfection validation data to the FDA in February 2015. Based on this data, the FDA believes that, when followed, the new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope are robust and demonstrate consistent and reliable cleaning and high-level disinfection. Olympus has now issued the new, validated instructions for reprocessing the TJF-Q180V duodenoscope at the FDA's request.

Key changes to the reprocessing procedure include:

Precleaning:

  • During immersion, raise and lower the elevator three times

Manual Cleaning:

  • Additional brushing of the forceps elevator recess area
  • The revised cleaning procedure requires brushing of the forceps elevator recess with two different-sized brushes. In addition to the brush that is currently used to clean the elevator recess area, the MAJ-1888 brush (or MAJ-1888 equivalent) will be provided for further cleaning of this area. Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.
  • Additional flushing of forceps elevator recess area
  • Additional raising/lowering the forceps elevator

Manual High Level Disinfection:

  • Additional manual flushing steps and increased flushing volume of each endoscope channel, as well as the elevator recess area
  • Additional raising/lowering the forceps elevator

In addition, FDA has the following recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V:

  • Implement the new manual cleaning and high level disinfection procedures for the Olympus TJF-Q180V duodenoscope in accordance with the manufacturer's reprocessing instructions.
  • Implement the new TJF-Q180V high level disinfection procedure immediately. The high level disinfection procedure does not require additional equipment for implementation.
  • Implement the new TJF-Q180V manual cleaning procedure as soon as possible. It involves the use of a new, smaller bristle cleaning brush (model MAJ-1888) which Olympus anticipates shipping to facilities no later than May 8, 2015. Continue using the existing cleaning procedure for manual cleaning of the TJF-Q180V until the new brush is available.
  • Train appropriate staff on Olympus' new reprocessing instructions and implement them as soon as possible.
  • Contact Olympus directly with specific questions and concerns or to schedule a site visit with their Endoscopy Support Specialists.

For more information visit FDA.gov.

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