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FDA, Olympus issue new cleaning rules


June 1, 2015

FDA, Olympus issue new cleaning rules

Infections lead to new processes for GI scopes


In light of an outbreak of deadly healthcare-acquired infections in U.S. healthcare facilities during February and March caused by improperly disinfected duodenoscopes, federal regulators have issued warnings that led the nation's largest supplier of medical scopes to issue urgent updates on how the devices should be cleaned.

Pennsylvania-based Olympus Corp. issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope in a 13-page letter to customers in March after the FDA and CDC warned that it may be impossible to properly clean and disinfect the complicated instruments. In May, the company began shipping customers new small-bristle cleaning brushes designed to clean inside the duodenoscopes' tiny channels.

"These new reprocessing procedures should be implemented as soon as possible," wrote Laura Storms, Olympus vice president of regulatory and clinical affairs and quality assurance, in a letter dated March 26. Until the new brushes are received, the letter said that customers should continue cleaning the scopes according to the owner's manual.

The move was made after customers began questioning whether procedures should be stopped. To prevent a potential health hazard for the patients who need the potentially lifesaving procedures?duodenoscopes are used to peer deep into a patient's digestive tract with high-resolution cameras and surgical tools?Olympus was under pressure to issue new guidelines.

"The removal of its device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year," according to the FDA bulletin.


New processes

Outbreaks of antibiotic-resistant bacterial infections in hospitals in the Los Angeles and Philadelphia areas were the catalyst for the new guidelines. In mid-February, the University of California's Ronald Reagan Medical Center was faced with an outbreak of carbapenem-resistant Enterobacteriaceae (CRE), which is highly resistant to antibiotics and can kill up to 50% of infected patients. According to a report in the Los Angeles Times, two patients died in that outbreak, and nearly 180 more people may have been exposed to CRE from poorly disinfected duodenoscopes.

Then, in early March, officials at Cedars-Sinai Medical Center in Los Angeles discovered that four patients were infected with CRE and 67 other people may have been exposed. In that case, one of the four died from factors unrelated from CRE, and the other three were eventually treated and released. Shortly after, the CDC and FDA both issued interim guidelines for reprocessing.

"If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection," the FDA bulletin said. "If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections."

According to Olympus' new guidelines, there are several key changes to the reprocessing procedure for the TJF-Q180V duodenoscope:

  • Precleaning. During immersion, the elevator mechanism should be raised and lowered three times.
  • Manual cleaning. This includes:
    • 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 said it planned to ship the brushes to facilities by May 8.
    • Additional flushing of the forceps elevator recess area.
    • Additional raising/lowering of the forceps elevator.
  • Manual high-level disinfection. This includes:
    • Additional manual flushing steps and increased flushing volume of each endoscope channel, as well as the elevator recess area.
    • Additional raising/lowering of the forceps elevator.


Staff should be trained appropriately on Olympus' new reprocessing instructions, which should be implemented as soon as possible.

Visit http://medical.olympusamerica.com/sites/default/files/pdf/150326_TJF-Q180V_Customer_letter.pdf to see the most recent scope reprocessing recommendations from Olympus.

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