Superbug scare: Fujifilm issues FDA-validated duodenoscope cleaning instructions

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The tip of a Fujifilm duodenoscope--Courtesy of Fujifilm

Fujifilm's ED-530XT duodenoscope became the latest to earn FDA-validated reprocessing instructions, certifying that it can be used safely and cleaned properly following last year's safety scare, in which the infected devices were implicated in spreading deadly pathogens like CRE, resulting in several injuries and a few fatalities.

The agency said that facilities using the Fujifilm device should train staff on the new instructions and implement them as soon as possible. Although Fujifilm's 250 and 450 duodenoscope models are still receiving formal validation for their reprocessing instructions, the FDA said the 530 model instructions should be used for those versions too.

Olympus earned the distinction of having FDA-validated reprocessing instructions in March. That was particularly significant because the company's scopes have been responsible for most of the outbreaks, including the deadly one at UCLA in Los Angeles, for which it is facing lawsuits. And the company still faces the possibility of having to redesign its scopes.

Meanwhile, the FDA is also expecting to validate the reprocessing of the scopes made by Pentax Medical, which also markets the devices in the U.S.

The updated reprocessing instructions for Fujifilm's ED-530XT scope call for additional use of a disposable brush. The company is providing 20 brushes per scope to all customers, according to a company field correction.

"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," the FDA wrote in a safety communication.

Fujifilm initiated testing of the reprocessing procedures in May, and met FDA's expectations by October. Now, the two sides have agreed on the instructions for use, and hopefully, proper cleaning and disinfection will commence.

The milestone is a win for Fujifilm, and FDA's plan to work with manufacturers. It should also help hospitals, which have been scrambling to improve disinfection by investing in expensive gas-cleaning procedures or retesting the devices following cleaning, which forces them to buy more units of the device because they become unavailable for a longer period of time.

But for the agency, the achievement does little to take the sting out of one of its more glaring regulatory failures. Subsequent to a well-publicized outbreak at the UCLA Health System in February that left two dead patients and at least 7 infections in its wake (along with similar instances in Seattle and Philadelphia around the same time), reporting revealed that the outbreaks had been occurring for years (one outbreak was identified from 1987). The FDA revealed prior to a public meeting on the topic that it has received 142 reports of contaminated duodenoscopes since 2010.

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

To make matters worse, the Olympus scope was never reviewed by the agency. The FDA said that it did not why it failed to review the device that caused the UCLA outbreak. Olympus has said the device did not need 510(k) clearance, according to CNN, but it has since submitted a 510(k) application for review, according to an FDA spokeswoman. The FDA has allowed Olympus to continue selling the scope while the application is under review.

Duodenoscopes are a type of endoscope used to visualize and treat problems in the duodenum, the first and shortest part of the small intestine. They are used during endoscopic retrograde cholangiopancreatography procedures, the least invasive way to drain fluids from pancreatic and biliary ducts blocked by tumors or gallstones, according to the FDA.

The agency has steadfastly maintained that the benefits of duodenoscopes outweigh the risks, pointing out that the chance of picking up an infection is quite low.

- read the release from the FDA | here's more from the FDA
- read Fujifilm's field correction announcing the new instructions

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FDA says it does not know why faulty Olympus duodenoscope was never cleared
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FDA advisory committee says duodenoscope cleaning must be improved to provide assurance of safety
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