UPDATED: FDA slaps three duodenoscope manufacturers with warning letters over related devices

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

The FDA has taken some steps to address duodenoscopes' role in spreading potentially deadly infections after superbug outbreaks surfaced earlier this year. But in its latest move, the agency is cracking down on three companies manufacturing duodenoscope devices, adding to the hotbed of scrutiny surrounding the products.

The agency last week sent letters to Olympus, Pentax and Fujifilm, saying the Japanese companies failed to report problems with scopes as they turned up and in some cases, did not make sure the devices could be properly cleaned, Bloomberg reports. Olympus, the largest U.S. maker of the devices, did not report cases for three years of 16 patients contracting Pseudomonas aeruginosa infections after undergoing a procedure with its duodenoscopes, the FDA said in its letter to the company. And Pentax did not bring up cases of patients developing CRE infections after being treated with the company's devices within the designated 30-day reporting period, the agency said in a separate letter.

Regulators came down on Olympus for not having a standard procedure for quickly reporting serious problems with its devices--a requirement for companies manufacturing the products. The FDA inspected four of the company's sites in the U.S. and Japan earlier this year and found "significant deviations" from appropriate protocol, the agency said in its letter.

The agency also cited Pentax and Fujifilm for not making sure their instructions for cleaning the scopes were up to par, and for potential design flaws. Fujifilm did not prove that sterilizing its device was a sufficient cleaning method. And the company did not look into whether possible design or manufacturing problems caused its products to spread infections.

Regulators are giving the companies 15 days to respond to the letters, asking them to spell out how they will fix the situation and prevent similar problems from reoccurring. Olympus spokesman Mark Miller told Bloomberg the company is reviewing the warning letter "so that we can provide the required response in a timely manner."

And Fujifilm is addressing the problems head-on, a company spokeswoman told FierceMedicalDevices in an email. "Fujifilm takes this issue very seriously and is working closely with FDA," the spokeswoman said. "Actions have been and will continue to be taken to ensure that our products and processes meet FDA requirements, and pose no risks to the health and safety of the public."

The letters come a couple weeks after the FDA revealed its first set of detailed recommendations for cleaning duodenoscope devices. The ideas, which included sterilizing the products after they're cleaned and using a chemical solution to destroy bacteria, stemmed from an FDA-led panel meeting in May, when experts recommended ways to better clean the products. The agency has received at least 142 reports of duodenoscope-related patient infections since 2010.

But the FDA is stopping short of pulling duodenoscopes from the market, saying the devices' benefits "continue to outweigh the risks" in certain patients, the agency said in a statement. And the risk of getting an infection from an inadequately cleaned device is "relatively low" given the number in use, FDA spokeswoman Jennifer Dooren told The Los Angeles Times earlier this month.

- read the Bloomberg story
- here's the Olympus letter

Editor's Note: This story was updated with a statement from Fujifilm.

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