FDA says it does not know why faulty Olympus duodenoscope was never cleared

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

The FDA's lead spokesperson, Karen Riley, said she doesn't know why the agency didn't discover that Olympus' now discredited duodenoscope was being marketed without the agency's required clearance.

"Why didn't we notice it? I don't know," Riley told CNN. The safety scare is reaching embarrassing proportions for the agency, and has also left dead patients in its wake from the dangerouss pathogens like CRE, apparently going back as far as 1987.

The agency noticed that the Olympus TJF-Q180V duodenoscope did not have clearance in late 2013 or early 2014, and requested that the company file for 510(k) clearance, but the application is still pending.

The FDA has not pulled the device from the market because that would create a shortage and endanger the 500,000 patients per year who benefit from the type of surgery that duodenoscopes enable. Pentax and Fujifilm also make the devices.

Olympus does not believe that the TJF-Q180V needs a clearance, according to CNN. According to the FDA database, the Olympus Evis Exera III video gastroscopes and colonoscopes have been cleared, but not the video duodenoscope, for the agency classifies those endoscopes separately from the other types.

Though all endoscopes are used to send doctors video of the inside of the body, they are used on different parts of the body. The duodenum is the first and shortest part of the small intestine.

CNN previously reported that one doctor experienced a bout of patients with pseudomonas from infected duodenoscopes in 1987, but the controversy exploded only recently, when a case occurred UCLA Medical Center, where at least 179 patients face possible exposure to CRE from two contaminated endoscopes, out of 7 used at that time.

Since then, several other hospitals have reported outbreaks of CRE linked to contaminated endoscopes, whose disinfection method has proven to be insufficient. The FDA did not require testing of the devices' cleaning system, but now says it will inspect that for future duodenoscopes that might hit the market.

Meanwhile, Reuters just reported that the wife of a man who died after infection from a drug-resistant form of E. coli bacteria is suing Olympus. Richard Bigler's death from cancer and E. coli occurred at Seattle's Virginia Mason Medical Center, which was hit by infections from dirty duodenoscopes between 2012 and 2014. Lawsuits against Olympus are also being filed stemming the the outbreak at UCLA.

Ten congressional representatives sent a letter to retiring FDA commissioner Margaret Hamburg. "While we recognize that duodenoscopes are not a leading cause in the spread of CRE, the continual occurrence of outbreaks must be taken very seriously," it says, pointing out that "from 2013 to 2014, the FDA received 75 reports of sterilization problems with duodenoscopes, affecting 135 patients."

Some hospitals have started quarantining the devices or switched to gas cleaning, but "many hospitals, however, may lack the resources to implement similar measures, and gas cleaning may put others at risk if residual amounts of the toxic gases remain on the scopes. It appears that if a superior cleaning procedure cannot be developed, the best solution will be to develop a new device," the letter says.

Even worse, other endoscopes could also be spreading diseases due to the challenges of cleaning them properly. The FDA just halted the pivotal clinical trial of an endoscopically delivered device therapy for Type 2 diabetes due to four cases of a bacterial infection of the liver among the 325 subjects.

- read the CNN story
- here's more about the lawsuit from Reuters
- here's the letter from Congress to FDA

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