FDA warns duodenoscope manufacturers of noncompliance

Olympus, Fujifilm and Pentax, which make duodenoscopes, have been warned about a lack of action on the agency's order for postmarket surveillance studies assessing the safety and efficacy of reprocessing the devices.
By Allen Cone  |  March 9, 2018 at 2:42 PM
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March 9 (UPI) -- The U.S. Food and Drug Administration on Friday warned all three duodenoscope manufacturers about failing to comply with required postmarket surveillance studies.

Receiving letters were Olympus, Fujifilm and Pentax, which make the flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine.

Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures annually to diagnose and treat problems in the pancreas and bile ducts, according to the FDA. Use of the devices is less invasive than surgery to drain fluids from the pancreas and bile ducts blocked by cancerous tumors, gallstones and other GI tract conditions.

FDA wants the companies to submit a plan by March 24 outlining how study milestones will be achieved. If the companies don't adequately respond to the warning letter, the FDA said it may take additional action, including seizure, injunction and civil money penalties.

"The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we've seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real world clinical settings and whether we need to take additional action to further improve the safety of these devices," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "We expect these device manufacturers to meet their study obligations to ensure patient safety."

In 2013, the FDA learned about a potential a link between multi-drug resistant bacteria and duodenoscopes. The agency then determined these cases of infection were occurring despite confirmation that device users followed proper manufacturer cleaning and disinfection or sterilization instructions.

In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether healthcare facilities can properly clean and disinfect the devices.

The FDA said at the time 135 cases of possible bacterial transmission from duodenoscopes have been reported from January 2013 to December 2014.

They were required to conduct a study to sample and culture reprocessed duodenoscopes in clinical use. The purpose was to learn what contributes to contamination as well-trained hospital staff are following the reprocessing instructions.

Olympus has failed to commence data collection, and Pentax and Fujifilm didn't provide provide sufficient data. In addition, Olympus and Pentax also have not complied with requirements for their respective human factors studies. Fujifilm, however, has been meeting those human factors requirements.

On Feb. 26, the FDA, Centers for Disease Control and Prevention, the American Society for Microbiology and other endoscope culturing experts released voluntary standardized protocols for duodenoscope surveillance sampling and culturing.

The FDA expects 50 percent of samples in the study to be processed by August 31 and 100 percent by the end of 2018. The agency expects 50 percent of human factors testing by Olympus and Pentax to be completed by May 3 and 100 percent by June 30, 2018.

Last September, the FDA cleared the first duodenoscope with a disposable distal cap for use in the upper gastrointestinal tract, which is meant to improve access to the device for cleaning and reprocessing.

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