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FDA Gives Stern Warning to 3 Scope Makers

The regulatory agency has issued warning letters to the makers of duodenoscopes. The scopes have received intense FDA scrutiny after superbug outbreaks in Los Angeles and Seattle.

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Made public on Monday, FDA letters inform scope makers Olympus, Pentax, and Fujifilm that FDA found several inadequacies during inspections in March and April at the companies' factories in Japan and the United States.

The agency says the manufacturers failed to report trouble with the complex scopes, and in some cases did not make sure that the devices could be sufficiently cleaned. FDA specifically cited Olympus and Pentax for failing to report to the agency that their devices "may have caused or contributed to a death or serious injury" within the required 30 days of when they learned of the events. FDA also cited Pentax and Fujifilm for failing to ensure that their scopes' cleaning instructions were valid.

The agency gave each company 15 days to respond to its letters. Olympus spokesperson Mark Miller wrote in an email that the company is "reviewing the FDA's warning letter so that we can provide the required response in a timely manner." Pentax spokesperson Shannon Coughlin wrote that Pentax Medical "is reviewing the letter closely and intends to respond within FDA's requested time line." Fujifilm told Bloomberg News that the company is working with FDA to make sure its products comply with regulations and "pose no risks to the health and safety of the public."

Mark Miller, the vice president, corporate and medical communications at Olympus stated the following in an email:

Olympus is closely reviewing the FDA warning letter issued on August 12th so that we can respond directly to the FDA in a timely manner.  We are committed to addressing the issues identified in the letter; for example, we are currently working to improve our MDR reporting system. The FDA's letter notes that Olympus learned in 2012 that 16 patients contracted Pseudomonas aeruginosa after a procedure with an Olympus device, and it suggests that the company submitted an MDR report on the incident only in 2015 (#8010047-2015-00218). To clarify, Olympus submitted an MDR report on the incident on May 25, 2012 (#8010047-2012-000157).  In 2015, Olympus submitted additional MDR reports to "unbundle" the 2012 MDR on the 16 patients and to include additional information, including that 22 patients were involved in the event.

"Fujifilm takes this issue very seriously and is working closely with FDA," said Fujifilm spokesperson Diane Rainey in an email. "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. As part of this ongoing process, the company filed a 510(k) notice for the ED530-XT on August 10, 2015."

In its letter to Olympus, FDA said the company took three years to report 16 cases of Pseudomonas aeruginosa infections that occurred after endoscopic procedures using its devices. Medical device companies are legally required to report such incidents within 30 days of receiving reports about them.

In a separate letter to Pentax, the agency said that company failed to report cases of carbapenem-resistant Enterobacteriaceae (CRE) infection after endoscopic procedures involving its duodenoscopes within the 30-day timeframe.

Just two weeks ago, FDA suggested four options for hospitals to decontaminate the complex devices, in addition to manufacturers' instructions.

Duodenoscopes are threaded through the digestive tract and into the small intestine. They provide the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. However, the scopes' movable "elevator" mechanism at the tip, while improving efficiency and effectiveness, is challenging to disinfect, according to FDA. Duodenoscopes are used in more than 500,000 procedures annually in the U.S.

At least seven patients were infected and two died from a drug-resistant superbug at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. The exposures to drug-resistant CRE were linked to a contaminated, reprocessed Olympus duodenoscope. Another 11 CRE-related patient deaths have been linked to duodenoscope procedures at Virginia Mason Medical Center in Seattle between 2012 and 2014.

Four patients at Cedars-Sinai Medical Center in Los Angeles contracted CRE linked to the reusable but hard-to-clean medical devices, the hospital announced in March. Olympus has been selling some of its duodenoscopes without FDA 510(k) clearance related to modifications made in recent years. Olympus is also facing a slew of lawsuits, and the U.S. Justice Department has been investigating.

Learn more about regulatory affairs at MD&M Philadelphia, October 7-8, 2015.

Nancy Crotti is a contributor to Qmed and MPMN.

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