Olympus to Recall and Modify Hard-to-Clean Duodenoscope

Disclosures

January 15, 2016

In the bull's eye of a Congressional investigation, Olympus is voluntarily recalling its TJF-Q180V duodenoscope so it can be modified to reduce the risk of spreading bacterial infections, the US Food and Drug Administration (FDA) announced today.

The action comes in the wake of a Senate committee report that accuses Olympus, among other things, of knowing for 2 years about a design flaw that made the scope harder to clean before disclosing it to hospitals, physicians, and patients in February 2015. Eighty-five percent of the duodenoscopes used in the United States are made by Olympus, according to the report.

The committee report also faults hospitals for being slow to report infections, some fatal, caused by dirty duodenoscopes, and the FDA for a slow response. It calls for the agency to develop a more robust system to monitor medical device safety in general.

The decision by Olympus to recall and modify the design of its TJF-Q180V scope satisfies the report's recommendation to fix scopes currently on the market. The Olympus problem lies with the scope's closed elevator channel, which houses a guide wire and catheter, according to an FDA news release. The channel is supposed to be sealed against patient fluids and tissues that might otherwise leak in, but such leakage nevertheless has occurred. The interior of the closed elevator channel "cannot be cleaned and disinfected between uses," even when hospitals and other healthcare facilities follow all of the manufacturer's reprocessing instructions, the agency said. Olympus will replace the elevator channel sealing mechanism at the tip of the recalled scopes with a tighter version to reduce the risk of contaminants leaking inside.

To make this happen, the company will contact each healthcare facility that owns a TJF-Q180V duodenoscope and supply instructions on how to return the instrument for the fix. Olympus puts the estimated turnaround time at 4 days. The plan is to correct all 4400 scopes now in use in the United States by August 2016. The FDA said that while healthcare facilities await repair of their duodenoscopes, they may continue using them as long as they meticulously follow the manufacturer's reprocessing instructions.

Olympus also intends to conduct annual inspections of the duodenoscope in question to spot any wear and tear on the elevator channel sealing mechanism, or debris on the scope's tip, "which would require replacement of potentially contaminated parts," the FDA said.

Preventable Tragedies, Says Senator

Outbreaks of antibiotic resistant infections linked to dirty duodenoscopes dating back to 2012 prompted Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, to launch an investigation in January 2015. Her staff issued its report on January 13.

"Patients should be able to trust that the devices they need for treatment are safe and effective," Murray said in a news release. "Unfortunately, this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented."

The report concluded that the FDA's reliance on manufacturers and hospitals to report adverse events associated with medical devices is "unworkable and outdated, particularly when contrasted with the active post-market surveillance system for drugs." Congress, the report recommended, should require that the unique device identifier (UDI) for each device used in a procedure be recorded in third-party-payer claims, electronic health records, and registries so that the FDA can mine this information for any patterns of adverse events.

One contributing factor to the infection outbreaks, the report found, was the initial failure of Olympus and Fujifilm, a rival manufacturer, to get FDA clearance when they changed the design of scope elevator channels from open — and cleanable — to closed. The agency eventually instructed them to secure this clearance through the 510(k) process, which requires device makers to prove that their products are essentially equivalent to those already on the market (and ostensibly deemed safe and effective). Olympus filed the prerequisite 510(k) application for the TJF-Q180V duodenoscope, and the FDA said today that the device passes muster, taking into account the redesigned elevator channel.

To keep history from repeating itself, the report from Murray's staff urged the FDA to clarify its guidance to device makers on when they must seek 510(k) clearance for products they have modified.

The report also recommended that the FDA warn hospitals and clinicians about potential problems with medical devices as soon as they come to light, in contrast to the near 18-month gap between when the agency learned of the duodenoscope problem and when it issued its first safety alert. However, FDA garnered praise from Murray's investigators for its proposal last December to create an early-warning system for medical devices that resembles one already in existence for drugs.

Olympus Calls Report "An Important Contribution"

In a news release, Olympus called the report from Murray's HELP staff "an important contribution" to understanding patient infections that have followed endoscopic procedures to diagnose and treat disorders of the pancreas, bile duct, and gallbladder. Olympus spokesperson Mark Miller said that his company has cooperated with HELP investigators.

"Although we do not agree with all of the report's conclusions," Miller said, "we are closely reviewing the recommendations…as part of Olympus' ongoing efforts to increase patient safety associated with Olympus duodenoscopes."

More information about the voluntary recall initiated by Olympus is available on the FDA website.

To report any problems with the Olympus TJF-Q180V duodenoscope, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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