FDA Clears the Redesigned Olympus Duodenoscope


FDA clears a modified Olympus TJF-Q180V duodenoscope


Olympus recalls the Olympus TJF-Q180V duodenoscope


ALSO BREAKING NEWS — Senator’s Murray’s anticipated report just published: Findings on tainted medical scopes

Patients should be able to trust that the devices they need for treatment are safe and effective. 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. — Sen. Patty Murray (D-Wash.), whose staff began investigating the issue a year ago, said in a statement.



Highlights of Senator Murray’s report:

To enhance patient safety, the report recommends that:

  • the FDA quickly evaluate the design of duodenoscopes featuring a “closed” elevator wire channel;
  • the FDA implement a “phased recall” of these “closed” duodenoscope models, like the Olympus TJF-Q180V model;
  • the FDA update its guidance to clarify when manufacturers, who modify a legally marketed device, are required to apply for a new 510(k) clearance;
  • that Congress clarify the FDA’s authority so that a 510(k) application could be deemed incomplete in the absence of validation data demonstrating that a reusable medical device can safely cleaned and disinfected; and
  • that a hospital’s compliance with adverse event reporting related to medical devices be made a “Condition of Participation” in Medicare.

While FDA started investigating how closed-channel duodenoscopes cleaned according to manufacturers’ instructions spread infection in September of 2013, the agency took no action to alert hospitals, doctors and the public to the risk posed by closed-channel duodenoscopes for 17 months. At least 68 patients in seven different hospitals in the United States were infected with antibiotic-resistant bacteria linked to duodenoscopes during this period. — Quote from Senator Murray’s report.

Other highlights of the Senator’s investigation include:

  • identified problems with the FDA’s antiquated adverse event device (“MAUDE”) database;
  • slow and incomplete reporting by manufacturers and hospitals, which appear to hampered the FDA, rendering it incapable of accurately estimating the incidence and severity of ‘superbug’ infections linked to contaminated duodenoscopes; and
  • that, according to the report, “it appears that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers.”

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