FDA clears a modified Olympus TJF-Q180V duodenoscope
- FDA Press Release: “FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk” (January 15, 2016)
- Olympus Press Release: “Olympus Receives 510(k) Clearance for TJF-Q180V Duodenoscope”
ALSO BREAKING NEWS
Olympus recalls the Olympus TJF-Q180V duodenoscope
- Urgent: Olympus “Dear Customer” Letter, dated January 15, 2016
ALSO BREAKING NEWS — Senator’s Murray’s anticipated report just published:
- “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients“ — January 13, 2016.
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.
- Philadelphia Inquirer — “Tainted medical scopes have sickened hundreds in U.S., Europe, Senate probe finds.” (January 14, 2016)
- Dr. Muscarella’s updated guidance: “Updated guidance to prevent ‘superbug’ infections due to a contaminated duodenoscope” — Winter, 2015
- Olympus’ Response to Sen. Murray’s investigation: “Olympus Releases Statement in Response to US Senate HELP Committee Report” — January 13, 2016
- The Seattle Times: “More infections from dirty scopes, Sen. Murray investigation finds” (The Seattle Times — January 13, 2016)
- The Los Angeles Times: “Dirty scopes needlessly infected scores of patients, investigation finds” (The Los Angeles Times — January 13, 2016)
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.”
- SUPERBUGS and ENDOSCOPY — Read Dr. Muscarella’s series of more than 25 articles about ‘superbug’ infections linked to contaminated endoscopes.