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| Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia |
Facing increased scrutiny for recent superbug outbreaks tied to duodenoscopes, the FDA is planning to convene an advisory panel to discuss the spread of potentially deadly bacteria through the devices.
The agency's gastroenterology and urology devices panel will meet on May 14 to 15 to hash out duodenoscopes' role in transmitting infections to patients during certain surgical procedures, Reuters reports. The move comes weeks after the FDA warned doctors and hospitals that the devices' complex design may impede proper cleaning, contributing to the spread of deadly bacteria. Regulators said last month they would work to revise labels for duodenoscopes, planning to speed up modifications and update risk information.
But last week, the FDA revealed that the Olympus scope cited in recent outbreaks has been on the market since 2010 without the required approval, sparking backlash from patient groups and individuals affected by the infections. Regulators said they do not want to pull the devices from the market because it could lead to a shortage, as the products are used in half a million endoscopic retrograde cholangiopancreatography procedures in the U.S. each year.
The agency is also answering to reports that Olympus, the largest maker of duodenoscope devices, asked the FDA to water down its guidelines on cleaning procedures for the products. Regulators published a draft of nonbinding recommendations in 2011 to help devicemakers prove that their cleaning methods were up to par, and to make sure directions given to hospital staff were sufficient. But in its comments to the agency, Olympus pushed for more lax guidelines, proposing that the company and other manufacturers would "identify the worst case conditions" under which the device would need to be cleaned, and then companies that make the cleaning systems would test the process on behalf of the manufacturer. Olympus, Fujifilm Holdings and Pentax Medical all make versions of duodenoscopes.
Regulators are responding to public outcry, issuing updated final guidance today on cleaning guidelines for the devices. The move marks "a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse," the FDA said in a statement.
- read the Reuters story
- get the FDA's panel meeting notice (PDF)
- read the panel meeting notice
- here's the agency's updated guidance (PDF)
- and here's the FDA statement