Pentax updates on FDA-cleared scope labeling to fight “superbugs”

The FDA said it cleared updated reprocessing instructions for Pentax’s ED-3490TK video duodenoscopes to avoid infectious outbreaks of “superbugs.”

Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually.

Duodenoscopes are an FDA-identified culprit in a string of “superbug” outbreaks, due to the complex designs of the devices impeding cleaning and processing, leaving residual body fluids and organic debris that can pass from patient-to-patient with reuse.

The new reprocessing instructions include a “more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilization procedures,” according to an FDA release.

The updated instructions include additional text, figures, cautions and warnings to clarify the validated reprocessing procedure. The federal watchdog said the updated instructions “demonstrate consistent and reliable cleaning, high-level disinfection and sterilization.”

In January, the FDA said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of bacterial infections.

Olympus said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device.

The redesigned endoscope from Olympus comes on the heels of a new report from the U.S. Senate’s health committee, which slapped blame on medical device companies and hospitals for deadly outbreaks of so-called “superbug” infections linked to the scopes.

Last December, the FDA said it cleared Fujifilm Holdings‘ (TSE:4901) revised manual reprocessing instructions for its ED-530XT duodenoscope, replacing reprocessing instructions included on the original device label.

The FDA said FujiFilm is currently undergoing formal validation testing for official revised reprocessing instructions for its 250 and 450 models of duodenoscopes.

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