FDA clears FujiFilm reprocessing label for ’superbug’-susceptible duodenoscopes

The FDA last week 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.

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.

While the reprocessing instructions were specific for the ED-530XT, the FDA urged health care facilities to use the reprocessing instructions for FujiFilm’s 250 and 450 duodenoscope models as well.

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

In February, the FDA issued a safety communication in response to a “superbug” outbreak in California related to duodenoscopes, looking to speed label changes related to reprocessing of the devices to avoid future outbreaks.

FujiFilm began testing for revised reprocessing instructions in May, according to the FDA. The newly inked reprocessing instructions include “a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures,” the FDA said.

The federal watchdog requested that health care facilities train staff appropriately on the newly published reprocessing instructions as soon as possible, and said individuals could contact Fuji’s endoscopy division with any questions or concerns.

In August, the FDA published warning letters it sent earlier this month to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan.

The inspections followed a string of deadly “superbug” infections attributed to duodenoscopes made by Olympus (TYO:7733),  FujiFilm and Hoya‘s (TYO:7741) Pentax subsidiary.

Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March, some of which led to patients’ deaths.

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