FDA warns again on Pentax duodenoscopes

January 17, 2017 By Sarah Faulkner Leave a Comment

The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax. These gaps can be difficult to clean, increasing the risk of infection transmission among patients.

The federal watchdog has identified improperly-cleaned duodenoscopes as a potential source for superbug infections. In February and March 2015, inadequately-cleaned duodenoscopes were tied to deadly suberbug outbreaks in hospitals in Connecticut, Virginia, California and Washington. The scopes associated with the infectious outbreak were made by Olympus (TYO:7733) and Pentax.

Following the outbreak, the FDA published warning letters that it sent to the endoscope makers, warning them about violations that it found during spring inspections at plants located in the U.S. and Japan.

In February last year, the FDA cleared updated reprocessing instructions for Pentax’s duodenoscopes to avoid infectious outbreaks of superbugs. In its most recent safety communication, the FDA advised health care facilities to continue to closely follow the validated instructions when reprocessing the device and to pay close attention to any physical damage.

Pentax distributed a letter to its customers today, informing them of the design issue and outlining the company’s strategy to closely inspect the distal cap area of all customers’ ED-3490TK duodenoscopes. Any scope with signs of physical damage, the company recommended, should be removed from use.

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