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.
FDA warns again on Pentax duodenoscopes
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 FDA issued a statement today warning that