Pentax alerts FDA to additional scope design flaw linked to infection risk

The FDA has issued an update to its safety communication regarding the risk for infection associated with the design of the Pentax ED-3490TK duodenoscope.

In February 2016, the FDA announced its validation of Pentax’s updated reprocessing protocols to replace those in the original device label, following the Agency’s safety communication issued the year before alerting health care providers of the increased risk for patient infection associated with the complex design of endoscopic retrograde cholangiopancreatographic endoscopes. Since then, Pentax has informed the FDA that “cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress.”

The difficulty in cleaning and disinfecting these areas can increase the risk for patient infection, according to the safety communication.

In response to this additional information, the FDA recommended that facilities continue to follow the previously validated reprocessing instructions, and promptly train staff and implement the protocols if they have not already done so.

“In lieu of manual high-level disinfection, facilities may opt to use the ED-3490TK Video Duodenoscope with an Automated Endoscope Reprocessor (AER) that has provided validation data and test reports to FDA that demonstrate acceptable high-level disinfection or liquid chemical sterilization of duodenoscopes,” according to the safety communication.

The FDA also recommended that facilities remove scopes with visible signs of damage — including “loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, cracks and gaps in the adhesive that seals the device’s distal cap or other signs of wear or damage” — immediately for assessment, repair or replacement.

Pentax will provide customers with in-servicing and training, according to the safety communication.

In related news, the FDA also recently announced that Fujifilm plans to remove and replace a number of older duodenoscope models from clinical use. – by Adam Leitenberger

Reference:

FDA. ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions. Accessed January 17, 2017. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537146.htm.