FDA Warns of Adhesive Cracks in Certain Duodenoscopes — Physician’s First Watch

Medical News |
January 18, 2017

FDA Warns of Adhesive Cracks in Certain Duodenoscopes

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The FDA is alerting clinicians about a potential defect in the PENTAX ED-3490TK duodenoscope that can lead to increased risk for infection transmission.

The adhesive that attaches the distal cap to the distal tip can develop cracks and gaps that can result in microbes and fluid entering the device. Given that these regions are difficult to clean and disinfect, the FDA says that it could boost the risk for infection transmission. Contaminated duodenoscopes have been implicated in outbreaks of carbapenem-resistant Enterobacteriaceae in recent years.

The agency recommends that facilities follow the reprocessing procedures for PENTAX's ED-3490TK Video Duodenoscope that were released in February 2016. Duodenoscopes showing visible signs of wear or damage (e.g., loose parts, damaged channel walks, tubing kinks or bends, holes in distal end, cracks or gaps in sealing adhesive) should be taken out of service and repaired or replaced.

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