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PENTAX Issues New Duodenoscope Reprocessing Instructions

Hospitals using PENTAX ED-3490TK video duodenoscopes should begin training staff on revised instructions newly validated by the Food and Drug Administration (FDA).

PENTAX issued updated instructions for their video duodenoscopes in response to the FDA’s Safety Communication in February 2015, which warned that in the absence of proper reprocessing, residual bodily fluids may remain in microscopic crevices of the duodenoscope. The updated instructions provide direction regarding the cleaning, high-level disinfection, and sterilization of the device. Lack of sterilization might cause the transmission of bacteria and bloodborne pathogens between patients, including bacteria resistant to multiple drugs, according to reports.

The ECRI Institute listed dirty endoscopes as the top health technology hazard in 2016 for patients in hospitals and other health care facilities. The FDA has been working with duodenoscope manufacturers to revise and validate their reprocessing instructions to ensure patient safety.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Matt Buechner is the policy and advocacy associate for America's Essential Hospitals.

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