FDA News

FDA approves new design, labeling for Pentax duodenoscopes

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.

Pentax informed its customers of a voluntary recall of the scopes to replace the forceps elevator, O-ring seal and distal end cap, and updated the product’s operation manual to recommend annual maintenance. The FDA approved the new design and labeling changes.

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.

The design changes were made to reduce the risk for leakage of patient fluids into the close elevator channel and under the distal cap.

“The complex design of duodenoscopes may impede effective reprocessing,” according to the safety communication. “The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect duodenoscopes.”

The FDA recommended that health care facilities replace any old operation manuals and continue to follow the updated reprocessing instructions. – by Alex Young

Reference: FDA. Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared. Accessed: Feb. 7, 2018.

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.

Pentax informed its customers of a voluntary recall of the scopes to replace the forceps elevator, O-ring seal and distal end cap, and updated the product’s operation manual to recommend annual maintenance. The FDA approved the new design and labeling changes.

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.

The design changes were made to reduce the risk for leakage of patient fluids into the close elevator channel and under the distal cap.

“The complex design of duodenoscopes may impede effective reprocessing,” according to the safety communication. “The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect duodenoscopes.”

The FDA recommended that health care facilities replace any old operation manuals and continue to follow the updated reprocessing instructions. – by Alex Young

Reference: FDA. Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared. Accessed: Feb. 7, 2018.