Pentax Warns on Infection Risks From Some of its Endoscopes

PENTAX Medical recently issued a field correction to customers on a potential risk for contamination on one of its duodenoscope models. PENTAX duodenoscope model ED-3490TK has been declared a risk for patient infection due to an issue with the silicone adhesive used on the distal tip during manufacturing. In some cases, cracks may form in the adhesive that may make the scope susceptible to fluid leakage. PENTAX insists that they are “working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with leakage, if leakage were to occur, into or out of the distal cap area”

The Pentax release includes the following action steps:

“The validated manual reprocessing procedures included in the current Instructions for Use (S041 R01) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labeling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required.

Additionally, PENTAX recommends that you immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. Continuing to use devices with integrity issues (i.e. holes, cracks, kinks and scratches) can contribute to persistent device contamination and subsequent patient infection.

PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX field staff will assess duodenoscope functionality and will send duodenoscopes for in-house servicing to recondition worn parts, as needed. PENTAX will contact your facility to schedule time to inspect your ED-3490TK duodenoscope inventory and heightened vigilance will be applied to the integrity of the distal cap during these inspections.”

Read the entire notice here: FIELD CORRECTION Importance of following Validated Reprocessing Instructions PENTAX Medical ED-3490TK Duodenoscope

The infection risk with duodenoscopes across all the major scope manufacturers continues to be an issue for hospitals. Hospitals must continue to be vigilant in their use of duodeonscopes and must ensure processes are followed strictly to minimize infection risk. Where strong processes are missing, hospitals must work to ensure the proper people and systems are in place to upgrade processes to the highest standards.