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FDA Approves Validated Reprocessing Instructions for Pentax Scope
The FDA today announced it has reviewed Pentax’s updated, validated manual reprocessing instructions for its ED-3490TK video duodenoscope, and recommends facilities using the device implement them as soon as possible.
Following the FDA’s initial safety communication issued in February 2015, the agency “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,” according to the FDA press release.
Pentax began modifying its reprocessing protocol in February 2015, began validation testing in May, performed additional safety testing between July and September, and submitted cleaning, high-level disinfection and sterilization reports to the FDA in October. The FDA then requested additional cleaning test data, which Pentax submitted in January 2016, and after review, the FDA deemed these data to be adequate.
The updated reprocessing instructions “include a more rigorous protocol for precleaning, manual cleaning, high-level disinfection and liquid chemical sterilization procedures,” according to the press release. The instructions have also been expanded to clarify the procedure. “The Agency believes that when followed, these updated, validated reprocessing instructions demonstrate consistent and reliable cleaning, high-level disinfection and sterilization,” of this Pentax scope model.