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FDA clears use of reprocessors for certain duodenoscopes
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The FDA has issued an update to its safety communication regarding the use of automated endoscope reprocessors for the reprocessing of certain duodenoscopes.
The agency is notifying health care facilities that Custom Ultrasonics has completed validation testing of its System 83 Plus Automated Endoscope Reprocessors (AERs).
“[The] FDA has determined that the validation data demonstrate the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V duodenoscope and the Pentax ED-3490TK duodenoscope,” the safety communication said.
The FDA issued a recall on the reprocessors in 2015 after the company allegedly failed to validate the compatibility of its AERs with closed-channel duodenoscopes. The recall was later lifted, and the AERs were allowed to remain in use while the company completed its validation process.
The System 83 Plus AER may now be used to reprocess only the Pentax and Olympus duodenoscopes. The FDA said they are not validated for use on Fujifilm duodenoscopes or duodenoscopes with open elevator wire channels.
Reference:
FDA. Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication. Accessed: April 10, 2018.