FDA OKs limited duodenoscope sterilization by Custom Ultrasonics AERs

The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain duodenoscopes.
With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA release.
The new clearance comes after the company supplied validation testing data which showed that the System 83 plus products can “effectively achieve high-level disinfection” of the specific scopes. The System 83 products are still not validated for reprocessing any Fujifilm Holdings (TSE:4901)  duodenoscopes or duodenoscopes with open elevator wire channels.
Custom Ultrasonics has issued a notification to its users informing them of the updated labeling. The notification includes an updated label and operators manual containing reprocessing instructions for the scopes it’s now cleared to clean and disinfect.
The FDA will continue to review critical factors that contribute to patient infections due to duodenoscopes and how to mitigate them, and will update on further clearances as they become available, according to an FDA release.
Last June, Custom Ultrasonics said that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and ...

Source: Mass Device - April 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration Custom Ultrasonics Olympus Pentax Source Type: news