The US Food and Drug Administration has determined that the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope
The US Food and Drug Administration, FDA, has notified health care facilities that Custom Ultrasonics has completed validation testing of the System Plus AERs with specific duodenoscopes and 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.
As a result, the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope. The System 83 Plus is not validated for the reprocessing of Fujifilm duodenoscopes or duodenoscopes with open elevator wire channels.
The news follows on from a Consent Decree between Custom Ultrasonics and the FDA, due to, among other things, repeated violations of the Quality System Regulation. The issue dates back to September 2012, when the FDA ordered Custom Ultrasonics to cease manufacturing and distributing, and to recall the System 83 Plus Washer/Disinfector.
In April 2015, FDA inspected Custom Ultrasonics to evaluate compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA’s Quality System regulations, and the Consent Decree.
The recall order took place in November 2015 to all Custom Ultrasonics’ AERs from health care facilities due to the firm’s violations of the FD&C Act, applicable regulations, and the Consent Decree.
As a follow-up, Custom Ultrasonics was inspected in April 2017. This inspection verified the corrections implemented by Custom Ultrasonics, and found the firm in compliance. The FDA allowed the company to resume manufacturing, marketing, and distribution of the System 83.
The FDA said it will continue to work with Custom Ultrasonics as the firm takes steps to fully comply with requirements of the FD&C Act.