To Our Valued Customers,
On Friday November 13, 2015 the FDA posted a Safety Communication regarding the Custom Ultrasonics System 83 Plus Washer/Disinfector. The FDA recommends a Transition from the Custom Ultrasonics Endoscope Washer/Disinfector to Alternate Reprocessing Methods. First and foremost, the Custom Ultrasonics System 83 Plus Washer/Disinfector has not been linked to any transmission of infection from the endoscope to the patient. Custom Ultrasonics has no safety concerns regarding the safety and efficacy of the System 83 Plus Washer/Disinfector.
Custom Ultrasonics was inspected by the FDA in April 2015. At that time, the FDA required Custom Ultrasonics to perform additional validation testing in four particular areas. The four areas of validation were:
Custom Ultrasonics has been complying with these requests. Custom Ultrasonics completed the validation of the performance of the pre-filters used in the System 83 Plus according to the observation as it was documented on the FDA Form 483 and the remainder of the items are in the process of being completed. Custom Ultrasonics has been performing testing at independent laboratories since July 2015 and we will continue to perform the required testing until it is completed. Custom Ultrasonics will continue to submit data to the FDA as we receive it. Custom Ultrasonics continues to comply with any requests that we receive from the FDA and look forward to a positive resolution to this issue.
Custom Ultrasonics has been a leader in the market for over 31 years and we continue to stand by the safety and efficacy of the System 83 Plus Washer/Disinfector. Custom Ultrasonics will continue to support our loyal customers in any way possible.
If you have any questions or concerns please contact us at 215-364-1477 and we will be happy to discuss this matter.
Please refer back to this website for any additional information.
Please see the Product Documentation Tab for Updated Informational Bulletin IB-001
Please review the FDA and SGNA links below concerning recent CRE outbreaks:
PLease review additional information from Olympus regarding the TJF-Q180V