Updated December 16, 2015
Custom Ultrasonics met with the FDA on December 11, 2015. The meeting was productive and Custom Ultrasonics is working closely with the FDA to resolve the current issues that were addressed in the FDA Safety Communication dated November 13, 2015. Custom Ultrasonics is developing a plan to move forward and will continue to submit all performance data to the FDA, as requested.
The next step in this process, at the request of the FDA, is to submit a plan of action which will address the use of the System 83 Plus. In addition, to this plan, there will be action items that will be put into place to resolve FDA regulatory questions. Custom Ultrasonics is currently formulating this plan and will be submitting it to the FDA shortly.
We understand that all of our customers are concerned with the information that was released by the FDA in their Safety Communication. It is Custom Ultrasonics’ top priority to address this matter and we are working diligently and cooperatively with the FDA towards a resolution. Patient safety is our first concern and we continue to stand by the safety and efficacy of the System 83 Plus.
Updated December 9, 2015
Custom Ultrasonics would like to give all of our valued customers an update to the recent FDA communication that we received on November 13, 2015.
Custom Ultrasonics will be meeting with the FDA Friday December 11, 2015. We will be discussing the proposal that Custom Ultrasonics delivered to the FDA on November 24, 2015. Once Custom Ultrasonics meets with the FDA we will be able to make a determination as to the next step we need to take.
Posted November 16, 2015 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
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