June 14, 2017
Re: Custom Ultrasonics, Inc. Receives Resumption of Manufacturing Letter from FDA
During the week of April 24, 2017, the Food and Drug Administration (FDA) conducted an inspection at Custom Ultrasonics’ manufacturing facility in Ivyland PA. As a result of the inspection and extensive new validation testing of the System 83 Plus™, the FDA has reinstated the manufacturing, packing, and distribution of the System 83 Plus™ Washer/Disinfector (including components and systems) for use in the reprocessing of flexible endoscopes that are not duodenoscopes as of June 12, 2017.
The FDA required Custom Ultrasonics to perform validation testing on the System 83 Plus™, water filtration system and the inline disc filter. These filters were tested by independent laboratories and the performance data was reviewed and accepted by the FDA, with no changes in design. New validations were also requested on reprocessing bronchoscopes and non-GI endoscopes using the System 83 Plus™. Validations were conducted using an FDA approved protocol representing worst-case conditions. All validations met the defined performance criteria. The validations were completed using ortho-Phthalaldehyde high-level disinfectant (OPA) and Tergal 800 detergent. This new, stringent FDA approved protocol met the same strict standards the FDA has required of other automated endoscope reprocessor (AER) manufacturers.
While Custom Ultrasonics continues to work with the FDA to validate the System 83 Plus™ for duodenoscopes, the company continues to warn against the reprocessing of duodenoscopes in the System 83 Plus™ Washer/Disinfector until further notice.
Custom Ultrasonics has undergone many changes in the past several years. The leadership of our new President and CEO has taken Custom Ultrasonics into a new era of progress. Custom Ultrasonics has significantly expanded its Quality, Regulatory and Engineering Departments, as evidenced by the company passing a recent inspection of its facility and quality system with no Form 483s, in preparation for Custom Ultrasonics’ re-entry into the automated endoscope reprocessing market and beyond. For over 30 years, Custom Ultrasonics has been a pioneer in the AER market, and under the guidance of our President and CEO, Custom Ultrasonics will continue in that role.
Custom Ultrasonics will be disseminating additional information in the near future as we resume manufacturing the System 83 Plus™ Washer/Disinfector. For additional information please refer to the website customultrasonics.com or please feel free to contact us at email@example.com or firstname.lastname@example.org
Custom Ultrasonics, Inc.
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