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Technical Bulletin TB-019
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm604203.htm
Date: April 10, 2018
Affected Product(s): System 83 Plus™, System 83 Plus™ 2, and System 83 Plus™ 9 Automated Endoscope Reprocessors (AERs)
Purpose: Medical Device Notification / Labeling Change
Regarding: System 83 Plus™ AERs and Olympus TJF-Q180V and Pentax ED-3490TK Duodenoscope Reprocessing
Country Affected: USA and Canada
Timing / When: Effective Immediately
The purpose of this Technical Bulletin is to inform all System 83 Plus users that Custom Ultrasonics, Inc. (CUI) has successfully completed validation testing with specific duodenoscopes in the System 83 Plus automated endoscope reprocessor (AER). The validation testing was conducted according to the rigorous criteria established by FDA to evaluate AER reprocessing effectiveness of the recess around the duodenoscope’s elevator area. The System 83 Plus™ AERs have been validated to reprocess the Olympus model TJF-Q180V duodenoscope and the Pentax model ED-3490TK duodenoscope using the following validated process and instructions for use:
- Use only ortho-Phthalaldehyde solution (OPA) having a nominal active ingredient composition of 0.55%, a minimum recommended concentration (MRC) of 0.3%
- Apply minimum contact conditions of 12 minutes at 20°C
- Assure that the OPA re-use period does not exceed 14 days or that the OPA concentration does not drop to the MRC.
Validation reports and a protocol for the Olympus model TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope were provided to the FDA for review and it has been determined based on these validations that the System 83 Plus™ can effectively achieve high-level disinfection of these duodenoscopes when used in accordance with its instructions for use as described in the updated Operator’s Manual.
The duodenoscopes that are validated for reprocessing in the System 83 Plus™ are the Olympus TJF-Q180V and the Pentax ED-3490TK using ortho‐Phthalaldehyde Solution high‐level disinfectant (OPA) for a minimum of 12 minutes at 20°C. The System 83 Plus™ is not validated for the reprocessing of the FUJIFILM duodenoscopes and of duodenoscopes with open elevator wire channels.
Users may reprocess the Olympus TJF-Q180V and the Pentax ED-3490TK duodenoscopes in the System 83 Plus™ using OPA, effective immediately. The duodenoscopes must undergo thorough manual cleaning, according to the duodenoscope manufacturer’s cleaning instructions, and including brushing and flushing of the “sealed forceps elevator recess,” as well as, brushing and flushing of the instrument/suction channel and flushing of all other channels of the duodenoscope, prior to processing the duodenoscope in the System 83 Plus™. Please see the complete reprocessing instructions for the System 83 Plus in the updated Operator’s Manual Revision 04102018.
The System 83 Plus™ has been added to the FDA’s website, Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation[1] and its list of AERs with demonstrated validation testing for the reprocessing of these duodenoscopes. Validation testing of additional make and model duodenoscopes is ongoing. CUI will update users when additional validation testing has been completed.
Actions to be taken by the User:
If you have not yet transitioned to using OPA, please contact CUI service department, Monday through Friday between the hours of 8:00 AM through 5:00 PM EST or email us at service@customultrasonics.com, in order to schedule a System 83 Plus™ configuration conversion to OPA.
Users will receive an acknowledgment form and new label(s) with this Technical Bulletin release. The new label is to replace the current label on the lid of the System 83 Plus™. If you do not receive it or need additional labels, please notify Custom Ultrasonics, Inc. and they will be provided. To obtain the System 83 Plus™ Operator’s Manual that has been updated pursuant to this notification or for other product information, please visit the Custom Ultrasonics website at: customultrasonics.com.
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland, PA 18974
Phone: (215) 364-1477
To obtain the Operator's Manual and other product information, please go to the Custom Ultrasonics website: www.customultrasonics.com. Once you are registered, a copy of the manual, and if applicable, other product information can be downloaded under the Product Documentation field. Adobe PDF reader is required to open and view the document.
For new users to the site select the My Profile tab to login. Select the Register button under New User. Complete the required field and press the Register button. Authorized user will then be provided with a registration confirmation email.
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 sales@customultrasonics.com or info@customultrasonics.com
Custom Ultrasonics, Inc.
New Product Features and Announcements
Sales Representatives Wanted
Custom Ultrasonics Inc. (CUI) has resumed manufacturing the System 83 Plus Washer/Disinfector and is looking to expand our sales force. CUI has territories available throughout the United States. If you would like additional information about joining our sales team, please contact Robert E. Blanchard, Director of Product Management and Sales at: robert.blanchard@customultrasonics.com
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NOTE:
To obtain the Operator"s Manual and other product information, please go to the Custom Ultrasonics website:
www.customultrasonics.com
Select My Profile to log on. For New Users, registration is required. If you are not currently registered as a user, select the Register button. Complete the information and a log on and password will be provided.
Once you are registered, a copy of the manual, and, if applicable, other product information can be downloaded under the Product Documentation field. Adobe PDF reader is required to open and view the document.
