Infection Control, Gastroenterology, Pulmonology, General Surgery, Anesthesiology, Internal Medicine
All Custom Ultrasonics' System 83 Plus Automated Endoscope Reprocessors (AERs) used in health care facilities to wash and disinfect flexible endoscopes, including duodenoscopes, and scope accessories between uses. The System 83 Plus AERs include the System 83 Plus, System 83 Plus 2, and the System 83 Plus 9 AERs.
The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 URGENT MEDICAL DEVICE RECALL, and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes. Based on the Agency’s February 2016 Safety Communication, at this time, facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. In addition, we are revising our February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus AERs remain in service for the reprocessing of endoscopes other than duodenoscopes.
In January 2007, Custom Ultrasonics, Inc. entered into a Consent Decree with FDA due to, among other things, repeated violations of the Quality System Regulation.
In April 2015, the FDA inspected Custom Ultrasonics Inc. to evaluate compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA’s Quality System regulations, and the Consent Decree.
In the November 12, 2015 Recall Order, the FDA ordered Custom Ultrasonics to recall all of its AERs from health care facilities due to the firm’s violations of the FD&C Act, applicable regulations, and the Consent Decree.
In November 2015, the FDA issued a Safety Communication recommending that health care facilities using Custom Ultrasonics’ System 83 Plus AERs transition to alternate methods to reprocess flexible endoscopes, which include duodenoscopes.
On January 29, 2016, the FDA sent a letter to Custom Ultrasonics reinforcing the terms of the Recall Order and instructing Custom Ultrasonics to remove its AERs from the market because the Agency had determined that the Custom Ultrasonics recall strategy submitted to FDA was inadequate.
On February 23, 2016, FDA revised the November 2015 Safety Communication to emphasize that health care facilities using Custom Ultrasonics’ AERs should transition to alternative methods to reprocess flexible endoscopes.
Since our February 2016 Safety Communication:
Custom Ultrasonics has provided customers with a label to affix to System 83 Plus AERs in a prominent location with a warning stating the following:
The design of duodenoscopes is complex and therefore makes duodenoscopes harder to clean than most other flexible endoscopes. Because inadequately reprocessed duodenoscopes have been associated with patient infections and death, health care facilities should not use Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes, and should have transitioned to alternative methods of reprocessing these particular endoscopes.
The Agency has created a website to provide the public with up-to-date information about AERs for which the Agency has reviewed adequate reprocessing validation for duodenoscopes.
The FDA’s ongoing investigation of duodenoscope reprocessing and endoscopic retrograde cholangiopancreatography (ERCP) associated infections in health care facilities has not demonstrated an association between Custom Ultrasonics AERs and bacterial infections with flexible endoscopes that are not duodenoscopes. Custom Ultrasonics' System 83 Plus AERs remain available for use for reprocessing flexible endoscopes that are not duodenoscopes, in part, because of an absence of such an association with flexible endoscopes.
The FDA advises health care facilities to:
The FDA continues to recommend the following best practices for all flexible endoscopes:
To help mitigate the risk of patient infection, the FDA has been reviewing duodenoscope reprocessing validation study protocols and test data for all AER manufacturers as they conduct additional testing with duodenoscopes to demonstrate AER reprocessing effectiveness.
The FDA continues to work with Custom Ultrasonics Inc. to ensure all customers, per the May 6, 2016 URGENT MEDICAL DEVICE RECALL receive labels to affix on each System 83 Plus unit in a prominent location stating:
The FDA will continue to provide updates as new information becomes available.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports to the agency via the Medical Device Reporting (MDR) process if they suspect their health care facility’s Custom Ultrasonics AER has caused or contributed to patient infection. If a health care provider suspects bacterial contamination of an endoscope, we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
Page Last Updated: 08/17/2016
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May 6, 2016
May 6, 2016
The purpose of this letter is to advise you that Custom Ultrasonics, Inc. (CUI) System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. This recall is for all System 83 Plus, System 83 Plus 2 and System 83 Plus 9 Automated Endoscope Reprocessors (AER), intended for cleaning and high level disinfection of endoscopes.
Reason for the Recall:
Custom Ultrasonics, Inc. (CUI) has been working with FDA to address concerns with the System 83 Plus Automated Endoscope Reprocessors (AER), as described in the agency’s Safety Communications and recall orders dated November 13, 2015, and January 29, 2016. The System 83 Plus AERs will remain in use in the field for reprocessing certain endoscopes.
Risk to Health:
AERs are intended to adequately wash and disinfect endoscopes to mitigate the risk of patient infection. Inadequate validation and instructions for use could result in an increased risk of infection transmission.
Actions to be taken by the User:
Effective Immediately, Custom Ultrasonics AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes.
Custom Ultrasonics will be providing customers with a label to affix in a prominent location on the System 83 Plus AER’s on or before June 3, 2016 stating the following;
WARNING: This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer.
Custom Ultrasonics will provide a technical bulletin with immediate instructions to reflect that the device should not be used for cleaning and/or high-level disinfection of any duodenoscopes until further written notice. To obtain an electronic copy of the technical bulletin see Custom Ultrasonics website at: customultrasonics.com (Registration is required to obtain access).
The U.S. Food and Drug Administration are aware of and has agreed to this corrective action. This warning does not affect using the System 83 Plus on endoscopes other than duodenoscopes.
Product Information Table
Manufacturer’s Model Number
System 83 Plus
System 83 Plus 2 System 83 Plus 9
All Serial Numbers
All Manufacturing/Distribution Dates
Additional Action by Custom Ultrasonics:
Custom Ultrasonics is working to complete validation of the cleaning and high-level disinfection process for duodenoscopes and update any instructions accordingly. An update to this notice and instructions will be provided after completion and approval by the FDA.
Custom Ultrasonics, Inc. regrets any inconvenience related to this matter. Please contact CUI for any inquiries.
Custom Ultrasonics, Inc.
144 Railroad Drive, Ivyland, PA 18974
Phone: (215) 364-1477
URGENT CUSTOM ULTRASONICS SAFETY NOTIFICATION CORRECTIVE ACTION
Affected Product(s): All System 83 Plus, System 83 Plus 2 and System 83 Plus 9 Automated Endoscope Reprocessor (AER) All Serial Numbers
Your facility will receive a label no later than June 3, 2016 to be affixed in a prominent location on your System 83 Plus device. Once you receive your label, we request you complete and return this acknowledgment form to Custom Ultrasonics, Inc. By returning this form, you are acknowledging receipt of both the written customer and user notification and warning label described in the medical device safety notification corrective action.
Facility Name ___________________________________________________________________________________________
Facility Address (physical location of device) ___________________________________________________________________
City, State and Postal Code _________________________________________________________________________________
List of all System 83 Plus 2 or 83 Plus 9 Device Models and Serial Number
Authorized by: (Name, Title and Department) Signature ___________________________________________________________________________________________
Contact, Phone and Email _____________________________________________________________________
Contact Information: Please contact Custom Ultrasonics, Inc. Monday through Friday, 8:00 AM to 5:00PM EST or email us at firstname.lastname@example.org
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA:
Please email this acknowledgement form after receiving your device labels to email@example.com
On April 29, 2016 the FDA granted Custom Ultrasonics permission to distribute the following letter to all System 83 Plus Washer/Disinfector AER Healthcare Professionals.
April 29, 2016
Dear Healthcare Professional:
Custom Ultrasonics, Inc. (CUI) has been working with FDA to address concerns with the System 83 Plus Automated Endoscope Reprocessors (AER), as described in the agency’s Safety Communications and recall orders dated November 13, 2015, and January 29, 2016. We are contacting you to provide important updated information on System 83 Plus usage. The System 83 Plus AERs will remain in use in the field for reprocessing certain endoscopes. However the System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. CUI will be communicating additional details and instructions to our customers as part of a corrective action within the next five days.
CUI is committed to the safety and efficacy of reprocessing. FDA continues to work with the industry and CUI to validate their reprocessing instructions and to enhance the safety margin of the methods used to clean and disinfect all duodenoscopes manufactured by Olympus, Pentax and Fujifilm.
CUI regrets any inconvenience and appreciates your patience in this matter. We want to assure our customers who reprocess duodenoscopes that we are working with FDA to resolve duodenoscope issues as quickly as possible. CUI is committed to advance the safety and efficacy of reprocessing duodenoscopes in the System 83 Plus AERs.
As new information becomes available it will be disseminated to CUI customers. We encourage you to contact us if you have any questions.
President and CEO
Custom Ultrasonics Inc.
February 19, 2016
The Democratic staff of the Senate Committee on Health, Education. Labor and Pensions recently released a report on the transmission of multi-drug organisms, primarily Carnapenem-resistant Enterobacteriaceae (CRE). This report is a comprehensive study investigating the transmission of the multi-drug resistant organism during the performance of Endoscopic Retrograde Cholangiopancreatography procedures (ERCP).
For over 32 years Custom Ultrasonics has been an advocate of patient safety and we look forward to being an active participant in the discussion and implementation of more stringent regulations. Custom Ultrasonics has been a pioneer in reprocessing endoscopes utilizing a process that is safe and effective. Custom Ultrasonics was the first automated endoscope reprocessor (AER) to introduce ultrasonics for cleaning, address each channel of the scope individually, provide a standardized and validated process, high pressure adapter ports for specialty channels and channel monitoring. All of these design elements are focused on providing the highest level of patient safety.
Validation concerns were brought to our attention by FDA during a “For Cause” Inspection in April of 2015. At that time Custom Ultrasonics received one observation with four parts. Each observation required validation based upon the fact that the inspectors did not feel that our validation data was robust. Custom Ultrasonics has been working with a nationally known laboratory, under the guidance of the FDA, to conduct additional validation testing as recommended. Custom Ultrasonics continues to perform validation studies in accordance with protocols reviewed and approved by FDA and in conjunction with industry standards.
Although we may not agree with all statements made in the report, with regards to Custom Ultrasonics, we applaud The HELP Committee, Minority’s efforts to address a vital issue that needs to be addressed by all stakeholders. The HELP Committee’s commitment to protect patients is much appreciated. It is with the same passion that Custom Ultrasonics is dedicated to resolving and addressing all questions and concerns that pertain to the System 83 Plus. We will be meeting with the HELP Committee staff to assist the Committee in any way.
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.
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