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Surveillance of Guideline Practices for Duodenoscope and Linear Endoscope Reprocessing in a Large Healthcare System.  

Jack J. Brandabur, MD, James E. Leggett, MD, Lian Wang, MS, Rebecca L. Bartles, MPH, CIC, Linda Baxter, MPH, MBA, George A. Diaz, MD, Gary L. Grunkemeir, PhD, Shannan Hove, RN, Margaret Oethinger, MD, PhD.
A recent study was performed at 21 Providence Health System and Affiliated Hospitals to assess the adequacy of currently recommended duodenoscope and linear echoendoscope (DLE) automatic endoscope reprocessing (AER) and high-level disinfection (HLD).  The article was published in Gastrointestinal Endoscopy GIE September 2016 Volume 84 Issue, 3 Pages 392-399.
The results of this study showed that microbial growth was recovered from 201 of 4032 specimens (5%) or 189 of 2238 encounters (8.4%), including 23 specimens (.6%) or 21 encounters (.9%) for a high-concern pathogen.  Wide variations in culture-positivity rate were observed across facilities.  No striking difference in culture-positivity rate was seen among 8 DLE models, 3 DLE manufacturers, DLE age, manual or bedside cleanser, or automatic flushing system use.  However, there was suggestive evidence that Custom Ultrasonics’ AER (Warminster, PA USA) had a lower culture positivity rate than Medivators AER (Cantel Medical Corp., Little Falls, NJ , USA) for high-concern pathogen growth      (0/0179 vs 21/2735 specimens or 0/547 vs 20/1582 encounters). It was noted in the conclusion that the observed better performance of the Custom Ultrasonics AER deserves further investigation.
To download the complete study please click on the link:

Surveillance of Guideline Practices for Duodenoscopesand Linear Endoscope Reporcessingin a Large Healthcare System

Disclaimer: Custom Ultrasonics, Inc. (CUI) makes no endorsements or recommendations based upon any articles on its website.  Please consult CUI’s labeling for indications and instructions for use of its products.

 

 

 

 

 

 

 

FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Communication

August 17, 2016

Audiences:

  • Personnel working in endoscopy reprocessing units in health care facilities
  • Health care providers that perform endoscopic procedures
  • Infection Control practitioners
  • Risk Managers
  • Purchasers and other Hospital Administration staff

Medical Specialties:

Infection Control, Gastroenterology, Pulmonology, General Surgery, Anesthesiology, Internal Medicine

Product:

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.

Purpose:

The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 URGENT MEDICAL DEVICE RECALLdisclaimer icon, 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.

Summary of Problem and Scope:

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:

  • The FDA has reviewed the available reprocessing validation data from Custom Ultrasonics, as well as the available published literature on Custom Ultrasonics AER performance. In addition, Custom Ultrasonics has provided updated information concerning corrective actions the firm is taking in response to the violations identified during the Agency’s April 2015 inspection.
  • Custom Ultrasonics proposed a modified recall strategy that the FDA determined adequately addresses the identified risks to the public health.
  • On May 6, 2016, Custom Ultrasonics issued an URGENT MEDICAL DEVICE RECALLdisclaimer icon for all System 83 Plus, System 83 Plus 2 and System 83 Plus 9 AERs stating that they should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice, leaving the units in place only to reprocess other endoscopes.
    • 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:

      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.
  • The FDA continues to work closely with Custom Ultrasonics as the firm conducts additional reprocessing validation studies and takes steps to correct the violations identified during inspection.
  • 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.

Recommendations for Health Care Facilities and Staff:

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:

  • Identify and transition to alternate methods to reprocess duodenoscopes, such as manual high-level disinfection, alternative AERs, liquid chemical sterilization, or other sterilization methods according to the duodenoscope manufacturers’ reprocessing instructions. Regardless of reprocessing method, hospital staff should manually clean duodenoscopes according to the manufacturer’s instructions.
    • Before transitioning to an alternative method, be sure that the duodenoscopes your facility uses are compatible with the alternative method by referring to the duodenoscope manufacturer’s reprocessing instructions and the AER manufacturer’s instructions.
  • Submit a report to Custom Ultrasonics, Inc. and to the FDA via MedWatch, as described below, if you suspect your health care facility’s Custom Ultrasonics AER has caused or contributed to patient infection.

The FDA continues to recommend the following best practices for all flexible endoscopes:

  • Always clean endoscopes and their accessories thoroughly before high-level disinfection, liquid chemical sterilization, or other sterilization methods.
  • Ensure ready access and promote strict adherence to manufacturer’s instructions for cleaning other flexible endoscopes.
  • Implement a comprehensive quality control program for reprocessing flexible endoscopes, including:
    • written procedures for monitoring training and adherence to the program
    • documentation of equipment, tests, processes, and quality monitors used during the reprocessing procedure.
  • Ensure that staff responsible for reprocessing endoscopes understand the importance of their role in reprocessing the device and maintain proficiency in performing required reprocessing tasks.
  • Adhere to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals, as included in Additional Resources below.

FDA Activities:

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 RECALLdisclaimer icon receive labels to affix on each System 83 Plus unit in a prominent location stating:

"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."

The FDA will continue to provide updates as new information becomes available.

Reporting Problems to the FDA:

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.

Contact Information:

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.

Additional Resources

Page Last Updated: 08/17/2016
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FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Contact FDA

 

Updated Information Concerning FDA's Safety Notification to Custom Ultrasonics Inc.

May 6, 2016

URGENT:

MEDICAL DEVICE RECALL

All System 83 Plus, System 83 Plus 2 and System 83 Plus 9 Automated Endoscope Reprocessors (AER)

 

 

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:

Product Information Table

Product Names
 
Manufacturer’s Model Number
Serial Number
Manufacturing/Distribution Dates
Additional details
Quantity
System 83 Plus
System 83 Plus 2 System 83 Plus 9
All Serial Numbers
All Manufacturing/Distribution Dates
N/A
2439

 

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 

www.customultrasonics.com

 

  

URGENT CUSTOM ULTRASONICS SAFETY NOTIFICATION CORRECTIVE ACTION

ACKNOWLEDGEMENT FORM

 

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. 

 

Date                 ___________________________________________________________________________________________

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 recall@customultrasonics.com

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA:

  • Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm form available to fax or mail), or
  • Call FDA 1-800-FDA-1088

 

Please email this acknowledgement form after receiving your device labels to recall@customultrasonics.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

UPDATED INFORMATION CONCERNING FDA's Safety Notification LETTER TO CUSTOM ULTRASONICS, INC. dated November 13, 2015 and reaffirmed on January 29, 2016

Re: System 83 Plus, System 83 Plus 2, and System 83 Plus 9 Automated Endoscope Reprocessors all Serial Numbers

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.

 

Sincerely,

Alicia Nakonetschny

President and CEO

Custom Ultrasonics Inc.

 

 

Custom Ultrasonics Inc. Response to the US Senate HELP Committee Report

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.  

**Update Custom Ultrasonics Response to the FDA's Safety Communication:

Date Issued November 13, 2015 Update**

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:

  1. Validate the performance of the water filter assembly
  2. Validate the pre-filters (disk filters) that are used on the adapters
  3. Validate the compatibility of various High Level Disinfectants in the System 83 Plus
  4. Validate the reprocessing of specific duodenoscopes

 

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.