August 17, 2016
- 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
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.
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 RECALL 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.
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.
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.
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.
- Custom Ultrasonics Inc. Urgent: Medical Device Recall All System 83 Plus, System 83 Plus 2 and System 83 Plus 9 Automated Endoscope Reprocessors (AER) – May, 6, 2016
Association of periOperative Registered Nurses: Guidelines for Processing Flexible Endoscopes. Published January 2016 Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication
- Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. CDC Health Advisory. September 11, 2015
- AAMI Standard ST91: Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities. Published April 2015
American Society for Gastrointestinal Endoscopy: Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011
- Preventing Cross-Contamination in Endoscope Processing: FDA Safety Communication. November 19, 2009 [ARCHIVED]
- The Centers for Disease Control and Prevention/Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities: 2008
- American College of Chest Physicians and American Association for Bronchology Consensus Statement: Prevention of Flexible Bronchoscopy-Associated Infection: 2005