AUDIENCE: Risk Manager, Gastroenterology, Pulmonology, General Surgery
ISSUE: 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, FDA is revising its February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
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 FDA will continue to provide updates as new information becomes available.
BACKGROUND: FDA 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.
RECOMMENDATION: 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.
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.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA safety communication, and previous MedWatch safety alert, at: