The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order.
On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs). On November 24, 2015, Custom Ultrasonics submitted a recall strategy to the FDA, which the Agency found inadequate. Custom Ultrasonics has to date made no additional proposals to FDA to recall its AERs.
On January 29, 2016, the FDA sent a letter to Custom Ultrasonics reinforcing the terms of the Recall Order and requiring Custom Ultrasonics to remove its AERs from the market. The FDA further notified Custom Ultrasonics that it could take additional measures under the Consent Decree should Custom Ultrasonics fail to initiate or diligently implement the recall or take other required actions.
Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 Safety Communication. The full text of that safety communication appears below.
[Originally Posted 11/13/2015]
AUDIENCE: Risk Manager, Gastroenterology, Pulmonology, General Surgery
ISSUE: In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors (AERs) from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. FDA is recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
As part of the FDA’s ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.
The FDA’s most recent inspection of the Custom Ultrasonics’ facility in April 2015 documented continued violations. Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. The identified violations could result in an increased risk of infection transmission.
BACKGROUND: AERs are free-standing units used in health care facilities to disinfect flexible endoscopes and scope accessories between uses. Custom Ultrasonics AERs are intended to wash and high-level disinfect cleaned flexible endoscopes used in gastrointestinal and pulmonary tracts.
RECOMMENDATION: The FDA recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative reprocessing methods as soon as possible. Facilities are advised to:
- Identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs, or other cleaning and sterilization methods according to the endoscope manufacturers’ reprocessing instructions.
- Before transitioning to an alternative method, be sure that the endoscopes your facility uses are compatible with the alternative method by referring to the endoscope manufacturer’s reprocessing instructions.
- Submit a report to Custom Ultrasonics 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.
Healthcare professionals and patients 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
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.
[11/13/2015 - Safety Communication - FDA]