In a Safety Alert issued February 23, 2016, the FDA revised its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics of Ivyland, PA, regarding its November 2015 Recall Order. 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 automated endoscope reprocessors (AERs) can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.
In January 2007, Custom Ultrasonics entered into a Consent Decree because the company failed to comply with the Food, Drug & Cosmetics Act and its implementing regulations. In 2012 and 2013, under the terms of the Consent Decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components. The FDA ordered Custom Ultrasonics to recall AER devices after the company failed to obtain FDA clearance following a significant change to the software operating system for one of its AERs. After Custom Ultrasonics obtained clearance for the significant change to the software operating system, the cleared devices were permitted to remain on the market. Since the 2012 and 2013 orders, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.
On November 12, 2015, in accordance with the Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), the 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.
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 patient gastrointestinal and pulmonary tracts.
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.
See the FDA Safety Alert
See the FDA Medical Devices Communication
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See the Medical Law Perspectives March 11, 2015 Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?