The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being issued due to “continued violations of federal law and a consent decree entered with the company in 2007”. These violations can increase the risk of transmitting bacteria, a problem that has recently come to light following several superbug outbreaks associated with tainted duodenoscopes. Custom Ultrasonics was ordered to recall all of its AERs from health care facilities, which are advised to use alternative methods to reprocess flexible endoscopes.
The recall affects some 2,800 AERs in hospitals and outpatients clinics located around the country, the FDA announcement said. All models are affected, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Custom Ultrasonics must submit a written recall proposal to the FDA within seven business days. William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” according to the announcement. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”
AERs are supposed to disinfect endoscopes between uses. Before these devices are placed in an AER, the scopes must be thoroughly cleaned to remove any visible debris. This is not the first recall Custom Ultrasonics has issued. The FDA ordered the company to recall all AER models and components in 2012. The recall was issued because Custom Ultrasonics failed to obtain proper clearance after a significant change to the software operating system. The scopes remained on the market after being properly cleared, but the company has not been allowed to continue manufacturing or distributing new units.
During the FDA’s most recent April 2015 inspection of Custom Ultrasonics’ facility, the agency “documented continued violations” which include failing to verify that the AERs can adequately sanitize endoscopes to prevent patient infection. The FDA gave the company an opportunity to correct these violations, but a follow-up review “determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.”