On November 13, 2015 the Food and Drug Administration ordered Custom Ultrasonics to recall all automated endoscope reprocessors (AERs) from use in health care facilities because of an increased risk of infection transmission with ineffectively cleaned medical scopes.
The agency also issued a safety communication recommending to health care facilities currently using Custom Ultrasonics devices that they find alternative methods to reprocess flexible endoscopes.
The FDA is taking these actions to minimize the risk of patient infections associated with reprocessed endoscopes. The FDA has been working with other agencies, hospitals, and manufacturers to uncover the factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.
An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in use in hospitals and outpatient clinics in the U.S. The recall order applies to Custom Ultrasonics AERs, 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 of receipt of the recall order.
William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said the manufacturer “failed to meet its legal and regulatory obligations.” The 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 Class II—moderate risk—medical devices used for cleaning and high-level disinfection of endoscopes between uses. AERs are designed to clean and disinfect exterior surfaces and interior channels of endoscopes to prevent the spread of infection when the devices are used in subsequent procedures. Visible debris must be removed before the device is placed in the AER. The technician must manually scrub the elevator mechanism and the recesses surrounding the elevator mechanism.
In 2012, under the terms of the consent decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing AERs. The FDA ordered the recall after the company failed to obtain FDA clearance following a significant change to the software operating system for one AER. 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 order, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing AERs, though the company has continued to service them.
In its most recent inspection of Custom Ultrasonics’ facility in April 2015, the FDA documented continued violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company’s submissions, the agency determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.
Endoscopes have been linked to outbreaks of drug-resistant bacterial infections in hospitals in Los Angeles, Seattle, Pittsburgh, and Chicago. Two of the patients infected in Los Angeles died. On November 20, a North Carolina woman filed a wrongful death lawsuit against endoscope manufacturer Olympus Corp. and Custom Ultrasonics. Her husband died from an antibiotic-resistant bacterial infection following an endoscopy procedure.