Custom Ultrasonics Endoscope Washer Recall Issued Under Consent Decree

Federal regulators have ordered the recall of nearly 3,000 devices used to clean endoscopes between patients, indicating that they have not been proven to be effective at preventing the transmission of infections. 

The Custom Ultrasonics automated endoscope reprocessors (AERS) recall was announced on November 13, after the FDA concluded that the company had violated a 2012 consent decree order by being unable to prove that the devices properly cleaned endoscopes.

The agency also issued a safety communication urging health care facilities to transition away from using the devices to other reprocessing methods.

The recall and warning come amid increasing concerns about infection outbreaks linked to improperly cleaned duodenoscopes, a type of endoscope used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

Several outbreaks have occurred in recent years at hospitals throughout the U.S., which have been linked to difficulties in cleaning the devices. Improperly cleaned or reprocessed medical devices may lead to the spread of infections from one patient to another, increasing the risk of severe injury and deaths.

According to the FDA, the recall affects about 2,800 Custom Ultrasonic AERs currently used in hospitals and outpatient clinics nationwide; including the System 83 Plus, System 83 Plus 2, and System 83 Plus 9. Custom Ultrasonics was given seven days from notification to come up with a written recall proposal.

In 2012, Custom Ultrasonics was ordered to stop manufacturing and distributing AERs and was forced to recall the devices after failing to obtain proper approval for significant changes it made to the software of one of its devices. That came as a failure to abide by an earlier 2007 consent decree. As part of a consent decree, the company obtained clearance for the devices, allowing them to stay on the market.

Following an April 2015 inspection (PDF), a number of violations were revealed, including an inability to prove that the AERs can clean and disinfect endoscopes sufficiently to prevent infections. The FDA indicates that the company was given a chance to correct the problems and failed to do so.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” Dr. William Maisel, deputy director and chief scientist for the FDA’s Center for Devices and Radiological Health, said in the press release. “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.”

Health care facilities that use the devices have been instructed to transition to alternate methods of cleaning their endoscopes.

Duodenoscope Infections

The safety and effectiveness of medical scope cleaning between patients has been a major concern within the medical community since duodenoscope infection outbreaks reported earlier this year, including an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that was revealed in February by UCLA’s Ronald Reagan Medical Center. The outbreak caused at least seven infections, two deaths, and raised concerns that nearly 200 other patients had been placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections have been linked to problems with the “reprocessing” instructions used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

Last month, the FDA ordered new mandatory studies designed to help the agency analyze the effectiveness of the current cleaning instructions and how they are implemented in real-world hospital settings. The agency indicates that the collected data will help it make decisions that will reduce the risk of duodenoscope infections and outbreaks.

In August, the FDA posted a warning letter to Olympus, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. Two other duodenoscope manufacturers, Pentax and Fujifilm, also received FDA warning letters.

The letters, issued on August 12, suggest that duodenoscope makers knew for years that their devices were linked to infection outbreaks, but failed to warn the FDA or address the problem. The companies are also currently under investigation by the Department of Justice.

In May, an FDA advisory committee determined that the devices “do not provide a reasonable assurance of safety and effectiveness” due to the difficulty cleaning them. The panel said that manual cleaning is still important and needs to continue, but also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.

Despite the concerns, the panel also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the FDA to develop a guide of best practices to make sure that manufacturer instructions are followed, in addition to the need for better instructions overall.

Also in August, the FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures. Olympus Corp. issued expanded cleaning instructions which were approved by the FDA earlier this year.

Several duodenoscope infection lawsuits have already been filed  against Olympus over the infections linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.