FDA Urges Hospitals to Stop Using Custom Ultrasonics Duodenoscope Cleaning Machines

The Food and Drug Administration (FDA) has taken new steps in its efforts to deal with a series of superbug infections linked to the duodenoscope, a device used to examine the intestinal tract to diagnose and treat conditions including gallstones.

Duodenoscopes can be difficult to clean and sterilize between uses and the devices have been linked to at least 250 cases of antibiotic-resistant infections worldwide from 2012 to early 2015. A number of deaths appear linked to the infections, according to the New York Times.

The FDA’s latest action involves Custom Ultrasonics, a Pennsylvania company that makes endoscope cleaning machines. The company has been haggling with the FDA over the terms of a mandatory recall of 2,800 endoscope cleaning machines, or automated endoscope reprocessors, FierceMedicalDevices reports. The agency has just issued a new advisory to hospitals requesting that they “transition to alternative methods to reprocess flexible endoscopes as soon as possible.” The agency also reposted the November 13, 2015 safety alert issued at the time of the mandatory recall to remind hospitals why the issue is critical to patient safety.

An April 2015 inspection of the Custom Ultrasonics facility documented continued violations, including “inability to validate that the AERs [automatic endoscope reprocessors] can adequately wash and disinfect endoscopes,” according to the FDA alert. “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.”

At that time, the company said it “continues to comply with any requests that we receive from the FDA and look forward to a positive resolution to this issue,” FierceMedicalDevices reports. But Custom Ultrasonics responded to the recall order with a proposal to fix the reprocessors rather than remove them from the market entirely, according to the FDA. The company has not submitted a written strategy for the repair, which has led the FDA to ask hospitals to transition to another reprocessing system.

The FDA has been criticized for being slow to act on the issue of duodenoscope safety and contamination. According to FierceMedicalDevices, the agency knew of 142 instances of contaminated duodenoscopes since 2010, and outbreaks linked to poorly cleaned devices have been documented as far back as 1987.

A 2015 outbreak of carbapenem-resistant Enterobacteriaceae (CRE) infections that left two patients dead and seven injured at a Los Angeles hospital led the FDA to act, though the agency continues to stress that the risk of infection is low, and is outweighed by benefits of the devices, which enable a critical procedure called Endoscopic Retrograde Cholangiopancreatography.

The FDA advisory says hospitals should implement a “comprehensive quality control program for reprocessing endoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.”



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