|System 83 Plus 2 AER--Courtesy of Custom Ultrasonics|
The biggest loser in the duodenoscope safety scare isn't Olympus, which recently had its updated scope cleared by the FDA. It's duodenoscope reprocessor Custom Ultrasonics.
The FDA has had enough with the Ivyland, PA, company's haggling over the terms of a mandatory recall of all 2,800 of its endoscope cleaning machines, or automated endoscope reprocessors. It just issued another plea to hospitals requesting that they "transition to alternative methods to reprocess flexible endoscopes as soon as possible."
The agency also reposted its Nov. 13 safety alert issued at the time of the mandatory recall to remind stakeholders why the issue is critical to patient safety.
An inspection of the company's facility in April 2015 documented continued violations, including "inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection," the alert says.
At the 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."
But company's response to the recall order was a proposal to fix its reprocessors rather than remove from the market entirely, according to an agency letter to Custom Ultrasonics CEO Alicia Nakonetschny. And the company hasn't submitted a written strategy for doing so, leading the FDA to ask hospitals to carry out a de facto recall.
Last year, the agency was criticized for being slow to act on the issue of duodenoscope safety and contamination. After all, it knew of 142 instances of contaminated duodenoscopes since 2010, and outbreaks linked to poorly cleaned devices have been documented going as far back as 1987.
A well-publicized outbreak of CRE bacterial infections earlier this year that left two patients dead and 7 injured at a hospital in Los Angeles in January 2015 finally led the agency to take action, though it 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 specialized endoscopes are used to visualize and treat the duodenum, or the part of the small intestine closest to the stomach.
- read the notice on the FDA website